510(k) · Cleared
ClearedNovoknee Total Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novosource, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Sep 16, 2013 as substantially equivalent to K123339 (Novosource, Inc., 2013) and 1 other predicate after a 124-day review. Its family tree reaches back 3 generations to 2002. 10 later devices descend from it.
- Decided
- Sep 16, 2013
- Review
- 124 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K021657 (2002). 10 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK021657 Uknee Total Knee SystemUnited Orthopedic Corp. · 2002
- 2 generations backK051640 U2 Total Knee SystemUnited Orthopedic Corp. · 2006 · Recalled
- 1 generation backK123339 TK1 Total Knee SystemNovosource, Inc. · 2013
- This deviceK131398 Novoknee Total Knee SystemNovosource, Inc. · 2013
- Descendant · cites it directly · 8 of its ownK150783 Progressive Orthopaedic Total Knee SystemThe Progressive Orthopaedic Company, LLC · 2015
- Descendant · 2 generations on · 3 of its ownK170753 Acculoc Total Knee SystemRootloc Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK261032 NovoKnee (SteriKnee)NovoSource · 2026
- Descendant · 3 generations on · 0 of its ownK231975 PNK Total Knee SystemTjc Life Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK210695 CPM Medical Consultants Tibial Revision Knee SystemCpm Medical Consultants, LLC · 2021
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K150783Progressive Orthopaedic Total Knee SystemThe Progressive Orthopaedic Company, LLC · 2015 · cites it directly8descendants
- K170753Acculoc Total Knee SystemRootloc Co., Ltd. · 2018 · 2 generations on3descendants
- K261032NovoKnee (SteriKnee)NovoSource · 2026 · cites it directly0descendants
- K231975PNK Total Knee SystemTjc Life Co., Ltd. · 2023 · 3 generations on0descendants
- K210695CPM Medical Consultants Tibial Revision Knee SystemCpm Medical Consultants, LLC · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K021657 | Uknee Total Knee System | United Orthopedic Corp. | 2002 | — |
| −2 | K051640 | U2 Total Knee System | United Orthopedic Corp. | 2006 | 1 |
| −1 | K123339 | TK1 Total Knee System | Novosource, Inc. | 2013 | — |
| 0 (this device) | K131398 | Novoknee Total Knee System | Novosource, Inc. | 2013 | — |
| +1 | K150783 | Progressive Orthopaedic Total Knee System | The Progressive Orthopaedic Company, LLC | 2015 | — |
| +2 | K170753 | Acculoc Total Knee System | Rootloc Co., Ltd. | 2018 | — |
| +1 | K261032 | NovoKnee (SteriKnee) | NovoSource | 2026 | — |
| +3 | K231975 | PNK Total Knee System | Tjc Life Co., Ltd. | 2023 | — |
| +2 | K210695 | CPM Medical Consultants Tibial Revision Knee System | Cpm Medical Consultants, LLC | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 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 |
|---|---|---|---|
| * | K123339 | TK1 Total Knee SystemSummary page 1…the Orthopedics panel/87 as a Class 11device. Device Product Code: JWH Predicate Device: NovaKnee Total Knee System (K123339) United Orthopedic U2 Total Knee (K051640) Device Description: The present 510k submission is… | 2013 |
| * | K051640 | U2 Total Knee SystemSummary page 1…evice Product Code: JWH Predicate Device: NovaKnee Total Knee System (K123339) United Orthopedic U2 Total Knee (K051640) Device Description: The present 510k submission is for a cruciate retaining (CR) version of the NovoKnee Total Knee System. T… | 2006 |
What descends from it? (10)
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 11 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K150783 (The Progressive Orthopaedic Company, LLC, 2015) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K123339.
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. 2013, 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 NovoKnee Total Knee System IsIndicated In knee arthroplasty for reduction or relief of pain and/or improved knee function Inskeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss-of joint configuration, particularly when there is pateilofemoral…
Read the full statement (110 words)
The NovoKnee Total Knee System IsIndicated In knee arthroplasty for reduction or relief of pain and/or improved knee function Inskeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss-of joint configuration, particularly when there is pateilofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities.
The NovoKnee Total Knee System may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. The NovoKnee Total Knee System isdesigned for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131398 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131398: Novoknee 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/K131398
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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