Genesys CrossFT, Hi-Fi
GENESYS CrossFT 4.5 mm Suture Anchor, w/2 Hi-Fi #2 (5 metric) Sutures w/Needles
2manufacturers in China registered for this device type
14catalogue numbers in this listing
5510(k) clearances naming this product code
1recall
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 | ConMed Corporation, United States |
|---|---|
| FDA product code | MAI |
| Device type | Fastener, Fixation, Biodegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K101100 |
| Record published | 2015-10-24 |
| Record revised | 2024-08-05 (version 7) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: KEEP DRY; Storage environment temperature up to 40 °C; Storage environment temperature up to 104 °F |
| Packaging | Carton |
| Sizes | Outer diameter 4.5 to 6.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CFBC-6503B | Outer Diameter 6.5 mm | In distribution |
| CFBC-5503 | In distribution | |
| CFBC-4503 | Outer Diameter 4.5 mm | In distribution |
| CFBC-5502B | Outer Diameter 5.5 mm | In distribution |
| CFBC-6503 | In distribution | |
| CFBC-5503B | Outer Diameter 5.5 mm | In distribution |
| CFBC-4502 | Outer Diameter 4.5 mm | In distribution |
| CFBC-6502 | In distribution | |
| CFBC-4502B | Outer Diameter 4.5 mm | In distribution |
| CFBC-5502 | Outer Diameter 5.5 mm | In distribution |
| CFBC-4502NB | Outer Diameter 4.5 mm | In distribution |
| CFBC-4502N | Outer Diameter 4.5 mm | In distribution |
| CFBC-6502B | Outer Diameter 6.5 mm | In distribution |
| CFBC-4503B | Outer Diameter 4.5 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 |
|---|---|
| K252946 | 2025-10-15 |
| K240090 | 2024-03-05 |
| K180763 | 2018-07-19 |
| K171592 | 2017-08-29 |
| K170501 | 2017-03-17 |
Recalls Naming This Product
2 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 | Closed |
|---|---|---|---|---|---|---|---|
| ConMed Corporation | 510(k) number | 2026-07-14 | Class II | Labeling design | Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability. | 2 units | |
| Linvatec Corporation | 510(k) number | 2013-03-06 | Class II | Mixed-up of materials/components | Incorrect blue/white suture was used. | 60 each of both units | 2013-07-22 |
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.