Tritis
Non Absorbable ACL Tibial Fixation System
7manufacturers in China registered for this device type
20catalogue numbers in this listing
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 | Covidien LP, United States |
|---|---|
| FDA product code | MBI |
| Device type | Fastener, Fixation, Nondegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| 510(k) | K052810 |
| Record published | 2015-10-22 |
| Record revised | 2025-06-24 (version 10) |
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 |
| Storage | Special storage condition: ; |
| Sizes | Outer diameter 8 to 38 mm; length 28 to 38 mm |
| Distribution end date | 2021-02-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2620SS | Outer Diameter 9 mm | In distribution |
| 2631SS | Length 38 mm | In distribution |
| 2640SS | Length 30 mm | In distribution |
| 2621SS | Outer Diameter 9 mm | In distribution |
| 2611SS | Outer Diameter 8 mm | In distribution |
| 2630SS | Length 30 mm | In distribution |
| 2641SS | Length 38 mm | In distribution |
| 2610SS | Length 30 mm | In distribution |
| 2156SS | Withdrawn | |
| 2159SS | Withdrawn | |
| 2151SS | Outer Diameter 8 mm | Withdrawn |
| 2153SS | Outer Diameter 10 mm | Withdrawn |
| 2166SS | Withdrawn | |
| 2154SS | Outer Diameter 11 mm | Withdrawn |
| 2163SS | Withdrawn | |
| 2170SS | Withdrawn | |
| 2158SS | Outer Diameter 38 mm | Withdrawn |
| 8305SS | Length 28 mm | Withdrawn |
| 2152SS | Outer Diameter 9 mm | Withdrawn |
| 2167SS | Outer Diameter 12 mm | 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
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.