Shoulder Innovations Humeral Short Stem System
Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 14mm High x 38mm Diameter R21mm Articulation.
5manufacturers in China registered for this device type
87catalogue numbers in this listing
1510(k) clearance
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 | Shoulder Innovations, 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 | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K102670 |
| Record published | 2023-09-28 |
| Record revised | 2024-05-15 (version 4) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 56mm Open Norris Ring | In distribution | |
| 21mm x 56mm | In distribution | |
| 28mm Broach | In distribution | |
| 19mm x 50mm | In distribution | |
| Humeral Cut Protector – 56mm | In distribution | |
| Humeral Cut Protector – 52mm | In distribution | |
| Version Control | In distribution | |
| 40mm | In distribution | |
| 32mm x 6mm | In distribution | |
| Humeral Head Gauge | In distribution | |
| Humeral Cut Protector – 48mm | In distribution | |
| Humeral Cut Protector – 40mm | In distribution | |
| Sizer Disk – 48mm | In distribution | |
| 38mm Broach | In distribution | |
| Sizer Disk – 56mm | In distribution | |
| 44mm x 6mm | In distribution | |
| 15mm x 40mm | In distribution | |
| Multi-Use T-handle | In distribution | |
| 18mm x 44mm | In distribution | |
| 18 mm x 52mm | In distribution | |
| Humeral Head Distractor | In distribution | |
| 14mm x 38mm | In distribution | |
| 21mm x 52mm | In distribution | |
| 44mm Broach | In distribution | |
| 18mm x 56mm | In distribution | |
| Multi-Use Tool | In distribution | |
| 21mm x 44mm | In distribution | |
| 18mm x 46mm | In distribution | |
| Sizer Disk – 40mm | In distribution | |
| 48mm | In distribution | |
| 16mm x 42mm | In distribution | |
| 21mm x 52mm | In distribution | |
| Humeral Stem Drill | In distribution | |
| 18mm x 52mm | In distribution | |
| 44mm Open Norris Ring | In distribution | |
| Screwdriver | In distribution | |
| 15mm x 44mm | In distribution | |
| Calcar Planar – 61mm | In distribution | |
| Humeral Cut Protector – 44mm | In distribution | |
| Broach Impactor Handle | In distribution | |
| 18 mm x 40mm | In distribution | |
| Impaction Stand Assembly | In distribution | |
| 21mm x 48mm | In distribution | |
| 15mm x 52mm | In distribution | |
| 21mm x 44mm | In distribution | |
| Head Trial Insert | In distribution | |
| Calcar Planar – 45mm | In distribution | |
| Impaction Stand | In distribution | |
| 19mm x 50mm | In distribution | |
| 18mm x 40mm | In distribution | |
| 18mm x 48mm | In distribution | |
| 28mm x 6mm | In distribution | |
| 15mm x 40mm | In distribution | |
| 15mm x 44mm | In distribution | |
| 52mm | In distribution | |
| 2D Humeral Cut Guide | In distribution | |
| 21mm x 50mm | In distribution | |
| K-Wire 1.6mm | In distribution | |
| Sizer Disk. 44mm | In distribution | |
| 20mm x 52mm | In distribution | |
| K-Wire Guide | In distribution | |
| 21mm x 50mm | In distribution | |
| 17mm x 44mm | In distribution | |
| 44mm | In distribution | |
| 20mm x 52mm | In distribution | |
| 15mm x 48mm | In distribution | |
| 18mm x 46mm | In distribution | |
| 38mm x 6mm | In distribution | |
| 16mm x 42mm | In distribution | |
| 18mm x 48mm | In distribution | |
| Inspection Gauge | In distribution | |
| 15mm x 52mm | In distribution | |
| 14mm x 38mm | In distribution | |
| 21mm x 48mm | In distribution | |
| 18mm x 44mm | In distribution | |
| 52mm Open Norris Ring | In distribution | |
| K-Wire Guide | In distribution | |
| 48mm Open Norris Ring | In distribution | |
| Humeral Head Impactor | In distribution | |
| 21mm x 56mm | In distribution | |
| Sizer Disk – 52mm | In distribution | |
| 56mm | In distribution | |
| Calcar Planar – 53mm | In distribution | |
| Steinmann Pin | In distribution | |
| 32mm Broach | In distribution | |
| 40mm Open Norris Ring | In distribution | |
| 17mm x 44mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Shoulder Innovations Inset Reverse Total Shoulder | Shoulder Innovations, Inc | 181 |
| 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 |
| Identity™ | Zimmer, Inc. | 29 |
| 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 |
|---|---|
| K173824 | 2018-10-23 |
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.