Integra® Freedom Wrist Arthroplasty System
The Integra Freedom Wrist Arthroplasty radial component is made of Cobalt Chrome Molybdenum Alloy (CoCrMo) and has a concave articulating surface and is fixed by means of a stem which is…
The Integra Freedom Wrist Arthroplasty radial component is made of Cobalt Chrome Molybdenum Alloy (CoCrMo) and has a concave articulating surface and is fixed by means of a stem which is inserted into the radial intramedullary canal.
1manufacturer
70catalogue 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 | Ascension Orthopedics, 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 | Manufacturer |
| 510(k) | K132250 |
| Record published | 2017-10-09 |
| Record revised | 2023-02-21 (version 7) |
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 |
| Storage | Special storage condition: Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish. |
| Distribution end date | 2026-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 348291 | 28.63 mm L x 10.3 mm H; Size 1 Standard | In distribution |
| 348111E | 28.16 mm dia x 26.36 mm L; Size 1 | In distribution |
| 348320E | 5.93 mm dia x 23.5 mm L | In distribution |
| 348317 | 5.93 mm dia x 21 mm L | In distribution |
| 348121E | 31.17 mm dia x 30.49 mm L; Size 2 | In distribution |
| 348003 | 35.6 mm dia x 23 mm L; Size 3 | In distribution |
| 348291E | 28.65 mm L x 10.3 mm H; Size 1 Standard | In distribution |
| 348292E | 28.65 mm L x 12.3 mm H; Size 1 +2 | In distribution |
| 348295E | 32.2 mm L x 14.3 mm H; Size 2 +2 | In distribution |
| 348240 | 4.5 mm dia x 40 mm L | In distribution |
| 348292 | 28.65 mm L x 12.3 mm H; Size 1 +2 | In distribution |
| 348200E | 5.93 mm dia x 3.5 mm depth | In distribution |
| 348298 | 35.75 mm L x 16.3 mm H; Size 3 +2 | In distribution |
| 348335E | 5.93 mm dia x 38.5 mm L | In distribution |
| 348121 | 31.17 mm dia x 30.49 mm L; Size 2 | In distribution |
| 348299E | 35.75 mm L x 18.3 mm H; Size 3 +4 | In distribution |
| 348225E | 4.5 mm dia x 25 mm L | In distribution |
| 348330E | 5.93 mm dia x 33.5 mm L | In distribution |
| 348217E | 4.5 mm dia x 17.5 mm L | In distribution |
| 348245 | 4.5 mm dia x 45 mm L | In distribution |
| 348002 | 32.05 mm dia x 21.5 mm L; Size 2 | In distribution |
| 348335 | 5.93 mm dia x 38.5 mm L | In distribution |
| 348225 | 4.5 mm dia x 25 mm L | In distribution |
| 348215E | 4.5 mm dia x 15 mm L | In distribution |
| 348122E | 31.17 mm dia x 30.49 mm L; Size 2 | In distribution |
| 348296E | 32.2 mm L x 16.3 mm H; Size 2 +4 | In distribution |
| 348340E | 5.93 mm dia x 43.5 mm L | In distribution |
| 348315E | 5.93 mm dia x 18.5 mm L | In distribution |
| 348215 | 4.5 mm dia x 15 mm L | In distribution |
| 348200 | 5.93 mm dia x 3.5 mm depth | In distribution |
| 348293E | 28.65 mm L x 14.3 mm H; Size 1 +4 | In distribution |
| 348315 | 5.93 mm dia x 18.5 mm L | In distribution |
| 348317E | 5.93 mm dia x 21 mm L | In distribution |
| 348003E | 35.6 mm dia x 23 mm L; Size 3 | In distribution |
| 348220 | 4.5 mm dia x 20 mm L | In distribution |
| 348340 | 5.93 mm dia x 43.5 mm L | In distribution |
| 348112 | 28.16 mm dia x 26.36 mm L; Size 1 | In distribution |
| 348001 | 28.5 mm dia x 20 mm L; Size 1 | In distribution |
| 348001E | 28.5 mm dia x 20 mm L; Size 1 | In distribution |
| 348122 | 31.17 mm dia x 30.49 mm L; Size 2 | In distribution |
| 348132 | 34.19 mm dia x 34.37 mm L; Size 3 | In distribution |
| 348131 | 34.19 mm dia x 34.37 mm L; Size 3 | In distribution |
| 348320 | 5.93 mm dia x 23.5 mm L | In distribution |
| 348131E | 34.19 mm dia x 34.37 mm L; Size 3 | In distribution |
| 348345E | 5.93 mm dia x 48.5 mm L | In distribution |
| 348111 | 28.16 mm dia x 26.36 mm L; Size 1 | In distribution |
| 348325 | 5.93 mm dia x 28.5 mm L | In distribution |
| 348296 | 32.2 mm L x 16.3 mm H; Size 2 +4 | In distribution |
| 348235 | 4.5 mm dia x 35 mm L | In distribution |
| 348295 | 32.2 mm L x 14.3 mm H; Size 2 +2 | In distribution |
| 348297E | 35.75 mm L x 14.3 mm H; Size 3 Standard | In distribution |
| 348217 | 4.5 mm dia x 17.5 mm L | In distribution |
| 348325E | 5.93 mm dia x 28.5 mm L | In distribution |
| 348220E | 4.5 mm dia x 20 mm L | In distribution |
| 348294E | 32.2 mm L x 12.3 mm H; Size 2 Standard | In distribution |
| 348297 | 35.75 mm L x 14.3 mm H; Size 3 Standard | In distribution |
| 348299 | 35.75 mm L x 18.3 mm H; Size 3 +4 | In distribution |
| 348330 | 5.93 mm dia x 33.5 mm L | In distribution |
| 348002E | 32.05 mm dia x 21.5 mm L; Size 2 | In distribution |
| 348230E | 4.5 mm dia x 30 mm L | In distribution |
| 348345 | 5.93 mm dia x 48.5 mm L | In distribution |
| 348240E | 4.5 mm dia x 40 mm L | In distribution |
| 348112E | 28.16 mm dia x 26.36 mm L; Size 1 | In distribution |
| 348132E | 34.19 mm dia x 34.37 mm L; Size 3 | In distribution |
| 348293 | 28.65 mm L x 14.3 mm H; Size 1 +4 | In distribution |
| 348230 | 4.5 mm dia x 30 mm L | In distribution |
| 348294 | 32.2 mm L x 12.3 mm H; Size 2 Standard | In distribution |
| 348298E | 35.75 mm L x 16.3 mm H; Size 3 +2 | In distribution |
| 348235E | 4.5 mm dia x 35 mm L | In distribution |
| 348245E | 4.5 mm dia x 45 mm L | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Maestro Total Wrist | Biomet Orthopedics | 136 |
| Freedom Wrist Arthroplasty System | Smith & Nephew, 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 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233674 | 2024-05-30 |
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.