Extremity orthopedic implants are used to treat conditions and injuries of the hands, wrists, feet, ankles, and shoulders. The market for these implants is growing quickly, driven by aging populations, rising sports injuries, and more demand for mobility-preserving procedures.

Orthopedic device manufacturers are responding with innovations in materials, additive manufacturing, and patient-specific design to improve implant performance and surgical outcomes. Technologies like 3D printing, advanced titanium alloys, and porous structures are creating implants that more accurately mimic bone and promote faster healing.

“Strong demographic tailwinds are shaping the extremity orthopedic device industry, including an aging yet increasingly active population and rising deformity prevalence, particularly in foot and ankle,” said Albert DaCosta, global president of Foot & Ankle at global orthopedic device company Zimmer Biomet. “At the same time, growing sub-specialization among surgeons fuels demand for anatomically specific, procedure-focused implant systems.”

Companies manufacturing extremity orthopedic devices must also navigate complex regulatory requirements, maintain strict quality controls, and manage cost pressures while speeding product development cycles. Surgeons also increasingly expect implants tailored to specific anatomies and procedure, spurring manufacturers toward more flexible, data-driven production strategies.

“Migration to the ambulatory surgery center setting and ongoing reimbursement pressure increase the importance of efficiency, cost-effectiveness, and streamlined instrumentation,” said DaCosta. “Together, these forces accelerate innovation and simultaneously push the market toward greater economic discipline and value-based differentiation.”

The ongoing shift in the site of care from hospitals to ambulatory surgery centers (ASCs) is also impacting how technologies are designed and delivered. As more orthopedic cases move to outpatient settings, device companies are prioritizing streamlined instrumentation, portable imaging, and implants designed for minimally invasive techniques.

“We have been focused on this shift for years by developing ASC-friendly instrumentation, streamlined surgical workflows, and procedure-based solutions that improve efficiency in these settings,” said Gary Justak, global president and general manager of Enovis Foot & Ankle. “Recent innovations, such as our sterile, procedure-specific instrument kits—including the Arsenal Joint Prep Instrument Kit and Bone Harvesting Kit—help simplify setup, reduce complexity, and support the growing demand for procedures performed in ASC environments.”

In January 2025, Zimmer Biomet began a deal to acquire Paragon 28 to expand its extremity orthopedic device portfolio. The Englewood, Colo.-based company was established in 2010 and boasts a suite of surgical offerings and product systems spanning all major foot and ankle segments. These include fracture and trauma, deformity correction, and joint replacement.

The company’s SMART28 anatomy-specific surgical modules give foot and ankle surgeons the objective data needed for diagnosis and creation of patient-specific surgical plans, as well as assessment of outcomes. Released in August 2024, it combines artificial intelligence, data analytics, and 3D modeling designed specifically for foot and ankle treatments.

SMART Bun-Yo-Matic is touted as the first foot and ankle orthopedic device that lets a surgeon address rotation using only standard AP and lateral images and view the foot at 3D anatomy based on X-ray input. It aims to transform hallux valgus correction with precise patient measurements and powerful visualization tools, as well as enhance surgical accuracy by spotting abnormal anatomy and measuring corrections effectively.

“The foot and ankle space is one of the fastest-growing areas of orthopedics,” said DaCosta. “By combining our highly specialized solutions with Zimmer Biomet’s scale, resources, and global commercial infrastructure, we’re able to accelerate innovation, expand access to our technologies, and serve more patients than ever before.”

The SMART28 portfolio also includes MAVEN patient-specific instrumentation and the first and only FDA-approved, 3D-printed, patient-specific talus implant in multiple materials.

The transaction for Paragon 28—valued at about $1.2 billion—closed in April 2025. In addition to strengthening and expanding Zimmer Biomet’s foot and ankle offering, it expedited penetration opportunities into the fast-growing ambulatory surgery center space.

“The acquisition is about expanding impact at scale, enabling Paragon 28’s innovations to reach more surgeons and more patients, enter new markets, and continue driving advancements in the treatment of complex foot and ankle cases,” said DaCosta.

In February, Zimmer Biomet and its newly-minted Paragon 28 subsidiary launched the Phantom TTC nail system, a next-gen device that was engineered around the true circular arc of hindfoot anatomy. Its curved design follows the anatomic arc extending from the posterior calcaneus through the subtalar joint, into the talus, and along the tibial metaphysis. The company said this addresses the limitations of straight TTC nails, which rely on non-anatomic trajectories.

There’s no plantar incision needed to implant the nail, which addresses soft tissue disruptions and protects the plantar neurovascular bundle. The companies reported a 47.5% increase in calcaneal bone contact compared to straight nails.

Its built-in torsional stability is achieved through anatomic form-fit and threaded peg fixation across tibial, calcaneal, and subtalar segments. A revision-friendly trajectory can circumvent straight-nail tunnels and compromised cortical pathways.

The nail is compatible with both primary and revision TTC fusion surgeries, including complex Charcot reconstruction, post-traumatic cases, and failed straight-nail arthrodesis.

“Paragon 28 was founded to bring unwavering focus and dedication to the foot and ankle space, and that mission continues—now with even greater momentum through the acquisition by Zimmer Biomet,” said DaCosta. “By leveraging Zimmer Biomet’s expansive enabling technology platform, we can meaningfully accelerate our innovation pipeline and preserve the specialized expertise and passion that define our approach in the foot and ankle space.”

The bunion correction market is one of the largest segments in foot and ankle. Minimally invasive techniques continue to gain traction in this market.

Global orthopedic device manufacturer Enovis’ first-generation Pecaplasty system (acquired from its 2023 acquisition of Novastep) features an enabling jig technology that essentially provides the surgeon with an extra set of hands. According to the company, this helps improve accuracy and reproducibility in MIS distal metatarsal osteotomy procedures. Enovis said that traditional jigs, however, can bring a learning curve that can slow adoption of the technology.

Last year’s AOFAS meeting saw the introduction of Pecaplasty Wires First, the next generation of this percutaneous bunion surgery system.

“With Pecaplasty Wires First, we focused on simplifying one of the most technically demanding parts of the procedure—placing fixation wires for the osteotomy,” said Justak. “By streamlining this step, the system helps reduce complexity, shorten the learning curve, and make the procedure more repeatable for surgeons. That ultimately helps accelerate adoption of MIS techniques and enables patients to benefit from more consistent outcomes sooner. The design also helps reduce the number of fluoroscopy shots required during the procedure, which can lower radiation exposure for the surgical team.”

The company’s DynaNail TTC (tibiotalocalcaneal) fusion system addresses degenerative conditions, joint deformities, and revision procedures with a technology that adapts to the body throughout the healing process. It’s powered by Enovis’ patented pseudoelastic NiTiNOL technology and offers sustained, intraoperative and post-operative compression to optimize biomechanical stability while promoting faster, stronger fusions.

DynaNail continuously responds to bone resorption, lowering the risk of nonunion and enhancing long-term outcomes. Between now and Q1 2027, Enovis Foot & Ankle said it plans to launch nine new products—the company plans to make generational improvements to its core, established technologies.

“A great example is the upcoming launch of DynaNail 2.0, which builds on over a decade of clinical success with the DynaNail platform,” said Justak. “The updated implant and targeting jig further simplify the surgical technique while increasing post-operative sustained dynamic compression—from an already industry-leading six millimeters to eight millimeters. For patients with the most complex pathologies, particularly those at high risk of bone resorption, that additional compression can help improve the probability of fusion and healing.”

Enovis said it also plans to introduce new products to expand its portfolio and help define emerging treatment categories. Over the last few years, it’s expanded the DynaNail  platform with DynaNail Mini, Mini Hybrid, and Helix, which move sustained dynamic compression into further indications. This year, the company said it will continue building on that platform with new technologies as well as investing in enabling technologies to help surgeons perform procedures more efficiently while improving outcomes.

“Minimally invasive surgery continues to grow rapidly in foot and ankle, but it also presents unique challenges,” said Justak. “Surgeons are often operating through very small incisions with limited direct visualization of rotation, angulation, and instrument positioning. The future of foot and ankle surgery will include technologies that restore that visibility and provide more real-time intraoperative feedback. At Enovis, we are actively exploring systems and platforms that can bring additional data and visualization into the operating room to help surgeons perform these procedures with greater precision and confidence.”

Small Bones, Big Manufacturing Challenges

Bethlehem, Pa.-based EXALTA develops and manufactures extremity implant systems spanning total ankle replacement, foot and ankle constructs (Lapidus, MTP, Evans, and Cotton wedges), and small and mini-fragment fixation solutions. The company also makes associated instrumentation that supports intra-operative handling, insertion, and locking.

“Across these families, the features that most commonly drive yield or inspection complexity are small-diameter, fine-pitch threads (thread start quality, runout, and gaging robustness), locking interfaces (locking hole threads and head seats, including concentricity and surface integrity), anatomically contoured plates (flatness and bow/twist control, plus metrology approach), countersinks and seating geometries (seat angle and coaxiality), self-retaining drivers and screw recesses (tight angle tolerances to ensure function),” said Rick Healy, R&D manager at EXALTA.

Upper Saddle River, N.J.-based Triangle Manufacturing’s implant portfolio includes spinal cages, non-fixated spinal systems, bone screws, plates, total and partial knee systems, patient-specific knee systems, total hip systems, and shoulder systems. The company also produces high-speed and low-speed drill and shaving systems, depth gages, taps, grafting systems, powered and non-powered handpiece systems, rasps, drill guides, and ACL assemblies and components.

The company said it approaches each new program through a structured product realization process that integrates design for manufacturing (DFM) and design for inspection (DFI) principles. The proactive methodology allows potential yield and inspection challenges to be identified and mitigated before production starts.

“Historically, the most significant contributors to yield and inspection complexity have included introduction and validation of advanced inspection technologies, organizational turnover within OEM partners that can create technical knowledge gaps, and undefined or misaligned acceptance criteria between customers and manufacturers—often referred to internally as ‘the gray area,’” said Ken Gredick, VP of engineering at Triangle. “In the end, inspection directly affects yield. If you cannot inspect it, you cannot make it.”

Orchid Orthopedic Solutions manufactures a variety of extremity orthopedic implants, including screws and plates for foot and ankle, hands and wrist, and elbows. The company also makes baseplates and stems for shoulders and intramedullary nails for long bones. It does forming (casting and forging) and application of bone in-growth coating for baseplates and stems, as well as machining of screws and plates.

The company said the application of coating, like thermal plasma spray (TPS), hydroxyapatite (HA), and sintered bead was originally developed for application to large joint implants. It was built around a larger substrate size, more coating thickness, and the wider tolerances of hip and knee implants.

Extremity implants generally have a smaller size and more complex geometries. This makes it challenging to mask areas that don’t need a coating to hold parts during the pre-coat blasting and the plasma spray process itself. Since plasma spray is a line-of-sight process, some features on shoulder and elbow implants are challenging to reach and achieve consistent coating thickness, the company said.

“Some of the extremity implants, like ankles, use CoCr as the substrate material and are generally polished before coating,” said Netaji Khot, global commercial manager, Coating, at Orchid. “Handling such highly polished implants through the coating process is challenging during the masking, blasting, and coating stages. In the case of shoulder implants, coating areas are very specific. Masking the adjacent areas and transitioning the coating from coated to uncoated areas within small intricate geometries makes it unique, compared to large joints.”

Khot noted that challenges for coating extremity implants are more driven by design intent and less by variabilities in manufacturing or processes. Their coating process has been used for decades so it’s well understood, matured, and has overcome the majority of process variability challenges.

“We observed that most extremity implants carry dual-layer coatings (TPS+HA or Bead sinter + HA), which adds emphasis to the necessity of robust control on both processes to ensure the final product meets required dimensional and mechanical properties,” said Khot. “Defined frequency for coupon testing limits the risks associated with dual-layer coating.”

The company has been applying plasma spray and sintered coatings on orthopedic implants since the early 1980s. Its process has grown and improved over the years, achieving mechanical properties and compliance with global regulatory requirements.

“Implementing automation has limited human interference in key steps,” said Khot. “It reduces variability and achieves consistent quality and efficiencies, while eliminating significant challenges in handling the complex geometries, forms, and shapes of extremity implants.”

Freeport, Pa.-based Oberg Medical manufactures nitinol staple implants used in extremity orthopedic applications. Nitinol compression staples are low-profile, shape-memory alloy implants used primarily for foot and ankle fusion and osteotomies. They provide continuous, dynamic compression across bones, improving healing rates and stability.

The staples transition from a malleable, “open” state at lower temperatures to a rigid, “closed” state at body temperature to create constant compression. Nitinol compression staples have been increasingly used in foot and ankle surgery in particular because of their simple implantation, reproducibility, and favorable biomechanical features.

“Due to the shape memory of the nitinol materials we use to manufacture nitinol staple implants, proprietary manufacturing processes ensure we can achieve the manufacturing tolerances and 3D profiles required on these parts,” said Shawn Schafer, VP of business operations at Oberg Medical. “We run specific gage R&R studies to minimize the variation and impacts of our inspection methods.”

Unlike traditional staples, nitinol staples maintain pressure over time. Their low-profile design minimizes soft tissue irritation and they are available in various sizes, and for some systems can be reloaded or removed. Specific clinical applications include LisFranc arthrodesis, 1st MTP joint fusion, Akin osteotomy, and hallux valgus correction.

“On the inspection side, we use scanning CMM technology to ensure consistent inspection process and prove capability in the manufacturing process to reduce redundant inspection or ‘over-inspection’ that can deter process efficiency and cost,” said Schafer.