DJO Surgical
Disc Ulna 2.5X53MM LT W/ E+ Brng
1manufacturer
74catalogue numbers in this listing
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 | Encore Medical, L.P., United States |
|---|---|
| FDA product code | JDC |
| Device type | Prosthesis, Elbow, Constrained, Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3150 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K013042 |
| Record published | 2017-04-12 |
| Record revised | 2025-07-14 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 540-45-100 | In distribution | |
| 540-44-150 | In distribution | |
| 540-34-150 | In distribution | |
| 540-00-000 | In distribution | |
| 540-35-100 | In distribution | |
| 540-35-150 | In distribution | |
| 540-45-200 | In distribution | |
| 540-00-001 | In distribution | |
| 540-44-100 | In distribution | |
| 540-24-115 | In distribution | |
| 540-00-004 | In distribution | |
| 540-63-115 | In distribution | |
| 540-55-115 | In distribution | |
| 540-34-100 | In distribution | |
| 540-15-075 | In distribution | |
| 540-44-200 | In distribution | |
| 540-36-100 | In distribution | |
| 540-64-075 | In distribution | |
| 540-13-155 | In distribution | |
| 540-65-115 | In distribution | |
| 540-23-155 | In distribution | |
| 540-00-003 | In distribution | |
| 540-24-075 | In distribution | |
| 540-46-100 | In distribution | |
| 540-54-115 | In distribution | |
| 540-45-150 | In distribution | |
| 540-23-115 | In distribution | |
| 540-13-075 | In distribution | |
| 540-53-115 | In distribution | |
| 540-00-005 | In distribution | |
| 540-36-200 | In distribution | |
| 540-14-075 | In distribution | |
| 540-53-075 | In distribution | |
| 540-54-155 | In distribution | |
| 540-65-075 | In distribution | |
| 540-15-155 | In distribution | |
| 540-46-200 | In distribution | |
| 540-52-053 | In distribution | |
| 540-33-124 | In distribution | |
| 540-43-084 | In distribution | |
| 540-64-155 | In distribution | |
| 540-23-075 | In distribution | |
| 540-55-075 | In distribution | |
| 540-36-150 | In distribution | |
| 540-52-084 | In distribution | |
| 540-33-084 | In distribution | |
| 540-01-001 | In distribution | |
| 540-22-053 | In distribution | |
| 540-24-155 | In distribution | |
| 540-64-115 | In distribution | |
| 540-12-084 | In distribution | |
| 540-22-084 | In distribution | |
| 540-35-200 | In distribution | |
| 540-25-075 | In distribution | |
| 540-25-115 | In distribution | |
| 540-63-075 | In distribution | |
| 540-53-155 | In distribution | |
| 540-34-200 | In distribution | |
| 540-14-155 | In distribution | |
| 540-01-005 | In distribution | |
| 540-46-150 | In distribution | |
| 540-25-155 | In distribution | |
| 540-00-002 | In distribution | |
| 540-43-124 | In distribution | |
| 540-13-115 | In distribution | |
| 540-62-084 | In distribution | |
| 540-12-053 | In distribution | |
| 540-62-053 | In distribution | |
| 540-15-115 | In distribution | |
| 540-65-155 | In distribution | |
| 540-55-155 | In distribution | |
| 540-54-075 | In distribution | |
| 540-63-155 | In distribution | |
| 540-14-115 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nexel® | Zimmer, Inc. | 78 |
| 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 | Biomet Orthopedics | 31 |
| 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
Recalls Naming This Product
5 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 |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2014-05-15 | Class II | Nonconforming Material/Component | Surface finish is different than specified. The implant has 30 grit blast on the exterior of the flange when the print calls for the glass bead blast. The patient may experience pain requiring surgical intervention. | 1 | 2015-03-16 |
| Biomet, Inc. | 510(k) number | 2011-12-14 | Not classified | Process change control | A Discovery Condyle Kit w/ Hexalobula was opened during an elbow joint replacement surgery, and was found to contain two male condyles. | 10 units | 2012-12-12 |
| Biomet, Inc. | 510(k) number | 2011-04-29 | Not classified | Packaging process control | The firm initiated this recall after becoming aware that a Discovery Condyle Kit with Hexalobula contained two male condyles instead of a male and female condyle. | 10 KITS | 2011-08-29 |
| Biomet, Inc. | 510(k) number | 2008-05-23 | Not classified | Packaging process control | The component in the package is not the correct size. | 6 | 2009-09-22 |
| Biomet, Inc. | 510(k) number | 2008-05-23 | Not classified | Packaging process control | The component in the package is not the correct size. | 5 | 2009-09-22 |
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.