510(k) · Cleared

Cleared

HLS Noetos System

K013906510(k) TraditionalCleared Jul 17, 2002233-day reviewClass II21 CFR 888.3560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Tornier · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Jul 17, 2002 as substantially equivalent to K000232 (Corin USA, 2000) and 3 other predicates after a 233-day review. Its family tree reaches back 2 generations to 1989. 3 later devices descend from it.

Decided: Jul 17, 2002
Review: 233 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 4

Its longest line of descent runs back 2 generations to K884796 (1989). 8 ancestors in all, the oldest K872379 (1987). 3 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 2 generations backK884796 P.F.C.(TM) Modular Knee SystemJohnson & Johnson Professionals, Inc. · 1989 · Recalled
1 generation backK984158 P.F.C. Modular Plus Offset Tibial TrayDepuy, Inc. · 1999
This deviceK013906 HLS Noetos SystemTornier · 2002
Descendant · cites it directly · 1 of its ownK094013 HLS Kneetec SystemTornier · 2011
Descendant · 2 generations on · 0 of its ownK111970 Kneetec PFJ&HLS Kneetec Patellar ComponentTornier · 2012
Descendant · cites it directly · 0 of its ownK032079 HLS Noetos SystemTornier · 2003

Most influential descendants

Showing 3 of 3 · See all

K094013HLS Kneetec SystemTornier · 2011 · cites it directly1descendant
K111970Kneetec PFJ&HLS Kneetec Patellar ComponentTornier · 2012 · 2 generations on0descendants
K032079HLS Noetos SystemTornier · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K884796	P.F.C.(TM) Modular Knee System	Johnson & Johnson Professionals, Inc.	1989	16
−1	K984158	P.F.C. Modular Plus Offset Tibial Tray	Depuy, Inc.	1999	—
0 (this device)	K013906	HLS Noetos System	Tornier	2002	—
+1	K094013	HLS Kneetec System	Tornier	2011	—
+2	K111970	Kneetec PFJ&HLS Kneetec Patellar Component	Tornier	2012	—
+1	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
1999	1	0
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2011	1	0
2012	1	0

FIG. 1 — Lineage of K013906, 1989–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (4)

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	Applicant	Decided	Recalls
*	K000232	Rotaglide + Modular Knee System with Fixed Meniscus Summary page 1 …Class II Classification panel: Orthopedic Product code: 87JWH 5) Equivalent / Predicate device ROTAGLIDE + Total Knee System, Cork Medical (K000232), NfL4LL/BURSTEIN 11, Zimmer (K872379), PFC Modular Total Knee System, Demty (K984158), NEX-GEN Complete Knee Solution Legacy Pos…	Corin USA	2000	—
*	K872379	Insall/Burstein* II Modular Total Knee Summary page 1 …Orthopedic Product code: 87JWH 5) Equivalent / Predicate device ROTAGLIDE + Total Knee System, Cork Medical (K000232), NfL4LL/BURSTEIN 11, Zimmer (K872379), PFC Modular Total Knee System, Demty (K984158), NEX-GEN Complete Knee Solution Legacy Posterior Stabilized, Zimmer (K99 158 1).…	Zimmer, Inc.	1987	11
*	K984158	P.F.C. Modular Plus Offset Tibial Tray Summary page 1 …JWH 5) Equivalent / Predicate device ROTAGLIDE + Total Knee System, Cork Medical (K000232), NfL4LL/BURSTEIN 11, Zimmer (K872379), PFC Modular Total Knee System, Demty (K984158), NEX-GEN Complete Knee Solution Legacy Posterior Stabilized, Zimmer (K99 158 1). Tornier S.A.…	Depuy, Inc.	1999	—
*	K991581	Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex Fixed Bearing… Summary page 1 …ical (K000232), NfL4LL/BURSTEIN 11, Zimmer (K872379), PFC Modular Total Knee System, Demty (K984158), NEX-GEN Complete Knee Solution Legacy Posterior Stabilized, Zimmer (K99 158 1). Tornier S.A. i.5 - 1 === Page 2…	Zimmer, Inc.	1999	7

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K094013	HLS Kneetec System	Tornier	2011	1
K032079	HLS Noetos System	Tornier	2003	0

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 13 years and passes through 3 companies; a new generation was cleared every 9.8 years on median.
5 of the 8 ancestors have a recall of any class.
Of its descendants, K094013 (Tornier, 2011) has gone furthest, with 1 descendant of its own.

How does its category compare?

All JWH devices

JWH 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

2007high 33 (2012) · low 11 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWH

55in 2025

2007high 168 (2009) · low 55 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JWH

2in 2025

2007high 109 (2009) · low 2 (2020)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JWH

9,306in 2025

2007high 14,987 (2019) · low 1,305 (2007)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 cemented system with fixed tibial bearing is intended

for cemented use only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K013906 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013906: HLS Noetos System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013906

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026