Cleared Traditional

K190704 - Signature Ceramic Femoral Head

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

K190704 · Signature Orthopaedics Pty, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
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

Submission Details

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.

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 420
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