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
K253357Substantially Equivalent

b-ONE® Bipolar Head

b-ONE Ortho Corp., Cedar Knolls NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253357 is the FDA 510(k) clearance record for b-ONE® Bipolar Head, a class II device, cleared for B-One Ortho, Corp. on under FDA product code KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented). FDA records list 12 510(k) clearances for B-One Ortho, Corp., from to . As of , FDA records show no recalls naming K253357.

Clearance record

Decision date
Received
(195 days to decision)
Product code
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Regulation
21 CFR 888.3390
Device class
Class II
Review panel
Orthopedic
Applicant
B-One Ortho, Corp. 3 Wing Dr., Suite 259, Cedar Knolls NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KWY

Trailing 12 months
1 clearance under product code KWY in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KWY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260