Hex Button
by Pioneer Surgical Technology
510(k) K992617
Hex Button is a Class II device made by Pioneer Surgical Technology, cleared under FDA 510(k) K992617 on 27 Oct 1999, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK992617 | Date27 Oct 1999 | StatusActive |
Official records
- FDA 510(k) database K992617
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HTN
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K992617
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| 02.221.002S | 02221002S / 02.221.002S | 10886982055552 | — | On the market |
| 02.221.003S | 02221003S / 02.221.003S | 10886982055569 | — | On the market |
| 02.221.004S | 02221004S / 02.221.004S | 10886982055583 | — | On the market |
| 04.221.002S | 04221002S / 04.221.002S | 10886982120960 | — | On the market |
| 04.221.003S | 04221003S / 04.221.003S | 10886982120977 | — | On the market |
| 04.221.004S | 04221004S / 04.221.004S | 10886982120991 | — | On the market |
| 298.805 | 298805 / 298.805 | 20886982182545 | — | On the market |
| 498.804 | 498804 / 498.804 | 20886982236958 | — | On the market |
| 498.805 | 498805 / 498.805 | 20886982236965 | — | On the market |
| Hex Button 400-776 | 2232-01-25 / 400-776 | 00846468063979 | — | On the market |
| Hex Button 400-777 | 2232-01-35 / 400-777 | 00846468063986 | — | On the market |
| Hex Button 400-778 | 2232-01-50 / 400-778 | 00846468063993 | — | On the market |
| Hex Button 400-782 | 2232-02-25 / 400-782 | 00846468064006 | — | On the market |
| Hex Button 400-783 | 2232-02-35 / 400-783 | 00846468064020 | — | On the market |
| Hex Button 400-784 | 2232-02-50 / 400-784 | 00846468064037 | — | On the market |
Similar devices
Other devices filed under FDA product code HTN (Washer, Bolt Nut).
- A.L.P.S.® 110018026 by Biomet Orthopedics, Inc.
- A.L.P.S.® 8563-27-042 856327042 by Biomet Orthopedics, Inc.
- IO Freedom 147-45825 by Extremity Medical, LLC
- MicroLink All-Suture Button Fixation System (Radiolucent) by Conmed Corporation
- Axis 130-65930 by Extremity Medical, LLC
- Arthrex® AR-8555-40 by Arthrex, Inc.
- T2 1832-0009S by Stryker GmbH
- TENSOR® Suture Button System by GLOBUS MEDICAL, INC.
- M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System 03.65.763 by Medacta International SA
- CMC MINI TIGHTROPE by Arthrex, Inc.