Fixone Biocomposite Anchor
Fixone Biocomposite Anchors secure sutures for reattaching soft tissue to bone. The B and N screw-in types support repairs in the shoulder, foot and ankle, knee or elbow, including tendon…
Fixone Biocomposite Anchors secure sutures for reattaching soft tissue to bone. The B and N screw-in types support repairs in the shoulder, foot and ankle, knee or elbow, including tendon and ligament reconstruction procedures.
The anchor is made from biodegradable PLGA copolymer and beta tricalcium phosphate. A nonabsorbable ultrahigh molecular weight polyethylene suture passes through its eyelet. The cannulated anchor comes preloaded on an insertion device for placement in bone.
Listed Item
The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The anchor ismanufactured from biodegradable materials (PLGA copolymer and beta-TCP). A nonabsorbable UHMWPE suture is inserted into the anchor. The anchor is implanted using a provided driver. B,N,BN type(Knotted suture anchors) are ‘screw-in’ anchors used alone or in combination with Kc,KcN type(Knotless suture anchors) for soft-tissue repair. Kc,KcN type(Knotless suture anchor) are used for a soft-tissue repair in combination with the B,N,BN type. SL type ‘push-in’ anchors that are ideal for soft-tissue repair in narrow or deep areas. S type are ‘push-in’ anchors that are ideal for soft-tissue repair in the foot, ankle, hand and wrist The Fixone Biocomposite Anchor consists of cannulated anchors with an eyelet. They are pre-loaded on an insertion device. The Fixone Biocomposite Anchor is intended to provide secure reattachment of the soft tissue to bone. Devices are provided sterile. Single use only.
Fixation Options
The knotted B, N and BN types can be used alone or with compatible Kc or KcN knotless anchors during repair. The anchors are supplied sterile and are intended for single use.
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) | K230892 |
| 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 |
|---|---|---|
| BAB-45003ch | In distribution | |
| SAL-30002ni | In distribution | |
| KAB-47501ca | In distribution | |
| BAN-47503b | In distribution | |
| KAB-55001da | In distribution | |
| NAB-47502d | In distribution | |
| KAB-55001ca | In distribution | |
| BAN-55002c | In distribution | |
| SAB-30002e | In distribution | |
| SAL-30002i | In distribution | |
| BAB-55002dh | In distribution | |
| BAN-55003b | In distribution | |
| BAN-47502c | In distribution | |
| BAB-55003ch | 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.