Universal 2™ Total Wrist System
The UNI2SET is the Universal 2 Total Wrist set intended for cement fixation. The system consists of components to replace the articulation of the distal radius and proximal row of carpal…
The UNI2SET is the Universal 2 Total Wrist set intended for cement fixation. The system consists of components to replace the articulation of the distal radius and proximal row of carpal bones of the wrist joint, as well as corresponding instrumentation. The radial component has a concave articulating surface and is fixed by means of a stem which is inserted and cemented into the radial intramedullary canal. It is manufactured from cast CoCr alloy. The carpal component is a titanium plate which is fixed into the carpal bones with a cemented central peg and two titanium screws. Instrumentation is provided to assist in the surgical implantation.
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) | K030037 |
| Record published | 2017-10-09 |
| Record revised | 2023-02-21 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| 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 |
|---|---|---|
| 261201 | 24.7 mm dia x 24 mm L; Size Small | In distribution |
| 262401 | 42.8 mm L x 18.75 mm H; Size Large +1 | In distribution |
| 264520 | 4.5 mm dia x 20 mm L | In distribution |
| 262302 | 38.6 mm L x 17.7 mm H; Size Medium +2 | In distribution |
| 264535 | 4.5 mm dia x 35 mm L | In distribution |
| 264530S | 4.5 mm dia x 30 mm L | In distribution |
| 262102 | 31.3 mm L x 15.3 mm H; Size Extra Small +2 | In distribution |
| 262400 | 42.8 mm L x 16.25 mm H; Size Large Standard | In distribution |
| 264530 | 4.5 mm dia x 30 mm L | In distribution |
| 264515S | 4.5 mm dia x 15 mm L | In distribution |
| 263200LF | 31.2 mm dia x 45.1 mm L; Size Small | In distribution |
| 263300LF | 34 mm dia x 49.8 mm L; Size Medium | In distribution |
| 262402 | 42.8 mm L x 21.25 mm H; Size Large +2 | In distribution |
| 262100 | 31.3 mm L x 10.3 mm H; Size Extra Small Standard | In distribution |
| 264525 | 4.5 mm dia x 25 mm L | In distribution |
| 264515 | 4.5 mm dia x 15 mm L | In distribution |
| 264535S | 4.5 mm dia x 35 mm L | In distribution |
| 261101 | 31.2 mm dia x 21.5 mm L; Size Extra Small | In distribution |
| 262200 | 34.8 mm L x 11.9 mm H; Size Small Standard | In distribution |
| 262301 | 38.6 mm L x 15.2 mm H; Size Medium +1 | In distribution |
| 263400LF | 37.2 mm dia x 55 mm L; Size Large | In distribution |
| 261401 | 42.7 mm dia x 28 mm L; Size Large | In distribution |
| 262101 | 31.3 mm L x 12.8 mm H; Size Extra Small +1 | In distribution |
| 262201 | 34.8 mm L x 14.4 mm H; Size Small +1 | In distribution |
| 263100RT | 28.1 mm dia x 40.5 mm L; Size Extra Small | In distribution |
| 262300 | 38.6 mm L x 12.7 mm H; Size Medium Standard | In distribution |
| 263100LF | 28.1 mm dia x 40.5 mm L; Size Extra Small | In distribution |
| 262202 | 34.8 mm L x 16.9 mm H; Size Small +2 | In distribution |
| 263200RT | 31.2 mm dia x 45.1 mm L; Size Small | In distribution |
| 263300RT | 34 mm dia x 49.8 mm L; Size Medium | In distribution |
| 261301 | 38.5 mm dia x 26 mm L; Size Medium | In distribution |
| 263400RT | 37.2 mm dia x 55 mm L; Size Large | In distribution |
| 264520S | 4.5 mm dia x 20 mm L | In distribution |
| 264525S | 4.5 mm dia x 25 mm L | In distribution |
| 263600LF | 31.2 mm dia x 45.1 mm L; Size Small | Withdrawn |
| 263800LF | 37.2 mm dia x 55 mm L; Size Large | Withdrawn |
| 263600RT | 31.2 mm dia x 45.1 mm L; Size Small | Withdrawn |
| 263800RT | 37.2 mm dia x 55 mm L; Size Large | Withdrawn |
| 263700LF | 34 mm dia x 49.8 mm L; Size Medium | Withdrawn |
| UNI2SET | 21.5 in L x 10.3 in W | Withdrawn |
| 263500RT | 28.1 mm dia x 40.5 mm L; Size Extra Small | Withdrawn |
| 263500LF | 28.1 mm dia x 40.5 mm L; Size Extra Small | Withdrawn |
| 263700RT | 34 mm dia x 49.8 mm L; Size Medium | Withdrawn |
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 |
| 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.