Instrument
Specialty Reunion RSA Baseplate Centering Guide Assy
9manufacturers in China registered for this device type
6catalogue numbers in this listing
4510(k) clearances naming this product code
5recalls on this code
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Stryker Trauson (Changzhou) Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Howmedica Osteonics Corp, United States |
|---|---|
| FDA product code | KWS |
| Device type | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2023-08-09 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| I-U0252GR32 | Diameter: 32.0 Millimeter | In distribution |
| I-U0257GR28 | Diameter: 28.0 Millimeter | In distribution |
| I-U0252GR36 | Diameter: 36.0 Millimeter | In distribution |
| I-U0262CG0L | Side: LEFT | In distribution |
| I-U0252GR40 | Diameter: 40.0 Millimeter | In distribution |
| I-U0262CG0R | Side: RIGHT | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 442 |
| Reunion | Stryker GmbH | 321 |
| DJO Surgical | Encore Medical, L.P. | 266 |
| SMR Shoulder | Limacorporate | 209 |
| Tornier Flex Shoulder System | Tornier Inc. | 187 |
| Anatomical Shoulder™ | Zimmer, Inc. | 166 |
| Arthrex® | Arthrex, Inc. | 154 |
| Comprehensive Shoulder System | Biomet Orthopedics | 111 |
| Flex Shoulder System | Tornier Inc. | 109 |
| Aequalis™ PerFORM+ | Tornier Inc. | 108 |
| Aequalis™ Ascend™ Flex | Tornier Inc. | 102 |
| Anatomic Shoulder Prosthesis | Medacta International SA | 90 |
Showing 12 of 326. All products under Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K103835 | 2011-05-05 |
| K103104 | 2010-11-22 |
| K062113 | 2006-10-03 |
| K990598 | 1999-03-15 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2026-07-30 | Not classified | Process change control | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to | 12,156 US | |
| 2015-05-12 | Class II | Process control | A package labeled as Part #5901-S-4818, Lot MAC7C14, standard humeral head trial, contained part # 5901-E-4818 Lot MAC7C14, offset humeral head trial. | 21 units | 2016-10-05 |
| 2008-11-13 | Not classified | Packaging | Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices. | 322 total units – all types | 2010-01-20 |
| 2007-11-15 | Not classified | Process control | Delamination: Loosening of the titanium plasma coating on the product was observed on twelve non-distributed units. | 915 units | 2010-01-25 |
| 2007-05-09 | Not classified | Process control | The plasma spray may delaminate from the proximal portion of the humeral stem. | 232 units | 2008-03-07 |
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.