BETA
Orthopedic implant manufacturer commercializing OSSIOfiber mineral-fiber and polymer fixation devices for bone and soft-tissue procedures.
OSSIO develops and sells orthopedic fixation implants built from its OSSIOfiber composite of mineral fibers and degradable polymer. Founded in 2014, it has commercial headquarters in Palmetto, Florida, a Massachusetts office and development and manufacturing operations in Caesarea, Israel.
Its current portfolio includes compression and interference screws, staples, suture anchors, trimmable nails and hammertoe fixation implants. U.S. commercialization began in 2019. Expansion includes the 2026 MIA bunion system, sports-medicine products and an exclusive pediatric distribution agreement with OrthoPediatrics. OSSIO reported its 100,000th implant use in July 2026; this is a company-reported adoption measure.
Published clinical evidence includes small prospective hammertoe studies and two-year follow-up, rather than proof of superiority across the entire portfolio. Financing announcements include a $38.5 million Series C in 2022 and $27.6 million equity round in 2024. Regulatory clearances and clinical evidence should be interpreted by product, procedure and labeled patient population.
Reviewed FDA decisions identify Class II devices cleared through 510(k), with applicant OSSIO, Ltd. Indications vary by family, procedure, implant size and patient age. Pediatric labeling includes growth-plate restrictions. [56][64][63][10][7][33][38][1]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [28][24]
Latest recorded source review: 2026-10-20.
Documented commercial product families.
Bio-integrative implant system for fixation during hammertoe correction. [36]
FDA-clearedCurrently listed in OSSIO's marketed portfolio; exact configurations and local availability vary
Compression fixation of specified fractures, osteotomies, arthrodesis and bone grafts. [38]
FDA-clearedCurrently listed in OSSIO's marketed portfolio; exact configurations and local availability vary
Solid and cannulated fixation nails that can be trimmed intraoperatively. [41]
FDA-clearedCurrently listed in OSSIO's marketed portfolio; exact configurations and local availability vary
Threaded fixation-nail family, including current beveled configurations used in the MIA bunion system. [40][39]
FDA-clearedCurrently listed in OSSIO's marketed portfolio; exact configurations and local availability vary
Staples for fixation of specified arthrodesis, osteotomies and fractures in hand or foot surgery. [35]
FDA-clearedCurrently listed in OSSIO's marketed portfolio; exact configurations and local availability vary
Suture-to-bone fixation anchors, including small and large configurations with procedure-specific labeling. [37]
FDA-clearedCurrently listed in OSSIO's marketed portfolio; exact configurations and local availability vary
Soft-tissue or bone/tendon fixation to bone, including labeled reconstruction applications. [34]
FDA-clearedCurrently listed in OSSIO's marketed portfolio; exact configurations and local availability vary
Original 2019 clearance; current standalone commercial availability not established. [46]
Commercial availability not establishedUnresolved; excluded from current-portfolio totals
OSSIO is expanding clinical evidence for its marketed material platform. A July 2026 company announcement describes interim work from a multicenter 50-patient KneeBar study. This procedure-level research is not counted as an additional device authorization, and the interference screw announced for launch in 2026 is included in the commercial portfolio. [72][63]
Publicly documented relationships; coverage may be incomplete.
| Partner | Territory / scope | Products |
|---|---|---|
| OrthoPediatrics [74][75] | U.S. children’s hospitals | OSSIOfiber implants |
| B1 Solutions [76] | Arkansas | OSSIOfiber implants |
| ABS Med [77] | Not publicly specified | Bone regeneration implants |
Sources checked October 16, 2026.
Company announced interference-screw launch activities, a KneeBar study update and its 100,000th implant use. The use total is company-reported. [72]
OSSIO announced an exclusive pediatric distribution agreement. Potential access to children's hospitals is distinct from confirmed facility adoption. [71]
Company introduced a bunion correction system using beveled threaded trimmable fixation nails and procedure instrumentation. [70]
OSSIO announced the opening of its Palmetto U.S. headquarters; Woburn remains an office and Caesarea a development/manufacturing base. [69]
Questa Capital led the announced round, with participation from existing investors, to expand commercial operations and U.S. capacity. [68]
MVM Partners led the announced financing for commercialization and product expansion. [67]
In 24 followed patients, radiographic fusion was reported in 23 at two years, with advanced integration. This small cohort does not establish portfolio-wide comparative superiority or complete implant disappearance in every patient. [44]
Company reported first commercial hammertoe cases at Polaris Surgery Center in Ohio. [32]
FDA cleared the original Pin Product Family, K181180. Current standalone availability remains unresolved. [46]
Accessed 10/29/2026