MSS – Monobloc Stem
Small hum. eccentric rev. metaphysis +0mm/+3mm
9manufacturers in China registered for this device type
92catalogue numbers in this listing
1510(k) clearance
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 | Medacta International SA, Switzerland |
|---|---|
| FDA product code | PHX |
| Device type | Shoulder Prosthesis, Reverse Configuration |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| Establishment | Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K250644 |
| Record published | 2026-02-06 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 04.01.0372 | In distribution | |
| 04.01.0359 | In distribution | |
| 04.01.0365 | In distribution | |
| 04.01.0440 | In distribution | |
| 04.01.0360 | In distribution | |
| 04.01.0506 | In distribution | |
| 04.01.0384 | In distribution | |
| 04.01.0493 | In distribution | |
| 04.01.0492 | In distribution | |
| 04.01.0351 | In distribution | |
| 04.01.0350 | In distribution | |
| 04.01.0429 | In distribution | |
| 04.01.0357 | In distribution | |
| 04.01.0426 | In distribution | |
| 04.01.0374 | In distribution | |
| 04.01.0367 | In distribution | |
| 04.01.0366 | In distribution | |
| 04.01.0358 | In distribution | |
| 04.01.0386 | In distribution | |
| 04.01.0487 | In distribution | |
| 04.01.0496 | In distribution | |
| 04.01.0375 | In distribution | |
| 04.01.0382 | In distribution | |
| 04.01.0505 | In distribution | |
| 04.01.0371 | In distribution | |
| 04.01.0356 | In distribution | |
| 04.01.0385 | In distribution | |
| 04.01.0381 | In distribution | |
| 04.01.0431 | In distribution | |
| 04.01.0352 | In distribution | |
| 04.01.0495 | In distribution | |
| 04.01.0344 | In distribution | |
| 04.01.0341 | In distribution | |
| 04.01.0346 | In distribution | |
| 04.01.0436 | In distribution | |
| 04.01.0435 | In distribution | |
| 04.01.0437 | In distribution | |
| 04.01.0439 | In distribution | |
| 04.01.0504 | In distribution | |
| 04.01.0353 | In distribution | |
| 04.01.0441 | In distribution | |
| 04.01.0376 | In distribution | |
| 04.01.0430 | In distribution | |
| 04.01.0503 | In distribution | |
| 04.01.0498 | In distribution | |
| 04.01.0501 | In distribution | |
| 04.01.0494 | In distribution | |
| 04.01.0388 | In distribution | |
| 04.01.0354 | In distribution | |
| 04.01.0343 | In distribution | |
| 04.01.0362 | In distribution | |
| 04.01.0500 | In distribution | |
| 04.01.0488 | In distribution | |
| 04.01.0345 | In distribution | |
| 04.01.0370 | In distribution | |
| 04.01.0433 | In distribution | |
| 04.01.0497 | In distribution | |
| 04.01.0491 | In distribution | |
| 04.01.0387 | In distribution | |
| 04.01.0349 | In distribution | |
| 04.01.0379 | In distribution | |
| 04.01.0378 | In distribution | |
| 04.01.0427 | In distribution | |
| 04.01.0369 | In distribution | |
| 04.01.0422 | In distribution | |
| 04.01.0502 | In distribution | |
| 04.01.0368 | In distribution | |
| 04.01.0355 | In distribution | |
| 04.01.0507 | In distribution | |
| 04.01.0438 | In distribution | |
| 04.01.0425 | In distribution | |
| 04.01.0361 | In distribution | |
| 04.01.0383 | In distribution | |
| 04.01.0424 | In distribution | |
| 04.01.0423 | In distribution | |
| 04.01.0421 | In distribution | |
| 04.01.0490 | In distribution | |
| 04.01.0432 | In distribution | |
| 04.01.0489 | In distribution | |
| 04.01.0499 | In distribution | |
| 04.01.0364 | In distribution | |
| 04.01.0348 | In distribution | |
| 04.01.0434 | In distribution | |
| 04.01.0420 | In distribution | |
| 04.01.0363 | In distribution | |
| 04.01.0380 | In distribution | |
| 04.01.0419 | In distribution | |
| 04.01.0377 | In distribution | |
| 04.01.0428 | In distribution | |
| 04.01.0342 | In distribution | |
| 04.01.0347 | In distribution | |
| 04.01.0373 | 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 |
| SMR Shoulder | Limacorporate | 90 |
| Humelock II Cemented Reversible Shoulder | Fx Solutions | 83 |
| Perform™ Humeral System | Tornier Inc. | 74 |
Showing 12 of 232. All products under Shoulder Prosthesis, Reverse Configuration
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261016 | 2026-06-10 |
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 |
|---|---|---|---|---|---|---|
| Medacta Usa Inc | 510(k) number | 2026-04-30 | Class II | Device Design | Surgical instruments used during shoulder arthroplasty procedures does not progressively translate to replicate implant geometry, so the reaming guide and the stem reamer are positioned approximately 0.2 mm per size more laterally than inte | 50 |
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.