KinematX
KinematX Radial Stem - Size 2; Sterile Packed
1manufacturer
14catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Extremity Medical, LLC, United States |
|---|---|
| FDA product code | JWJ |
| Device type | Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3800 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K191525 |
| Record published | 2020-10-27 |
| Record revised | 2025-07-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 137-30002-S | In distribution | |
| 137-50012-S | In distribution | |
| 115-21000-S | In distribution | |
| 137-50015-S | In distribution | |
| 137-30201-S | In distribution | |
| 137-30601-S | In distribution | |
| 137-30001-S | In distribution | |
| 137-30401-S | In distribution | |
| 115-31000-S | In distribution | |
| 137-30402-S | In distribution | |
| 137-30202-S | In distribution | |
| 137-30602-S | In distribution | |
| 137-31000-S | In distribution | |
| 115-11000-S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Maestro Total Wrist | Biomet Orthopedics | 136 |
| Freedom Wrist Arthroplasty System | Smith & Nephew, Inc. | 70 |
| Integra® Freedom Wrist Arthroplasty System | Ascension Orthopedics, Inc. | 70 |
| Remotion | Stryker GmbH | 53 |
| Universal 2™ Total Wrist System | Ascension Orthopedics, Inc. | 43 |
| Universal2 Total Wrist Implant System | Smith & Nephew, Inc. | 34 |
| Integra® | Ascension Orthopedics, Inc. | 1 |
| Precise | Stryker GmbH | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191525 | 2020-03-04 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.