Orthopedic Implants in North Carolina

Structure Medical, LLC is a contract manufacturer of spine, trauma, and arthroscopic medical implants, instruments, and cutting tools serving top-tier OEMs since 2004. The company operates three manufacturing facilities in North Carolina, Florida, and Alabama, encompassing 105,000 square feet with 175 CNC machines and over 300 employees. Core product lines include precision-machined implants for spine and trauma applications, surgical instruments for musculoskeletal procedures, and cutting tools such as reamers and drill bits. Structure Medical specializes in complex, high-precision manufacturing using full 5-axis CNC protocols with spindle speeds up to 43,000 rpm and laser tool management systems. The company offers production-level prototyping services, utilizing the same equipment for prototype and production phases to ensure consistency and reduce time-to-market. Key capabilities include cost-effective manufacturing to tight tolerances, vendor-managed inventory (VMI) programs, and rapid prototyping for new product development. All facilities are ISO 13485 certified and FDA 21 CFR Part 820 compliant, meeting regulatory requirements for Class II and III medical devices.

Ditron Dental USA LLC is a dental implant and prosthetic component manufacturer with over 50 years of clinical experience. The company designs and manufactures in-house a comprehensive 3rd-generation dental implant system featuring the Molecular Precision MPI, Ultimate Precision ULT, and Tissue Level 1 implant lines, engineered to single-micron accuracy with zero-defect production standards. Product portfolio includes dental implants in multiple diameters and lengths, prosthetic abutments with MolecuLock implant-abutment connection technology (microgap <0.5 microns to prevent peri-implant disease), surgical kits with standard and stopper drill options, and single insertion drivers for both implant and abutment placement. The Tissue Level Precision Implant (TL1) features a pink-anodized concave neck platform switch designed for superior aesthetic integration and optimal biologic space. Ditron offers both conventional and digital workflow solutions, from single-tooth to All-on-X and overdenture treatment. The company provides comprehensive surgical kits with color-coded drill systems, prosthetic components, and a lifetime warranty on all implants and abutments when used per Instructions for Use. Additionally, Ditron operates an education division offering live surgery courses ranging from 1-day surgical training to 3-day live patient courses. The company supports multiple dental implant brands including Augma, Anatotemp, Citagenix, Saeshin, Shining 3D, and Infinix. Primary markets include dental practices and implant centers requiring precision implant systems with advanced micro-level engagement and biologic compatibility.

Diamond Orthopedic manufactures innovative orthopedic fixation devices, primarily faceted bone screws engineered for fracture fixation and small joint fusions. The company's proprietary faceted threadform technology reduces insertional torque by approximately 50% compared to traditional helical screws, while improving bone-device contact and achieving up to 61% greater pullout strength in early healing phases. Products are designed for hand surgery, fracture fixation, and orthopedic fusion applications. The company markets directly to surgeons and operates a distributor network throughout the United States, while also providing OEM solutions to other medical device manufacturers. Clinical validation includes testing conducted at OrthoKinetic Testing Technologies in both biological (ovine) and non-biological substrates. Diamond Orthopedic positions itself as a fixation specialist delivering consistency and biomechanical advantage in orthopedic procedures, with testimonials from hand surgeons highlighting reduced insertion torque and improved fixation characteristics, particularly for patients with compromised bone quality.

Anton Hipp GmbH is a German medical technology manufacturer founded in 1970, headquartered in Germany with products distributed across more than 50 countries. The company specializes in precision surgical instruments, orthopedic implants, and patient-specific implants manufactured using additive manufacturing (PSI) technology. Core product lines include the ARCOS® Titanium Mini Osteosynthesis System for bone fixation, TMJ and temporomandibular joint systems, IMF systems, neurosurgical instruments, and specialized retractor systems (MCC/CCR). Additionally, the company produces surgical scissors, general surgical instruments, esthetic surgery instruments, ENT (otorhinolaryngology) tools, and dental/sinus lift instruments. A particular focus is patient-specific implants created through additive manufacturing, enabling customized solutions with high precision and optimal fit for individual patient anatomy. All products are manufactured in Germany using advanced technologies and efficient manufacturing processes. The company emphasizes high quality, precision, and excellent customer service, positioning itself as a strong partner for hospitals, surgical centers, and dental facilities globally. Anton Hipp maintains a global network of experts and demonstrates consistent customer proximity. The company participates in major international medical device trade shows including Medica, Arab Health, and regional surgical/dental symposia.

PROTECT3D manufactures custom 3D-printed orthotic braces and protective devices designed for rapid, patient-specific fabrication via iPhone-based 3D scanning. The company specializes in anatomically precise, lightweight bracing solutions delivered in 2–3 days, marketed primarily to athletes, clinical providers, military/tactical teams, and individual patients. Core product lines include Ankle Foot Orthoses (AFOs) for foot drop and ankle arthritis, custom protective facemasks for facial/orbital fracture recovery in sports settings, hand and wrist splints and casts with waterproof/breathable properties, and CMC joint braces. PROTECT3D operates an FDA-certified manufacturing facility using advanced polymers and proprietary digital fabrication processes. The company reports 95%+ fit accuracy and serves 100+ NCAA, NFL, and professional sports teams across NBA, WNBA, and MLS. Clinical applications extend to military personnel and general patient populations. While specific FDA 510(k) or CE marking details are not explicitly stated on the site, the company references FDA certification of its manufacturing facility. Turnaround times—60 seconds to scan, 90 minutes to design-ready, 48 hours to delivery in select cases—position the offering as a speed-to-market differentiator in orthotic customization. Founded by former college athletes, the company emphasizes biomechanics-informed design and clinical validation through endorsements from orthopedic surgeons, athletic trainers, and high-profile sports medicine programs (Duke, Christopher Newport, Purdue).

Trio Labs is a medical technology manufacturing company specializing in ultra-precise micro metal parts using proprietary Resin Infused Powder Lithography (RIPL) technology. The company manufactures custom and production-scale microscale components for MedTech applications, including precision surgical instruments, miniaturized infusion pumps, microneedle arrays, and orthopedic implants. RIPL combines additive manufacturing design flexibility with CNC-level tolerances (as tight as 0.0005"), eliminating traditional constraints of injection molding and CNC machining. Trio Labs supports medical device manufacturers from prototyping through full production runs, with expert guidance in biocompatible materials and micro-scale complex geometries. Founded in 2015 and based in Morrisville, North Carolina, the company serves the advanced MedTech sector with rapid turnaround and design-to-specification capabilities.

Retrofix Screws, LLC manufactures orthopedic implants specialized in distal fibula fracture fixation. The company produces the RetroFix Screw, a single-use cannulated taper screw designed with patented features for optimal patient outcomes in ankle fracture repair. The screw incorporates titanium construction for biocompatibility and strength, with design elements including cannulation for ease of insertion, a fluted recessed head to reduce post-operative discomfort, partial threading for compression at the fracture site, and internal reversed threads for aided removal via extractor. The taper design provides greater medial-lateral fill of the distal fibula and can create compression when contacting the intramedullary canal isthmus. The company serves orthopedic surgeons and healthcare providers across the United States with a focus on patient-first quality and streamlined surgical procedures. Instructions for use and surgical technique documents are available for clinical reference.

Exotoe LLC manufactures ExoToe™, a next-generation extramedullary hammertoe fixation device designed to address limitations of traditional K-wire fusion and intramedullary fixation approaches. The ExoToe™ implant is a precision surgical device measuring just 0.6mm in thickness that preserves the medullary bone canal, eliminating the need for intramedullary canal insertion. It features interoperative anatomic angle adjustability, allowing surgeons to achieve straight or customized angle correction during the procedure. The device is available in three sizes (5.5, 6.5, and 7.5mm) and is crafted from premium 316 stainless steel. Key competitive advantages include rotational stability at the proximal interphalangeal joint fusion site, compatibility with supplemental K-wire fixation across the metatarsophalangeal joint, ease of implantation using standard crimping forceps, and reversibility through Mini-Hohmann retractor removal if needed. ExoToe™ is indicated for primary hammertoe correction and revision cases. The company is also developing ExoClip™, a complementary implant solution. Exotoe LLC partners with Surgical Design Innovations, which brings extensive medical device development expertise including product design, mechanical and cadaveric testing, and early clinical evaluation. The device is supported by a detailed surgical technique guide and has received positive feedback from podiatric surgeons regarding ease of use and fusion site stability.

Restor3d is a medical device manufacturer specializing in patient-specific 3D-printed orthopedic implants for musculoskeletal reconstruction. The company combines advanced 3D printing technology with AI-driven design automation and digital health solutions to deliver personalized implants tailored to individual patient anatomy. Primary product lines include foot and ankle solutions (total ankle replacement), knee replacement systems, and hip reconstruction devices. All implants are designed using osseointegrative biomaterials and supported by scientific research and pre-surgical planning tools. Restor3d operates a data-first approach to enhance implant architecture and enable surgeons to optimize surgical outcomes through precise anatomical fit and personalized instrumentation. The company serves orthopedic surgeons and healthcare institutions seeking advanced solutions for total joint arthroplasty and reconstruction. Regulatory status and specific certifications are not detailed on the available website content.

Smart On X (formerly Smart Denture Conversions, established 2019) is a dental medical device and solution provider specializing in full-arch implant prosthetics and denture conversion techniques. Founded by Dr. Brandon Kofford, DMD, MS, FACP, a Board-Certified Prosthodontist, the company develops innovative products and protocols that streamline the conversion of conventional dentures to implant-supported prosthetics. The Smart Denture Conversion technique significantly reduces chairtime for practitioners while delivering superior aesthetics and reduced patient wait times for provisional dentures. Smart On X manufactures a portfolio of dental prosthetic components, including the Omnibut multi-unit abutment system, Rapid Arches, Rapid Set Pickup Acrylic, and related digital dentistry tools. The company offers comprehensive practitioner training through on-demand educational content, virtual and in-person training programs, and industry events. Based in Apex, North Carolina, Smart On X serves dental implant practitioners and laboratories seeking efficiency gains and improved clinical outcomes in full-arch fixed restorations.

Tobra Medical is a specialty medical device company founded in 2015, headquartered in Wake Forest, North Carolina. The company designs and manufactures innovative single-use disposable devices for autograft bone and specimen collection during surgical procedures. Their product portfolio includes the Tobra Bone Basket for simplified collection of autologous bone particles during drilling, the Tobra Specimen Basket for sterile specimen handling, and FeatherFlow tubing for enhanced bone and specimen management. Tobra Medical focuses on user-friendly, economical solutions developed in collaboration with surgeons, medical engineers, and OR personnel to improve clinical efficiency and patient outcomes across orthopedic, neurosurgical, ENT, and oral-maxillofacial surgical specialties.

Cutting Edge Spine (CES) is a privately held orthopedic medical device manufacturer founded in 2009, headquartered in Waxhaw, North Carolina. The company specializes in developing and commercializing innovative spinal implant systems featuring proprietary bioactive materials and trabecular fixation technologies. CES holds three FDA-cleared product lines and an extensive patent portfolio for trabecular fixation across orthopedic applications. The company is recognized as the first to market in the U.S. with several bioactive spinal technologies, including hydroxyapatite (HA)-enhanced PEEK interbody systems designed to optimize osseointegration and early bone apposition. Core product offerings include lumbar interbody systems (EVOS-ha, EVOL-ha-C), lateral interbody fusion systems (EVOL-ha-DLIF), sacroiliac joint fusion systems (EVOL-SI), and specialized trabecular fixation screws. CES emphasizes clinical efficacy, quality assurance, and continuous R&D investment to deliver cost-effective solutions that improve patient outcomes while addressing healthcare provider economic concerns.

Orthopedic Appliance Company, Inc. is a custom orthotics and prosthetics provider established in 1960, serving Western North Carolina, Upstate South Carolina, Eastern Tennessee, North Georgia, and Bryant, Arkansas. The company specializes in fabrication and fitting of custom-made orthopedic bracing, artificial limbs (prosthetics), and related devices. Product lines include custom orthotics for lower and upper extremities, prosthetic limbs, functional electrical stimulation (FES) devices, foot care products, and mastectomy products. The company operates multiple clinical locations offering in-person consultations, measurements, and fittings. Services are provided Monday–Friday at primary locations, with appointment-based clinics at satellite locations. The company emphasizes custom fabrication using latest innovations in orthotics and prosthetics technology, though specific FDA clearances, ISO certifications, or regulatory details are not disclosed on the website. Target market is individual patients requiring custom orthotic/prosthetic care rather than institutional hospital procurement.

Spinal Alignment Solutions manufactures PI-Rods, patient-specific pre-contoured spinal fusion rods designed to achieve optimal segmental lordosis alignment during lumbar spine surgery. The product line includes six curved rod configurations (lumbar L1-S1 and short segment rods) that are selected based on a single pelvic incidence measurement from lateral radiographs. The rod profiles are derived from normative data from asymptomatic subjects and patients with successful fusion outcomes, with segmental lordosis targets stratified by pelvic incidence per vertebral level. The company's approach moves beyond generic one-size-fits-all rods by enabling surgeons to match patient anatomy more precisely. The planning process involves measuring pelvic incidence on a true lateral radiograph, marking femoral head centers and S1 endplate landmarks, and selecting the appropriate PI-Rod configuration. The rods arrive OR-ready with dorsal laser marks designating target landing zones for pedicle screw placement. The technology is supported by peer-reviewed spine surgery literature (Diebo et al., JBJS 2024) demonstrating improved outcomes in degenerative fusion cases with excellent patient-reported outcomes and no adjacent-segment complications in the study cohorts. Intended for orthopedic spine surgeons performing lumbar fusion procedures.