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

b-ONE Ortho Corp.

Cedar Knolls, NJ, US

B-ONE ORTHO, CORP. appears in FDA device records in Cedar Knolls, NJ. FDA records list 12 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
12
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 12 510(k) clearances for b-ONE Ortho Corp. between 2018 and 2026. The busiest year on record is 2021, with 3. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for b-ONE Ortho Corp., by decision year
YearClearances
20182
20192
20201
20213
20222
20241
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253357b-ONE® Bipolar HeadKWYSubstantially Equivalent
K240528b-ONE® Total Hip SystemLZOSubstantially Equivalent
K222431b-ONER MOBIO Total Knee SystemJWHSubstantially Equivalent
K213673b-ONE MOBIO Total Knee SystemJWHSubstantially Equivalent
K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula SystemMAISubstantially Equivalent
K210483MOBIO Total Knee SystemJWHSubstantially Equivalent
K202768KOSMO Femoral StemLZOSubstantially Equivalent
K202429Mobio Total Knee SystemJWHSubstantially Equivalent
K182705Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System CupsLZOSubstantially Equivalent
K183025MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar ComponentJWHSubstantially Equivalent
K180446b-ONE Total Knee SystemJWHSubstantially Equivalent
K173380b-ONE® Total Hip SystemLZOSubstantially Equivalent

Registered establishments

FDA registered establishments for b-ONE Ortho Corp., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30152598763015259876B-ONE ORTHO, CORP.3 Wing Drive Suite #259, Cedar Knolls, NJ 07927 US2026and 14 more, listed in full below
30425082543042508254b-ONE Ortho Corp.159 Dwight Pl, Fairfield, NJ 07004 US2026and 14 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets b-ONE Ortho Corp. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of , FDA export datePage updated Source: openFDA, public domain