AlternatiV+ Screw-In Anchor
4.75MM Screw-IN Suture Anchor
2manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | Genesis Biologics, Inc., United States |
|---|---|
| FDA product code | MAI |
| Device type | Fastener, Fixation, Biodegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K230892 |
| Record published | 2024-10-08 |
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 |
| Sizes | Outer diameter 4.75 to 5.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20BN4753 | Outer Diameter 4.75 mm | In distribution |
| 20BN5503 | Outer Diameter 5.5 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
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.