Cleared Special

K192024 - Cemented TSI Hip Stem

K192024 is an FDA 510(k) clearance for Cemented TSI Hip Stem, manufactured by Signature Orthopaedics Pty, Ltd.. The device is a Class 2 Orthopedic device with product code LZO cleared through the Special 510(k) pathway after a 326-day FDA review.

K192024 · Signature Orthopaedics Pty, Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2020
Decision
326d
Days
Class 2
Risk

K192024 is an FDA 510(k) clearance for the Cemented TSI Hip Stem. 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 June 19, 2020 after a review of 326 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Elevated predicate reliance profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K192024

510(k) Number K192024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2019
Decision Date June 19, 2020
Days to Decision 326 days
Submission Type Special
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
204d slower than avg
Panel avg: 122d · This submission: 326d
Pathway characteristics
Modification to existing cleared device.

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 533
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K192024.
Corin Optimized Positioning System (OPS) Femoral
K193545 · Corin USA · Aug 2020
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M-Vizion Femoral Revision System Extension
K191816 · Medacta International S.A. · Apr 2020
PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar
K200007 · Microport Orthopedics, Inc. · Apr 2020
Zimmer Hip Joint Replacement
K200112 · Zimmer GmbH · Apr 2020
K192024 · Cemented TSI Hip Stem
Download PDF FDA Summary Signature Orthopaedic…