510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K180446Substantially Equivalent

b-ONE Total Knee System

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

K180446 is the FDA 510(k) clearance record for b-ONE Total Knee System, a class II device, cleared for B-One Ortho, Corp. on under FDA product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer). FDA records list 12 510(k) clearances for B-One Ortho, Corp., from to . As of , FDA records show no recalls naming K180446.

Clearance record

Decision date
Received
(234 days to decision)
Product code
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Regulation
21 CFR 888.3560
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 JWH

Trailing 12 months
14 clearances under product code JWH in the twelve months to October 2026, September 2026 the highest month at 6.
Show the numbers
Monthly 510(k) clearances under FDA product code JWH, trailing twelve months
MonthClearances
November 20251
December 20251
January 20261
February 20260
March 20260
April 20261
May 20260
June 20261
July 20262
August 20261
September 20266
October 20260