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 16, 2021 as substantially equivalent to K200912 (Maxx Orthopedics, Inc., 2020) and 2 other predicates after a 70-day review. Its family tree reaches back 7 generations to 1994. 1 later device descends from it.
- Decided
- Nov 16, 2021
- Review
- 70 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K936079 (1994). 39 ancestors in all, the oldest K810520 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK936079 Ecactech Porous Coated Finned Tibial Tray CompnentExactech, Inc. · 1994
- 6 generations backK011976 Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc. · 2001
- 5 generations backK030686 Optetrak Total Knee System - Molded Metal-Back Tibial ComponentExactech, Inc. · 2003
- 4 generations backK100900 Motivation Knee SystemEncore Medical L.P. · 2010 · Recalled
- 3 generations backK122239 Foundation Knee System with Tinbn Coating Foundation PS Knee System…Encore Medical L.P. · 2013
- 2 generations backK182872 LINK GEMINI SL Total Knee SystemWaldemar Link GmbH & Co. KG · 2019
- 1 generation backK200912 Freedom (R) - TiNbN Coated KneeMaxx Orthopedics, Inc. · 2020
- This deviceK212839 Opulent TiNbN Coated KneeMeril Healthcare Pvt., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK222816 Opulent TiNbN Coated KneeMeril Healthcare Pvt., Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K222816Opulent TiNbN Coated KneeMeril Healthcare Pvt., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K936079 | Ecactech Porous Coated Finned Tibial Tray Compnent | Exactech, Inc. | 1994 | — |
| −6 | K011976 | Optetrak Total Knee System Size 0/1 Delta (Line Extension) | Exactech, Inc. | 2001 | — |
| −5 | K030686 | Optetrak Total Knee System - Molded Metal-Back Tibial Component | Exactech, Inc. | 2003 | — |
| −4 | K100900 | Motivation Knee System | Encore Medical L.P. | 2010 | 4 |
| −3 | K122239 | Foundation Knee System with Tinbn Coating Foundation PS Knee System with Tinbn… | Encore Medical L.P. | 2013 | — |
| −2 | K182872 | LINK GEMINI SL Total Knee System | Waldemar Link GmbH & Co. KG | 2019 | — |
| −1 | K200912 | Freedom (R) - TiNbN Coated Knee | Maxx Orthopedics, Inc. | 2020 | — |
| 0 (this device) | K212839 | Opulent TiNbN Coated Knee | Meril Healthcare Pvt., Ltd. | 2021 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (3)
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 |
|---|---|---|---|
| * | K200912 | Freedom (R) - TiNbN Coated KneeSummary page 5…Maxx Opulent - Freedom® - TiNbN Predicate device Orthopedics K200912 TiNbN Coated Knee Inc., USA Coated Re… | 2020 |
| * | K160771 | Destiknee Total Knee SystemSummary page 5…Coated Knee Inc., USA Coated Reference Meril Healthcare Destiknee Total K160771 and Knee device Pvt. Ltd. Knee System K172936 5.7 Device Description: The Op… | 2016 |
| * | K172936 | Destiknee™ Total Knee SystemSummary page 5…Reference Meril Healthcare Destiknee Total K160771 and Knee device Pvt. Ltd. Knee System K172936 5.7 Device Description: The Opulent TiNbN Coated Knee comprises of a Femoral Component and Tibial Component as described belo… | 2017 |
| † | K082019 | Freedom Total Knee System | 2009 |
| † | K090411 | Freedom Metal Backed Tibial Component | 2009 |
| † | K091280 | Freedom Total Knee Cruciate Retaining (CR) Femoral Component | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222816 | Opulent TiNbN Coated Knee | 2022 | 0 |
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 27 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 15 of the 39 ancestors have a recall of any class.
- Of its descendants, K222816 (Meril Healthcare Pvt., Ltd., 2022) has gone furthest, with 0 descendants of its own.
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. 2021, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212839 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212839: Opulent TiNbN Coated Knee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212839
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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