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Fixone Hybrid Anchor
AJU PHARM. CO., LTD. · Model KAP-47501ca · UDI-DI 08800039100571
1
510(k) clearances
17,071
Adverse events
97
Recalls
149
Facilities
Description
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.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-14 | ConMed Corporation | Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability. |
| 2025-12-17 | Aju Pharm Co., Ltd. | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. |
| 2025-12-17 | Aju Pharm Co., Ltd. | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. |
| 2025-12-17 | Aju Pharm Co., Ltd. | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. |
| 2025-12-17 | Aju Pharm Co., Ltd. | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. |
| 2025-12-17 | Aju Pharm Co., Ltd. | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. |
| 2025-12-17 | Aju Pharm Co., Ltd. | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. |
| 2025-12-17 | Aju Pharm Co., Ltd. | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. |
| 2025-12-17 | Aju Pharm Co., Ltd. | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. |
| 2023-04-13 | DePuy Mitek, Inc., a Johnson & Johnson Co. | IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be r |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.