HXA
11 FDA 510(k) clearances · Product code
88 daysmedian time to decision
144 days90th percentile
11clearances measured
FDA profile
- Official device name
- Prosthesis, Tendon, Passive
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3025
- Medical specialty
- Orthopedic
- Flags
- Implant
- Adverse events (MAUDE)
- 1996: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Universal Tendon Spacer (K243477) | Askorn Medical | 2025-01-10 |
| SINGLE SIZE TENDON SPACER (K000019) | Medist International | 2000-03-29 |
| OVAL SHAPES (K973385) | Technical Products, Inc. | 1997-12-05 |
| AVANTA ORTHOPAEDICS TENDON SPACER (K964359) | Avanta Orthopaedics, Inc. | 1997-03-25 |
| PHOENIX BONE SCREWS PBS-TYPE SERIES (K930125) | Phoenix Bioengineering, Inc. | 1993-12-30 |
| H-H HUNTER ACTIVE TENDON IMPLANT DC (K872285) | Holter-Hausner Intl. | 1987-09-28 |
| H-H HUNTER ACTIVE TENDON IMPLANT BC (K872293) | Holter-Hausner Intl. | 1987-09-28 |
| H-H HUNTER ACTIVE TENDON IMPLANT PC (K872284) | Holter-Hausner Intl. | 1987-09-28 |
| H-H HUNTER ACTIVE TENDON IMPLANT (K853438) | Holter-Hausner Intl. | 1985-09-30 |
| TENDON ROD MODEL OR41PO3-6 (K781943) | Holter-Hausner Intl. | 1978-12-04 |
| PASSIVE TENDON IMPLANT (K780320) | Holter-Hausner Intl. | 1978-03-17 |
Track HXA automatically
Every clearance here is in the API, with alerts when new ones post.