510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K033242Substantially Equivalent

Knee Interpositional Mini-Repair System (Kimrs)

Imaging Therapeutics, Inc., San Mateo CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033242 is the FDA 510(k) clearance record for KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS), a class II device, cleared for Imaging Therapeutics, Inc. on under FDA product code HSH (Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)). FDA records list 2 510(k) clearances for Imaging Therapeutics, Inc., from to . As of , FDA records show no recalls naming K033242.

Clearance record

Decision date
Received
(85 days to decision)
Product code
HSH Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)
Regulation
21 CFR 888.3590
Device class
Class II
Review panel
Orthopedic
Applicant
Imaging Therapeutics, Inc. 1720 S. Amphlett Blvd., San Mateo CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HSH

Trailing 12 months

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

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