Fixone Hybrid Anchor
Fixone Hybrid Knotless Anchor secures sutures to bone during soft-tissue repair. It provides a fixation point for procedures involving the shoulder, foot and ankle, knee or elbow, including…
Fixone Hybrid Knotless Anchor secures sutures to bone during soft-tissue repair. It provides a fixation point for procedures involving the shoulder, foot and ankle, knee or elbow, including rotator-cuff and Achilles-tendon repair.
The anchor combines a biodegradable PLGA copolymer and beta-tricalcium-phosphate portion with a nonabsorbable PEEK tip. The hybrid construction therefore includes both degradable and permanent material, rather than an implant made entirely from absorbable material.
Listed Item
The Fixone Hybrid Knotless Anchor is intended for reattaching soft tissue to bone with sutures. The anchor is manufactured from biodegradable materials (PLGA copolymer and beta-TCP) and nonabsorbable PEEK tip. A nonabsorbable suture manufactured from cobraided UHMWPE only or UHMWPE and PET fibers is inserted into the anchor. The anchor is implanted using a provided driver.
Suture and Instruments
Nonabsorbable suture is incorporated into the anchor. The suture uses UHMWPE fibers alone or UHMWPE combined with PET fibers. A provided driver places the anchor, while associated instruments prepare the hole in bone for the fixation procedure.
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 | Aju Pharm Co., Ltd., South Korea |
|---|---|
| FDA product code | MAI |
| Device type | Fastener, Fixation, Biodegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| 510(k) | K203523 |
| Record published | 2025-01-06 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KAPN-55001nc | In distribution | |
| KAPN-47501nc | In distribution | |
| KAP-47501ca | In distribution | |
| KAPN-47501c | In distribution | |
| KAP-55001ca | In distribution | |
| KAPN-55001c | 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 |
|---|---|
| K230892 | 2023-06-09 |
| K203523 | 2021-12-25 |
| K192484 | 2020-03-11 |
| K192032 | 2020-03-03 |
| K171299 | 2017-08-24 |
Recalls Naming This Product
8 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Aju Medical Co., Ltd. | 510(k) number | 2025-12-17 | Class II | Nonconforming Material/Component | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. | 233 units |
| Aju Medical Co., Ltd. | 510(k) number | 2025-12-17 | Class II | Nonconforming Material/Component | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. | 1,088 units |
| Aju Medical Co., Ltd. | 510(k) number | 2025-12-17 | Class II | Nonconforming Material/Component | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. | 600 units |
| Aju Medical Co., Ltd. | 510(k) number | 2025-12-17 | Class II | Nonconforming Material/Component | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. | 400 units |
| Aju Medical Co., Ltd. | 510(k) number | 2025-12-17 | Class II | Nonconforming Material/Component | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. | 1,163 units |
| Aju Medical Co., Ltd. | 510(k) number | 2025-12-17 | Class II | Nonconforming Material/Component | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. | 200 units |
| Aju Medical Co., Ltd. | 510(k) number | 2025-12-17 | Class II | Nonconforming Material/Component | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. | 2,569 units |
| Aju Medical Co., Ltd. | 510(k) number | 2025-12-17 | Class II | Nonconforming Material/Component | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. | 416 units |
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.