Humelock II Cemented Reversible Shoulder
Humelock II Cemented Reversible Shoulder combines a humeral stem with components that permit reverse shoulder reconstruction. The reverse assembly includes a glenoid baseplate, glenosphere,…
Humelock II Cemented Reversible Shoulder combines a humeral stem with components that permit reverse shoulder reconstruction. The reverse assembly includes a glenoid baseplate, glenosphere, humeral cup and connecting adaptors or screws.
The design permits conversion from an anatomic configuration while retaining a well-fixed compatible humeral stem. Glenospheres may be centred or eccentric, with or without a stabilization screw.
Listed Item
HUMELOCK REVERSED ECCENTRIC GLENOSPHERE W/ SCREW CoCr/TA6V 10° TILT Ø36 mm
Component Materials and Fixation
Glenospheres are cobalt-chromium-molybdenum alloy. Baseplates, screws and adaptors use titanium alloy, while humeral cups combine titanium alloy and polyethylene. The glenoid baseplate is intended for cementless screw fixation even when used with a cemented humeral stem.
9manufacturers in China registered for this device type
83catalogue numbers in this listing
3510(k) clearances naming this product 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 | Fx Solutions, France |
|---|---|
| FDA product code | PHX |
| Device type | Shoulder Prosthesis, Reverse Configuration |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| 510(k) | K150488 |
| Record published | 2016-06-09 |
| Record revised | 2025-02-06 (version 7) |
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, manufacturing date, serial number |
| Storage | Special storage condition: Store away from light and sunlight Store away from moisture |
| Sizes | Length 6 to 50 mm; height 3 to 9 mm; outer diameter 24 to 40 mm; angle 10 ° |
| Distribution end date | 2026-06-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 105-3600 | Outer Diameter 36 mm | In distribution |
| 109-4554 | In distribution | |
| 109-4544 | Length 44 mm | In distribution |
| 104-0606 | Height 6 mm | In distribution |
| 313-0709 | Height 9 mm | In distribution |
| 108-4558 | In distribution | |
| 108-4554 | In distribution | |
| 108-4552 | In distribution | |
| 109-4530 | Length 30 mm | In distribution |
| 112-0100 | Angle 10 ° | In distribution |
| 108-4538 | Length 38 mm | In distribution |
| 105-3613 | Outer Diameter 36 mm | In distribution |
| 109-4550 | Length 50 mm | In distribution |
| 109-4556 | In distribution | |
| 105-0006 | Length 6 mm | In distribution |
| 105-4011 | Outer Diameter 40 mm | In distribution |
| 108-4550 | Length 50 mm | In distribution |
| 109-4560 | In distribution | |
| 108-4540 | Length 40 mm | In distribution |
| 108-4515 | Length 15 mm | In distribution |
| 108-4548 | Length 48 mm | In distribution |
| 108-4524 | Length 24 mm | In distribution |
| 108-4556 | In distribution | |
| 105-0010 | Length 10 mm | In distribution |
| 105-4010 | Outer Diameter 40 mm | In distribution |
| 108-4520 | Length 20 mm | In distribution |
| 108-4528 | Length 28 mm | In distribution |
| 103-0603 | Height 3 mm | In distribution |
| 105-3603 | Outer Diameter 36 mm | In distribution |
| 108-4546 | Length 46 mm | In distribution |
| 313-0706 | Height 6 mm | In distribution |
| 109-4540 | In distribution | |
| 108-4525 | Length 25 mm | In distribution |
| 105-4001 | Outer Diameter 40 mm | In distribution |
| 103-0806 | Height 6 mm | In distribution |
| 109-4520 | Length 20 mm | In distribution |
| 108-4530 | Length 30 mm | In distribution |
| 108-4536 | Length 36 mm | In distribution |
| 314-0709 | Height 9 mm | In distribution |
| 108-4534 | Length 34 mm | In distribution |
| 108-4535 | Length 35 mm | In distribution |
| 109-4558 | In distribution | |
| 109-4525 | Length 25 mm | In distribution |
| 108-4522 | Length 22 mm | In distribution |
| 103-0809 | Height 9 mm | In distribution |
| 314-0703 | Height 3 mm | In distribution |
| 108-4560 | In distribution | |
| 104-0803 | Height 3 mm | In distribution |
| 104-0603 | In distribution | |
| 109-4522 | Length 22 mm | In distribution |
| 103-0606 | Height 6 mm | In distribution |
| 108-4544 | Length 44 mm | In distribution |
| 108-4526 | Length 26 mm | In distribution |
| 314-0706 | Height 6 mm | In distribution |
| 109-4552 | In distribution | |
| 103-0609 | Height 9 mm | In distribution |
| 109-4532 | Length 34 mm | In distribution |
| 108-4545 | Length 45 mm | In distribution |
| 108-4532 | Length 32 mm | In distribution |
| 109-4526 | Length 26 mm | In distribution |
| 109-4524 | Length 24 mm | In distribution |
| 104-0609 | Height 9 mm | In distribution |
| 105-3610 | Outer Diameter 36 mm | In distribution |
| 105-0024 | Outer Diameter 24 mm | In distribution |
| 109-4545 | Length 45 mm | In distribution |
| 109-4536 | Length 42 mm | In distribution |
| 109-4528 | Length 28 mm | In distribution |
| 109-4515 | Length 15 mm | In distribution |
| 104-0806 | Height 6 mm | In distribution |
| 103-0803 | Height 6 mm | In distribution |
| 108-4542 | Length 42 mm | In distribution |
| 104-0809 | Height 9 mm | In distribution |
| 105-4000 | Outer Diameter 40 mm | In distribution |
| 109-4548 | Length 48 mm | In distribution |
| 109-4546 | Length 46 mm | In distribution |
| 313-0703 | Height 3 mm | In distribution |
| 109-4535 | Length 35 mm | In distribution |
| 314-0609 | Height 9 mm | Withdrawn |
| 314-0606 | Height 6 mm | Withdrawn |
| 313-0603 | Height 3 mm | Withdrawn |
| 314-0603 | Height 3 mm | Withdrawn |
| 313-0609 | Height 9 mm | Withdrawn |
| 313-0606 | Height 6 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 |
| Perform™ Humeral System | Tornier Inc. | 74 |
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.