Cleared Traditional

K190704 - Signature Ceramic Femoral Head

K190704 is an FDA 510(k) clearance for Signature Ceramic Femoral Head, manufactured by Signature Orthopaedics Pty, Ltd.. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K190704 · Signature Orthopaedics Pty, Ltd. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 2019
Decision
163d
Days
Class 2
Risk

K190704 is an FDA 510(k) clearance for the Signature Ceramic Femoral Head. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Signature Orthopaedics Pty, Ltd. (Lane Cove West, AU). The FDA issued a Cleared decision on August 28, 2019 after a review of 163 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 Signature Orthopaedics Pty, Ltd. devices

FDA 510(k) Submission Details - K190704

510(k) Number K190704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2019
Decision Date August 28, 2019
Days to Decision 163 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
41d slower than avg
Panel avg: 122d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZO Device Classification - Class 2, Special Controls

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 507
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K190704.
PROFEMUR TL2 Stems
K191632 · Microport Orthopedics, Inc. · Oct 2019
BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System
K192416 · Zimmer GmbH · Oct 2019
MiniMAX
K192352 · Medacta International S.A. · Sep 2019
BIOLOX CONTOURA Ceramic Femoral Head
K191399 · Total Joint Othopedics, Inc. · Aug 2019
Libertas – Taper Uncemented Femoral Stem
K183684 · Maxx Orthopedics, Inc. · Aug 2019
Conformity Stem
K183312 · United Orthopedic Corporation · Aug 2019