Shoulder Innovations Inset Reverse Total Shoulder
Shoulder Innovations Inset Reverse Total Shoulder - Posterior Retractor for help in holding back soft tissue during surgery
5manufacturers in China registered for this device type
181catalogue 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 |
| Record published | 2021-08-28 |
| Record revised | 2023-05-03 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2021-08-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RSA Variable Angle Screw Drill Guide | In distribution | |
| RSA Peripheral Screw Drill | In distribution | |
| RSA Fixed Angle Drill Guide Adapter | In distribution | |
| RSA Glenosphere Trial – Offset +3mm, 36mm | In distribution | |
| RSA Locking Screw Drill Guide | In distribution | |
| RSA 27mm Reamer (4 blade, 5° rake) | In distribution | |
| RSA Jacobs Hall Drive Adaptor | In distribution | |
| RSA AO Central Screw Drill | In distribution | |
| RSA Glenosphere Extractor | In distribution | |
| RSA M4 x 0.7 Thread Rescue Tool | In distribution | |
| Glenoid Baseplate Stopdrill – Classic Grit Blasted – Ø9.8 x 10mm | In distribution | |
| RSA 40mm Concave Humeral Cut Protector – Small | In distribution | |
| RSA Concave Humeral Cut Protector – Large | In distribution | |
| RSA Glenosphere Trial – Offset +3mm, 33mm | In distribution | |
| RSA Glenosphere Insert+Impact Standard Glenosphere | In distribution | |
| RSA Central Screw Drill Guide | In distribution | |
| Glenoid Baseplate Stopdrill – Standard Grit Blasted – Ø9.8 x 25mm | In distribution | |
| RSA Screw Caddy Lid | In distribution | |
| RSA Easy Access Offset Bearing Trial 36 x 3mm | In distribution | |
| RSA Angled Glenosphere Cleanup Reamer | In distribution | |
| RSA 33mm Low Profile Combo Reamer | In distribution | |
| RSA Glenoid Periphery Reamer – 36mm | In distribution | |
| RSA Baseplate Inserter Lower Handle | In distribution | |
| RSA Ratcheting Axial Handle | In distribution | |
| RSA Grit Blasted STD Baseplate Stem Drill – 15 mm Depth Stop | In distribution | |
| RSA 5° Angled Reamer Sleeve | In distribution | |
| RSA Case Base | In distribution | |
| MTO Posterior Retractor | In distribution | |
| RSA Tray Lid | In distribution | |
| RSA Easy Access Offset Bearing Trial 42 x 6mm | In distribution | |
| RSA I70 Instrument Case | In distribution | |
| RSA Easy Access Constrained Bearing Trial 39 x 10deg | In distribution | |
| RSA Baseplate Inserter Threaded Rod | In distribution | |
| RSA Easy Access Offset Bearing Trial 33 x 3mm | In distribution | |
| RSA Offset Twistlock Spacer, +3mm | In distribution | |
| RSA Glenoid Angle Measure Tool, 10deg | In distribution | |
| RSA Central Compression Screw 6.0mm x 35mm | In distribution | |
| RSA Central Compression Screw 6.0mm x 20mm | In distribution | |
| RSA Constrained Bearing Trial 33 x 10deg | In distribution | |
| RSA Angled Reamer Handle | In distribution | |
| RSA Offset Bearing Trial 42 x 3mm | In distribution | |
| RSA Central Compression Screw 6.0mm x 30mm | In distribution | |
| RSA Sizer Disk Handle – 10° + 15° Angle | In distribution | |
| RSA Easy Access Neutral Bearing Trial 36 x 0mm | In distribution | |
| RSA Glenoid Periphery Reamer – 42mm | In distribution | |
| Glenoid Baseplate Stopdrill – Classic TPS – Ø10.76 x 10mm | In distribution | |
| RSA Easy Access Constrained Bearing Trial 39 x 5deg | In distribution | |
| RSA Screw Depth Gauge – Handle Assembly | In distribution | |
| RSA Glenosphere Trial – Offset +6mm, 36mm | In distribution | |
| RSA Constrained Spacer, 10 Degree | In distribution | |
| RSA 15° Angled Reamer Sleeve | In distribution | |
| RSA Humeral Tray Extractor T-Handle | In distribution | |
| RSA Humeral Tray Trial Plus 6mm Assembly | In distribution | |
| RSA Offset Twistlock Spacer, +0mm | In distribution | |
| RSA Glenoid Angle Measure Tool, 15deg | In distribution | |
| RSA Handle Extractor | In distribution | |
| RSA Offset Twistlock T-Handle Assembly | In distribution | |
| RSA Sizer Disk 24 + 27 mm | In distribution | |
| RSA Constrained Bearing Trial 33 x 5deg | In distribution | |
| RSA Easy Access Constrained Bearing Trial 42 x 5deg | In distribution | |
| RSA 42mm Low Profile Combo Reamer | In distribution | |
| RSA Grit Blasted Baseplate Stem Drill – 25 mm Depth Stop | In distribution | |
| RSA Easy Access Neutral Bearing Trial 42 x 0mm | In distribution | |
| RSA Easy Access Offset Bearing Trial 42 x 3mm | In distribution | |
| RSA Easy Access Offset Bearing Trial 33 x 6mm | In distribution | |
| RSA Offset Twistlock Base Assembly | In distribution | |
| RSA Offset Bearing Trial 39 x 6mm | In distribution | |
| RSA Constrained Bearing Trial 33 x 5deg | In distribution | |
| RSA Glenosphere Trial – Offset +6mm, 33mm | In distribution | |
| RSA Screw Caddy | In distribution | |
| RSA Humeral Tray Trial 38mm x 9mm | In distribution | |
| RSA Constrained Bearing Trial 39 x 5deg | In distribution | |
| RSA Case Base | In distribution | |
| RSA Humeral Tray Trial 38mm x 0mm | In distribution | |
| RSA Glenoid Periphery Reamer 33-36mm Assembly | In distribution | |
| RSA Central Compression Screw 6.0mm x 50mm | In distribution | |
| RSA Easy Access Offset Bearing Trial 39 x 3mm | In distribution | |
| RSA Constrained Bearing Trial 42 x 10deg | In distribution | |
| Glenoid Baseplate Stopdrill – Standard TPS – Ø10.76 x 25mm | In distribution | |
| RSA Angled Reamer Driveshaft | In distribution | |
| RSA Constrained Bearing Trial 39 x 10deg | In distribution | |
| RSA Glenoid Periphery Reamer – 33mm | In distribution | |
| RSA Glenoid Periphery Reamer 39-42mm Assembly | In distribution | |
| RSA 24mm Baseplate Reamer (0 deg) | In distribution | |
| RSA Glenoid Angle Measure Tool, 5deg | In distribution | |
| RSA Humeral Tray Trial Neutral Assembly | In distribution | |
| RSA Glenosphere Inserter T-Handle | In distribution | |
| RSA Easy Access Constrained Bearing Trial 33 x 10deg | In distribution | |
| RSA Glenosphere Trial – Standard 33mm | In distribution | |
| RSA Glenoid Periphery Reamer – 39mm | In distribution | |
| RSA Easy Access Offset Bearing Trial 36 x 6mm | In distribution | |
| RSA Neutral Bearing Trial 39 x 0mm | In distribution | |
| Glenoid Baseplate Stopdrill – Standard TPS – Ø10.76 x 10mm | In distribution | |
| RSA Angled Glenosphere Cleanup Reamer | In distribution | |
| RSA STD Angled Glenosphere Cleanup Reamer | In distribution | |
| RSA Humeral Convex Reamer | In distribution | |
| RSA Easy Access Constrained Bearing Trial 42 x 10deg | In distribution | |
| RSA 27mm Angled Reamer (0 deg) | In distribution | |
| RSA Humeral Tray Trial Plus 9mm Assembly | In distribution | |
| RSA Tray | In distribution | |
| RSA Glenosphere Trial – Standard 36mm | In distribution | |
| RSA Glenosphere Trial – Offset +3mm, 39mm | In distribution | |
| RSA T20 Driver | In distribution | |
| RSA Offset Bearing Trial 33 x 6mm | In distribution | |
| RSA Constrained Spacer, 5 Degree | In distribution | |
| RSA Humeral Tray Trial 38mm x 6mm | In distribution | |
| RSA Glenoid Angle Measure Tool, 25deg | In distribution | |
| RSA Glenoid Angle Measure Tool, 30deg | In distribution | |
| RSA Glenoid Periphery Reamer Handle – Assembly | In distribution | |
| RSA Central Compression Screw 6.0mm x 40mm | In distribution | |
| RSA Porous Coated Baseplate Stem Drill – 15mm Depth Stop | In distribution | |
| RSA Offset Bearing Trial 33 x 3mm | In distribution | |
| RSA Central Compression Screw 6.0mm x 25mm | In distribution | |
| RSA Glenosphere Trial – Offset +6mm, 39mm | In distribution | |
| RSA 39mm Low Profile Combo Reamer | In distribution | |
| RSA Glenosphere Trial – Standard 39mm | In distribution | |
| RSA Angled Glenosphere Cleanup Reamer | In distribution | |
| RSA Screw Depth Gauge – Probe Assembly | In distribution | |
| RSA 10° Angled Reamer Sleeve | In distribution | |
| RSA Glenoid Reamer Wrench | In distribution | |
| RSA Central Compression Screw 6.0mm x 15mm | In distribution | |
| RSA Porous Coated Baseplate Stem Drill – 25mm Depth Stop | In distribution | |
| RSA Set Screw Driver | In distribution | |
| RSA T15 Driver | In distribution | |
| RSA 24mm Angled Reamer (0 deg) | In distribution | |
| 12 Gage Retractor | In distribution | |
| RSA Humeral Tray Extractor | In distribution | |
| RSA Neutral Bearing Trial 33 x 0mm | In distribution | |
| RSA Baseplate Inserter Threaded Handle | In distribution | |
| RSA Peripheral Screw Depth Gauge | In distribution | |
| RSA Offset Bearing Trial 42 x 6mm | In distribution | |
| RSA Glenoid Periphery Reamer – 36mm | In distribution | |
| RSA 36mm Low Profile Combo Reamer | In distribution | |
| RSA Glenoid Angle Measure Tool, 0deg | In distribution | |
| RSA Easy Access Neutral Bearing Trial 33 x 0mm | In distribution | |
| RSA Locking Screw Drill Guide | In distribution | |
| RSA Glenosphere Trial – Offset +6mm, 42mm | In distribution | |
| RSA 44mm Concave Humeral Cut Protector – Medium | In distribution | |
| RSA Neutral Bearing Trial 36 x 0mm | In distribution | |
| RSA Glenoid Periphery Reamer AO Drive Shaft | In distribution | |
| RSA Screw Depth Gauge | In distribution | |
| RSA Central Compression Screw 6.0mm x 45mm | In distribution | |
| Glenoid Baseplate Stopdrill – Standard TPS – Ø10.76 x 15mm | In distribution | |
| RSA Easy Access Constrained Bearing Trial 36 x 5deg | In distribution | |
| RSA Constrained Bearing Trial 36 x 10deg | In distribution | |
| RSA STD Angled Glenosphere Cleanup Reamer | In distribution | |
| RSA Easy Access Constrained Bearing Trial 36 x 10deg | In distribution | |
| RSA Glenoid Periphery Reamer Eccentric Assembly | In distribution | |
| RSA Grit Blasted STD Baseplate Stem Drill – 10 mm Depth Stop | In distribution | |
| RSA Glenosphere Trial – Standard 42mm | In distribution | |
| RSA Offset Bearing Trial 39 x 3mm | In distribution | |
| RSA 24mm Reamer (4 blade, 5° rake) | In distribution | |
| RSA Glenosphere Trial – Offset +3mm, 42mm | In distribution | |
| RSA Offset Bearing Trial 36 x 3mm | In distribution | |
| RSA Glenoid Angle Measure Tool, 20deg | In distribution | |
| RSA Easy Access Offset Bearing Trial 39 x 6mm | In distribution | |
| RSA Humeral Reamer Guide Post | In distribution | |
| RSA Screw Driver Handle | In distribution | |
| RSA Sizer Disk Handle – 0° + 5° Angle | In distribution | |
| RSA Glenoid Periphery Reamer – 39-42mm | In distribution | |
| RSA Offset Bearing Trial 36 x 6mm | In distribution | |
| RSA Glenosphere Inserter Threaded Rod | In distribution | |
| RSA Humeral Tray Trial Locking Bolt | In distribution | |
| RSA Neutral Bearing Trial 42 x 0mm | In distribution | |
| RSA Grit Blasted Baseplate Stem Drill – 15 mm Depth Stop | In distribution | |
| RSA Central Screw Drill | In distribution | |
| RSA Tray | In distribution | |
| RSA Baseplate Inserter Handle | In distribution | |
| RSA STD Angled Glenosphere Cleanup Reamer | In distribution | |
| RSA Central Screw Drill Sleeve | In distribution | |
| RSA Constrained Bearing Trial 42 x 5deg | In distribution | |
| RSA Angled Reamer Driveshaft | In distribution | |
| RSA Glenoid Periphery Reamer – 33mm | In distribution | |
| RSA 27mm Baseplate Reamer (0 deg) | In distribution | |
| RSA Central Screw Depth Gauge – Assembly | In distribution | |
| RSA Constrained Bearing Trial 36 x 5deg | In distribution | |
| RSA Glenosphere Inserter Handle | In distribution | |
| RSA Glenosphere Insert+Impact | In distribution | |
| RSA Humeral Tray Separator | In distribution | |
| RSA Easy Access Neutral Bearing Trial 39 x 0mm | In distribution | |
| RSA 0° Angled Reamer Sleeve | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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.