510(k) · Cleared
ClearedDestiknee Total Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meril Healthcare Private Limited · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Dec 19, 2016 as substantially equivalent to K082019 (Maxx Orthopedics, Inc., 2009) and 2 other predicates after a 273-day review. Its family tree reaches back 4 generations to 1994. 3 later devices descend from it.
- Decided
- Dec 19, 2016
- Review
- 273 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K936079 (1994). 26 ancestors in all, the oldest K810520 (1981). 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK936079 Ecactech Porous Coated Finned Tibial Tray CompnentExactech, Inc. · 1994
- 3 generations backK011976 Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc. · 2001
- 2 generations backK030686 Optetrak Total Knee System - Molded Metal-Back Tibial ComponentExactech, Inc. · 2003
- 1 generation backK090411 Freedom Metal Backed Tibial ComponentMaxx Orthopedics, Inc. · 2009
- This deviceK160771 Destiknee Total Knee SystemMeril Healthcare Private Limited · 2016
- Descendant · cites it directly · 2 of its ownK172936 Destiknee™ Total Knee SystemMeril Healthcare Pvt., Ltd. · 2017
- Descendant · cites it directly · 1 of its ownK212839 Opulent TiNbN Coated KneeMeril Healthcare Pvt., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK222816 Opulent TiNbN Coated KneeMeril Healthcare Pvt., Ltd. · 2022
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K936079 | Ecactech Porous Coated Finned Tibial Tray Compnent | Exactech, Inc. | 1994 | — |
| −3 | K011976 | Optetrak Total Knee System Size 0/1 Delta (Line Extension) | Exactech, Inc. | 2001 | — |
| −2 | K030686 | Optetrak Total Knee System - Molded Metal-Back Tibial Component | Exactech, Inc. | 2003 | — |
| −1 | K090411 | Freedom Metal Backed Tibial Component | Maxx Orthopedics, Inc. | 2009 | — |
| 0 (this device) | K160771 | Destiknee Total Knee System | Meril Healthcare Private Limited | 2016 | — |
| +1 | K172936 | Destiknee™ Total Knee System | Meril Healthcare Pvt., Ltd. | 2017 | — |
| +1 | K212839 | Opulent TiNbN Coated Knee | Meril Healthcare Pvt., Ltd. | 2021 | — |
| +2 | 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 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K082019 | Freedom Total Knee SystemSummary page 5…Product Code: JWH Device Class: Class II 5.6 Predicate Device a. The Freedom® - Total Knee System (K082019, K090411, K091280) 5.7 Device Description: The DestikneeTM Total Knee System consists of following components. … | 2009 |
| * | K090411 | Freedom Metal Backed Tibial ComponentSummary page 5…Product Code: JWH Device Class: Class II 5.6 Predicate Device a. The Freedom® - Total Knee System (K082019, K090411, K091280) 5.7 Device Description: The DestikneeTM Total Knee System consists of following components. Femoral… | 2009 |
| * | K091280 | Freedom Total Knee Cruciate Retaining (CR) Femoral ComponentSummary page 5…ode: JWH Device Class: Class II 5.6 Predicate Device a. The Freedom® - Total Knee System (K082019, K090411, K091280) 5.7 Device Description: The DestikneeTM Total Knee System consists of following components. Femoral Component… | 2009 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 22 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
- 11 of the 26 ancestors have a recall of any class.
- Of its descendants, K172936 (Meril Healthcare Pvt., Ltd., 2017) has gone furthest, with 2 descendants of its own.
- 9 other devices also cite its predicate K082019.
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. 2016, 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 DestikneeTM- Total Knee System is indicated for patients with severe knee pain and disability due to:
Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis
Correction of functional deformities.
Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy.
Moderate valgus, varus, or flexion trauma.
Knee fractures untreatable by other methods.
The DestikneeTM Total Knee System 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/K160771 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160771: Destiknee Total Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160771
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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