DJO Surgical
EMPOWR REVISION KNEETM REV VVC+ TIBIAL INSERT e+, SZ 8, 19mm
8manufacturers in China registered for this device type
415catalogue numbers in this listing
4510(k) clearances naming this product code
3recalls on this code
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (2), 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 |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Encore Medical, L.P., United States |
|---|---|
| FDA product code | OIY |
| Device type | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K143242 |
| Record published | 2023-10-19 |
| Record revised | 2023-05-03 (version 6) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 348-12-755 | In distribution | |
| 341-13-711 | In distribution | |
| 242-02-107 | In distribution | |
| 344-10-709 | In distribution | |
| 801-05-740 | In distribution | |
| 801-05-739 | In distribution | |
| 346-16-708 | In distribution | |
| 315-0A-317 | In distribution | |
| 343-19-766 | In distribution | |
| 346-25-706 | In distribution | |
| 346-22-703 | In distribution | |
| 160-10-738 | In distribution | |
| 315-0C-319 | In distribution | |
| 801-05-816 | In distribution | |
| 391-13-705 | In distribution | |
| 344-19-704 | In distribution | |
| 348-19-708 | In distribution | |
| 346-12-101 | In distribution | |
| 348-14-755 | In distribution | |
| 348-22-708 | In distribution | |
| 215-0A-004 | In distribution | |
| 801-05-769 | In distribution | |
| 346-22-708 | In distribution | |
| 342-13-704 | In distribution | |
| 343-12-706 | In distribution | |
| 345-13-704 | In distribution | |
| 345-12-703 | In distribution | |
| 345-16-705 | In distribution | |
| 348-12-704 | In distribution | |
| 292-09-710 | In distribution | |
| 343-12-702 | In distribution | |
| 801-05-702 | In distribution | |
| 344-11-708 | In distribution | |
| 348-16-705 | In distribution | |
| 392-15-705 | In distribution | |
| 801-05-809 | In distribution | |
| 392-13-708 | In distribution | |
| 392-11-703 | In distribution | |
| 346-12-708 | In distribution | |
| 801-05-805 | In distribution | |
| 392-11-705 | In distribution | |
| 343-14-705 | In distribution | |
| 348-19-709 | In distribution | |
| 344-19-702 | In distribution | |
| 342-13-705 | In distribution | |
| 801-05-754 | In distribution | |
| 801-05-771 | In distribution | |
| 346-19-705 | In distribution | |
| 343-16-710 | In distribution | |
| 292-21-708 | In distribution | |
| 344-16-703 | In distribution | |
| 801-05-724 | In distribution | |
| 344-14-707 | In distribution | |
| 348-14-703 | In distribution | |
| 343-19-706 | In distribution | |
| 346-16-704 | In distribution | |
| 343-13-710 | In distribution | |
| 801-05-751 | In distribution | |
| 344-12-708 | In distribution | |
| 801-05-768 | In distribution | |
| 160-10-729 | In distribution | |
| 348-25-744 | In distribution | |
| 348-19-704 | In distribution | |
| 346-22-709 | In distribution | |
| 342-13-708 | In distribution | |
| 315-0C-008 | In distribution | |
| 346-10-706 | In distribution | |
| 348-12-709 | In distribution | |
| 346-25-708 | In distribution | |
| 801-05-704 | In distribution | |
| 292-18-704 | In distribution | |
| 344-13-711 | In distribution | |
| 348-19-766 | In distribution | |
| 292-18-702 | In distribution | |
| 120-01-729 | In distribution | |
| 344-16-704 | In distribution | |
| 343-14-709 | In distribution | |
| 801-05-539 | In distribution | |
| 315-0D-314 | In distribution | |
| 346-19-706 | In distribution | |
| 348-16-710 | In distribution | |
| 348-16-711 | In distribution | |
| 315-0B-314 | In distribution | |
| 315-0D-717 | In distribution | |
| 801-05-802 | In distribution | |
| 801-05-797 | In distribution | |
| 348-14-777 | In distribution | |
| 801-05-759 | In distribution | |
| 391-09-702 | In distribution | |
| 344-13-710 | In distribution | |
| 345-19-705 | In distribution | |
| 348-25-707 | In distribution | |
| 346-10-709 | In distribution | |
| 801-05-734 | In distribution | |
| 344-16-706 | In distribution | |
| 801-05-772 | In distribution | |
| 348-12-703 | In distribution | |
| 130-10-729 | In distribution | |
| 343-10-711 | In distribution | |
| 801-05-719 | In distribution | |
| 292-18-710 | In distribution | |
| 215-0B-006 | In distribution | |
| 345-16-703 | In distribution | |
| 346-16-702 | In distribution | |
| 344-12-705 | In distribution | |
| 345-11-702 | In distribution | |
| 346-12-100 | In distribution | |
| 391-13-702 | In distribution | |
| 346-25-703 | In distribution | |
| 242-01-105 | In distribution | |
| 341-13-705 | In distribution | |
| 801-05-795 | In distribution | |
| 348-22-702 | In distribution | |
| 392-15-703 | In distribution | |
| 344-16-710 | In distribution | |
| 392-19-710 | In distribution | |
| 345-19-702 | In distribution | |
| 346-14-710 | In distribution | |
| 344-12-710 | In distribution | |
| 315-0B-717 | In distribution | |
| 292-09-712 | In distribution | |
| 343-19-710 | In distribution | |
| 801-05-723 | In distribution | |
| 130-03-732 | In distribution | |
| 344-16-702 | In distribution | |
| 801-05-710 | In distribution | |
| 346-14-101 | In distribution | |
| 315-0D-010 | In distribution | |
| 391-13-706 | In distribution | |
| 343-16-704 | In distribution | |
| 346-16-707 | In distribution | |
| 315-0D-312 | In distribution | |
| 346-25-710 | In distribution | |
| 315-0A-312 | In distribution | |
| 391-13-708 | In distribution | |
| 292-11-702 | In distribution | |
| 346-16-101 | In distribution | |
| 315-0D-712 | In distribution | |
| 392-15-708 | In distribution | |
| 351-01-103 | In distribution | |
| 343-12-707 | In distribution | |
| 343-13-706 | In distribution | |
| 345-11-710 | In distribution | |
| 391-15-707 | In distribution | |
| 346-19-710 | In distribution | |
| 392-13-703 | In distribution | |
| 315-0C-714 | In distribution | |
| 120-01-738 | In distribution | |
| 292-09-702 | In distribution | |
| 346-19-707 | In distribution | |
| 801-05-725 | In distribution | |
| 343-10-707 | In distribution | |
| 801-05-755 | In distribution | |
| 346-14-755 | In distribution | |
| 801-05-794 | In distribution | |
| 343-14-702 | In distribution | |
| 344-14-708 | In distribution | |
| 343-11-708 | In distribution | |
| 801-05-714 | In distribution | |
| 346-22-702 | In distribution | |
| 120-01-726 | In distribution | |
| 346-10-710 | In distribution | |
| 346-22-711 | In distribution | |
| 343-10-704 | In distribution | |
| 150-01-726 | In distribution | |
| 346-25-755 | In distribution | |
| 348-10-702 | In distribution | |
| 801-05-782 | In distribution | |
| 242-02-106 | In distribution | |
| 346-22-704 | In distribution | |
| 348-12-702 | In distribution | |
| 391-13-710 | In distribution | |
| 343-16-709 | In distribution | |
| 292-15-702 | In distribution | |
| 345-13-705 | In distribution | |
| 342-13-702 | In distribution | |
| 801-05-787 | In distribution | |
| 346-10-755 | In distribution | |
| 345-10-703 | In distribution | |
| 801-05-554 | In distribution | |
| 346-10-702 | In distribution | |
| 348-25-709 | In distribution | |
| 342-11-705 | In distribution | |
| 346-25-766 | In distribution | |
| 346-14-705 | In distribution | |
| 801-05-765 | In distribution | |
| 343-14-704 | In distribution | |
| 343-13-705 | In distribution | |
| 341-13-709 | In distribution | |
| 801-05-722 | In distribution | |
| 343-16-755 | In distribution | |
| 348-22-707 | In distribution | |
| 345-11-708 | In distribution | |
| 292-13-710 | In distribution | |
| 801-05-820 | In distribution | |
| 801-05-774 | In distribution | |
| 348-10-704 | In distribution | |
| 348-16-703 | In distribution | |
| 343-11-710 | In distribution | |
| 343-19-711 | In distribution | |
| 346-25-100 | In distribution | |
| 346-22-710 | In distribution | |
| 215-0A-104 | In distribution | |
| 801-05-730 | In distribution | |
| 348-25-766 | In distribution | |
| 345-16-710 | In distribution | |
| 801-05-731 | In distribution | |
| 801-05-721 | In distribution | |
| 801-05-790 | In distribution | |
| 801-05-709 | In distribution | |
| 348-16-755 | In distribution | |
| 801-05-750 | In distribution | |
| 344-16-705 | In distribution | |
| 315-0C-317 | In distribution | |
| 215-12-075 | In distribution | |
| 348-19-711 | In distribution | |
| 343-16-707 | In distribution | |
| 315-0B-317 | In distribution | |
| 292-11-712 | In distribution | |
| 345-11-703 | In distribution | |
| 242-01-103 | In distribution | |
| 343-13-709 | In distribution | |
| 315-0A-714 | In distribution | |
| 343-16-706 | In distribution | |
| 801-05-748 | In distribution | |
| 343-14-707 | In distribution | |
| 801-05-814 | In distribution | |
| 801-05-813 | In distribution | |
| 315-0B-719 | In distribution | |
| 343-11-704 | In distribution | |
| 292-18-712 | In distribution | |
| 391-11-707 | In distribution | |
| 344-11-710 | In distribution | |
| 346-12-703 | In distribution | |
| 345-12-711 | In distribution | |
| 130-03-729 | In distribution | |
| 315-0C-314 | In distribution | |
| 391-15-705 | In distribution | |
| 343-19-707 | In distribution | |
| 344-19-703 | In distribution | |
| 292-09-706 | In distribution | |
| 346-22-100 | In distribution | |
| 315-0B-312 | In distribution | |
| 343-12-703 | In distribution | |
| 801-05-784 | In distribution | |
| 315-0C-717 | In distribution | |
| 348-12-710 | In distribution | |
| 343-16-705 | In distribution | |
| 392-11-704 | In distribution | |
| 130-10-735 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Persona® | Zimmer, Inc. | 552 |
| Genflex2 Total Knee System | Globus Medical, Inc. | 389 |
| Persona® Vivacit-E® | Zimmer, Inc. | 332 |
| Truliant, Activit-E | Exactech, Inc. | 272 |
| TriVerse Meniscal Insert PS | Signature Orthopaedics PTY Limited | 220 |
| U2™ Knee | United Orthopedic Corp. | 195 |
| BKS E-Vitalize | Ortho Development Corp. | 193 |
| Vanguard XP Instrumentation | Biomet Orthopedics | 169 |
| Attune | Depuy (Ireland) | 161 |
| Vanguard Complete Knee System | Biomet Orthopedics | 153 |
| EXp Tibial Inserts and Patellar Components | Globus Medical, Inc. | 144 |
| TriVerse Meniscal Insert AS | Signature Orthopaedics PTY Limited | 126 |
Showing 12 of 102. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K121727 | 2012-08-15 |
| K113756 | 2012-03-14 |
| K103223 | 2010-12-21 |
| K091956 | 2010-09-28 |
Recalls Naming This Product
27 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 |
|---|---|---|---|---|---|---|---|
| Encore Medical, L.P. | 510(k) number | 2026-02-16 | Class II | Process change control | Due to packaging discrepancy with incorrect product size mixed up. | 4 | |
| Encore Medical, L.P. | 510(k) number | 2026-02-16 | Class II | Process change control | Due to packaging discrepancy with incorrect product size mixed up. | 8 | |
| Encore Medical, L.P. | 510(k) number | 2026-01-15 | Class II | Process control | Knee and Humeral socket implants contain incorrect labeling. | 14 implants | |
| Encore Medical, L.P. | 510(k) number | 2026-01-05 | Class II | Labeling Change Control | 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices o | 19 | |
| Encore Medical, L.P. | 510(k) number | 2025-07-09 | Class II | Labeling Change Control | Knee implants contain incorrect labeling (size and/or side incorrect) | 18 implants | |
| Encore Medical, L.P. | 510(k) number | 2025-07-09 | Class II | Labeling Change Control | Knee implants contain incorrect labeling (size and/or side incorrect) | 40 implants | |
| Encore Medical, L.P. | 510(k) number | 2025-06-02 | Class II | Packaging change control | Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used. | 20 | |
| Encore Medical, L.P. | 510(k) number | 2025-06-02 | Class II | Packaging change control | Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used. | 20 | |
| Encore Medical, L.P. | 510(k) number | 2024-12-18 | Class II | Labeling Change Control | 5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product. | 33 | |
| Encore Medical, L.P. | 510(k) number | 2024-12-10 | Class II | Labeling Change Control | Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product. | 9 | |
| Encore Medical, L.P. | 510(k) number | 2023-08-22 | Class II | Labeling Change Control | Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee) | 36 | |
| Encore Medical, L.P. | 510(k) number | 2022-12-22 | Class II | Labeling Change Control | Tibial insert implant large boxes were labeled small and the small boxes were labeled large. If the incorrect labeling is identified this could lead to surgical delay and if the surgeon does not recognize the size discrepancy between the in | 216 | |
| Encore Medical, L.P. | 510(k) number | 2022-05-05 | Class II | Labeling mix-ups | A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If implanted, a risk may include leaving debris in the joint space. | 20 | |
| Encore Medical, L.P. | 510(k) number | 2021-05-12 | Class II | Mixed-up of materials/components | Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis. | 10 units | |
| Encore Medical, L.P. | 510(k) number | 2021-05-12 | Class II | Mixed-up of materials/components | Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis. | 10 units | |
| Encore Medical, L.P. | 510(k) number | 2021-02-05 | Class II | Nonconforming Material/Component | Incorrect assembly of a subcomponent by a vendor and as a result, the windows provided to show the size are facing the opposite direction. | 16 units | |
| Encore Medical, L.P. | 510(k) number | 2017-09-15 | Class II | Packaging process control | It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707. | 48 units | 2023-08-29 |
| Encore Medical, L.P. | 510(k) number | 2017-09-15 | Class II | Packaging process control | It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707. | 46 units | 2023-08-29 |
| Encore Medical, L.P. | 510(k) number | 2017-05-31 | Class II | Packaging process control | Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibial Insert. | 9 units | 2021-01-08 |
| Encore Medical, L.P. | 510(k) number | 2017-05-31 | Class II | Packaging process control | Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibial Insert. | 9 units | 2021-01-08 |
| Encore Medical, L.P. | 510(k) number | 2017-01-10 | Class II | Component design/selection | The Empowr PS Insert was reported as missing the impaction slot feature. | 24 units | 2017-05-11 |
| Encore Medical, L.P. | 510(k) number | 2016-11-15 | Class II | Mixed-up of materials/components | A size 4 Empowr baseplate was mislabeled as a size 6. The affected lot was laser marked as M6, marked with the lot number for the size 6 minus lot, and distributed as size 6 minus. | 7 units | 2017-01-20 |
| Encore Medical, L.P. | 510(k) number | 2016-09-19 | Class II | Under Investigation by firm | It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery. The current design of the captured box cut guides can create an instance where | 436 units | 2017-10-20 |
| Encore Medical, L.P. | 510(k) number | 2016-09-19 | Class II | Device Design | It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery. | 162 units | 2017-10-20 |
| Encore Medical, L.P. | 510(k) number | 2015-09-16 | Class II | Labeling design | The labeling is missing the size/diameter information. | 209 units | 2016-01-04 |
| Encore Medical, L.P. | 510(k) number | 2013-04-01 | Class II | Labeling mix-ups | U.S. Agent contacted Director Commercial Logistics, notifying him of incorrect color coded labels on two packages of e+tibial inserts. There were 8 e+ tibial inserts of the same lot number in Finished Goods as the two from the agency. Thes | 5 | 2013-07-01 |
| Encore Medical, L.P. | 510(k) number | 2012-08-09 | Class II | Incorrect or no expiration date | The firm is recalling one lot of 392-09-706, 3DKnee e+ Tibial insert, 9 mm, Size 6, Right. The shelf life labeling of specific lots for a component were found to be incorrect and were found to be expired. | 7 units | 2013-01-25 |
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.