510(k) Report

510(k) · Cleared

Cleared

Kneetec PFJ&HLS Kneetec Patellar Component

K111970510(k) TraditionalCleared Feb 23, 2012227-day reviewClass II21 CFR 888.3540

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

Tornier · KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer

Cleared on Feb 23, 2012 as substantially equivalent to K010100 (Howmedica Osteonics Corp., 2001) and 5 other predicates after a 227-day review. Its family tree reaches back 4 generations to 1989.

Decided
Feb 23, 2012
Review
227 days
Class
Class II
Product code
KRR
Recalls
None
Predicates
6

Its longest line of descent runs back 4 generations to K884796 (1989). 19 ancestors in all, the oldest K833921 (1984). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 2 other ancestors2004: 1 other ancestor2002: 1 other ancestor2001: 1 other ancestor1999: 2 other ancestors1991: 1 other ancestor1984: 1 other ancestor2000: 1 other ancestor1996: 1 other ancestor1992: 2 other ancestors1989: 1 other ancestor1987: 1 other ancestorK884796 · 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 · 2002K094013 · HLS Kneetec System · Tornier · 20111980198519901995200020052010
Other ancestors, by generation 1 generation back: 5 other ancestors2 generations back: 4 other ancestors3 generations back: 6 other ancestors K094013 · HLS Kneetec System · Tornier · 2011K013906 · 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 · 4 generations backK884796 P.F.C.(TM) Modular Knee SystemJohnson & Johnson Professionals, Inc. · 1989 · Recalled
  2. 3 generations backK984158 P.F.C. Modular Plus Offset Tibial TrayDepuy, Inc. · 1999
  3. 2 generations backK013906 HLS Noetos SystemTornier · 2002
  4. 1 generation backK094013 HLS Kneetec SystemTornier · 2011
  5. This deviceK111970 Kneetec PFJ&HLS Kneetec Patellar ComponentTornier · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K884796P.F.C.(TM) Modular Knee SystemJohnson & Johnson Professionals, Inc.198916
−3K984158P.F.C. Modular Plus Offset Tibial TrayDepuy, Inc.1999—
−2K013906HLS Noetos SystemTornier2002—
−1K094013HLS Kneetec SystemTornier2011—
0 (this device)K111970Kneetec PFJ&HLS Kneetec Patellar ComponentTornier2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198710
198910
199110
199220
199610
199920
200010
200110
200210
200410
200520
FIG. 1 — Lineage of K111970, 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 KRR? 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 KRR device

  1. #1 K231253 Overture Orthopaedics Patellofemoral Systemscore 5.6 · 1 generation · 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
*K010100Avon Patello-Femoral Joint Prosthesis
Summary page 1
…ssification panel: Orthopedic Product code: 87 KRR 6) Equivalent / Predicate device Avon Patello-Femoral Joint Prosthesis, Howmedica Osteonics Carp, 1(010100, K020841,1K041160, K(051948 Patello-Femoral Knee Implant, Journey. Smith & Nephew, Inc, K(051086 IlLS Kneetec, Tornier, K(094013…
Howmedica Osteonics Corp.2001—
*K020841Avon Patellar Component
Summary page 1
…ion panel: Orthopedic Product code: 87 KRR 6) Equivalent / Predicate device Avon Patello-Femoral Joint Prosthesis, Howmedica Osteonics Carp, 1(010100, K020841,1K041160, K(051948 Patello-Femoral Knee Implant, Journey. Smith & Nephew, Inc, K(051086 IlLS Kneetec, Tornier, K(094013…
Howmedica Osteonics Corp.2002—
*K041160Avon Extra-Small Patello-Femoral Replacement
Summary page 1
…: Orthopedic Product code: 87 KRR 6) Equivalent / Predicate device Avon Patello-Femoral Joint Prosthesis, Howmedica Osteonics Carp, 1(010100, K020841,1K041160, K(051948 Patello-Femoral Knee Implant, Journey. Smith & Nephew, Inc, K(051086 IlLS Kneetec, Tornier, K(094013…
Howmedica Osteonics Corp.2004—
*K051948Avon Patello-Femoral Joint Prosthesis
Summary page 1
…opedic Product code: 87 KRR 6) Equivalent / Predicate device Avon Patello-Femoral Joint Prosthesis, Howmedica Osteonics Carp, 1(010100, K020841,1K041160, K(051948 Patello-Femoral Knee Implant, Journey. Smith & Nephew, Inc, K(051086 IlLS Kneetec, Tornier, K(094013…
Howmedica Osteonics Corp.20057
*K051086Smith & Nephew Patello-Femoral Implant
Summary page 1
…evice Avon Patello-Femoral Joint Prosthesis, Howmedica Osteonics Carp, 1(010100, K020841,1K041160, K(051948 Patello-Femoral Knee Implant, Journey. Smith & Nephew, Inc, K(051086 IlLS Kneetec, Tornier, K(094013 Section 5 - Page…
Smith & Nephew, Inc.2005—
*K094013HLS Kneetec System
Summary page 2
…y: a femoral implant and a patella. The paldia of the knee joint may be resurfaced with the HI1S KNEETEC patellart component (found substantially equivalent in K09401 3) or KNEETEC PFJ patellar implant. 8) Materials The femoral implant is manufactured from chromium cobalt alloy (CoCr) acc…
Tornier2011—

Also cleared against K010100: 2 other devices →

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 23 years and passes through 3 companies; a new generation was cleared every 8.8 years on median.
  • 9 of the 19 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K010100.

How does its category compare?

All KRR devices

KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · KRR

1in 2023

2007: 22008: 32012: 12013: 12015: 12016: 12018: 12020: 12021: 12022: 12023: 1
2007high 3 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KRR

116in 2008

2008: 116 days median
2007high 116 (2008)2026

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

Recalls per year · KRR

3in 2022

2013: 12016: 12017: 22022: 3
2007high 3 (2022) · low 0 (2007)2026

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

Adverse event reports per year · KRR

36in 2025

2009: 122010: 62011: 32012: 92013: 92014: 262015: 182016: 142017: 152018: 142019: 162020: 62021: 82022: 92023: 122024: 252025: 36
2007high 36 (2025) · low 0 (2007)2025

MAUDE reports naming product code KRR, 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
20072—00
2008311600
20090—012
20100—06
20110—03
20121—09
20131—19
20140—026
20151—018
20161—114
20170—215
20181—014
20190—016
20201—06
20211—08
20221—39
20231—012
20240—025
20250—036
20260—0—

What is it indicated for?

The replacement of the patellofemoral joint with the KNEETEC PFJ device is indicated in the case of symptoms and serious signs affecting daily activities involving the joint:

- Serious degenerative arthritis of the patellofemoral joint,

- Failure of conservative procedures (realignment, arthroscopy, transfer of the tibial tuberosity) with the persistence of joint pain or dysfunction,

- Patellofemoral dislocation (dysplastic or other origin),

- Post-traumatic arthritis (patellar fracture).

The KNEETEC PFJ patellofemoral prosthesis is intended for cemented use only.

Indications for use as stated in the FDA summary.

Also cleared against K010100

2 other devices cite the same predicate.

  • K082088Mako Surgical Corp. Patellofemoral Knee Implant System IIMako Surgical Corp. · 2008
  • K051086Smith & Nephew Patello-Femoral ImplantSmith & Nephew, Inc. · 2005

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
  • K111902Aequalis Shoulder SystemTornier · 2011
  • K094013HLS Kneetec SystemTornier · 2011
  • K100142Aequalis Reversed Shoulder ProsthesisTornier · 2010
  • K091870Tornier, Piton Fixation Implant SystemTornier · 2009

Recent decisions in KRR

The KRR category page

  • K231253Overture Orthopaedics Patellofemoral SystemOverture Resurfacing, Inc. · 2023
  • K221048Episealer Patellofemoral SystemEpisurf Medical, Inc. · 2022
  • K211303Avon Patello-femoral Joint ProsthesisHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2021
  • K200122MOTO PFJ SystemMedacta International S.A. · 2020
  • K181280Patello-Femoral Wave (Kahuna) Arthroplasty SystemArthrosurface, Inc. · 20183 recalls

https://510kreport.com/device/K111970 · printed Nov 4, 2026

Cite this page

510(k) Report. “K111970: Kneetec PFJ&HLS Kneetec Patellar Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K111970

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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