510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K053094Substantially Equivalent

Orthoglide Medical Knee Implant and Instruments, Models 9063, 9064, 9065, 9060, 9062, 9057, 9056

Advanced Bio-Surfaces, Inc., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053094 is the FDA 510(k) clearance record for ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056, a class II device, cleared for Advanced Bio-Surfaces, Inc. on under FDA product code HSH (Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)). FDA records list 2 510(k) clearances for Advanced Bio-Surfaces, Inc., from to . As of , FDA records show no recalls naming K053094.

Clearance record

Decision date
Received
(95 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
Advanced Bio-Surfaces, Inc. 5909 Baker Rd., Minneapolis MN
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