SMR Shoulder
SMR Shoulder - TT HYBRID Glenoid Baseplate STANDARD LOW +3 - PEG L
6manufacturers in China registered for this device type
289catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Limacorporate, Italy |
|---|---|
| FDA product code | KWT |
| Device type | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3650 |
| 510(k) | K183042 |
| Record published | 2024-01-10 |
| 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 |
|---|---|---|
| 1352.15.051 | 140° Finned | In distribution |
| 1374.15.312 | Lat +2 mm – SMALL-R | In distribution |
| Stem Impactor | In distribution | |
| 9013.75.334 | 19° | In distribution |
| Humeral Head (CoCrMo) | Dia.54mm H.18 | In distribution |
| Trial Humeral Head | Dia. 40 H. 13 Ecc. 4mm | In distribution |
| Head Gauge | In distribution | |
| 1379.59.213 | STANDARD +3 – PEG S | In distribution |
| 1379.5G.030 | L | In distribution |
| Humeral Head (CoCrMo) | Dia.50mm H.17 | In distribution |
| 1379.59.101 | SMALL LOW +1 – PEG S | In distribution |
| Finned Trial Stem | Dia. 11mm | In distribution |
| Drive Shaft for Trial Glenosphere | In distribution | |
| 1379.59.133 | SMALL +3 – PEG L | In distribution |
| 1352.15.011 | 140° | In distribution |
| Compactor | #LONG | In distribution |
| 1379.59.223 | STANDARD LOW +3 – PEG L | In distribution |
| Trial Adaptor | Neutral Long | In distribution |
| Humeral Head (CoCrMo) | Dia.42mm H.17 | In distribution |
| Humeral Head (CoCrMo) | Dia.50mm H.22 | In distribution |
| Trial Humeral Head | Dia.44mm | In distribution |
| Humeral Head (CoCrMo) | Dia.42mm H.13 Ecc.4 | In distribution |
| 1379.59.321 | LARGE LOW +1 – PEG L | In distribution |
| 1352.15.015 | 140° | In distribution |
| SMALL-R Impactor Guide | # SMALL-R | In distribution |
| 1375.15.515 | 15°; S-R; Dia.27 mm | In distribution |
| SMALL-R Baseplate Extractor | In distribution | |
| 1379.59.111 | SMALL +1 – PEG S | In distribution |
| Humeral Body | Size L | In distribution |
| Trial Humeral Head | Dia. 52 H. 17mm | In distribution |
| Conical Trial Stem | Dia. 20 mm | In distribution |
| Trial Adaptor | # STD Ecc.2mm | In distribution |
| 1379.59.234 | STANDARD +4 – PEG L | In distribution |
| Glenoid Pusher | In distribution | |
| 1375.15.507 | 7°; S-R; Dia.27 mm | In distribution |
| Humeral Head (CoCrMo) | Dia.46mm H.14 | In distribution |
| Trial Adaptor | Long Ecc. 8mm | In distribution |
| 1304.15.023 | SHORT Dia. 23 mm | In distribution |
| 1379.59.200 | STANDARD LOW – PEG S | In distribution |
| 1360.54.816 | +3 mm Dia. 36 mm | In distribution |
| Humeral Cover | In distribution | |
| Trial Humeral Head | Dia. 40 H. 13mm Neutral | In distribution |
| Trial Stem | Dia. 23 mm | In distribution |
| 1379.59.134 | SMALL +4 – PEG L | In distribution |
| Trial Humeral Head | Dia.40 H.18mm | In distribution |
| Trial Humeral Head | Dia. 42 H. 12 Ecc. 4mm | In distribution |
| 1375.15.519 | 19°; S-R; Dia.27 mm | In distribution |
| 1379.59.102 | SMALL LOW +2 – PEG S | In distribution |
| Resection Mask | Right | In distribution |
| Drill Guide | In distribution | |
| Expansion Extractor | In distribution | |
| 1304.15.019 | SHORT Dia. 19 mm | In distribution |
| 1379.59.131 | SMALL +1 – PEG L | In distribution |
| 1304.15.017 | SHORT Dia. 17 mm | In distribution |
| 1379.59.333 | LARGE +3 – PEG L | In distribution |
| Trial Stem | Dia. 18 mm | In distribution |
| Humeral Head (CoCrMo) | Dia.54mm H.24 | In distribution |
| 1374.15.324 | Lat +4 mm – SMALL/STD | In distribution |
| Compactor | #LONG | In distribution |
| 1360.54.811 | STD Dia. 36 mm | In distribution |
| Glenoid Drill | SMALL/STD/LARGE | In distribution |
| Trial Stem | Dia. 21 mm | In distribution |
| Humeral Head (CoCrMo) | Dia.42mm H.12 Ecc.2 | In distribution |
| Humeral Head (CoCrMo) | Dia.46mm H.20 | In distribution |
| Reamer | SMALL-R #X-LONG | In distribution |
| Humeral Head (CoCrMo) | Dia.40mm H.13 Ecc.2 | In distribution |
| 1374.15.322 | Lat +2 mm – SMALL/STD | In distribution |
| Eccentrical Adaptor | Ecc.2mm | In distribution |
| 3 Pegs Removal Guide | #X-SMALL | In distribution |
| Cemented Stem | Dia 20mm | In distribution |
| Resection Jig | In distribution | |
| Pushrod Tip for Reverse | In distribution | |
| 1379.59.202 | STANDARD LOW +2 – PEG S | In distribution |
| Trial Humeral Body | Medium | In distribution |
| Conical Trial Stem | Dia. 14 mm | In distribution |
| 1304.15.016 | SHORT Dia. 16 mm | In distribution |
| Trial Stem | Dia. 16 mm | In distribution |
| Adaptor Taper | Eccentrical 6mm Long | In distribution |
| 1304.15.024 | SHORT Dia. 24 mm | In distribution |
| 1379.5G.324 | LARGE LOW +4 – PEG L | In distribution |
| 1379.59.311 | LARGE +1 – PEG S | In distribution |
| Eccentrical Adaptor | Ecc.2mm | In distribution |
| Eccentrical Adaptor | Ecc.8mm | In distribution |
| Pushrod Tip | In distribution | |
| Trial Humeral Head | Dia. 44 H. 13 Ecc. 4mm | In distribution |
| Trial Humeral Head | Dia.48mm | In distribution |
| Eccentrical Adaptor | Ecc.4mm | In distribution |
| Cemented Stem | Dia 14mm | In distribution |
| Inserter-Extractor Handle | In distribution | |
| Cemented Glenoid | Size STD | In distribution |
| Humeral Head (CoCrMo) | Dia.50mm H.21 | In distribution |
| Humeral Head (CoCrMo) | Dia.54mm H.19 | In distribution |
| 1375.15.565 | 15°X; S-R; Dia.27 mm | In distribution |
| 1379.59.301 | LARGE LOW +1 – PEG S | In distribution |
| 1304.15.014 | SHORT Dia. 14 mm | In distribution |
| 1379.5G.124 | SMALL LOW +4 – PEG L | In distribution |
| 1379.59.201 | STANDARD LOW +1 – PEG S | In distribution |
| Adaptor Taper | Neutral | In distribution |
| Humeral Head | Dia 42mm | In distribution |
| Trial Humeral Head | Dia. 44 H. 13 Ecc. 7mm | In distribution |
| Reamer | #X-LONG | In distribution |
| 1379.59.210 | STANDARD – PEG S | In distribution |
| Humeral Head (CoCrMo) | Dia.44mm H.13 Ecc.6 | In distribution |
| 1304.15.015 | SHORT Dia. 15 mm | In distribution |
| Humeral Reamer | Dia. 16 mm | In distribution |
| 1379.15.160 | SMALL | In distribution |
| Humeral Body | Size S | In distribution |
| Compactor | #SHORT | In distribution |
| Humeral Head | Dia 48mm | In distribution |
| Trial Humeral Head | Dia.46mm | In distribution |
| Humeral Head | Dia 46mm | In distribution |
| 1379.59.324 | LARGE LOW +4 – PEG L | In distribution |
| Humeral Head | Dia 54mm | In distribution |
| 1379.59.100 | SMALL LOW – PEG S | In distribution |
| Universal Stem for Extractor | In distribution | |
| Trial Humeral Head | Dia. 40 H. 13 Ecc. 7mm | In distribution |
| Finned Trial Stem | Dia. 13mm | In distribution |
| Trial Humeral Head | Dia.52mm | In distribution |
| Humeral Head (CoCrMo) | Dia.42mm H.12 Ecc.6 | In distribution |
| Liner | 6mm #L | In distribution |
| 1379.59.224 | STANDARD LOW +4 – PEG L | In distribution |
| Trial Stem | Dia. 20 mm | In distribution |
| Trial Stem | Dia. 17 mm | In distribution |
| Universal Stem for Extractor | In distribution | |
| Humeral Head (CoCrMo) | Dia.42mm H.18 | In distribution |
| Trial Stem | Dia. 19 mm | In distribution |
| Body Stopper | In distribution | |
| Cemented Glenoid | Size S-R | In distribution |
| 1379.59.214 | STANDARD +4 – PEG S | In distribution |
| 1360.54.815 | +3 mm Dia. 36 mm | In distribution |
| 1304.15.025 | SHORT Dia. 25 mm | In distribution |
| Trial Stem | Dia. 15 mm | In distribution |
| 1379.5G.322 | LARGE LOW +2 – PEG L | In distribution |
| Reamer | SMALL-R #MEDIUM | In distribution |
| Extractor | In distribution | |
| 1379.59.122 | SMALL LOW +2 – PEG L | In distribution |
| 1379.59.303 | LARGE LOW +3 – PEG S | In distribution |
| Cemented Glenoid | Size S | In distribution |
| Humeral Head (CoCrMo) | Dia.50mm H.16 | In distribution |
| 1304.15.016 | SHORT Dia. 16 mm | In distribution |
| Trial Humeral Head | Dia. 42 H. 12mm Neutral | In distribution |
| Anatomic Adaptor Sleeve | In distribution | |
| Cemented Stem | Dia 18mm | In distribution |
| Reamer | SMALL-R #LONG | In distribution |
| 1379.59.221 | STANDARD LOW +1 – PEG L | In distribution |
| 1304.15.026 | SHORT Dia. 26 mm | In distribution |
| Humeral Head (CoCrMo) | Dia.40mm H.13 Ecc.6 | In distribution |
| 9013.75.397 | In distribution | |
| 1375.15.510 | 10°; S-R; Dia.27 mm | In distribution |
| Humeral Head (CoCrMo) | Dia.44mm H.13 Ecc.2 | In distribution |
| Trial Humeral Body | Short | In distribution |
| 1304.15.018 | SHORT Dia. 18 mm | In distribution |
| Pliers for Trial Adaptor | In distribution | |
| Reamer | #LONG | In distribution |
| 1379.5G.330 | LARGE – PEG L | In distribution |
| Trial Humeral Head | Dia.52 H.23mm | In distribution |
| Eccentrical Adaptor | Ecc.8mm | In distribution |
| Liner | 6mm #S-R | In distribution |
| Humeral Head (CoCrMo) | Dia.46mm H.15 | In distribution |
| Extractor for Humeral Body | In distribution | |
| Glenoid Drill | SMALL/STD/LARGE | In distribution |
| 1379.59.233 | STANDARD +3 – PEG L | In distribution |
| Humeral Head | Dia 44mm | In distribution |
| Cemented Stem | Dia 16mm | In distribution |
| Trial Humeral Body | Medium | In distribution |
| Trial Humeral Head | Dia. 52 H. 22mm | In distribution |
| Threaded Extractor | In distribution | |
| Humeral Head (CoCrMo) | Dia.46mm H.19 | In distribution |
| 1379.59.112 | SMALL +2 – PEG S | In distribution |
| Conical Trial Stem | Dia. 24 mm | In distribution |
| Reamer | #SHORT | In distribution |
| Humeral Head | Dia 40mm | In distribution |
| 1379.59.130 | SMALL – PEG L | In distribution |
| 9013.75.398 | In distribution | |
| Reamer | #MEDIUM | In distribution |
| 9013.52.147 | In distribution | |
| 1379.15.170 | STANDARD | In distribution |
| 9013.75.121 | In distribution | |
| Trial Humeral Head | Dia.54mm | In distribution |
| Trial Adaptor | # STD Ecc.4mm | In distribution |
| 1375.15.560 | 10°X; S-R; Dia.27 mm | In distribution |
| 1304.15.014 | SHORT Dia. 14 mm | In distribution |
| Trial Mini Stem | Dia. 12 mm | In distribution |
| 9CCU.13.004 | Dia. 7,5 mm | In distribution |
| Pushrod Tip for LONG Humeral Body | In distribution | |
| Trial Adaptor | # STD | In distribution |
| 9013.75.142 | In distribution | |
| Compactor | #SHORT | In distribution |
| 1379.5G.120 | SMALL LOW – PEG L | In distribution |
| 1379.59.313 | LARGE +3- PEG S | In distribution |
| Trial Adaptor | Long Ecc. 4mm | In distribution |
| 1375.15.569 | 19°X; S-R; Dia.27 mm | In distribution |
| 1304.15.026 | SHORT Dia. 26 mm | In distribution |
| Trial Humeral Head | Dia.48 H.21mm | In distribution |
| 1379.59.123 | SMALL LOW +3 – PEG L | In distribution |
| Wrench | In distribution | |
| Trial Humeral Head | Dia.50mm | In distribution |
| Trial Humeral Head | Dia.44 H.19mm | In distribution |
| 1304.15.024 | SHORT Dia. 24 mm | In distribution |
| Glenoid Drill | In distribution | |
| 1379.59.314 | LARGE +4 – PEG S | In distribution |
| Trial Humeral Body | Long | In distribution |
| Trial Humeral Head | Dia. 48 H. 20mm | In distribution |
| 1379.59.132 | SMALL +2 – PEG L | In distribution |
| 1379.59.211 | STANDARD +1 – PEG S | In distribution |
| Trial Stem | Dia. 24 mm | In distribution |
| 1379.59.323 | LARGE LOW +3 – PEG L | In distribution |
| 1304.15.020 | SHORT Dia. 20 mm | In distribution |
| SMALL-R Cannulated Reamer | # SMALL-R | In distribution |
| 1379.59.113 | SMALL +3 – PEG S | In distribution |
| Trial Humeral Body | # SHORT | In distribution |
| Trial Humeral Head | Dia. 44 H. 14mm | In distribution |
| Glenoid Reamer | # SMALL-R/SMALL | In distribution |
| 1379.59.114 | SMALL +4 – PEG S | In distribution |
| Trial Humeral Head | Dia. 40 H. 17mm | In distribution |
| Trial Humeral Head | Dia. 54 H. 19mm | In distribution |
| 1374.15.314 | Lat +4 mm – SMALL-R | In distribution |
| Trial Humeral Head | Dia.42mm | In distribution |
| 9013.75.378 | 19° | In distribution |
| 1375.15.522 | +2 mm; S-R; Dia.27 mm | In distribution |
| 1379.5G.320 | LARGE LOW – PEG L | In distribution |
| 1360.54.810 | STD Dia. 36 mm | In distribution |
| 1375.15.524 | +4 mm; S-R; Dia.27 mm | In distribution |
| Trial Humeral Head | Dia. 50 H. 17mm | In distribution |
| Resection Mask | Left | In distribution |
| Adaptor Taper | Long | In distribution |
| Trial Humeral Head | Dia. 40 H. 12 Ecc. 2mm | In distribution |
| 9CC0.95.028 | Dia. 4,5 mm | In distribution |
| Cemented Stem | Dia 12mm | In distribution |
| Humeral Head (CoCrMo) | Dia.40mm H.12 Ecc.4 | In distribution |
| Trial Adaptor | # STD Ecc.8mm | In distribution |
| 9CC0.95.083 | Dia. 5,8 mm | In distribution |
| Trial Humeral Head | Dia. 42 H. 13 Ecc. 6mm | In distribution |
| 1304.15.018 | SHORT Dia. 18 mm | In distribution |
| Guide for Resection Jig | In distribution | |
| 1379.59.103 | SMALL LOW +3 – PEG S | In distribution |
| Glenoid Reamer | # LARGE | In distribution |
| Body Stopper | In distribution | |
| 1379.59.334 | LARGE +4 – PEG L | In distribution |
| Trial Humeral Head | Dia. 44 H. 13mm Neutral | In distribution |
| 9013.75.358 | 19° | In distribution |
| Cannulated Reamer | Dia. 7,5 mm | In distribution |
| Glenoid Impactor | # SMALL-R | In distribution |
| 1379.59.121 | SMALL LOW +1 – PEG L | In distribution |
| 1304.15.022 | SHORT Dia. 22 mm | In distribution |
| Impactor Guide | Small-R | In distribution |
| 1379.59.104 | SMALL LOW +4 – PEG S | In distribution |
| 1304.15.022 | SHORT Dia. 22 mm | In distribution |
| 1379.59.120 | SMALL LOW – PEG L | In distribution |
| Trial Stem | Dia. 14 mm | In distribution |
Showing 250 of 289 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 336 |
| Tornier Perform Humeral System | Tornier Inc. | 119 |
| Bigliani/Flatow® | Zimmer, Inc. | 119 |
| Trabecular Metal® | Zimmer, Inc. | 115 |
| Jarvis Glenoid Rerverse Shoulder Prosthesis | Fournitures Hospitalieres Industrie | 103 |
| Comprehensive® Shoulder System | Biomet Orthopedics | 86 |
| Alliance® | Zimmer, Inc. | 68 |
| Anatomical Shoulder™ | Zimmer, Inc. | 54 |
| Aetos Shoulder System | Smith & Nephew, Inc. | 53 |
| Perform™ Humeral System | Tornier Inc. | 47 |
| Bio-Modular® Shoulder System | Biomet Orthopedics | 43 |
| Catalyst CSR Shoulder System | Catalyst Orthoscience Inc | 39 |
Showing 12 of 164. All products under Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Recalls Naming This Product
3 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 | 2015-08-14 | Class II | Nonconforming Material/Component | The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble. | 110 units | 2016-02-26 |
| Limacorporate S.p.A. | 510(k) number | 2015-08-14 | Class II | Nonconforming Material/Component | The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble. | 93 units | 2016-02-26 |
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.