Cleared Traditional

b-ONE® Total Hip System (K240528) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K240528 · B-One Ortho, Corp. · Orthopedic device
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Nov 2024
Decision
266d
Days
Class 2
Risk

K240528 is an FDA 510(k) clearance for the b-ONE® Total Hip System. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by B-One Ortho, Corp. (Cedar Knolls, US). The FDA issued a Cleared decision on November 15, 2024 after a review of 266 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all B-One Ortho, Corp. devices

Submission Details

510(k) Number K240528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2024
Decision Date November 15, 2024
Days to Decision 266 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 122d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 291
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K240528.
ceramys™ femoral head system
K241483 · Encore Medical, L.P. · Feb 2025
Conformity Stem Extension Line, #0
K243466 · United Orthopedic Corporation · Jan 2025
BIOCERAM AZUL® HEAD
K243444 · Kyocera Corporation · Dec 2024
MUTARS® femoral stem cemented 160 mm and 200 mm
K240391 · Implantcast GmbH · Oct 2024
Conformity Stem Extension Line
K242249 · United Orthopedic Corporation · Aug 2024
Z1 Cemented Hip System
K241241 · Orchard Medical Development, LLC · Aug 2024