Orthopedic · 7 clearances · 5 unique sponsors
| Sponsor | Clearances | Last 12 mo | Most recent |
|---|---|---|---|
| BioPoly, LLC | 2 | 0 | 2022-11-22 |
| Accufix Surgical, Inc. | 2 | 0 | 2024-02-29 |
| Hyalex Orthopaedics, Inc. | 1 | 1 | 2026-04-03 |
| Restor3D, Inc. | 1 | 0 | 2022-05-25 |
| Montross Extremity Medical | 1 | 0 | 2023-04-19 |
Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
|---|---|---|---|---|
| 28545 | CPT | — | High | Standard CPT for toe prosthesis implantation |
| L3000 | HCPCS | Foot, insert, removable, molded to patient model, 'ucb' type, berkeley shell, each ✓ CMS-verified description | Medium | HCPCS foot/toe prosthetic component |
| Date | K-number | Sponsor | Device |
|---|---|---|---|
| 2026-04-03 | K250074 | Hyalex Orthopaedics, Inc. | HYALEX® MTP Hemiarthroplasty Implant |
| 2024-02-29 | K240268 | Accufix Surgical, Inc. | Accu-Joint Hemi Implant |
| 2023-04-19 | K221220 | Montross Extremity Medical | Montross Extremity Medical Hemi Implant System |
| 2022-11-22 | K222964 | BioPoly, LLC | BioPoly Lesser Toe Hemiarthroplasty Implant |
| 2022-05-25 | K201393 | Restor3D, Inc. | restor3d MTP Implant |
| 2021-02-02 | K203634 | BioPoly, LLC | BioPoly Great Toe Hemiarthroplasty Implant |
| 2020-12-08 | K200951 | Accufix Surgical, Inc. | Accu-Joint Hemi Implant |