Comprehensive® SRS
31 catalogue numbers from 211266, listed by Biomet Orthopedics, United States, under Prosthesis, Elbow, Constrained, Cemented. 1 manufacturer in China is registered for this product code.
1manufacturer
31catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | JDC |
| Device type | Prosthesis, Elbow, Constrained, Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3150 |
| 510(k) | K111746 |
| Record published | 2015-10-24 |
| Record revised | 2025-05-30 (version 7) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| 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 |
|---|---|---|
| 211266 | 30 MM | In distribution |
| 211251 | 60 MM | In distribution |
| 211238 | Ø12 mm 100mm Length | In distribution |
| 211239 | Ø14 mm 100mm Length | In distribution |
| 211276 | Ø14 mm 150 mm Length | In distribution |
| 211246 | Ø6 mm 200 mm Length | In distribution |
| 211230 | Ø6 mm 75mm Length | In distribution |
| 211287 | 15 MM 75 MM | In distribution |
| 211248 | Ø10 mm 200 mm Length | In distribution |
| 110029940 | Right 70 mm | In distribution |
| 211221 | 51 MM | In distribution |
| 211268 | LARGE SIZE | In distribution |
| 211277 | Ø44 mm 17 mm Height | In distribution |
| 211304 | 15 MM 200 MM | In distribution |
| 211289 | 19 MM 75 MM | In distribution |
| 211280 | Ø18 mm 75 mm Length | In distribution |
| 211243 | Ø10 mm 150 mm Length | In distribution |
| 211292 | 15 MM 100 MM | In distribution |
| 211294 | 5 MM 150 MM | In distribution |
| 405193 | 48 mm X 19 mm | In distribution |
| 211219 | Large 52 mm | In distribution |
| 211297 | 15 MM 150 MM | In distribution |
| 211231 | Ø8 mm 75mm Length | In distribution |
| 211233 | Ø12 mm 75mm Length | In distribution |
| 211223 | 71 MM | In distribution |
| 211281 | 20MM Ø 75MM LENGTH | In distribution |
| 211267 | SMALL SIZE | In distribution |
| 211284 | Ø14 mm 200 mm Length | In distribution |
| 211218 | Large 42 mm | In distribution |
| 211275 | Ø16 mm 100 mm Length | In distribution |
| 405194 | 54 mm X 22 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nexel® | Zimmer, Inc. | 78 |
| DJO Surgical | Encore Medical, L.P. | 74 |
| Tema Elbow | Limacorporate | 72 |
| Discovery Elbow System | Biomet Orthopedics | 72 |
| Arcos Modular Revision Hip System | Biomet Orthopedics | 58 |
| Latitude™ – Elbow | Tornier Inc. | 38 |
| Prosthesis, Elbow, Constrained, Cemented | Zimmer, Inc. | 37 |
| Latitude™ EV | Tornier Inc. | 36 |
| Comprehensive® SRS Instrument | Biomet Orthopedics | 30 |
| Solar | Howmedica Osteonics Corp | 27 |
| Zimmer® Nexel® Total Elbow | Zimmer, Inc. | 23 |
| Arrow | Teleflex Medical LLC | 13 |
Showing 12 of 28. All products under Prosthesis, Elbow, Constrained, Cemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K013042 | 2001-10-10 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2018-02-28 | Class II | Under Investigation by firm | During assembly, an SRS Humeral Distal Body implant failed to engage correctly at the point of reduction with a Discovery Elbow System Humeral Condyle. A mismatch between the screw holes in the Humeral Body & Elbow Condyle affects assembly | 634 | 2020-08-11 |
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.