Identity™
29 catalogue numbers from SBHS0719, listed by Zimmer, Inc., United States, under Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
29catalogue numbers in this listing
5510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shanghai (3), Zhejiang (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| 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 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | MBF |
| Device type | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3670 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K213856 |
| Record published | 2022-09-27 |
| Record revised | 2025-03-06 (version 2) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SBHS0719 | Size 19 | In distribution |
| SAHH4817T | 48mm X 17mm | In distribution |
| SBHS0708 | Size 8 | In distribution |
| SAHH4218T | 42mm X 18mm | In distribution |
| SAHS1118 | Size 18 | In distribution |
| SAHS1206 | Size 6 | In distribution |
| SAHAF125 | 125° | In distribution |
| SAHH4817 | 48mm X 17mm | In distribution |
| SAHH4823T | 48mm X 23mm | In distribution |
| SAHH5723 | 57mm X 23mm | In distribution |
| SAHH4215T | 42mm X 15mm | In distribution |
| SAHS1217 | Size 17 | In distribution |
| SAHAF135 | 135° | In distribution |
| SAHH3920T | 39mm X 20mm | In distribution |
| SAHTNE12 | +12mm | In distribution |
| SBHS0192 | In distribution | |
| SBHS1209 | Size 9 | In distribution |
| SAHH5121T | 51mm X 21mm | In distribution |
| SBHS1210 | Size 10 | In distribution |
| SAHS1218 | Size 18 | In distribution |
| SBHS1219 | Size 19 | In distribution |
| SAHH3616T | 36mm X 16mm | In distribution |
| SBHS0720 | Size 20 | In distribution |
| SAHH4522 | 45mm X 22mm | In distribution |
| SBHS0718 | Size 18 | In distribution |
| SAHS1205 | Size 5 | In distribution |
| SAHS1110 | Size 10 | In distribution |
| SAHH5124T | 51mm X 24mm | In distribution |
| SAHH4221T | 42mm X 21mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Shoulder Innovations Inset Reverse Total Shoulder | Shoulder Innovations, Inc | 181 |
| Shoulder Innovations Humeral Short Stem System | Shoulder Innovations, Inc | 87 |
| Comprehensive® Shoulder System | Biomet Orthopedics | 70 |
| BIO-Modular Shoulder System | Biomet Orthopedics | 41 |
| Shoulder Innovations InSet 95 Humeral Stem | Shoulder Innovations, Inc | 40 |
| Comprehensive® SRS Instrument | Biomet Orthopedics | 36 |
| Comprehensive® SRS | Biomet Orthopedics | 25 |
| Inhance | Depuy (Ireland) | 25 |
| SMR Shoulder | Limacorporate | 20 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | Synthes (U.S.A.) LP | 19 |
| BI-Angular System | Biomet Orthopedics | 16 |
| Global Unite | Depuy (Ireland) | 16 |
Showing 12 of 71. All products under Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253592 | 2026-04-13 |
| K251098 | 2025-08-11 |
| K250848 | 2025-07-02 |
| K240876 | 2024-06-12 |
| K213856 | 2022-09-15 |
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.