510(k) · Cleared
ClearedFoundation Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Orthopedics, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Dec 27, 1996 as substantially equivalent to K923277 (Encore Orthopedics, Inc., 1993) after an 81-day review. Its family tree reaches back 1 generation to 1993. 21 later devices descend from it.
- Decided
- Dec 27, 1996
- Review
- 81 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K923277 (1993). 21 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK923277 Foundation Knee SystemEncore Orthopedics, Inc. · 1993 · Recalled
- This deviceK964008 Foundation Knee SystemEncore Orthopedics, Inc. · 1996
- Descendant · cites it directly · 20 of its ownK122239 Foundation Knee System with Tinbn Coating Foundation PS Knee System…Encore Medical L.P. · 2013
- Descendant · 2 generations on · 9 of its ownK152431 LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled…Waldemar Link GmbH & Co. KG · 2016 · Recalled
- Descendant · 2 generations on · 8 of its ownK182872 LINK GEMINI SL Total Knee SystemWaldemar Link GmbH & Co. KG · 2019
- Descendant · 3 generations on · 3 of its ownK202684 GMK Total Knee System - TiNbN CoatingMedacta International S.A. · 2020
- Descendant · 3 generations on · 2 of its ownK202924 LinkSymphoKnee SystemWaldemar Link GmbH & Co. KG · 2021 · Recalled
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K122239Foundation Knee System with Tinbn Coating Foundation PS Knee System with Tinbn Coating…Encore Medical L.P. · 2013 · cites it directly20descendants
- K152431LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx…Waldemar Link GmbH & Co. KG · 2016 · 2 generations on9descendants
- K182872LINK GEMINI SL Total Knee SystemWaldemar Link GmbH & Co. KG · 2019 · 2 generations on8descendants
- K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A. · 2020 · 3 generations on3descendants
- K202924LinkSymphoKnee SystemWaldemar Link GmbH & Co. KG · 2021 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923277 | Foundation Knee System | Encore Orthopedics, Inc. | 1993 | 4 |
| 0 (this device) | K964008 | Foundation Knee System | Encore Orthopedics, Inc. | 1996 | — |
| +1 | K122239 | Foundation Knee System with Tinbn Coating Foundation PS Knee System with Tinbn… | Encore Medical L.P. | 2013 | — |
| +2 | K152431 | LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System… | Waldemar Link GmbH & Co. KG | 2016 | 16 |
| +2 | K182872 | LINK GEMINI SL Total Knee System | Waldemar Link GmbH & Co. KG | 2019 | — |
| +3 | K202684 | GMK Total Knee System - TiNbN Coating | Medacta International S.A. | 2020 | — |
| +3 | K202924 | LinkSymphoKnee System | Waldemar Link GmbH & Co. KG | 2021 | 11 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 8 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K923277 | Foundation Knee SystemSummary page 1…e using other techniques. Comparable Features to Predicate Device(s): This device is similar in features, design and indications as the Foundation® Primary Knee System (K923277) and Biomet Maxim® Knee System. | 1993 |
| * | — | Biomet Maxim® Knee System Named without a submission number |
What descends from it? (21)
See all 211 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122239 | Foundation Knee System with Tinbn Coating Foundation PS Knee System with Tinbn Coating… | 2013 | 20 |
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?
The indications for use of this femoral insert are noninflammatory degenerative joint disease including osteoarthritis or traumatic arthritis, 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, rheumatoid arthritis, treatment of fractures that are unmanageable using other techniques.
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/K964008 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964008: Foundation 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/K964008
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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