Cleared Traditional

Novae® Dual Mobility System, Hype® Hip System (K223745) - FDA 510(k) Clearance

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

K223745 · Serf · Orthopedic device
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Dec 2023
Decision
373d
Days
Class 2
Risk

K223745 is an FDA 510(k) clearance for the Novae® Dual Mobility System, Hype® 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 Serf (Decines Charpieu, FR). The FDA issued a Cleared decision on December 22, 2023 after a review of 373 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Serf devices

Submission Details

510(k) Number K223745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2022
Decision Date December 22, 2023
Days to Decision 373 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
251d slower than avg
Panel avg: 122d · This submission: 373d
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 Consultant

BioVera, Inc.
Robert A Poggie

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K223745.
Ceramic Femoral Head
K240452 · Microport Orthopedics, Inc. · Apr 2024
28mm/38D MDM X3 Insert for MDM Liner
K233724 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Mar 2024
Z1 Hip System
K233476 · Orchard Medical Development · Feb 2024
Actinia® hip stems
K232371 · Implantcast GmbH · Oct 2023
EMPHASYS Femoral Stems
K233233 · Depuy Ireland UC · Oct 2023
MINIMA S System
K231925 · Lima Corporate S.P.A. · Jul 2023