Orthopedics in Texas

Banister Medical is a precision contract manufacturer specializing in surgical instruments and orthopedic implants for world-class medical device companies. Founded over 44 years ago, the company manufactures complex, tight-tolerance components and assemblies from initial product launch through sustaining production for mature product lines. Core product categories include surgical instrumentation (complex surgical instruments for operating room use), orthopedic implants, and spinal implants for bone restoration applications. The company works with materials including steel alloys, cobalt chrome, titanium, PEEK, Radel™, and graphite. Manufacturing capabilities encompass multi-axis CNC turning and milling, electrical discharge machining, 12-axis Swiss turning, 5-axis CNC machining, laser welding and marking, heat treating, anodizing, plating, electropolishing, passivation, and full finishing operations. Quality systems include ISO 13485:2016 registration, ISO 10993 biocompatibility evaluation, ISO 19227 cleanliness standards for orthopedic implants, EU MDR compliance, and endotoxin conformance (≤20 mcg/device for sterile/non-sterile devices per GES09802 Index 4). The company emphasizes design for manufacturability, documented manufacturing and inspection protocols, strict calibration and maintenance schedules, and extensive technical expertise. Banister positions itself as offering 'big company capabilities with small company service' as an independent, reliable manufacturing source.

Scivita Medical Technology Co., Ltd. is a minimally invasive surgical device manufacturer headquartered in Suzhou, China. The company designs and manufactures single-use and reusable endoscopic instruments and systems for gynecology, urology, orthopedics, thoracic surgery, ENT, general surgery, respiratory, and gastroenterology applications. Product portfolio includes single-use video arthroscopes, transforaminal endoscopes, flexible and semi-flexible hysteroscopes, rigid and flexible cystoscopes, and ureteroscopes. The company also produces the Omni Power System for minimally invasive surgical procedures and operates a Dual-scope Platform integrating rigid and flexible endoscopy. Scivita maintains a CNAS-accredited testing center for full-chain endoscope validation and quality assurance. The company serves global markets through international presence and clinical education programs. Manufacturing capabilities encompass design, assembly, quality testing, and sterilization of single-use surgical instruments and integrated endoscopic systems. The company has demonstrated growth through new product launches and international conference presentations, including recent debuts at major urology and surgical conferences.

TYBR Health is a Houston-based medtech company founded in 2020, specializing in regenerative medicine and post-operative recovery solutions for orthopedic surgery. The company addresses a critical clinical gap: while surgical procedures for tendon and ligament repair are often technically successful, post-surgical tissue scarring and adhesions frequently result in long-term functional limitations and mobility restrictions affecting patient outcomes. TYBR Health's flagship product, B3 GEL™, is a naturally derived, flowable bio-gel barrier designed to be applied intraoperatively to coat tendons, ligaments, and surrounding tissues during minimally invasive procedures. The hydrogel creates a protective barrier that mitigates internal scarring and tissue tethering, supporting optimal healing and functional recovery. The solution targets the approximately 120,000 annual tendon procedures performed in the United States, where up to 40% of patients currently face lifelong mobility limitations despite surgical success.

Starr Frame LLC manufactures specialized minimally invasive surgical systems for orthopedic trauma, specifically designed for closed reduction of pelvic ring and acetabular fractures. The company's flagship products—the Starr Frame Orion®, Starr Frame®, and Reinert Reduction Instruments—enable surgeons to apply consistent, controlled reduction forces in a step-wise manner, facilitating precise deformity correction with reduced surgical time and minimized wound complications. These fluoroscopy-compatible systems feature radiolucent carbon fiber components and are engineered for percutaneous application, significantly shortening patient recovery periods compared to traditional open reduction methods. Starr Frame serves orthopedic trauma surgeons and trauma centers globally.

ThermoTek is a leading manufacturer of innovative thermoelectric medical and aesthetic solutions, founded in 1993 with over 30 years of experience. The company specializes in thermal management devices for post-surgical pain management, edema reduction, and deep vein thrombosis (DVT) prevention. Core product lines include the VascuTherm 5 (thermal, compression, and DVT therapy system), ARTEK Pro (thermoelectric device integrating cold, heat, and compression for post-surgical recovery), ARTEK Sport (portable ice therapy system), and Aesthetic Therapy (contact cooling for cosmetic procedures). ThermoTek also partners with Dignitana to offer DigniCap Delta, a thermoelectric scalp-cooling system for chemotherapy patients. The company operates across three sectors: medical (orthopedic surgery recovery, post-operative pain management), aesthetic (patient comfort during cosmetic procedures), and scientific/custom applications (thermal management for laser, semiconductor, and military industries). Products feature ice-less cooling technology with automatic on/off cycles. ThermoTek maintains ISO-certified quality standards and holds multiple active patents. The company distributes through an authorized dealer network across the United States and serves veterans through partnership with Veterans Affairs. Products are designed to comply with regulatory standards and improve patient outcomes while reducing dependence on pain medications.

NeuFit (operating as Neurological Fitness Equipment and Education LLC) manufactures and distributes the Neubie, an FDA-cleared direct current (DC) electrical stimulation device designed for tissue healing, neuromuscular re-education, and neurological rehabilitation. The Neubie is used across orthopedic recovery, neurological conditions (stroke, spinal cord injury, traumatic brain injury), athletic performance enhancement, and pain management. The company provides a comprehensive methodology called the NeuFit Method, which combines device stimulation with targeted movements and manual techniques to identify neurological limitations, reset dysfunctional patterns through neuroplasticity, and facilitate functional breakthroughs. The platform serves physical therapists, occupational therapists, chiropractors, physicians, athletic trainers, and sports teams. NeuFit reports 400+ clinics, 4,000+ certified practitioners, 75+ professional sports teams, and 15+ universities using the Neubie. Clinical outcomes reported include 90% of users experiencing tangible improvements in the first session, with reductions in pain, increased mobility, improved range of motion, and accelerated recovery timelines. The device is FDA-cleared (510(k)) and subject to US regulatory requirements limiting commercial use to licensed practitioners or under licensed practitioner supervision. The company emphasizes education through practitioner certification programs and provides business support materials for clinical practices incorporating the technology.

Lento Medical Innovation is a medical device startup specializing in personalized surgical planning and patient-specific solutions for total knee replacement (TKR) surgery. The company develops cloud-based digital health technology that enables remote collaboration between surgical teams and specialists to design custom surgical guides tailored to individual patient anatomy. Using advanced imaging integration (MRI) and evidence-based methodology, Lento delivers rapid manufacturing and deployment of custom surgical cutting guides to improve surgical precision, alignment, and patient outcomes. Their approach focuses on restoring native joint function through neutral boundary alignment methodology, combining pre-operative digital planning with intraoperative guidance instruments. The PtoleMedic System is CE-marked for European use and represents their flagship solution for orthopedic surgical workflow automation and personalized medicine in joint replacement.

Dr PRP USA LLC manufactures FDA 510(k)-cleared platelet-rich plasma (PRP) preparation systems and kits for clinical, medical spa, and regenerative medicine applications. The Dr. PRP System is a closed, sterile, single-use preparation kit designed for rapid PRP extraction and concentration. The company positions its platform as a safe, easy-to-use alternative to centrifuge-only workflows, emphasizing consistent results, high platelet concentration, and quick turnaround. Regulatory credentials include FDA 510(k) clearance for regenerative use. Dr PRP USA supplies both standalone PRP kits and compatible centrifuges, with compatibility information provided for practitioners who already own centrifuge equipment. The company offers multiple clinical and aesthetic treatment protocols including pain management, soft-tissue regeneration (prolotherapy), osteoporosis, wound healing, sexual health, ophthalmic applications, infertility support, hair restoration, skin rejuvenation, and migraine treatment. Aesthetic protocols combine PRP with complementary modalities such as fat grafting, fractional laser (Fraxel), IPL therapy, and microneedling (MTS). Dr PRP USA provides practitioner training through hands-on certification programs in regenerative techniques, led by clinical experts, and maintains a provider directory to connect patients with trained clinicians. The company targets medical professionals, med spas, treatment facilities, and clinical laboratories seeking FDA-cleared, user-friendly PRP solutions.

Xstim, Inc. manufactures the Xstim Spine Fusion Stimulator, a Class III FDA-approved electrical stimulation device designed to promote bone healing and fusion success following lumbar spinal fusion surgery. The device uses capacitive coupling technology to deliver low-level electrical impulses to the fusion site through hydrogel electrodes placed 4–6 inches apart adjacent to the surgical site. Clinical evidence demonstrates upregulation of bone morphogenetic proteins (BMPs) and multiple growth factors, with reported fusion success rates up to 85% in one- or two-level lumbar fusions. The technology is based on peer-reviewed research showing that specific electrical stimulation signals enhance bone healing phases within 30 minutes of exposure, with optimal effects at 24 hours. The Xstim device is compact, lightweight, and portable, designed for discreet, patient-driven treatment during the post-operative recovery and rehabilitation period. The company targets orthopedic surgeons, spine surgery centers, and patients recovering from lumbar fusion procedures. Regulatory approval includes FDA PMA (Premarket Approval) P230025. The product represents a non-invasive adjunct therapy aimed at improving clinical outcomes and reducing fusion failure rates in spine surgery patients.

INCELL Corporation LLC is a GMP (Good Manufacturing Practice) contract manufacturer and services provider headquartered in San Antonio, Texas. The company specializes in research, development, manufacturing, and cryostorage of cells, tissues, and support products for regenerative medicine applications. INCELL operates as both a manufacturer of proprietary cell culture media, collection and transport solutions, and cryopreservation media, and as a service provider offering cell and tissue culture, banking, and testing services. The company serves research institutions, clinical laboratories, and therapeutic development partners. INCELL manufactures branded product lines including M3™ and M4™ culture media families, EZ-CPZ™ cryopreservation media, collection and transport solutions (ZTM series), processing buffers (ZSol-F™), and RBC lysing buffers (ZAPR™). The company also develops and supplies proprietary cell lines, including monoclonal antibody-producing hybridoma lines and specialized cell lines (NCM460D, NCM356D). In addition to manufacturing, INCELL provides contract manufacturing services for regenerative medicine therapies, microbiology diagnostics and therapeutics, personalized medicine approaches (including patient tumor culture and cryostorage for cancer patients), and clinical trial support through its subsidiary 4RMED LLC. The company's regulatory expertise and manufacturing capabilities align with FDA oversight of human cells and tissues products. INCELL holds GMP certification and operates under standards applicable to cell and tissue manufacturing. The company serves pharmaceutical, biotechnology, academic research, and hospital laboratory markets, with notable focus on regenerative medicine and cell therapy development, including involvement in ALS cell therapy clinical applications.

TeDan Surgical Innovations, Inc. (TSI) is a medical device manufacturer specializing in innovative surgical access systems for spine, neurosurgery, and orthopedic procedures. The company develops and commercializes the Phantom brand of surgical access platforms, including minimally invasive lumbar (MIS), anterior lumbar, anterior cervical, lateral lumbar, and anterior-to-psoas systems for transforaminal, interbody, and lateral fusion approaches. TSI also produces neurosurgical access systems (Phantom TK) for cranial procedures, and manufactures specialized components such as neuromonitoring dilators. The company operates as part of the TSI Group under Halma Group (acquired 2023), which includes West Coast Surgical and Axcess Surgical subsidiaries. TSI provides vertically integrated contract development and manufacturing organization (CDMO+) services to spine OEM partners, offering precision machining, full product development, regulatory strategy, and manufacturing scalability. The company maintains manufacturing capacity in the United States and has expanded internationally, including a German subsidiary (TeDan Surgical Innovations GmbH). TSI focuses on surgeon-centered design, reproducible workflows, and improved intraoperative visualization. Products are engineered for simplicity, versatility, and assembly stability in complex spine and neurosurgical environments. The company engages actively in professional medical conferences (AANS, AO) and maintains partnerships with leading surgeon innovators.

Astura Medical is a surgeon-inspired medical device manufacturer specializing in minimally invasive spinal fixation systems. The company develops modular posterior spinal fusion and fixation solutions designed for orthopedic and spine surgeries. Their flagship product, Masada MIS, is a modular minimally invasive posterior spinal fixation system engineered to support complex spinal procedures with reduced surgical trauma and improved patient outcomes. Astura Medical is headquartered in Irving, Texas, and operates with a quality-driven, surgeon-centric design philosophy. The company serves orthopedic surgeons, spine specialists, and surgical centers with innovative MIS (minimally invasive surgery) technology for spinal stabilization and fusion procedures.

Cryo-Dynamics Inc. is an orthopedic medical device manufacturer specializing in motorized cold therapy systems for post-operative recovery, athletic injury management, and pain relief. The company's flagship product line, ARC™ Systems, represents a patented iceless cold therapy platform that combines deep thermal penetration with dynamic compression to accelerate healing and reduce inflammation. ARC™ Systems are complete therapeutic units comprising an insulated control unit, CryoDrive™ cartridges for thermal delivery, application-specific compression wraps, and power supply. The ARC™ Dynamic Compression Therapy Wraps are uniquely contoured anatomical devices constructed from high-quality stretch fabrics and advanced liquid bladder technology, delivering uniform cooling and compression relief. Founded nearly 20 years ago, Cryo-Dynamics has focused on advancing therapeutic technologies with an emphasis on user-friendly, effective solutions for both clinical practitioners and patients. The company also offers accessories, including an ARC™ carry bag for portability and patient convenience. Products are designed for orthopedic applications including post-surgical recovery, post-injury recuperation, athletic rehabilitation, and chronic pain management. The company operates a direct-to-consumer e-commerce platform and maintains commitment to regulatory compliance and therapeutic efficacy in the orthopedic cold therapy space.

PolarisAR Inc. develops mixed-reality surgical guidance technology for orthopedic procedures. The company's flagship product, STELLAR Knee, is a mixed-reality surgical navigation system designed for Total Knee Arthroplasty (TKA) procedures. STELLAR Knee delivers real-time, targeted surgical guidance directly onto the surgical field, enabling surgeons to simultaneously view patient anatomy and critical data. The system provides robot-like precision without the complexity or cost of conventional robotic surgery platforms. Key differentiators include seamless operating room integration with no requirement for external monitors, cameras, or towers; intuitive hand gesture and voice command control within the mixed reality environment; and compatibility with any implant system, allowing surgeons to select preferred implants while maintaining procedural flexibility. STELLAR Knee is designed to democratize access to advanced surgical technology by minimizing infrastructure costs and supporting diverse surgical workflows. The system functions as a digital surgical assistant, enhancing surgeon proficiency, workflow efficiency, and situational awareness during knee arthroplasty. PolarisAR targets orthopedic surgeons and surgical centers seeking precision guidance technology that balances advanced capability with cost-effectiveness and operational simplicity.

Bimini Health Tech is a medical device company specializing in reconstructive, aesthetic, and orthopedic solutions, with operations in 50+ countries serving 1.5M+ procedures annually. The company develops advanced technologies focused on women's health, particularly breast reconstruction and fat transfer procedures. Core product portfolio includes: PureGraft®, a proprietary adipose filtration system for harvesting and transferring fat grafts in reconstructive and aesthetic surgery; Essence ADM™, a sterile, ready-to-use acellular dermal matrix available in multiple sizes for plastic and reconstructive procedures; Serene™ Structured Saline Breast Implant, designed to provide silicone-like natural appearance and feel; Dermapose®, an office-based system for standardizing micro fat harvesting, purification, and injection as an alternative to synthetic dermal fillers; and Boost Micronizers for adipose tissue processing. Applications span reconstructive and aesthetic surgery, minimally invasive procedures, and orthopedic/sports medicine utilizing autologous adipose tissue and blood products. The company partners with leading physicians and maintains partnerships with major distributors including Arthrex, Genesis Biologics, GC Aesthetics, Bausch Health, and Crown Aesthetics. Bimini emphasizes scientific rigor, reproducibility, and clinical efficacy in product design and clinical applications.

PelvicBinder, Inc. manufactures specialized compression and support devices for trauma, post-surgical, and orthopedic patient populations. The company's flagship product, the PelvicBinder®, is a rapid-deployment pelvic compression device designed for reduction and stabilization of pelvic ring disruptions in trauma settings, particularly valuable in pre-hospital and emergency department environments. The pediatric variant, Pediatric PelvicBinder®, offers comparable functionality at reduced dimensions for younger patients. The product portfolio extends to the ZipperBelt® for sternotomy support and post-sternal surgical recovery, the RibFXBelt™ for rib fracture stabilization, and the BellyBinder™ for spinal cord injury and abdominal surgery patients. All products are manufactured in the USA. Distribution occurs through direct order channels (phone, fax, email). The company serves emergency medical services, trauma centers, surgical hospitals, and rehabilitation facilities. While specific FDA clearance status is not explicitly stated on the website, the clinical applications and regulatory environment suggest 510(k) or general medical device oversight. Products are available exclusively through PelvicBinder, Inc., emphasizing authentic product authenticity and quality control.

INRO Medical Designs manufactures specialized surgical nail splints for reconstructive surgery of the nail bed following traumatic nail avulsions. The INRO Surgical Nail Splint is a medical device designed to guide the injured nail to regrow to its original shape, size, and contour after trauma. The device provides improved patient comfort and protection during the healing phase, addressing a common healthcare injury where physicians previously had to fabricate makeshift solutions with unreliable outcomes. INRO's standardized splint offerings come in multiple sizes (regular, wide, small) to accommodate various patient anatomies and nail dimensions.

ERGO-FLEX Technologies is a Texas-based manufacturer of hands-free, automated therapy systems designed for chiropractic, physical therapy, and integrative health clinics. Since 2011, the company has developed non-surgical, drug-free pain relief and rehabilitation technologies. Core products include Back On Trac (FDA-cleared spinal decompression system with axial distraction and lateral flexion), Cervi-Trac (automated cervical traction), Knee On Trac (standalone knee traction device), Mito2 (3-in-1 responsive oxygen therapy system combining IHHT, EWOT, and recovery modes), and SomaCharge (clinical-grade PEMF therapy system). All equipment is manufactured and assembled in Conroe, Texas, featuring compact footprints, fully automated protocols, and minimal staff requirements. These solutions target chronic pain management, joint decompression, cellular energy optimization, and performance recovery across diverse wellness settings including med spas, gyms, and day spas.

MedCAD is a Dallas-based medical technology company founded in 2007, specializing in patient-matched surgical devices and virtual surgical planning solutions. The company leverages advanced 3D imaging, CAD software, and precision manufacturing to design customized implants, surgical guides, and anatomical models for complex reconstructive and corrective procedures. Core offerings include the AccuPlan® Surgical Planning System for virtual surgical design, AccuPlate® 3D-printed titanium reconstruction plates, AccuShape® cranial implants in PEEK or titanium, AccuModel® anatomical models for surgical visualization, and AccuStride® foot and ankle surgical solutions. MedCAD serves cranial, maxillofacial, orthognathic, oral, plastic, and orthopedic surgery specialties. The company manufactures in-house in Texas with FDA clearance for its surgical products. MedCAD's approach combines engineer and design expertise—including trained sculptors and product designers—to create precision instruments and implants tuned to individual patient anatomy, enabling surgeons to plan procedures virtually, reduce operative time, and improve clinical outcomes.

Transcend Biologics develops and distributes platelet-rich plasma (PRP) preparation systems for medical and veterinary professionals. Founded by leaders with 30+ years of experience in medical devices and regenerative medicine, the company specializes in sterile, closed-system PRP collection and processing solutions designed for point-of-care use. Their Tropocells® PRP system offers simple single-spin technology with multiple kit options (40 mL, 22 mL, 11 mL) optimized for platelet yield, platelet concentration, and red blood cell reduction. The systems are used across orthopedics, sports medicine, pain management, regenerative medicine, and veterinary practices. Transcend emphasizes clinical education, workflow integration, and ongoing training support to enable practitioners to implement autologous biologic preparation reliably and reproducibly.

McConnell Orthopedic Manufacturing Company designs and manufactures the McConnell System, a specialized surgical positioning and support platform for orthopedic procedures. The system addresses the critical need for safe, sterile, stable positioning and support of joints and extremities during major orthopedic operations. The device enables full ranges of motion and subtle position adjustments under sterile conditions by the surgeon or surgical assistant, reducing fatigue-related positioning errors during complex orthopedic cases. Products include the ASIP System #120, McConnell Accessories, and sterile disposable items. The company markets exclusively to hospitals, medical centers, and surgery centers. Customer service and sales support are provided through direct phone and email channels, with all orders processed via fax or email.

OrthoPress manufactures the FingerPress, a patented mechanical hand therapy device designed to treat PIP flexion contractures and other finger joint deformities without surgery. The FingerPress uses an innovative sliding-wedge ratcheting mechanism to gradually extend bent fingers, indicated for contractures up to 80 degrees. The device features adjustable force application via a simple squeeze-and-hold mechanism, four soft cushioning pads for extended daily wear, and a single-measurement fitting system. Founded by a patient who successfully self-treated his own finger contracture, OrthoPress provides an affordable, clinically-validated alternative to surgical intervention. The device is used by hand therapists and orthopedic surgeons for post-operative care (Dupuytren's fasciectomy), boutonnière deformity, PIP joint sprains, and finger fractures.

Medical Metrics, Inc. (MMI) is an independent, full-service imaging core laboratory and clinical consulting firm specializing in centralized image analysis, endpoint strategy design, and regulatory support for clinical trials and medical device development. Founded 21+ years ago, MMI serves over 260 clients and partners globally, having supported 695+ clinical trials and contributed to more than 50 FDA regulatory approvals and clearances. The company operates a science-first approach with a multidisciplinary team of biomedical engineers, medical imaging specialists, and physician reviewers who design customized imaging methodologies and protocols for device sponsors, biopharmaceutical companies, and contract research organizations. Core services include imaging endpoint strategy and scientific consulting, image review charter development, clinical site management and training, image quality and compliance monitoring, expert centralized image analysis (via independent physician readers), data interpretation, publication strategy, and post-market surveillance. MMI maintains expertise across multiple therapeutic areas including spine (fusion, motion preservation, deformity correction), orthopedics (joint arthroplasty, biologics, cartilage repair), cardiovascular (peripheral vascular disease, atherectomy, stents), neurology (stroke, aneurysm, tumor), ENT, gastrointestinal and urology, oncology, and artificial intelligence research. The firm is ISO 13485 certified and operates with emphasis on accuracy, reliability, independence, and integrity in imaging outcomes assessment.

Wenzel Spine, Inc. is a medical technology company founded in 2008 and headquartered in Austin, Texas, specializing in minimally invasive surgical solutions and diagnostic platforms for spinal disorders. The company is a recognized leader in stand-alone spine fusion technologies with over 17 years of expertise in expandable implant design and manufacturing. Wenzel Spine develops a comprehensive portfolio of devices designed to simplify spine surgery, reduce recovery time, and improve patient outcomes while preserving spinal anatomy and minimizing hardware burden. The company's mission emphasizes a "less is more" approach, often eliminating the need for supplemental fixation. With 21,000+ devices implanted, 11,000+ patients treated, and 300+ surgeon partners across North America and the European Union, Wenzel Spine maintains a strong commitment to ethical practices and regulatory compliance. The company serves orthopedic surgeons and spine specialists treating sacroiliac, lumbar, and cervical fusion patients through both innovative surgical systems and diagnostic software.