SMR Shoulder
Bone Graft Instrument Set - Superior Right 15° Glenoid Stopper Jig
9manufacturers in China registered for this device type
209catalogue numbers in this listing
1510(k) clearance
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 | Limacorporate, Italy |
|---|---|
| FDA product code | KWS |
| Device type | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| 510(k) | K191963 |
| Record published | 2019-11-09 |
| Record revised | 2024-09-11 (version 8) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1304.15.023 | SHORT Dia. 23 mm | In distribution |
| Trial Extension for Reverse Humeral Body | In distribution | |
| Positioning Handle for ‘K-Wire Insertion | In distribution | |
| Trial Ecc. Glenosphere | Dia. 36mm | In distribution |
| Trial Liner | +6mm Dia. 36mm | In distribution |
| 3 Pegs Glenoid Cement Compactor | X-SMALL | In distribution |
| 1304.15.025 | SHORT Dia. 25 mm | In distribution |
| 3 Pegs Glenoid Drill | #LARGE | In distribution |
| 9013.52.314 | 140° | In distribution |
| Mask S for K-Wire Insertion | # S | In distribution |
| Trial Retentive Liner | +3mm | In distribution |
| Mask STD for K-Wire Insertion | # STD | In distribution |
| Glenosphere | Dia. 36mm S-R | In distribution |
| Bone Graft Instrument Set | 10 mm | In distribution |
| CTA Head | Dia 50mm | In distribution |
| Humeral Body Screw | In distribution | |
| 3 Pegs Glenoid Drill Guide | X-SMALL | In distribution |
| Bone Graft Instrument Set | SMALL-R 5 mm | In distribution |
| Guide for Conical Reamer | In distribution | |
| Trial CTA Head | Dia.46mm | In distribution |
| Liner | Dia 36mm #+3 | In distribution |
| Cannulated Reamer | In distribution | |
| External Cutting Jig | In distribution | |
| Cemented Revision Stem | dia.13mm, h.150mm | In distribution |
| Stop Guide | 30° | In distribution |
| Trial Glenoid 3 Pegs | #STD | In distribution |
| 9013.52.138 | In distribution | |
| Liner | Size STD | In distribution |
| Trial Adaptor | Dia.36mm | In distribution |
| Liner | Dia 36mm #+6 | In distribution |
| Glenosphere Orienter | Dia.40mm | In distribution |
| Trial Resection Stem | Dia.7mm H50mm | In distribution |
| Drill | Dia. 5 mm length 190 mm | In distribution |
| Trial Revision Stem | Dia.16mm H210mm | In distribution |
| 3 Pegs Removal Guide | #LARGE | In distribution |
| Liner | 6mm #S | In distribution |
| Stem | Dia. 11mm L32mm | In distribution |
| Trial Extension for Reverse Humeral Body | In distribution | |
| 3 Pegs Glenoid Cement Compactor | SMALL | In distribution |
| Mask Adaptor | In distribution | |
| Reverse Humeral Body | Size #S | In distribution |
| Stopper | In distribution | |
| Guide for Conical Reamer | Short | In distribution |
| Compactor | #X-LONG | In distribution |
| 3 Pegs Glenoid Drill | #SMALL | In distribution |
| Resection Mask Reverse Prosthesis | In distribution | |
| Mask S 20° Post. for K-Wire Insertion | # S 20° POST. | In distribution |
| 9013.52.014 | SHORT | In distribution |
| Guide for Resection Jig – LA | In distribution | |
| Trial Liner | STD Dia. 36mm | In distribution |
| 1304.15.017 | SHORT Dia. 17 mm | In distribution |
| Glenosphere Extractor | In distribution | |
| 9CC0.13.032 | Dia. 24 mm | In distribution |
| Trial CTA Head | Dia.42mm | In distribution |
| 9013.52.024 | In distribution | |
| 9013.52.128 | In distribution | |
| 3 Pegs Removal Guide | #STD | In distribution |
| Liner | Size S-R | In distribution |
| Liner | Dia. 40mm +6 | In distribution |
| Eccentrical Glenosphere | Dia. 36mm | In distribution |
| Bone Graft Instrument Set | Superior Right 15° | In distribution |
| Bone Graft Instrument Set | Superior Left 20° | In distribution |
| Glenosphere Impactor-Extractor | In distribution | |
| 9013.52.139 | In distribution | |
| 9013.52.129 | SHORT | In distribution |
| Liner | Dia 36mm #STD | In distribution |
| Glenosphere Orienter | In distribution | |
| Mask STD 20° Post. for K-Wire Insertion | # STD 20° POST. | In distribution |
| TT Metal Back Press | In distribution | |
| Liner | Size S | In distribution |
| Conical Reamer | In distribution | |
| Mask for K-Wire Insertion | XS | In distribution |
| Stopper | # SMALL-R | In distribution |
| Trial Glenosphere | Dia.40 mm | In distribution |
| Mask STD 10° for K-Wire Insertion | # STD 10° | In distribution |
| Glenosphere | Dia. 40 mm | In distribution |
| 1304.15.019 | SHORT Dia. 19 mm | In distribution |
| Reverse Resection Jig – LA | In distribution | |
| Bone Graft Instrument Set | In distribution | |
| Mask STD 20° for K-Wire Insertion | # STD 20° | In distribution |
| Trial Glenosphere | Dia. 36mm | In distribution |
| Compactor | #MEDIUM | In distribution |
| T Driver for Trial Glenosphere | In distribution | |
| 1304.15.021 | SHORT Dia. 21 mm | In distribution |
| Bone Graft Instrument Set | 20° | In distribution |
| Humeral Body Trial Screw | In distribution | |
| Humeral Body Impactor | In distribution | |
| Guide for Conical Reamer | In distribution | |
| Revision Stem | dia.14mm, h.150mm | In distribution |
| K-Wire Positioning Jig | LARGE 10° ANT | In distribution |
| Bone Graft Instrument Set | 15 mm | In distribution |
| Glenosphere | Dia. 36mm | In distribution |
| Trial Liner | +3mm | In distribution |
| Trial Liner | STD | In distribution |
| Drill | Dia. 5mm | In distribution |
| Bone Graft Instrument Set | STD 15° ANT | In distribution |
| Resurfacing Head | Dia. 54mm | In distribution |
| Reamer | SMALL-R #SHORT | In distribution |
| Mask S 10° for K-Wire Insertion | # S 10° | In distribution |
| Trial Resection Stem | Dia.10mm H50mm | In distribution |
| Trial Resection Stem | Dia.10mm H80mm | In distribution |
| Reverse Humeral Body | In distribution | |
| Compactor | #MEDIUM | In distribution |
| Trial Retentive Liner | STD | In distribution |
| K-Wire Positioning Jig | LARGE 0° | In distribution |
| Trial Resection Stem | Dia.7mm H80mm | In distribution |
| Liner | Dia. 40mm STD | In distribution |
| Trial CTA Head | Dia.50mm | In distribution |
| Pin | In distribution | |
| Cemented Revision Stem | dia.13mm, h.210mm | In distribution |
| 9013.52.152 | 140° | In distribution |
| Trial Modular Augment | H40mm | In distribution |
| Reverse Resection Jig – DPA | In distribution | |
| 9013.52.175 | 140° | In distribution |
| Trial Retentive Liner | +6mm | In distribution |
| Guide-Screw SMALL-R Trial Glenosph. | # SMALL-R | In distribution |
| Bone Graft Instrument Set | STD | In distribution |
| Trial Reverse Humeral Body | In distribution | |
| 3 Pegs Glenoid Drill Guide | LARGE | In distribution |
| Trial Reverse Humeral Body | In distribution | |
| Resurfacing Head | Dia. 42mm | In distribution |
| Trial Modular Spacer | H50mm | In distribution |
| Trial Glenoid 3 Pegs | #SMALL | In distribution |
| Bone Graft Reamer | # STANDARD | In distribution |
| Bone Graft Instrument Set | In distribution | |
| Cemented Glenoid | #XS | In distribution |
| 3 Pegs Glenoid Cement Compactor | LARGE | In distribution |
| Trial Reverse Humeral Body | Short | In distribution |
| Bone Graft Instrument Set | SMALL-R | In distribution |
| Resurfacing Head | Dia. 50mm | In distribution |
| CTA Head | Dia 42mm | In distribution |
| K-Wire Positioning Jig | # S 10° ANT. | In distribution |
| 1374.15.325 | Lat +5 mm – SMALL/STD | In distribution |
| Resurfacing CTA Head | Dia. 50mm | In distribution |
| Bone Graft Instrument Set | 5 mm | In distribution |
| Compactor | #X-LONG | In distribution |
| 3 Pegs Glenoid Cement Compactor | STD | In distribution |
| Trial Modular Spacer | H30mm | In distribution |
| Guide for Conical Reamer | In distribution | |
| Trial Modular Augment | H20mm | In distribution |
| Trial Glenoid 3 Pegs | SMALL | In distribution |
| Revision Stem | dia.13mm, h.150mm | In distribution |
| Connector + Screw | Size S-R | In distribution |
| Resurfacing Head | Dia. 46mm | In distribution |
| Bone Graft Reamer | # SMALL-R/SMALL | In distribution |
| Trial Glenosphere | Dia.36 mm | In distribution |
| Compactor Handle | In distribution | |
| Glenoid Reamer | X-SMALL | In distribution |
| Liner | 6mm #STD | In distribution |
| Trial Glenoid 3 Pegs | X-SMALL | In distribution |
| Trial CTA Head | Dia.54mm | In distribution |
| Bone Graft Instrument Set | STD 15° | In distribution |
| Cemented Glenoid | #L | In distribution |
| Extension | In distribution | |
| Liner | Dia. 40mm +6 | In distribution |
| Revision Stem | dia.15mm, h.150mm | In distribution |
| Resurfacing CTA Head | Dia. 42mm | In distribution |
| Guide for Conical Reamer | Short | In distribution |
| Cemented Glenoid | #STD | In distribution |
| Trial Glenoid 3 Pegs | #LARGE | In distribution |
| Bone Graft Reamer | # LARGE | In distribution |
| 3 Pegs Glenoid Drill Guide | STD | In distribution |
| 1360.50.820 | Dia 36mm #+6 | In distribution |
| Bone Graft Instrument Set | Posterior 20° | In distribution |
| Trial Reverse Humeral Body | In distribution | |
| Trial Liner | +3mm Dia. 36mm | In distribution |
| Reverse Prosthesis Inserter | In distribution | |
| Revision Stem | dia.16mm, h.150mm | In distribution |
| 1304.15.015 | SHORT Dia. 15 mm | In distribution |
| Liner | Dia 36mm #STD | In distribution |
| Eccentrical Glenosphere | Dia 40mm S-R | In distribution |
| 9CCS.13.003 | S | In distribution |
| Guide-Screw for Trial Glenosphere | In distribution | |
| Glenosphere | Dia. 40mm S-R | In distribution |
| Glenosphere | Dia. 40 mm | In distribution |
| Stop Guide | 30° | In distribution |
| Trial Reverse Humeral Body | Short | In distribution |
| Liner | Dia 36mm #+6 | In distribution |
| 3 Pegs Glenoid Drill Guide | SMALL | In distribution |
| Bone Graft Instrument Set | STD | In distribution |
| Eccentrical Glenosphere | Dia. 36mm S-R | In distribution |
| 9CCS.13.002 | S | In distribution |
| Trial Glenosphere | Dia. 36mm | In distribution |
| Bone Graft Instrument Set | 5 mm | In distribution |
| Bone Graft Instrument Set | In distribution | |
| Trial Revision Stem | Dia.16mm H210mm | In distribution |
| Bone Graft Instrument Set | 15° | In distribution |
| Trial Glenoid 3 Pegs | LARGE | In distribution |
| Long Stem for Glenosphere Extractor | Long | In distribution |
| 3 Pegs Glenoid Drill | #STD | In distribution |
| Bone Graft Instrument Set | 15 mm | In distribution |
| 9CCS.10.001 | 140° | In distribution |
| Liner | Size L | In distribution |
| K-Wire Positioning Jig | # STD 10° ANT. | In distribution |
| Reverse Humeral Body | In distribution | |
| Cemented Glenoid | #S | In distribution |
| K-Wire Positioning Jig | LARGE 10° | In distribution |
| Baseplate Extractor | In distribution | |
| Glenosphere Impactor-Extractor | In distribution | |
| Glenosphere Impactor | In distribution | |
| Conical Reamer | In distribution | |
| Bone Graft Instrument Set | 10 mm | In distribution |
| Cemented Revision Stem | dia.15mm, h.180mm | In distribution |
| Trial Glenoid 3 Pegs | STD | In distribution |
| Trial Ecc. Glenosphere | Dia. 36mm | In distribution |
| Trial Liner | +6mm | In distribution |
| Mask S 20° for K-Wire Insertion | # S 20° | In distribution |
| Liner | Dia 36mm #+3 | In distribution |
| Connector + Screw | Size S-R | 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 |
| 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 |
| Cofield | Smith & Nephew, Inc. | 76 |
Showing 12 of 326. All products under Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K213785 | 2022-05-13 |
Recalls Naming This Product
2 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 |
|---|---|---|---|---|---|---|---|
| Limacorporate S.p.A. | 510(k) number | 2023-02-21 | Class II | Process control | Shoulder glenoid fossa prosthesis was manufactured without tantalum markers so in the absence of the markers, on already implanted devices, a correct radiographic assessment of the hybrid glenoid position can be performed by the evaluation | 1 | |
| Limacorporate S.p.A. | 510(k) number | 2016-04-08 | Class II | Component design/selection | Complaints of intra-operative breakage of the glenosphere impactors/extractors. | 314 units | 2016-12-05 |
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.