510(k) · Cleared
ClearedHLS Noetos System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tornier · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Oct 2, 2003 as substantially equivalent to K984158 (Depuy, Inc., 1999) and 2 other predicates after an 87-day review. Its family tree reaches back 3 generations to 1989.
- Decided
- Oct 2, 2003
- Review
- 87 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K884796 (1989). 10 ancestors in all, the oldest K872379 (1987). No later device cites it as a predicate yet.
- Root · 3 generations backK884796 P.F.C.(TM) Modular Knee SystemJohnson & Johnson Professionals, Inc. · 1989 · Recalled
- 2 generations backK984158 P.F.C. Modular Plus Offset Tibial TrayDepuy, Inc. · 1999
- 1 generation backK013906 HLS Noetos SystemTornier · 2002
- This deviceK032079 HLS Noetos SystemTornier · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K884796 | P.F.C.(TM) Modular Knee System | Johnson & Johnson Professionals, Inc. | 1989 | 16 |
| −2 | K984158 | P.F.C. Modular Plus Offset Tibial Tray | Depuy, Inc. | 1999 | — |
| −1 | K013906 | HLS Noetos System | Tornier | 2002 | — |
| 0 (this device) | K032079 | HLS Noetos System | Tornier | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 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 |
|---|---|---|---|
| * | K984158 | P.F.C. Modular Plus Offset Tibial TraySummary page 2…Implants Chirurgicaux 5) Equivalent / Predicate device - PFC Modular Total Knee System, DePuy (K984 158), - NEX-GEN Complete Knee Solution Legacy Constrained Condylar Knee L-CCK, Zimmer (K963 148)… | 1999 |
| * | K963148 | Nexgen Complete Knee SolutionSummary page 2…PFC Modular Total Knee System, DePuy (K984 158), - NEX-GEN Complete Knee Solution Legacy Constrained Condylar Knee L-CCK, Zimmer (K963 148) - HLS Noetos System, Tornier (KO13906). 6) Device description… | 1997 |
| * | K013906 | HLS Noetos System | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 14 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 6 of the 10 ancestors have a recall of any class.
- 4 other devices also cite its predicate K984158.
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 use as a total knee replacement for the relief of pain and significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis. This device is also indicated for the revision of knee prosthesis.
The HLS NOETOS Revision prosthesis is intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032079 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032079: HLS Noetos System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032079
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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