GFS Ultimate
GFS Ultimate is a fixation device for ligament and tendon repair. It combines medical-grade titanium with ultra-high molecular weight polyethylene suture to provide the fixation construct…
GFS Ultimate is a fixation device for ligament and tendon repair. It combines medical-grade titanium with ultra-high molecular weight polyethylene suture to provide the fixation construct used during the repair.
The design includes an adjustable loop length. This allows the loop configuration to be set as part of assembling the device according to its surgical instructions.
Listed Item
GFS Ultimate Large
Supply and Application
The devices are supplied sterile for patients requiring ligament or tendon repair. The selected size and loop arrangement form part of the repair construct, with the device used alongside the other components required by the chosen technique.
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Renolit Hansen Packaging Tech. (BJ) Ltd. | Beijing | Beijing | Contract manufacturer | 1 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Suzhou Endophix Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 17 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Parcus Medical, LLC, United States |
|---|---|
| FDA product code | MBI |
| Device type | Fastener, Fixation, Nondegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| 510(k) | K162198 |
| Record published | 2023-07-27 |
| Record revised | 2019-03-21 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10974 | In distribution | |
| 10972 | In distribution | |
| 10973 | In distribution | |
| 10973 | In distribution | |
| 10974 | In distribution | |
| 11184 | In distribution | |
| 10972 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 362 |
| HNM Sports Medicine | HNM Stainless, LLC. | 150 |
| Suture Anchors – HTA Headless Titanium Anchor and Zip Anchors | GM DOS Reis Industria E Comercio Ltda | 78 |
| Juggerknot® | Biomet Orthopedics | 77 |
| Fastener, Fixation, Nondegradable, Soft Tissue | Parcus Medical, LLC | 74 |
| endophix | Suzhou Endophix Co., Ltd. | 71 |
| Titan | Medline Industries, Inc. | 68 |
| TopLock | Fusion Orthopedics, LLC | 67 |
| HNM Medical | HNM Stainless, LLC. | 59 |
| Orthobutton CL | Riverpoint Medical LLC | 55 |
| Apollo | Medline Industries, Inc. | 53 |
| JuggerKnot Soft Anchor | Riverpoint Medical LLC | 46 |
Showing 12 of 618. All products under Fastener, Fixation, Nondegradable, Soft Tissue
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K221502 | 2022-07-26 |
| K221135 | 2022-05-19 |
| K212739 | 2021-10-06 |
| K202662 | 2021-02-22 |
| K202259 | 2020-10-28 |
| K201083 | 2020-07-23 |
| K193295 | 2020-01-23 |
| K192750 | 2020-01-16 |
| K192964 | 2019-11-22 |
| K191783 | 2019-10-09 |
| K190375 | 2019-04-24 |
| K183331 | 2019-02-07 |
| K170877 | 2017-06-02 |
| K170327 | 2017-03-30 |
| K162198 | 2016-11-18 |
| K152711 | 2015-11-20 |
| K133757 | 2014-02-04 |
| K122805 | 2013-02-05 |
| K120942 | 2012-04-20 |
| K113730 | 2012-01-17 |
| K091094 | 2009-09-30 |
| K090923 | 2009-06-30 |
| K090075 | 2009-03-06 |
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.