Cleared Traditional

Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups (K182705) - FDA 510(k) Clearance

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

K182705 · B-One Ortho, Corp. · Orthopedic device
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Feb 2019
Decision
140d
Days
Class 2
Risk

K182705 is an FDA 510(k) clearance for the Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups. 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 February 14, 2019 after a review of 140 days - within the typical 510(k) review window.

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 K182705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2018
Decision Date February 14, 2019
Days to Decision 140 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
18d slower than avg
Panel avg: 122d · This submission: 140d
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 K182705.
Delta Dual Mobility System
K181491 · Lima Corporate S.P.A. · May 2019
Zimmer Biomet Ceramic Heads
K181171 · Zimmer, Inc. · Apr 2019
Libertas Acetabular Hooded Liner
K183365 · Maxx Orthopedics, Inc. · Feb 2019
LINK MP Monoblock Hip Prosthesis
K183141 · Waldemar Link GmbH & Co. KG · Feb 2019
Zimmer Segmental System Proximal Femoral Component
K183136 · Zimmer, Inc. · Jan 2019
Zimmer Biomet Select Ceramic Heads
K181761 · Zimmer, Inc. · Dec 2018