510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853730Substantially Equivalent

Freeman-Samuelson Mark II Press-Fit Total Knee Rep

Protek, Inc., Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853730 is the FDA 510(k) clearance record for FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP, a class II device, cleared for Protek, Inc. on under FDA product code MBV (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer). FDA records list 25 510(k) clearances for Protek, Inc., from to . As of , FDA records show no recalls naming K853730.

Clearance record

Decision date
Received
(165 days to decision)
Product code
MBV Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
Regulation
21 CFR 888.3560
Device class
Class II
Review panel
Orthopedic
Applicant
Protek, Inc. 2601 Fortune Cir. E. Suite 105b, Indianapolis IN
Third party review
No

Clearances, product code MBV

Trailing 12 months

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

FDA records show no clearances under product code MBV in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MBV, 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