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
K240528Substantially Equivalent

b-ONE® Total Hip System

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

K240528 is the FDA 510(k) clearance record for b-ONE® Total Hip System, a class II device, cleared for B-One Ortho, Corp. on under FDA product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented). FDA records list 12 510(k) clearances for B-One Ortho, Corp., from to . As of , FDA records show no recalls naming K240528.

Clearance record

Decision date
Received
(266 days to decision)
Product code
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Regulation
21 CFR 888.3353
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 LZO

Trailing 12 months
8 clearances under product code LZO in the twelve months to October 2026, March 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LZO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20262
April 20261
May 20260
June 20261
July 20261
August 20260
September 20262
October 20260