OSSIOfiber® Suture Anchor
OSSIOfiber Suture Anchor fixes suture to bone during tendon and ligament repair. It consists of an anchor body and eyelet preloaded on an inserter, with sutures and needles included in…
OSSIOfiber Suture Anchor fixes suture to bone during tendon and ligament repair. It consists of an anchor body and eyelet preloaded on an inserter, with sutures and needles included in selected configurations.
The anchor and eyelet are made from PLDLA polymer reinforced with continuous mineral fibers. The polymer degrades by hydrolysis, and the composite implant gradually transfers load to the surrounding anatomy as healing progresses.
Listed Item
OSSIOfiber® Suture Anchor 4.75 mm with Needles, Black Tape, Blue/White & #2 Suture. Package contains: 1 Implant, 1 Inserter, 1 Black 1.8mm Suture Tape, 1 Blue/White Round #2 Suture, 4 Stainless Steel MO-6 Needles.
Repair Components
Configuration options include sutures, suture tape, needles and a suture snare. The listed 4.75 mm kit combines an implant and inserter with black suture tape, a blue-and-white round suture and stainless steel needles. Anchors are supplied sterile for single use and have applications in soft tissue fixation at the shoulder, foot, ankle, knee, hand, wrist and elbow.
Who Else Makes It
All of them in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Record
| Listed by | Ossio Ltd., Israel |
|---|---|
| FDA product code | MAI |
| Device type | Fastener, Fixation, Biodegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K213415 |
| Record published | 2022-06-06 |
| Record revised | 2026-05-14 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store at a normal relative humidity; Special storage condition: Do not expose product to temperatures greater than 47°C or 116°F; Storage environment temperature 7 to 30 °C; Special storage condition: Keep dry |
| Sizes | Outer diameter 2.5 to 5.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OF1034751S | Outer Diameter 4.75 mm | In distribution |
| OF1034755S | Outer Diameter 4.75 mm | In distribution |
| OF1035551S | Outer Diameter 5.5 mm | In distribution |
| OF1032552S | Outer Diameter 2.5 mm | In distribution |
| OF1034754S | Outer Diameter 4.75 mm | In distribution |
| OF1034753S | Outer Diameter 4.75 mm | In distribution |
| OF1034752S | Outer Diameter 4.75 mm | In distribution |
| OF1032553S | Outer Diameter 2.5 mm | In distribution |
| OF1032554S | Outer Diameter 2.5 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 545 |
| Fix2Lock | Osteonic Co., Ltd. | 118 |
| Delta | Stryker Leibinger Gmbh & Co. KG | 110 |
| Reunite Screw System | Biomet Orthopedics | 85 |
| ComposiTCP | S.B.M | 61 |
| ActivaScrew™ Interference | Bioretec Ltd. | 54 |
| Ligafix | S.B.M | 40 |
| Twinfix | Smith & Nephew, Inc. | 28 |
| Biosure | Smith & Nephew, Inc. | 27 |
| TorqLoc Interference | Bioretec Ltd. | 27 |
| FiberFIX | Nanova BIO Materials Inc | 25 |
| AlphaVent | Stryker GmbH | 23 |
Showing 12 of 176. All products under Fastener, Fixation, Biodegradable, Soft Tissue
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K254055 | 2026-02-24 |
| K252022 | 2025-08-19 |
| K251309 | 2025-05-27 |
| K243760 | 2025-04-03 |
| K213415 | 2022-03-28 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.