ComposiTCP
Threaded anchor system Ø 4.5 mm with one Blue non-sliding suture and one White/Green sliding suture
2manufacturers in China registered for this device type
61catalogue 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 | S.B.M |
|---|---|
| FDA product code | MAI |
| Device type | Fastener, Fixation, Biodegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| 510(k) | K122228 |
| Record published | 2015-09-23 |
| Record revised | 2025-11-24 (version 9) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature up to 33 °C |
| Sizes | Outer diameter 4.5 to 11 mm; length 20 to 35 mm |
| Distribution end date | 2022-07-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ComposiTCP 30 round head | Length 30 mm | In distribution |
| ComposiTCP 30 flat head | Outer Diameter 9 mm | In distribution |
| Double loaded BroadBand suture anchor | Outer Diameter 6.5 mm | In distribution |
| ComposiTCP 30 round head | Length 25 mm | In distribution |
| ComposiTCP 30 flat head | Outer Diameter 7 mm | In distribution |
| Non-sliding BroadBand | Outer Diameter 4.5 mm | In distribution |
| ComposiTCP 60 round head | Outer Diameter 10 mm | In distribution |
| ComposiTCP 30 flat head | Outer Diameter 11 mm | In distribution |
| Suture Anchor Punch Tap | In distribution | |
| Suture Anchor Punch Tap | In distribution | |
| ComposiTCP 30 flat head | Length 30 mm | In distribution |
| Double loaded MaxBraid suture anchor | Outer Diameter 4.5 mm | In distribution |
| Non-sliding BroadBand | Outer Diameter 6.5 mm | In distribution |
| ComposiTCP 60 round head | Length 35 mm | In distribution |
| ComposiTCP 60 round head | Outer Diameter 9 mm | In distribution |
| ComposiTCP 30 flat head | Length 25 mm | In distribution |
| ComposiTCP 30 round head | Outer Diameter 8 mm | In distribution |
| ComposiTCP 60 flat head | Length 35 mm | In distribution |
| ComposiTCP 30 round head | Outer Diameter 7 mm | In distribution |
| ComposiTCP 60 flat head | Outer Diameter 10 mm | In distribution |
| ComposiTCP 30 round head | Length 25 mm | In distribution |
| Non-sliding BroadBand | Outer Diameter 5.5 mm | In distribution |
| ComposiTCP 60 flat head | Outer Diameter 11 mm | In distribution |
| ComposiTCP 60 flat head | Length 35 mm | In distribution |
| ComposiTCP 30 round head | Outer Diameter 9 mm | In distribution |
| Double loaded BroadBand suture anchor | Outer Diameter 6.5 mm | In distribution |
| Double loaded MaxBraid suture anchor | Outer Diameter 6.5 mm | In distribution |
| ComposiTCP 30 round head | Outer Diameter 8 mm | In distribution |
| ComposiTCP 30 flat head | Outer Diameter 8 mm | In distribution |
| Double loaded MaxBraid suture anchor | Outer Diameter 5.5 mm | In distribution |
| Double loaded BroadBand suture anchor | Outer Diameter 6.5 mm | In distribution |
| ComposiTCP 30 flat head | Length 25 mm | In distribution |
| ComposiTCP 60 round head | Length 30 mm | In distribution |
| ComposiTCP 30 round head | Outer Diameter 9 mm | In distribution |
| ComposiTCP 60 round head | Outer Diameter 8 mm | Withdrawn |
| ComposiTCP 60 round head | Length 33 mm | Withdrawn |
| ComposiTCP 60 round head | Outer Diameter 8 mm | Withdrawn |
| ComposiTCP 30 round head | Length 35 mm | Withdrawn |
| ComposiTCP 30 round head | Length 35 mm | Withdrawn |
| ComposiTCP 30 round head | Length 20 mm | Withdrawn |
| ComposiTCP 60 round head | Length 20 mm | Withdrawn |
| ComposiTCP 30 round head | Length 25 mm | Withdrawn |
| ComposiTCP 60 round head | Length 30 mm | Withdrawn |
| ComposiTCP 30 flat head | Outer Diameter 10 mm | Withdrawn |
| ComposiTCP 60 flat head | Length 25 mm | Withdrawn |
| ComposiTCP 60 flat head | Outer Diameter 7 mm | Withdrawn |
| ComposiTCP 30 round head | Outer Diameter 10 mm | Withdrawn |
| ComposiTCP 30 flat head | Length 30 mm | Withdrawn |
| ComposiTCP 30 round head | Outer Diameter 8 mm | Withdrawn |
| ComposiTCP 60 round head | Length 25 mm | Withdrawn |
| ComposiTCP 30 round head | Length 25 mm | Withdrawn |
| ComposiTCP 60 round head | Outer Diameter 8 mm | Withdrawn |
| ComposiTCP 60 round head | Length 20 mm | Withdrawn |
| ComposiTCP 30 round head | Outer Diameter 7 mm | Withdrawn |
| ComposiTCP 60 flat head | Length 25 mm | Withdrawn |
| ComposiTCP 60 flat head | Length 25 mm | Withdrawn |
| ComposiTCP 60 round head | Length 30 mm | Withdrawn |
| ComposiTCP 30 round head | Outer Diameter 7 mm | Withdrawn |
| ComposiTCP 30 round head | Length 25 mm | Withdrawn |
| ComposiTCP 30 round head | Outer Diameter 7 mm | Withdrawn |
| ComposiTCP 60 flat head | Outer Diameter 8 mm | Withdrawn |
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 |
| 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 |
| Twist AP Suture Anchors | Parcus Medical, LLC | 17 |
Showing 12 of 176. All products under Fastener, Fixation, Biodegradable, Soft Tissue
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Science & BIO Materials, S.B.M. SAS | UDI-DI | 2021-10-07 | Class II | Process control | Mislabeled product. | 72 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.