Global Steptech
GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 56 +5mm RIGHT CEMENTED
9manufacturers in China registered for this device type
60catalogue numbers in this listing
9510(k) clearances naming this product code
11recalls 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 | Depuy Orthopaedics, Inc., 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, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K092122 |
| Record published | 2019-09-26 |
| Record revised | 2019-12-23 (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 |
|---|---|---|
| 1130-56-005 | In distribution | |
| 1130-52-007 | In distribution | |
| 1130-40-883 | In distribution | |
| 1130-56-993 | In distribution | |
| 1130-40-005 | In distribution | |
| 1130-52-885 | In distribution | |
| 1130-40-107 | In distribution | |
| 1130-48-883 | In distribution | |
| 1130-48-107 | In distribution | |
| 1130-40-105 | In distribution | |
| 1130-40-997 | In distribution | |
| 1130-40-993 | In distribution | |
| 1130-44-885 | In distribution | |
| 1130-48-103 | In distribution | |
| 1130-56-887 | In distribution | |
| 1130-44-883 | In distribution | |
| 1130-44-887 | In distribution | |
| 1130-52-103 | In distribution | |
| 1130-48-885 | In distribution | |
| 1130-56-995 | In distribution | |
| 1130-52-993 | In distribution | |
| 1130-56-007 | In distribution | |
| 1130-44-005 | In distribution | |
| 1130-52-887 | In distribution | |
| 1130-44-003 | In distribution | |
| 1130-40-885 | In distribution | |
| 1130-48-997 | In distribution | |
| 1130-48-003 | In distribution | |
| 1130-40-887 | In distribution | |
| 1130-56-105 | In distribution | |
| 1130-56-103 | In distribution | |
| 1130-48-993 | In distribution | |
| 1130-56-885 | In distribution | |
| 1130-52-883 | In distribution | |
| 1130-56-003 | In distribution | |
| 1130-48-105 | In distribution | |
| 1130-52-003 | In distribution | |
| 1130-44-103 | In distribution | |
| 1130-48-887 | In distribution | |
| 1130-52-107 | In distribution | |
| 1130-52-997 | In distribution | |
| 1130-44-107 | In distribution | |
| 1130-44-007 | In distribution | |
| 1130-52-105 | In distribution | |
| 1130-44-997 | In distribution | |
| 1130-48-995 | In distribution | |
| 1130-44-105 | In distribution | |
| 1130-44-995 | In distribution | |
| 1130-56-107 | In distribution | |
| 1130-52-005 | In distribution | |
| 1130-48-007 | In distribution | |
| 1130-40-007 | In distribution | |
| 1130-56-997 | In distribution | |
| 1130-40-003 | In distribution | |
| 1130-52-995 | In distribution | |
| 1130-40-995 | In distribution | |
| 1130-40-103 | In distribution | |
| 1130-44-993 | In distribution | |
| 1130-48-005 | In distribution | |
| 1130-56-883 | 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 |
|---|---|
| K092122 | 2009-07-27 |
| K091751 | 2009-07-14 |
| K081620 | 2008-06-30 |
| K060874 | 2006-06-28 |
| K052472 | 2005-10-06 |
| K000575 | 2000-03-10 |
| K992065 | 1999-07-12 |
| K981487 | 1998-07-13 |
| K974044 | 1998-01-22 |
Recalls
2 of these are 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 |
|---|---|---|---|---|---|
| 2017-11-28 | Class II | Employee error | The screw in specific lots of the GLOBAL UNITE Anatomic Body and GLOBAL UNITE Fracture Body was inverted during assembly to the body, which will cause the humeral stem to sit proud and may cause surgical delays. | 85 | 2020-03-27 |
| 2017-08-31 | Class II | Nonconforming Material/Component | The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a surgical delay. | Quantities co-mingled under initial product | 2020-03-12 |
| 2008-07-10 | Not classified | Device Design | Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable. | 1,521 of all devices. | 2009-10-28 |
| 2008-07-10 | Not classified | Device Design | Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable. | 1, 521 of all devices. | 2009-10-28 |
| 2008-07-10 | Not classified | Device Design | Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable. | 1,521 of all devices. | 2009-10-28 |
| 2008-07-10 | Not classified | Device Design | Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable. | 1,521 of all devices. | 2009-10-28 |
| 2008-07-10 | Not classified | Device Design | Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable. | 1,521 of all devices. | 2009-10-28 |
| 2008-07-10 | Not classified | Device Design | Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable. | 1,521 of all devices. | 2009-10-28 |
| 2008-07-10 | Not classified | Device Design | Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable. | 1, 521 of all devices. | 2009-10-28 |
| 2008-07-10 | Not classified | Device Design | Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable. | 1,521 of all devices. | 2009-10-28 |
| 2007-07-13 | Not classified | Packaging process control | Package Integrity: The outer peelable pouch seals may be compromised due to creasing, although the inner pouch seals are intact. | 3,530 | 2009-06-23 |
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.