510(k) Report

510(k) · Cleared

Cleared

HLS Kneetec System

K094013510(k) SpecialCleared May 5, 2011492-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 May 5, 2011 as substantially equivalent to K013906 (Tornier, 2002) and 5 other predicates after a 492-day review. Its family tree reaches back 3 generations to 1989. 1 later device descends from it.

Decided
May 5, 2011
Review
492 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
6

Its longest line of descent runs back 3 generations to K884796 (1989). 13 ancestors in all, the oldest K833921 (1984). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 2 other ancestors1991: 1 other ancestor1984: 1 other ancestor2000: 1 other ancestor1996: 1 other ancestor1992: 2 other ancestors1989: 1 other ancestor1987: 1 other ancestor2012: 1 descendant clearedK884796 · P.F.C.(TM) Modular Knee System · Johnson & Johnson Professionals, Inc. · 1989 · recalledK984158 · P.F.C. Modular Plus Offset Tibial Tray · Depuy, Inc. · 1999K013906 · HLS Noetos System · Tornier · 200219801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 6 other ancestors 1 generation forward: 1 descendant K013906 · HLS Noetos System · Tornier · 2002K984158 · P.F.C. Modular Plus Offset Tibial Tray · Depuy, Inc. · 1999K884796 · P.F.C.(TM) Modular Knee System · Johnson & Johnson Professionals, Inc. · 1989 · recalled0
  1. Root · 3 generations backK884796 P.F.C.(TM) Modular Knee SystemJohnson & Johnson Professionals, Inc. · 1989 · Recalled
  2. 2 generations backK984158 P.F.C. Modular Plus Offset Tibial TrayDepuy, Inc. · 1999
  3. 1 generation backK013906 HLS Noetos SystemTornier · 2002
  4. This deviceK094013 HLS Kneetec SystemTornier · 2011
  5. Descendant · cites it directly · 0 of its ownK111970 Kneetec PFJ&HLS Kneetec Patellar ComponentTornier · 2012

Most influential descendants

Showing 1 of 1 · See all
  • K111970Kneetec PFJ&HLS Kneetec Patellar ComponentTornier · 2012 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K884796P.F.C.(TM) Modular Knee SystemJohnson & Johnson Professionals, Inc.198916
−2K984158P.F.C. Modular Plus Offset Tibial TrayDepuy, Inc.1999—
−1K013906HLS Noetos SystemTornier2002—
0 (this device)K094013HLS Kneetec SystemTornier2011—
+1K111970Kneetec PFJ&HLS Kneetec Patellar ComponentTornier2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198710
198910
199110
199220
199610
199920
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
FIG. 1 — Lineage of K094013, 1989–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K013906HLS Noetos System
Summary page 1
…11 Classification panel: Orthopedic Product code: 87 JW- 5) Equivalent / Predicate device HLS Noetos System, Tornier, K013906 PFC Modular Plus Offset Tibial Tray, De~uy, Inc., K984158 Nex~en Complete Knee Solution Legacy Posterior Stabilized, Zi…
Tornier2002—
*K984158P.F.C. Modular Plus Offset Tibial Tray
Summary page 1
…ct code: 87 JW- 5) Equivalent / Predicate device HLS Noetos System, Tornier, K013906 PFC Modular Plus Offset Tibial Tray, De~uy, Inc., K984158 Nex~en Complete Knee Solution Legacy Posterior Stabilized, Zimmer, K991581I AGC Total Knee System, lBiomet, Inc., K8330…
Depuy, Inc.1999—
*K991581Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex Fixed Bearing…
Summary page 1
…LS Noetos System, Tornier, K013906 PFC Modular Plus Offset Tibial Tray, De~uy, Inc., K984158 Nex~en Complete Knee Solution Legacy Posterior Stabilized, Zimmer, K991581I AGC Total Knee System, lBiomet, Inc., K833021, K912245, K984054…
Zimmer, Inc.19997
*K833921Agc Total Knee Prosthesis
Our reading of the summary gave K833021, FDA’s number for Peri-Guard Pericardial Patch-Hernia (Genetic). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “AGC Total Knee System”.
Biomet, Inc.19842
*K912245Agc Revision Knee Prothesis
Summary page 1
…et Tibial Tray, De~uy, Inc., K984158 Nex~en Complete Knee Solution Legacy Posterior Stabilized, Zimmer, K991581I AGC Total Knee System, lBiomet, Inc., K833021, K912245, K984054 Section 5- P'age I/ p…
Biomet, Inc.19913
*K984054Agc V2 Revision Knee System
Summary page 1
…Tray, De~uy, Inc., K984158 Nex~en Complete Knee Solution Legacy Posterior Stabilized, Zimmer, K991581I AGC Total Knee System, lBiomet, Inc., K833021, K912245, K984054 Section 5- P'age I/ page 5…
Biomet, Inc.1999—

Also cleared against K013906: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K111970Kneetec PFJ&HLS Kneetec Patellar ComponentTornier20120

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 22 years and passes through 3 companies; a new generation was cleared every 8.8 years on median.
  • 8 of the 13 ancestors have a recall of any class.
  • Of its descendants, K111970 (Tornier, 2012) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K013906.

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. 2011, this device’s year, is highlighted.

FDA decisions per year · JWH

20in 2025

2007: 182008: 172009: 112010: 192011: 252012: 332013: 312014: 332015: 272016: 182017: 252018: 252019: 282020: 222021: 242022: 172023: 202024: 192025: 202026 (partial year): 12
2007high 33 (2012) · low 11 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWH

55in 2025

2007: 74 days median2008: 81 days median2009: 168 days median2010: 85 days median2011: 87 days median2012: 85 days median2013: 128 days median2014: 98 days median2015: 87 days median2016: 88 days median2017: 118 days median2018: 90 days median2019: 133 days median2020: 59 days median2021: 61 days median2022: 56 days median2023: 57 days median2024: 89 days median2025: 55 days median2026 (partial year): 63 days median
2007high 168 (2009) · low 55 (2025)2026

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

Recalls per year · JWH

2in 2025

2007: 142008: 102009: 1092010: 322011: 272012: 852013: 312014: 132015: 112016: 172017: 612018: 142019: 52020: 22021: 82022: 122023: 672024: 72025: 22026 (partial year): 4
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

2007: 1,3052008: 1,4832009: 1,8702010: 3,2862011: 5,1332012: 5,2032013: 6,1352014: 6,7222015: 6,8812016: 7,5862017: 12,2632018: 14,0712019: 14,9872020: 12,5922021: 9,4082022: 8,3642023: 8,9472024: 10,8282025: 9,306
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071874141,305
20081781101,483
2009111681091,870
20101985323,286
20112587275,133
20123385855,203
201331128316,135
20143398136,722
20152787116,881
20161888177,586
2017251186112,263
201825901414,071
201928133514,987
20202259212,592
2021246189,408
20221756128,364
20232057678,947
20241989710,828
2025205529,306
202612634—

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 intended for the revision of knee prostheses.

The HLS Kneetec is intended for cemented use only.

Indications for use as stated in the FDA summary.

Also cleared against K013906

1 other device cites the same predicate.

  • K032079HLS Noetos SystemTornier · 2003

More from Tornier

44 FDA decisions under this applicant name. See the company

  • K112144Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis Reversed Fracture…Tornier · 2012
  • K111970Kneetec PFJ&HLS Kneetec Patellar ComponentTornier · 2012
  • K111902Aequalis Shoulder SystemTornier · 2011
  • K100142Aequalis Reversed Shoulder ProsthesisTornier · 2010
  • K091870Tornier, Piton Fixation Implant SystemTornier · 2009

Recent decisions in JWH

The JWH category page

  • K262057GMK ExtensionMedacta International SA · 2026
  • K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts · 2026
  • K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd. · 2026
  • K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem…B-One Ortho, Corp. · 2026
  • K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc. · 2026

https://510kreport.com/device/K094013 · printed Nov 6, 2026

Cite this page

510(k) Report. “K094013: HLS Kneetec System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K094013

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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