TopLock
Knotted Anchor Cannulated Instrument Kit 4.75mm/2.0mm
7manufacturers in China registered for this device type
67catalogue numbers in this listing
1510(k) clearance
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 | Fusion Orthopedics, LLC, United States |
|---|---|
| FDA product code | MBI |
| Device type | Fastener, Fixation, Nondegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Record published | 2024-04-29 |
| Record revised | 2025-07-18 (version 2) |
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 |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TP-KL-1000-S | In distribution | |
| CD-TP-9000 | In distribution | |
| TN-TP-1000 | In distribution | |
| CD-TP-7023 | In distribution | |
| CD-TP-2000-SC | In distribution | |
| TP-AN-5052 | In distribution | |
| TP-KT-1100-S | In distribution | |
| TP-AN-3802-S | In distribution | |
| TP-KL-7400 | In distribution | |
| CD-TP-9035 | In distribution | |
| CD-KL-4700 | In distribution | |
| TN-TP-6535 | In distribution | |
| TP-KT-4700 | In distribution | |
| CD-KT-4715 | In distribution | |
| TP-AN-5002 | In distribution | |
| CD-TP-8535 | In distribution | |
| TP-AN-3552-S | In distribution | |
| TP-AN-3501 | In distribution | |
| CD-TP-7031 | In distribution | |
| CD-TP-8021 | In distribution | |
| TP-AN-4502-S | In distribution | |
| TP-KL-4750 | In distribution | |
| CD-KT-4720-S | In distribution | |
| TN-TP-6035 | In distribution | |
| TP-AN-3552 | In distribution | |
| TP-AN-4552-S | In distribution | |
| TP-AN-5002-S | In distribution | |
| CD-KT-4720 | In distribution | |
| CD-KT-3500 | In distribution | |
| TP-KT-2100-S | In distribution | |
| TN-TP-6038 | In distribution | |
| TP-KL-2000-S | In distribution | |
| TP-AN-3802 | In distribution | |
| CD-TP-8035 | In distribution | |
| TN-TP-6045 | In distribution | |
| CD-TP-2100-SC | In distribution | |
| TN-TP-1000 | In distribution | |
| CD-TP-7026 | In distribution | |
| TN-TP-6050 | In distribution | |
| TP-AN-3502 | In distribution | |
| TP-AN-3852-S | In distribution | |
| TP-AN-3551 | In distribution | |
| CD-TP-3100-SC | In distribution | |
| TP-AN-3501-S | In distribution | |
| TP-KT-3500 | In distribution | |
| CD-TP-7042 | In distribution | |
| CD-TP-8030 | In distribution | |
| TN-TP-1050 | In distribution | |
| TP-KL-3500 | In distribution | |
| CD-TP-8546 | In distribution | |
| TN-TP-2000 | In distribution | |
| TP-AN-3551-S | In distribution | |
| TP-AN-4502 | In distribution | |
| TP-AN-5052-S | In distribution | |
| TP-AN-4552 | In distribution | |
| CD-TP-7017 | In distribution | |
| TopLock CD-TP-8046 | In distribution | |
| TP-KL-3550 | In distribution | |
| CD-KT-4715-S | In distribution | |
| CD-TP-9535 | In distribution | |
| CD-TP-8530 | In distribution | |
| CD-TP-8521 | In distribution | |
| TP-AN-3852 | In distribution | |
| CD-KL-3500 | In distribution | |
| CD-KT-3500-S | In distribution | |
| TP-AN-3502-S | In distribution | |
| TN-TP-1050 | 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 |
| HNM Medical | HNM Stainless, LLC. | 59 |
| Orthobutton CL | Riverpoint Medical LLC | 55 |
| Apollo | Medline Industries, Inc. | 53 |
| JuggerKnot Soft Anchor | Riverpoint Medical LLC | 46 |
| Twinfix | Smith & Nephew, Inc. | 45 |
Showing 12 of 618. All products under Fastener, Fixation, Nondegradable, Soft Tissue
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K193377 | 2020-11-25 |
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.