Sinefix
The FDA filing identifies SINEFIX as a PEEK implant for reattaching rotator cuff tendon to the humerus. Its described baseplate sits over the tendon and attaches to the humerus using a…
The FDA filing identifies SINEFIX as a PEEK implant for reattaching rotator cuff tendon to the humerus.
Its described baseplate sits over the tendon and attaches to the humerus using a medial anchor through the tendon and a lateral anchor into bone.
Listed Item
Rotator cuff repair device
Intended Reattachment
The filing indicates the PEEK SINEFIX for soft-tissue-to-bone reattachment in rotator cuff repairs involving tendon ruptures up to two centimeters. The baseplate and anchors are described as facilitating healing at the natural bone-tendon interface.
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 | Baat Medical Products B.V., Netherlands |
|---|---|
| FDA product code | MBI |
| Device type | Fastener, Fixation, Nondegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K220966 |
| Record published | 2025-07-03 |
| Record revised | 2026-04-03 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 5 |
| Distribution end date | 2026-04-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Medial Driver | In distribution | |
| Trocar | In distribution | |
| Repusher | In distribution | |
| SINEFIX Instrument Tray | In distribution | |
| Medial anchor inserter | In distribution | |
| Lateral anchor inserter | In distribution | |
| Stop clip | In distribution | |
| Base plate inserter | In distribution | |
| Lateral Driver | In distribution | |
| Punch | In distribution | |
| SINEFIX | In distribution | |
| SINEFIX Easy Grip | In distribution | |
| Tray | Withdrawn | |
| Repusher | Withdrawn | |
| SINEFIX | Withdrawn |
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 |
|---|---|
| K254176 | 2026-03-16 |
| K220966 | 2023-03-08 |
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.