510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080029Substantially Equivalent

Mako Surgical Corp. Patellofemoral Knee Implant System

Mako Surgical Corp., Ft. Lauderdale FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080029 is the FDA 510(k) clearance record for MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM, a class II device, cleared for Mako Surgical Corp. on under FDA product code KRR (Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer). FDA records list 42 510(k) clearances for Mako Surgical Corp., from to . As of , FDA records show no recalls naming K080029.

Clearance record

Decision date
Received
(133 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
Mako Surgical Corp. 2555 Davie Rd., Suite 110, Ft. Lauderdale FL
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