510(k) K121835
- Device
- DOMED TRI-PEG PATELLA, HIGHLY CROSS LINKED DOMED TRI-PEG PATELLA WITH VE
- Applicant
- ENCORE MEDICAL, L.P.
- 510(k) number
- K121835
- Product code
- JWH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-07-20
- Date received
- 2012-06-22
- Regulation
- 888.3560
- Classification name
- Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAELA NORRIS
- Address
- 9800 Metric Blvd. Austin TX US 78758 78758
FDA Registration Numbers#
- 3010097171
- 3014302784
- 1226188
- 9617083
- 1424263
- 3010220595
- 3005852519
- 9617840
- 3016096064
- 1218882
- 3010178296
- 9614209
- 3013791180
- 3007963827
- 3006563559
- 3012130008
- 3008102042
- 3004450489
- 3002807295
- 2242737
- 1833920
- 3010057495
- 3004153240
- 1319660
- 3013014058
- 3011187779
- 3026776
- 3013176080
- 3002558847
- 3015542154
- 3012329926
- 1835572
- 2246552
- 1000517406
- 3008824097
- 3033796901
- 3009887475
- 3007353762
- 9681258
- 3009732568
- 1833986
- 3009888740
- 1531174
- 3040391045
- 3005596372
- 2030624
- 3010462278
- 3011015572
- 3004976965
- 3007516837
- 1223434
- 3008110533
- 1720929
- 1832228
- 1064858
- 1828288
- 3015916578
- 1038671
- 3008544874
- 3034676720
- 1020279
- 8043792
- 3000236920
- 1226544
- 3002806603
- 3009656988
- 1644408
- 1219655
- 3014644608
- 3009106092
- 3003639920
- 3005718816
- 9681642
- 3016090213
- 3030446955
- 3012491394
- 3007923096
- 3006694268
- 3009555440
Source Documents#
Other 510(k) Records For Product Code JWH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261458 | ATTUNE Total Knee System; ATTUNE Cementless Knee System | DePuy Ireland UC | 2026-06-25 |
| K261032 | NovoKnee (SteriKnee) | NovoSource | 2026-04-27 |
| K253793 | Materialise TKA Guide System | Materialise NV | 2026-01-06 |
| K252974 | EMPOWR Knee | Encore Medical L.P. | 2025-12-19 |
| K253197 | ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors | Depuy Ireland UC | 2025-11-19 |
| K253314 | Freedom Infinia™ Total Knee System | Maxx Orthopedics, Inc. | 2025-10-29 |
| K253144 | Freedom® Total Knee System – Titan PCK Components | Maxx Orthopedics, Inc. | 2025-10-22 |
| K252725 | Stem Extension Line (U2 Total Knee System—PSA Type) | United Orthopedic Corporation | 2025-09-25 |
| K251554 | Materialise TKA Guide System | Materialise NV | 2025-07-14 |
| K251776 | EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert) | Encore Medical L.P. | 2025-07-08 |
| K251241 | EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) | Encore Medical L.P. | 2025-07-02 |
| K251717 | Freedom® Total Knee System – Titanium Tibial Base Plate | Maxx Orthopedics, Inc. | 2025-06-26 |
| K242410 | NextStep Arthropedix Total Knee System | Nextstep Arthropedix | 2025-05-08 |
| K250889 | EXULT Knee Replacement System | Corentec Co., Ltd. | 2025-04-17 |
| K250677 | LEGION Total Knee System | Smith & Nephew, Inc. | 2025-04-02 |
Legacy Summary#
summary
FDA Review#
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