Surgical Instruments in Indiana

BoxSPINE is a medical device company specializing in ready-to-use, pre-sterilized spinal implants and surgical instruments designed for ambulatory surgery centers (ASCs) and spine care providers. The company develops proprietary, single-use disposable surgical kits targeting the posterior lumbar spine market. BoxSPINE's product strategy emphasizes infection reduction, improved operative room efficiency, and cost containment through simplified inventory management. The company partners with leading technology providers to deliver advanced surgical solutions; notably, BoxSPINE has entered a strategic distribution agreement with PathKeeper Surgical to bring PathKeeper's radiation-free, sub-millimetric spinal navigation systems to key US ASC locations under the 'BoxSPINE 100' initiative. The company is led by experienced medical device executives with a combined track record in surgical device manufacturing, sales, and business development. BoxSPINE's target market includes ASCs seeking to reduce primary and secondary costs while maintaining high patient safety standards and minimizing infection and revision rates associated with current spinal implant systems.

Precision Medical Industries is a full-service, vertically integrated molded medical device manufacturing partner based in Northeast Indiana. The company specializes in custom-molded silicone handles and components for orthopedic surgical instruments and medical devices. Their end-to-end capabilities span design, prototyping, manufacturing, and post-launch support—all performed in a single facility to reduce lead times, improve pricing flexibility, and lower costs for device manufacturers. PMI manufactures custom molded handles designed to exact product specifications, providing enhanced control and performance for orthopedic applications. The company emphasizes rapid turnaround (custom orders in as little as 12 weeks versus 24–40 week industry standard) and scalable production capacity. All manufacturing exceeds ISO 13485:2016 quality standards. PMI serves as a contract manufacturer and strategic partner for medical device OEMs seeking accelerated go-to-market timelines, design consultation, and flexible volume production.

Complexus Medical is a contract manufacturer specializing in orthopedic and spine surgical instruments and implants. Founded in 1968 as a tool and die shop, the company has evolved into a precision manufacturer serving the medical device sector. Primary products include complex orthopedic instruments, surgical hand tools, metallic and non-metallic implantable components for knee replacement, and single-piece surgical instruments. The company operates from Mishawaka, Indiana, and offers in-house capabilities spanning design, precision machining, assembly, and finishing. Complexus is committed to regulatory compliance and adherence to international standards for medical device manufacturing. The company serves OEM medical device manufacturers seeking to outsource component and assembly production to reduce costs and accelerate time to market. Core competencies include precision metalworking, implant fabrication, and complex surgical instrument assembly. Regulatory compliance and quality control are central to operations, with programs designed to meet statutory requirements and international standards for orthopedic and spine devices.

Paragon Medical is a medical device manufacturing and component supplier specializing in end-to-end product development and precision manufacturing for medical OEMs. The company designs and manufactures precision components, surgical instrumentation, orthopedic implants, drug delivery systems, and single-use disposable devices across multiple surgical specialties including orthopaedics, cardiovascular, surgical robotics, dental, endoscopy, laparoscopy, and gastroenterology. Paragon operates FDA-registered manufacturing facilities with ISO 8 Class 100,000 certified cleanrooms for medical-grade packaging and labeling. The company provides comprehensive services spanning concept development, design control, regulatory affairs and FDA submissions, verification and validation testing, manufacturing scale-up, and commercialization support. Manufacturing capabilities include precision machining, additive manufacturing, and assembly of components from surgical materials, specialty alloys, and plastics in volumes ranging from prototype quantities to multi-million unit production runs. Paragon serves medical device manufacturers requiring contract manufacturing, OEM partnerships, and integrated new product development support. The company emphasizes vertical supply chain integration and functions as an extension of client in-house development teams.

Micropulse, Inc. is an orthopedic manufacturing and supply company founded in 1988 and headquartered in Columbia City, Indiana. Since 2003, the company has focused exclusively on the orthopedic market, serving major, mid-tier, small, and start-up orthopedic device and implant companies. Micropulse manufactures precision orthopedic instruments, orthopedic implants, custom surgical cases and trays, and provides sterile packaging services. The company operates under a Quality Management System compliant with ISO 13485:2016 and 21 CFR Part 820, positioning it as a regulated medical device manufacturer. Core capabilities include CNC machining, assembly, sterilization, and custom packaging for complete product solutions delivered under single purchase orders. Micropulse differentiates through vertical integration—machining, assembly, sterilization, and packaging under one roof—enabling customers to source implants and instruments from a single supplier with streamlined supply chain management. The company emphasizes quality, regulatory compliance, continuous improvement, integrity, and responsive customer service. Micropulse serves as a contract manufacturer and supplier for orthopedic OEMs and device companies navigating evolving regulatory requirements, price compression, and market consolidation. The company is led by CEO and Founder Brian Emerick.

ContainMed is a contract manufacturer of precision medical devices and instruments based in Indianapolis, Indiana. The company specializes in precision-machined implants and surgical instruments, custom graphic cases, and modular tray systems for surgical and orthopedic applications. Their product portfolio includes Graphic Cases for instrument organization and transport, Screw & Implant Caddies for secure storage and delivery of orthopedic hardware, and VersaPod, a proprietary modular tray system with FDA 510(k) clearance designed for flexible surgical instrument and implant delivery across various medical device platforms. ContainMed operates as a full-service contract manufacturer, offering capabilities from design and precision machining to custom packaging solutions. The company serves medical device manufacturers and surgical specialties of all sizes, providing both private-label manufacturing services and branded product lines. Their modular tray system is marketed as a robust, market-leading solution for diverse delivery and containment requirements in orthopedic and general surgical settings.

Nanovis is a medical technology company specializing in nanotechnology-based surface technologies for orthopedic, spinal, and dental implants. Founded in 2006 and headquartered in Columbia City, Indiana, the company develops innovative nano-structured surfaces designed to enhance bone integration, reduce infections, and improve patient outcomes. The company's core technology, nanoVIS Ti™ Surface Technology, features controlled nanotube arrays that promote superior mineralization and osseointegration. Key product lines include Nano FortiFix® Pedicle Screws and Nano FortiCore® Interbodies for spinal fusion procedures. Nanovis has achieved significant regulatory milestones, including FDA clearance for the industry's first nanotechnology-designated pedicle screws and PEEK interbodies with porous titanium endplates. The company maintains strategic partnerships with major OEM partners, including an exclusive interbody technology agreement with Medtronic established in 2024. With a robust intellectual property portfolio and clinical validation through NIH-funded research, Nanovis is advancing the field of implant integration technology.

Qualitex NE LLC is a precision contract manufacturing specialist serving the medical device, automotive, appliance, and agricultural sectors. The company operates two primary business units: Qualitex Medical and Qualitex Gage. Qualitex Medical is an ISO 9001, ISO 13485, and FDA-registered medical device manufacturer offering rapid prototyping, production machining, and full assembly capabilities for orthopedic implants, surgical instruments, and custom medical components. The company has manufactured over 35,000 external fixation rings for foot and ankle surgeries and 6,800+ surgical instruments for OEM partners ranging from Fortune 500 companies to startups. Qualitex Gage provides custom-designed gage and check fixtures for dimensional verification and quality control across industries. The company maintains an ISO 17025-accredited metrology laboratory equipped with multiple CMMs and optical comparators, supporting inspection processes and dimensional analysis. Core capabilities include CNC machining, wire EDM, CMM programming, production machining, and SPC systems implementation. Quality certifications include ISO 9001 and ISO 13485 for medical manufacturing, with demonstrated expertise in geometric dimensioning and tolerancing, dimensional layout services, and automated gage systems with PLC integration.

Instrumental Machine & Development (IMD) is a quality-focused manufacturer of orthopedic and medical instrumentation based in Warsaw, Indiana. The company specializes in the design, manufacturing, and assembly of orthopedic surgical instruments, sterilization trays, and operating room accessories. IMD serves the orthopedic surgical community with comprehensive capabilities spanning single machining operations to full-scale manufacturing and assembly services. The company maintains ISO 13485:2016 certification for medical device quality management systems and is ANAB-accredited, demonstrating commitment to regulatory compliance and manufacturing excellence. IMD offers robotics integration, equipment services, and custom product development to support orthopedic facilities and instrument manufacturers. The company emphasizes on-time delivery, quality assurance, and customized solutions tailored to customer specifications. IMD's manufacturing and assembly capabilities support both OEM partnerships and direct hospital/surgical center procurement.

Nuell, Inc. is an orthopedic surgical equipment repair and refurbishment specialist serving the healthcare industry since 1968. Based in Warsaw, Indiana, the company provides comprehensive repair services for powered orthopedic surgical instruments, including specialty equipment repairs. In addition to repairs, Nuell offers new and refurbished powered equipment sales to help hospitals and surgical centers maintain and upgrade their orthopedic surgical instrument inventory. The company emphasizes quality and reliability in repair work, positioning itself as a specialized service provider for medical facilities requiring dependable orthopedic equipment maintenance and sourcing.

Revelation Medical Devices (RMD) is an ISO 13485:2016 certified contract manufacturer specializing in precision medical device design, prototyping, and production for the orthopedic and spinal markets. With over 45 years of manufacturing heritage (formerly Stamets Tool & Engineering), RMD operates a 14,000 sq ft facility in Auburn, Indiana—strategically located 45 minutes from Warsaw, the orthopedic capital. The company serves medical device OEMs, startups, and established innovators with full-cycle capabilities including 3/4/5-axis CNC milling, live-tool turning, laser/TIG welding, laser etching, passivation, polishing, poly manufacturing, and non-sterile packaging/labeling. FDA-registered (No. 1836116) and committed to quality, on-time delivery, and partnership-driven development.

Trifecta Medical, LLC is a world-class designer-manufacturer of custom, private-labeled orthopaedic and surgical case-tray systems. The company specializes in designing and manufacturing instrument-implant shipping, storage, and surgical facilitation systems that integrate protection, organization, cleaning, sterilization, and marketing capabilities. With over 100 years of combined industry experience, Trifecta's design team collaborates with orthopedic device manufacturers and surgical instrument suppliers to create robust, functional, and aesthetically refined case-tray solutions. The company is committed to rapid turnaround, quality manufacturing, competitive pricing, and responsiveness to customer specifications and timelines.

SpiTrex Orthopedics is a contract manufacturing partner specializing in orthopedic implants and surgical instruments. Operating as a fully integrated global manufacturing platform with facilities in Plymouth, IN (SpiTrex CTE); Lancaster, PA (SpiTrex MDI); Carlsbad, CA (SpiTrex 3D); and Le Locle, Switzerland (SpiTrex SWI), the company offers end-to-end manufacturing solutions from prototype development through validated production and finishing. Core capabilities encompass both additive manufacturing (3D printing) and subtractive manufacturing technologies tailored to high-performance implant and instrument production. All facilities are ISO 13485–certified and FDA-registered, meeting regulatory requirements for medical device manufacturing. The company provides design support, process validation, quality assurance, and scalable manufacturing aligned with medical device commercialization timelines. SpiTrex Orthopedics serves orthopedic device manufacturers requiring precision contract manufacturing with demonstrated compliance and manufacturing agility.

Genysys 22 is a vertically integrated orthopedic instrument and implant manufacturer specializing in contract manufacturing and rapid prototyping. The company serves the orthopedic device sector (spine, extremity, trauma, large joint) with in-house capabilities spanning turning, milling, Swiss turning, bending, welding, wire EDM, polishing, laser marking, and final assembly. ISO 13485:2016 certified, Genysys 22 combines old-school craftsmanship with modern machining to deliver prototypes within days and scaled production runs with rigorous quality control. The company emphasizes fast turnaround, reduced delivery time, and customer-centric service, functioning as an extension of client engineering and manufacturing operations.