510(k) K222816
- Device
- Opulent TiNbN Coated Knee
- Applicant
- Meril Healthcare Pvt. Ltd.
- 510(k) number
- K222816
- Product code
- JWH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-11-18
- Date received
- 2022-09-19
- Regulation
- 888.3560
- Classification name
- Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Clearance type
- Traditional
- Third party reviewed
- No
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#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases