510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K111970Substantially Equivalent

Kneetec Pfj&hls Kneetec Patellar Component

TORNIER Inc., Saint-Ismier Cedex, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111970 is the FDA 510(k) clearance record for KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT, a class II device, cleared for Tornier on under FDA product code KRR (Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer). FDA records list 140 510(k) clearances for Tornier, from to . As of , FDA records show no recalls naming K111970.

Clearance record

Decision date
Received
(227 days to decision)
Product code
KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
Regulation
21 CFR 888.3540
Device class
Class II
Review panel
Orthopedic
Applicant
Tornier 161 Rue Lavoisier, Saint-Ismier Cedex, FR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KRR

Trailing 12 months

FDA records hold no clearances under product code KRR in the trailing twelve months.

FDA records show no clearances under product code KRR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KRR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260