Data / Medical devices / Joint, Hip, External Limb Component
Joint, Hip, External Limb Component (ISL): 18 FDA-registered makers in 9 countries
18 establishments in 9 countries are registered with the FDA to make Joint, Hip, External Limb Component (product code ISL, Class 1, 21 CFR 890.3420). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- ISL
- Device class
- 1
- Regulation
- 890.3420
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| China | 3 |
| India | 3 |
| Taiwan | 2 |
| Colombia | 1 |
| Mexico | 1 |
| Canada | 1 |
| Germany | 1 |
| Hong Kong | 1 |
Makers of Joint, Hip, External Limb Component
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 |
|---|---|---|---|---|---|---|---|---|
| Alm Ortho, Inc. | Scarborough, ME, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baoji Shengtaike Industry & Trade Co. Ltd. | Baoji City Shanxi, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Brace Align | Soddy Daisy, TN, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Blatchford, Inc. | Miamisburg, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fillauer, LLC | Chattanooga, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Himile Mechanical Manufacturing (shandong) Co., Ltd. | Weifang Shandong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huae Trade Technology Co.,ltd. | Beijing, China | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heuer International (A division of GST Corporation Limited) | NOIDA Uttar Pradesh, India | Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiundar Industrial Co., Ltd. | SHULIN CITY Taipei, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kamex International S.A.S | Cajica Cundinamarca, Colombia | Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lords Mark Industries Ltd. | Daman and Diu Dadra and Nagar Haveli, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| O And P De Mexico S.A. De C.V. | Guadalajara Jalisco, Mexico | Contract manufacturer, Foreign private label distributor, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Otto Bock Healthcare Canada | BURLINGTON Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH | DUDERSTADT Lower Saxony, Germany | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Professional Products, Inc. | Defuniak Spgs, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Regal Prosthesis Limited | Kwai Chung NT, Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tahoma Enterprises Inc | Sindian City Taipei, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tynor Orthotics (P) Ltd. | Mohali Punjab, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.