510(k) · Cleared
ClearedNexgen Complete Knee Solution Legacy Posterior Stabilized Flex Fixed Bearing and Tivanium TI-6AL-4V Alloy Femoral
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Oct 13, 2006 as substantially equivalent to K991581 (Zimmer, Inc., 1999) after a 28-day review. Its family tree reaches back 1 generation to 1999. 25 later devices descend from it.
- Decided
- Oct 13, 2006
- Review
- 28 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991581 (1999). 25 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK991581 Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS)…Zimmer, Inc. · 1999 · Recalled
- This deviceK062768 Nexgen Complete Knee Solution Legacy Posterior Stabilized Flex Fixed…Zimmer, Inc. · 2006
- Descendant · cites it directly · 16 of its ownK142787 Zimmer Persona Personalized Knee SystemZimmer, Inc. · 2014
- Descendant · 2 generations on · 15 of its ownK172524 Zimmer Persona Personalized Knee SystemZimmer, Inc. · 2018
- Descendant · 3 generations on · 6 of its ownK173890 GMK Sphere - Kinematic AlignmentMedacta International S.A. · 2018
- Descendant · cites it directly · 5 of its ownK173057 Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 4 of its ownK181947 Persona Revision Knee SystemZimmer, Inc. · 2018 · Recalled
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K142787Zimmer Persona Personalized Knee SystemZimmer, Inc. · 2014 · cites it directly16descendants
- K172524Zimmer Persona Personalized Knee SystemZimmer, Inc. · 2018 · 2 generations on15descendants
- K173890GMK Sphere - Kinematic AlignmentMedacta International S.A. · 2018 · 3 generations on6descendants
- K173057Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc. · 2018 · cites it directly5descendants
- K181947Persona Revision Knee SystemZimmer, Inc. · 2018 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991581 | Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex… | Zimmer, Inc. | 1999 | 7 |
| 0 (this device) | K062768 | Nexgen Complete Knee Solution Legacy Posterior Stabilized Flex Fixed Bearing… | Zimmer, Inc. | 2006 | — |
| +1 | K142787 | Zimmer Persona Personalized Knee System | Zimmer, Inc. | 2014 | — |
| +2 | K172524 | Zimmer Persona Personalized Knee System | Zimmer, Inc. | 2018 | — |
| +3 | K173890 | GMK Sphere - Kinematic Alignment | Medacta International S.A. | 2018 | — |
| +1 | K173057 | Zimmer Knee Joint Replacement Prostheses MR Labeling | Zimmer, Inc. | 2018 | 2 |
| +2 | K181947 | Persona Revision Knee System | Zimmer, Inc. | 2018 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K991581 | Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex Fixed Bearing…Summary page 1…Bearing Femoral and Articular Surface Components, manufactured by Zimmer, Inc., K991581, cleared July 30, 1999 Device Description: The LPS-Flex Fi… | 1999 |
What descends from it? (25)
See all 254 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?
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.
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?
This device is indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. - Collagen disorders, and/or avascular necrosis of the femoral condyle. - Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy - Moderate valgus, varus, or flexion deformities. - The salvage of previously failed surgical…
Read the full statement (140 words)
This device is indicated for patients with severe knee pain and disability due to:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- Collagen disorders, and/or avascular necrosis of the femoral condyle.
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
- Moderate valgus, varus, or flexion deformities.
- The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
Specific uses with LPS-Flex femorals:
- Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range.
- The LPS-Flex femoral, when used with the LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062768 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062768: Nexgen Complete Knee Solution Legacy Posterior Stabilized Flex Fixed Bearing and Tivanium TI-6AL-4V Alloy Femoral.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062768
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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