Anatomical Shoulder™ Domelock®
T-Dome 132R00 / 138L00 - eccentric
9manufacturers in China registered for this device type
10catalogue numbers in this listing
10510(k) clearances naming this product code
5recalls on this code
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Changzhou Atomic HI-Tech Radiation Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 8 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | PHX |
| Device type | Shoulder Prosthesis, Reverse Configuration |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K142403 |
| Record published | 2017-07-27 |
| Record revised | 2023-06-28 (version 5) |
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 |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Height 17 to 19 mm; outer diameter 46 to 48 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01.04227.224 | 132R00/138L00 | In distribution |
| 01.04227.226 | 129R10/141L10 | In distribution |
| 01.04227.230 | 129L10/141L10 | In distribution |
| 01.04227.221 | 129R00/141L00 | In distribution |
| 01.04213.465 | Height 19 mm | In distribution |
| 01.04227.218 | 132L00/138R00 | In distribution |
| 01.04212.485 | Outer Diameter 48 mm | In distribution |
| 01.04558.201 | In distribution | |
| 01.04227.216 | 129R00/141L00 | In distribution |
| 01.04227.219 | 132R00/138L00 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 297 |
| FX V135 | Fx Shoulder Solutions SAS | 131 |
| Prima TT Glenoid | Limacorporate | 129 |
| Shoulder Innovations Inset Reverse Total Shoulder | Shoulder Innovations, Inc | 124 |
| Equinoxe | Exactech, Inc. | 123 |
| Veritas rTSA | restor3d, inc. | 112 |
| DJO Surgical | Encore Medical, L.P. | 109 |
| R1 Reverse Shoulder System | Catalyst Orthoscience Inc | 100 |
| Tornier Perform™ Humeral System | Tornier Inc. | 96 |
| MSS – Monobloc stem | Medacta International SA | 92 |
| SMR Shoulder | Limacorporate | 90 |
| Humelock II Cemented Reversible Shoulder | Fx Solutions | 83 |
Showing 12 of 232. All products under Shoulder Prosthesis, Reverse Configuration
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261683 | 2026-06-16 |
| K193099 | 2020-01-29 |
| K172767 | 2017-11-30 |
| K170711 | 2017-06-01 |
| K133378 | 2014-05-12 |
| K130661 | 2013-05-09 |
| K122692 | 2012-12-03 |
| K060704 | 2006-05-19 |
| K053274 | 2006-01-25 |
| K052906 | 2005-12-19 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Zimmer, Inc. | 510(k) number | 2016-05-17 | Class II | Device Design | In some cases it has been difficult or not possible to disassemble the adjusted Dome Centric from the AS Humeral Rasp after initial positioning of the AS Humeral Trial Head which resulted in the whole construct of the Dome Centric with the | 177 | 2016-10-31 |
Recalls
5 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 |
|---|---|---|---|---|
| 2026-05-20 | Class II | Under Investigation by firm | Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. | 13 units |
| 2026-05-20 | Class II | Under Investigation by firm | Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. | 435 units |
| 2026-05-20 | Class II | Under Investigation by firm | Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. | 11 units |
| 2026-05-20 | Class II | Under Investigation by firm | Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. | 429 units |
| 2026-05-20 | Class II | Under Investigation by firm | Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. | 474 units |
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.