Gentle Threads
11 catalogue numbers from 905608, listed by Biomet Orthopedics, United States, under Fastener, Fixation, Biodegradable, Soft Tissue. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
11catalogue 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 | Biomet Orthopedics, United States |
|---|---|
| FDA product code | MAI |
| Device type | Fastener, Fixation, Biodegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| 510(k) | K041274 |
| Record published | 2015-10-24 |
| Record revised | 2025-05-30 (version 7) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 905608 | 9 MM 30 MM FULL THREAD | In distribution |
| 905630 | 10 MM 35 MM FULL THREAD | In distribution |
| 905623 | 11 MM 25 MM FULL THREAD | In distribution |
| 905605 | 8 MM 30 MM FULL THREAD | In distribution |
| 905629 | 10 MM 30 MM FULL THREAD | In distribution |
| 905626 | 12 MM 25 MM FULL THREAD | In distribution |
| 905628 | 10 MM 25 MM FULL THREAD | In distribution |
| 905620 | 10 MM 25 MM ROUND HEAD | In distribution |
| 905617 | 9 MM 25 MM ROUND HEAD | In distribution |
| 905615 | 8 MM 25 MM ROUND HEAD | In distribution |
| 905606 | 9 MM 20 MM FULL THREAD | 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
10 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 |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2018-07-20 | Class II | Process control | The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10×30 have been commingled. | 52 | 2020-06-04 |
| Biomet, Inc. | 510(k) number | 2018-07-20 | Class II | Process control | The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10×30 have been commingled. | 52 | 2020-06-04 |
| Biomet, Inc. | 510(k) number | 2018-03-28 | Class II | Nonconforming Material/Component | Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle. | 54 | 2019-03-29 |
| Biomet, Inc. | 510(k) number | 2018-03-28 | Class II | Nonconforming Material/Component | Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle. | 108 | 2019-03-29 |
| Biomet, Inc. | 510(k) number | 2018-03-28 | Class II | Nonconforming Material/Component | Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle. | 53 | 2019-03-29 |
| Biomet, Inc. | 510(k) number | 2018-03-28 | Class II | Nonconforming Material/Component | Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle. | 54 | 2019-03-29 |
| Biomet, Inc. | 510(k) number | 2018-03-28 | Class II | Nonconforming Material/Component | Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle. | 54 | 2019-03-29 |
| Biomet, Inc. | 510(k) number | 2018-03-28 | Class II | Nonconforming Material/Component | Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle. | 107 | 2019-03-29 |
| Biomet, Inc. | 510(k) number | 2015-06-03 | Class II | Mixed-up of materials/components | Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed with the Part Number: 905627 Lot: 753410 Gentle Threads Interference Screw 9x35mm Full Thread. If the incorrect screw is used various failures ma | 53 units | 2015-12-22 |
| Biomet, Inc. | 510(k) number | 2015-06-03 | Class II | Mixed-up of materials/components | Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed with the Part Number: 905627 Lot: 753410 Gentle Threads Interference Screw 9x35mm Full Thread. If the incorrect screw is used various failures ma | 41 units | 2015-12-22 |
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.