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Comment: I’m sensing some possible LLM usage here —pythoncoder (talk | contribs) 08:21, 9 September 2025 (UTC)
- Comment: In accordance with Wikipedia's Conflict of interest policy, I disclose that I have a conflict of interest regarding the subject of this article. Jarvisteam (talk) 17:13, 8 September 2025 (UTC)
| Product type | Biointegrative orthopedic implant material |
|---|---|
| Country | Caesarea, Israel |
| Introduced | 2019 |
| Markets | United States |
| Website | ossio |
OSSIOfiber is the brand name for a type of fiber-reinforced biointegrative composite material used for internal fixation in orthopedic surgery. The material is designed to provide mechanical strength for bone healing and then be gradually absorbed and replaced by native bone, eliminating the need for permanent metal hardware.[1]
The implants are composed of continuous mineral fibers made from silicon dioxide, sodium oxide, calcium oxide, and other minerals, which are bound together by a poly(L-lactic-co-D,L-lactic acid) (PLDLA) polymer matrix.[2][1] The technology was developed to address limitations of both permanent metal implants, which can cause stress shielding and may require removal, and earlier generations of bioabsorbable polymers, which sometimes led to inflammatory reactions.[3][4]
History and development
[edit]OSSIO, Inc. was founded in 2014 by biomechanics researcher Orahn Preiss-Bloom.[5] The company's commercial headquarters are in Woburn, Massachusetts, with research and manufacturing facilities in Caesarea, Israel.[6]
The company has received a series of FDA 510(k) clearances for its products:
January 2019: OSSIOfiber Bone Pin Family.[7]
March 2020: OSSIOfiber Hammertoe Fixation System.[8]
October 2020: OSSIOfiber Compression Screw portfolio.[7]
March 2022: OSSIOfiber Suture Anchors.[9]
December 2023: Clearance for pediatric use in patients aged 2 and older where growth plates are not crossed by the implant.[10]
The first commercial use of an OSSIOfiber implant occurred in May 2019.[7] By June 2025, the company reported that over 50,000 implants had been used in surgical procedures in the United States.[11]
Products and clinical applications
[edit]OSSIOfiber technology is used in several product lines for various orthopedic applications. The implants are generally indicated for the maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts, often requiring additional immobilization.[12]
Hammertoe Fixation System: Implants for proximal interphalangeal (PIP) joint arthrodesis to correct hammertoe deformities.[13]
Trimmable Fixation Nails: Solid core and threaded nails used for fixation in the extremities, including the hand, wrist, foot, and ankle.[14]
Compression Screws: Cannulated, headless screws used to provide compression across a fracture or fusion site, such as in Lisfranc injuries and hallux valgus correction.[1]
Compression Staples: Trimmable staples designed to provide compression for arthrodesis, osteotomies, and fractures, particularly in the hand and foot.[15]
Suture Anchors: Devices used to attach soft tissues (ligaments and tendons) to bone, such as in rotator cuff repair and Achilles tendon repair.[16]
Clinical evaluation
[edit]The clinical performance of OSSIOfiber implants has been evaluated in several studies.
Hammertoe correction
[edit]The first-in-human clinical evaluation was a prospective, multicenter, single-arm study published in 2020, assessing the Hammertoe Fixation Implant in 25 patients. At the 26-week follow-up, the study reported an 88% radiographic fusion rate and 100% clinical stability. Patients reported significant improvements in pain and function. The study concluded there were "no serious adverse events related to the device or procedure."[2]
A 2025 multicenter retrospective cohort study evaluated real-world outcomes of the same procedure in 45 patients (82 toes). This independent study reported a radiographic union rate of 92.7% and significant improvements in patient-reported outcome measures. However, it also reported a 30.5% overall complication rate. Of the 82 toes, 4.9% (4 toes) required re-intervention for painful malunion or non-union, and 6.1% (5 toes) were converted to traditional Kirschner wire fixation.[17]
Other applications
[edit]A 2023 retrospective case series evaluated the use of OSSIOfiber compression screws for Lisfranc injuries in 10 patients. Over a median follow-up of 9 months, nine of the ten patients showed improved pain scores and began progressive weight-bearing. One patient (10%) experienced persistent pain and required a second surgery to remove the hardware.[18]
A 2025 case series reported on five patients who received OSSIOfiber trimmable fixation nails for carpometacarpal (CMC) joint fusions. At the three-month follow-up, radiographic evidence of fusion was observed in all treated joints, and no significant adverse events related to the implant were noted.[19]
Summary of key clinical studies
[edit]| Study | Indication | Study Type | N (Patients/Toes) | Follow-up | Key Positive Outcomes | Reported Complications / Adverse Events | Ref. |
|---|---|---|---|---|---|---|---|
| Cicchinelli et al. (2020) | Hammertoe Correction | Prospective, Multicenter, Single-Arm | 25 / 25 | 26 weeks | 88% radiographic fusion; 100% clinical stability; significant pain/function improvement. | "No serious adverse events related to the device or procedure were observed." One case of mild swelling. | [2] |
| Jimenez et al. (2025) | Hammertoe Correction | Retrospective, Multicenter Cohort | 45 / 82 | 6.7 months (mean) | 92.7% union rate; significant improvement in patient-reported outcome scores. | 30.5% overall complication rate; 4.9% required re-intervention; 6.1% converted to K-wire fixation. | [17] |
| Ashkani-Esfahani et al. (2023) | Lisfranc Injury | Retrospective Case Series | 10 / 10 | 9 months (median) | 9/10 patients had improved pain and began progressive weight-bearing. | One patient (10%) required hardware removal due to persistent pain. | [18] |
| Ligh et al. (2025) | CMC Joint Fusion | Retrospective Case Series | 5 / 7 (joints) | 6 months | Radiographic evidence of fusion in all subjects at 3 months; all subjects pain-free at 6 weeks. | "No significant adverse events to the trimmable bone nail." | [19] |
Adverse events
[edit]Post-market surveillance data from the FDA's Manufacturer and User Facility Device Experience (MAUDE) database includes reports of adverse events associated with OSSIOfiber implants. In 2024, reports were filed for a patient who required removal of multiple compression staples and screws eight to twelve months after a bunion correction procedure due to localized pain. The manufacturer's investigation noted that bone healing and fusion had been achieved and that the root cause was likely a local reaction to one of the implant's materials, which is listed as a potential adverse effect in the instructions for use.[20][21]
See also
[edit]References
[edit]- ^ a b c "The Science Behind OSSIOfiber". OSSIO, Inc. 16 April 2023. Retrieved 8 September 2025.
- ^ a b c Cicchinelli, L. D.; Štalc, J.; Richter, M.; Miller, S. (27 November 2020). "Prospective, Multicenter, Clinical and Radiographic Evaluation of a Biointegrative, Fiber-Reinforced Implant for Proximal Interphalangeal Joint Arthrodesis". Foot & Ankle Orthopaedics. 5 (4) 2473011420966311. doi:10.1177/2473011420966311. PMC 8564933. PMID 35097911.
- ^ "Novel Polymer-Based Orthopedic Implant Shows Complete Integration". Inotiv. Retrieved 8 September 2025.
- ^ Böstman, O.; Pihlajamäki, H. (March 2000). "Adverse tissue reactions to bioabsorbable fixation devices". Clinical Orthopaedics and Related Research (372): 216–227. doi:10.1097/00003086-200003000-00026. PMID 10738433.
- ^ "Who We Are". OSSIO, Inc. 16 April 2023. Retrieved 8 September 2025.
- ^ "OSSIO Announces U.S. Launch and First Commercial Use of the Bio-Integrative OSSIOfiber® Compression Screw Portfolio". Ortho Spine News. 22 March 2021. Retrieved 8 September 2025.
- ^ a b c "Press Releases". OSSIO, Inc. 16 April 2023. Retrieved 8 September 2025.
- ^ "510(k) Premarket Notification K190652". U.S. Food and Drug Administration. 6 March 2020. Retrieved 8 September 2025.
- ^ "OSSIO Announces U.S. Launch and First Commercial Use of OSSIOfiber® Suture Anchors". Ortho Spine News. 17 October 2022. Retrieved 8 September 2025.
- ^ "OSSIO's Groundbreaking Option for Fixing Bone Fractures in Children Receives FDA Clearance". The Pediatric Orthopedic Center. 6 December 2023. Retrieved 8 September 2025.
- ^ "OSSIO Launches Small OSSIOfiber® Suture Anchors". Business Wire. 16 June 2025. Retrieved 8 September 2025.
- ^ "OSSIO Receives FDA 510(k) Clearance for OSSIOfiber® Hammertoe Fixation System". OSSIO, Inc. 13 March 2020. Retrieved 8 September 2025.
- ^ "OSSIOfiber® Hammertoe Fixation System". OSSIO, Inc. Retrieved 8 September 2025.
- ^ "OSSIO introduces OSSIOfiber® Threaded Trimmable Fixation Nail". Ortho Spine News. 14 November 2024. Retrieved 8 September 2025.
- ^ "OSSIOfiber® Compression Staple". OSSIO, Inc. Retrieved 8 September 2025.
- ^ "OSSIOfiber® Suture Anchors". OSSIO, Inc. Retrieved 8 September 2025.
- ^ a b Jimenez, T. D.; Wingo, T.; Ubillus, H.; Walls, R. J. (April 2025). "Clinical Outcomes of a Biointegrative Fiber-Reinforced Implant for Hammertoe Correction: A Multicenter Retrospective Cohort Study". Foot & Ankle Orthopaedics. 10 (2): 873–885. doi:10.1093/sysbio/syae049. PMC 12177405. PMID 39158356.
- ^ a b Ashkani-Esfahani, S.; Mehta, A.; Bhamidipati, A.; Hearns, S.; O'Neill, C.; Waryasz, G. R. (December 2023). "Bio-Integrative Screws for Lisfranc Injuries: A Retrospective Case-Series on an Early Experience". Cureus. 15 (12): 966–974. doi:10.7759/cureus.50409. PMC 10753658. PMID 38229611.
- ^ a b Ligh, C.; Gurewitsch, A.; Katz, M.; Osterman, A. L. (12 June 2025). "Bio-integrative fiber-reinforced fixation device in carpometacarpal (CMC) joint fusions following carpal boss removal: A case series". International Journal of Surgery Case Reports. 114: 109225. doi:10.1016/j.ijscr.2025.109225 (inactive 8 September 2025).
{{cite journal}}: CS1 maint: DOI inactive as of September 2025 (link) CS1 maint: article number as page number (link) - ^ "MAUDE Adverse Event Report: OSSIO LTD. OSSIOFIBER COMPRESSION STAPLE SYSTEM". U.S. Food and Drug Administration. Retrieved 8 September 2025.
- ^ "MAUDE Adverse Event Report: OSSIO LTD. OSSIOFIBER COMPRESSION STAPLE SYSTEM". U.S. Food and Drug Administration. Retrieved 8 September 2025.