Comprehensive
8 catalogue numbers from 405807, listed by Biomet Orthopedics, United States, under Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
8catalogue numbers in this listing
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 | Biomet Orthopedics, United States |
|---|---|
| FDA product code | KWS |
| Device type | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| 510(k) | K120121 |
| Record published | 2016-10-27 |
| Record revised | 2026-02-09 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 405807 | MINI GLENOID BASEPLATE REAMER | In distribution |
| 405803 | MINI GLENOID BASEPLATE PIN SIZER | In distribution |
| SSI004997 | Standard | In distribution |
| 405809 | MINI GLENOID BASEPLATE IMPACTOR | In distribution |
| SSI004999 | In distribution | |
| SSI004706 | Medium | In distribution |
| 110003481 | In distribution | |
| SSI004992 | Short Mini | 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
Recalls Naming This Product
10 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2021-01-15 | Class II | Labeling Change Control | Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. It has been determined through a complaint investigation that a 40 MM length central screw was packaged a | 49 | 2023-03-09 |
| Biomet, Inc. | 510(k) number | 2020-11-25 | Class II | Process control | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device. | 7428 | 2024-05-08 |
| Biomet, Inc. | 510(k) number | 2020-09-02 | Class II | Packaging process control | Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) baseplates and no (0) adapters or with no (0) baseplates a | 3 units | 2020-12-31 |
| Biomet, Inc. | 510(k) number | 2020-02-25 | Class II | Packaging process control | Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may be packaged with two (2) baseplates and no (0) adapters. | 21 units | 2020-08-05 |
| Biomet, Inc. | 510(k) number | 2018-12-21 | Class II | Packaging process control | The product was potentially being packaged without a taper adapter. | 52 | 2020-05-06 |
| Biomet, Inc. | 510(k) number | 2017-04-26 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a voluntary recall for a single lot of the Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System after it was determined that two pieces from the lot were moved to finished goods and shipped des | 16 | 2018-03-30 |
| Biomet, Inc. | 510(k) number | 2017-02-17 | Class II | Process design | Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components. | 28,253 in total | 2018-01-29 |
| Biomet, Inc. | 510(k) number | 2015-01-07 | Class II | Process control | The taper adaptor is missing from the packaging, which may result in a delay in surgery greater than 30 minutes. | 11- 6 consumed, 5 with distributors | 2015-10-22 |
| Biomet, Inc. | 510(k) number | 2008-03-13 | Not classified | Device Design | The glenoid implant may not seat fully on the face of the natural glenoid due to inadequate measurement tolerances (tolerance stack-up) in the design of the cutter. Use of the instrument may lead to incomplete seating of the glenoid implan | 189 | 2008-10-15 |
| Biomet, Inc. | 510(k) number | 0012-12-06 | Class II | Nonconforming Material/Component | Biomet is recalling Part Number PT-113950 PT Hybrid Glenoid Post, following an investigation which identified that the male thread of the post may be oversized. This oversized condition can vary in degree and may lead to the following thre | 1050 | 2013-11-08 |
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.