# K111970: Kneetec PFJ&HLS Kneetec Patellar Component

- Pathway: 510(k) (Traditional)
- Applicant: Tornier
- Decided: Feb 23, 2012 after 227 days
- Product code: KRR (Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K884796 (1989). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010100: Avon Patello-Femoral Joint Prosthesis, Howmedica Osteonics Corp. (2001) Summary page 1.
- K020841: Avon Patellar Component, Howmedica Osteonics Corp. (2002) Summary page 1.
- K041160: Avon Extra-Small Patello-Femoral Replacement, Howmedica Osteonics Corp. (2004) Summary page 1.
- K051948: Avon Patello-Femoral Joint Prosthesis, Howmedica Osteonics Corp. (2005) Summary page 1.
- K051086: Smith & Nephew Patello-Femoral Implant, Smith & Nephew, Inc. (2005) Summary page 1.
- K094013: HLS Kneetec System, Tornier (2011) Summary page 2.

## Indications for use
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.

Source page: https://510kreport.com/device/K111970
Methodology: https://510kreport.com/methodology