Freedom Wrist Arthroplasty System
4.5MM Screw AND Locking CAP 17.5MM Length
1manufacturer
70catalogue numbers in this listing
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 | Smith & Nephew, Inc., 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 | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K132250 |
| Record published | 2022-12-22 |
| Record revised | 2025-09-24 (version 4) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 348345 | In distribution | |
| 348001 | SIZE 1 | In distribution |
| 348317 | In distribution | |
| 348220E | In distribution | |
| 348317E | In distribution | |
| 348299 | In distribution | |
| 348122E | In distribution | |
| 348240E | In distribution | |
| 348295 | In distribution | |
| 348235E | In distribution | |
| 348225 | In distribution | |
| 348001E | In distribution | |
| 348294 | In distribution | |
| 348215E | In distribution | |
| 348335 | In distribution | |
| 348297 | In distribution | |
| 348296 | In distribution | |
| 348291E | In distribution | |
| 348335E | In distribution | |
| 348299E | In distribution | |
| 348340 | In distribution | |
| 348294E | In distribution | |
| 348200E | In distribution | |
| 348330E | In distribution | |
| 348330 | In distribution | |
| 348298E | In distribution | |
| 348293 | In distribution | |
| 348320E | In distribution | |
| 348295E | In distribution | |
| 348002E | In distribution | |
| 348315 | In distribution | |
| 348340E | In distribution | |
| 348325E | In distribution | |
| 348200 | In distribution | |
| 348245E | In distribution | |
| 348131E | In distribution | |
| 348297E | In distribution | |
| 348132 | SIZE 3 | In distribution |
| 348291 | In distribution | |
| 348003E | In distribution | |
| 348296E | In distribution | |
| 348111E | In distribution | |
| 348121E | In distribution | |
| 348315E | In distribution | |
| 348235 | In distribution | |
| 348122 | SIZE 2 | In distribution |
| 348217E | In distribution | |
| 348131 | SIZE 3 | In distribution |
| 348325 | In distribution | |
| 348240 | In distribution | |
| 348217 | In distribution | |
| 348132E | In distribution | |
| 348003 | SIZE 3 | In distribution |
| 348225E | In distribution | |
| 348121 | SIZE 2 | In distribution |
| 348111 | SIZE 1 | In distribution |
| 348298 | In distribution | |
| 348112E | In distribution | |
| 348215 | In distribution | |
| 348292E | In distribution | |
| 348230 | In distribution | |
| 348292 | In distribution | |
| 348245 | In distribution | |
| 348345E | In distribution | |
| 348230E | In distribution | |
| 348293E | In distribution | |
| 348112 | SIZE 1 | In distribution |
| 348220 | In distribution | |
| 348002 | SIZE 2 | In distribution |
| 348320 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Maestro Total Wrist | Biomet Orthopedics | 136 |
| 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 |
| KinematX | Extremity Medical, LLC | 14 |
| Integra® | Ascension Orthopedics, Inc. | 1 |
| Precise | Stryker GmbH | 1 |
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.