Tigon Medical
The Tigon Medical Button System uses implants to facilitate fixation of bone to bone or soft tissue to bone. Its listed procedures include proximal biceps and pectoralis repairs at the…
The Tigon Medical Button System uses implants to facilitate fixation of bone to bone or soft tissue to bone. Its listed procedures include proximal biceps and pectoralis repairs at the shoulder, distal biceps repair at the elbow, and ligament and tendon repairs at the knee.
The buttons use eyelet geometry and are available in widths from 2.25 to 2.7 mm and lengths from 6.65 to 8 mm. The filing describes single-cortex function, with the button resting in the intramedullary cavity or against the opposite cortex at the fixation site.
Listed Item
2.6 mm All-Suture Anchor – w/ F&A inserter and (1) 1.5mm White/Blue TigoLoop & (1) White/Black USP #2 TigoCable
Button Fixation
The FDA summary identifies the system as a soft-tissue fixation fastener. The button material is Ti-6Al-4V ELI to ASTM F136, with unicortical and bicortical fixation configurations.
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 | Tigon Medical LLC, United States |
|---|---|
| FDA product code | MBI |
| Device type | Fastener, Fixation, Nondegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K211049 |
| Record published | 2023-06-06 |
| Record revised | 2025-09-23 (version 4) |
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, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TIGB8 | In distribution | |
| TM-KASP001-04S | In distribution | |
| LIG29KL-TIGLASSO | In distribution | |
| TM-EDAP001-SS | In distribution | |
| TM-ASAP003-04TLS | In distribution | |
| LIG29-X | In distribution | |
| TIGD47-B | In distribution | |
| TIGT7512-U | In distribution | |
| TIG248-38SS | In distribution | |
| TM-ASAP002-03TT | In distribution | |
| TIGB12 | In distribution | |
| TIG255-39STT | In distribution | |
| TIG248-38TT | In distribution | |
| TIG55-X | In distribution | |
| TIG255-39SSS | In distribution | |
| TM-ASAP002-01SS | In distribution | |
| TM-ASAP001-01T | In distribution | |
| TIG255-39SS | In distribution | |
| TM-ASAP003-04TLT | In distribution | |
| TM-EDAP002-SS | In distribution | |
| TM-ASAP002-01TT | In distribution | |
| TIG55-TIGLASSO | In distribution | |
| TM-ASAP003-04TTT | In distribution | |
| TIG48-TIGLASSO | In distribution | |
| TIG29KL-TIGLASSO | In distribution | |
| TM-ASAP001-04T | In distribution | |
| TIG65-TIGLASSO | In distribution | |
| TIG29-X | In distribution | |
| TM-SASP001-04S | In distribution | |
| TM-ASAP003-02TTT | In distribution | |
| TM-KASP001-01S | In distribution | |
| TIGD57-B | In distribution | |
| TIG29-TIGLASSO | 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 |
|---|---|
| K260921 | 2026-04-21 |
| K252596 | 2025-12-04 |
| K242529 | 2024-12-20 |
| K220464 | 2023-03-22 |
| K211049 | 2021-08-04 |
| K182507 | 2019-01-21 |
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.