Data / Medical devices / Prosthesis, Tendon, Passive
Prosthesis, Tendon, Passive (HXA): 7 FDA-registered makers in 3 countries
7 establishments in 3 countries are registered with the FDA to make Prosthesis, Tendon, Passive (product code HXA, Class 2, 21 CFR 888.3025). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 11 510(k) clearances under this code, the latest on January 10, 2025, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HXA
- Device class
- 2
- Regulation
- 888.3025
- Medical specialty
- Orthopedic
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| Malaysia | 3 |
| United States | 2 |
| France | 2 |
Makers of Prosthesis, Tendon, Passive
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Wright Medical Technology, Inc. | Arlington, TN, United States | Complaint file establishment, Specification developer | 3 | September 28, 1987 | 0 | 0 | 0 | api.fda.gov |
| Wright Medical Technology, Inc. | Arlington, TN, United States | Manufacturer | 2 | September 28, 1987 | 0 | 0 | 0 | api.fda.gov |
| Askorn Medical | Cesson Sevigne Bretagne, France | Specification developer | 1 | January 10, 2025 | 0 | 0 | 0 | api.fda.gov |
| Simagec | ROUSSET CEDEX Bouches-du-Rhone, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Simpang Ampat Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Perai Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Bandar Cassia Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 10, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.