Humelock Reversed Shoulder
Humelock Reversed Shoulder is a shoulder replacement system that places the joint's ball on the glenoid side and its matching cup on the humeral side. This reversed arrangement is intended…
Humelock Reversed Shoulder is a shoulder replacement system that places the joint’s ball on the glenoid side and its matching cup on the humeral side. This reversed arrangement is intended for patients with a nonfunctional rotator cuff.
A screw-fixed glenoid baseplate supports a cobalt-chromium-molybdenum glenosphere. On the humeral side, a titanium alloy shell with a polyethylene insert connects through a taper to a stem placed in the upper arm bone.
Listed Item
HUMELOCK REVERSED STEM TA6V Ø40/16 CEMENTLESS LOCKABLE Ti/HA
Stem and Fixation Options
The system includes cemented and cementless stems. Cementless stems have a titanium and hydroxyapatite coating proximally and optional cortical screws for additional fixation. Optional post extensions, humeral spacers and anti-rotation components allow different constructs. Glenospheres and humeral cups are available in centered, offset, height and constraint options.
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 | Fx Solutions, France |
|---|---|
| FDA product code | PHX |
| Device type | Shoulder Prosthesis, Reverse Configuration |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| 510(k) | K162455 |
| Record published | 2017-01-31 |
| Record revised | 2026-07-01 (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 |
| Storage | Special storage condition: Store away from light and sunlight Store away from moisture |
| Sizes | Outer diameter 6 to 40 mm |
| Distribution end date | 2026-06-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 317-4016 | Outer Diameter 16 mm | In distribution |
| 317-3212 | Outer Diameter 32 mm | In distribution |
| 317-3614 | Outer Diameter 36 mm | In distribution |
| 313-3206 | Outer Diameter 06 mm | In distribution |
| 317-3208 | Outer Diameter 32 mm | In distribution |
| 317-3610 | Outer Diameter 10 mm | In distribution |
| 317-3210 | Outer Diameter 32 mm | In distribution |
| 317-4012 | Outer Diameter 12 mm | In distribution |
| 317-4014 | Outer Diameter 16 mm | In distribution |
| 313-3610 | Withdrawn | |
| 313-4012 | Withdrawn | |
| 313-3612 | Outer Diameter 36 mm | Withdrawn |
| 906-0050 | Withdrawn | |
| 313-4014 | Outer Diameter 14 mm | Withdrawn |
| 313-4010 | Outer Diameter 10 mm | Withdrawn |
| 313-3210 | Outer Diameter 10 mm | Withdrawn |
| 313-3608 | Outer Diameter 8 mm | Withdrawn |
| 312-0000 | Withdrawn | |
| 313-3208 | Outer Diameter 08 mm | Withdrawn |
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 |
|---|---|
| K163669 | 2017-05-17 |
| K162455 | 2017-01-17 |
| K150488 | 2015-11-13 |
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.