510(k) · Cleared
ClearedOpulent TiNbN Coated Knee
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meril Healthcare Pvt., Ltd. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Nov 18, 2022 as substantially equivalent to K212839 (Meril Healthcare Pvt., Ltd., 2021) after a 60-day review. Its family tree reaches back 8 generations to 1994.
- Decided
- Nov 18, 2022
- Review
- 60 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K936079 (1994). 40 ancestors in all, the oldest K810520 (1981). No later device cites it as a predicate yet.
- Root · 8 generations backK936079 Ecactech Porous Coated Finned Tibial Tray CompnentExactech, Inc. · 1994
- 7 generations backK011976 Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc. · 2001
- 6 generations backK030686 Optetrak Total Knee System - Molded Metal-Back Tibial ComponentExactech, Inc. · 2003
- 5 generations backK100900 Motivation Knee SystemEncore Medical L.P. · 2010 · Recalled
- 4 generations backK122239 Foundation Knee System with Tinbn Coating Foundation PS Knee System…Encore Medical L.P. · 2013
- 3 generations backK182872 LINK GEMINI SL Total Knee SystemWaldemar Link GmbH & Co. KG · 2019
- 2 generations backK200912 Freedom (R) - TiNbN Coated KneeMaxx Orthopedics, Inc. · 2020
- 1 generation backK212839 Opulent TiNbN Coated KneeMeril Healthcare Pvt., Ltd. · 2021
- This deviceK222816 Opulent TiNbN Coated KneeMeril Healthcare Pvt., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K936079 | Ecactech Porous Coated Finned Tibial Tray Compnent | Exactech, Inc. | 1994 | — |
| −7 | K011976 | Optetrak Total Knee System Size 0/1 Delta (Line Extension) | Exactech, Inc. | 2001 | — |
| −6 | K030686 | Optetrak Total Knee System - Molded Metal-Back Tibial Component | Exactech, Inc. | 2003 | — |
| −5 | K100900 | Motivation Knee System | Encore Medical L.P. | 2010 | 4 |
| −4 | K122239 | Foundation Knee System with Tinbn Coating Foundation PS Knee System with Tinbn… | Encore Medical L.P. | 2013 | — |
| −3 | K182872 | LINK GEMINI SL Total Knee System | Waldemar Link GmbH & Co. KG | 2019 | — |
| −2 | K200912 | Freedom (R) - TiNbN Coated Knee | Maxx Orthopedics, Inc. | 2020 | — |
| −1 | K212839 | Opulent TiNbN Coated Knee | Meril Healthcare Pvt., Ltd. | 2021 | — |
| 0 (this device) | K222816 | Opulent TiNbN Coated Knee | Meril Healthcare Pvt., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JWH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JWH device
- #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K212839 | Opulent TiNbN Coated KneeSummary page 5…pulent TiNbN Opulent TiNbN Predicate device Healthcare Pvt. K212839 Coated Knee Coated Knee Ltd.… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 15 of the 40 ancestors have a recall of any class.
How does its category compare?
All JWH devicesJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · JWH
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 2025
MAUDE reports naming product code JWH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 18 | 74 | 14 | 1,305 |
| 2008 | 17 | 81 | 10 | 1,483 |
| 2009 | 11 | 168 | 109 | 1,870 |
| 2010 | 19 | 85 | 32 | 3,286 |
| 2011 | 25 | 87 | 27 | 5,133 |
| 2012 | 33 | 85 | 85 | 5,203 |
| 2013 | 31 | 128 | 31 | 6,135 |
| 2014 | 33 | 98 | 13 | 6,722 |
| 2015 | 27 | 87 | 11 | 6,881 |
| 2016 | 18 | 88 | 17 | 7,586 |
| 2017 | 25 | 118 | 61 | 12,263 |
| 2018 | 25 | 90 | 14 | 14,071 |
| 2019 | 28 | 133 | 5 | 14,987 |
| 2020 | 22 | 59 | 2 | 12,592 |
| 2021 | 24 | 61 | 8 | 9,408 |
| 2022 | 17 | 56 | 12 | 8,364 |
| 2023 | 20 | 57 | 67 | 8,947 |
| 2024 | 19 | 89 | 7 | 10,828 |
| 2025 | 20 | 55 | 2 | 9,306 |
| 2026 | 12 | 63 | 4 | — |
What is it indicated for?
The Opulent TiNbN Coated Knee is indicated for the following:
• Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, and polyarthritis.
• Correction of functional deformities.
• Post-traumatic loss of knee join contour, particularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy.
• Moderate valgus, varus, or flexion trauma.
• Knee fractures untreatable by other methods.
• Revision surgery where sufficient bone and soft tissue integrity are present.
The Opulent TiNbN Coated Knee is intended for cemented use only. This device is for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222816 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222816: Opulent TiNbN Coated Knee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222816
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026