510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K832302Substantially Equivalent

Mark I Total Knee Sys. Arthroplasty

Advanced Biosearch Assn., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K832302 is the FDA 510(k) clearance record for MARK I TOTAL KNEE SYS. ARTHROPLASTY, a class II device, cleared for Advanced Biosearch Assn. on under FDA product code MBV (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer). FDA records list 22 510(k) clearances for Advanced Biosearch Assn., from to . As of , FDA records show no recalls naming K832302.

Clearance record

Decision date
Received
(33 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
Advanced Biosearch Assn. 4221 Richmond Rd., NW, Walker MI
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