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
K892398Substantially Equivalent

Bipolar Hip System

Orthomet, Inc., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K892398 is the FDA 510(k) clearance record for BIPOLAR HIP SYSTEM, a class II device, cleared for Orthomet, Inc. on under FDA product code KXA (Prosthesis, Hip, Femoral, Resurfacing). FDA records list 60 510(k) clearances for Orthomet, Inc., from to . As of , FDA records show no recalls naming K892398.

Clearance record

Decision date
Received
(46 days to decision)
Product code
KXA Prosthesis, Hip, Femoral, Resurfacing
Regulation
21 CFR 888.3400
Device class
Class II
Review panel
Orthopedic
Applicant
Orthomet, Inc. 6301 Cecilia Cir., Minneapolis MN
Third party review
No

Clearances, product code KXA

Trailing 12 months

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

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