Cleared Traditional

K181340 - Cemented TSI Hip Stem

K181340 is the FDA 510(k) clearance for Cemented TSI Hip Stem by Signature Orthopaedics Pty, Ltd.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K181340 · Signature Orthopaedics Pty, Ltd. · Orthopedic device
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Feb 2019
Decision
266d
Days
Class 2
Risk

K181340 is an FDA 510(k) clearance for the Cemented TSI Hip Stem. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Signature Orthopaedics Pty, Ltd. (Lane Cove West, AU). The FDA issued a Cleared decision on February 11, 2019 after a review of 266 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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 K181340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2018
Decision Date February 11, 2019
Days to Decision 266 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
144d slower than avg
Panel avg: 122d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 435
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K181340.
CPT Hip System
K191735 · Zimmer, Inc. · Mar 2020
Conformity stem, cemented
K191056 · United Orthopedic Corporation · Jan 2020
EXETER Centralizer, EXETER 2.5mm Plug
K191414 · Stryker Orthopaedics · Aug 2019
Libertas Hip Replacement System
K180973 · Maxx Orthopedics, Inc. · Sep 2018
REDAPT Anteverted Cemented Liner
K160923 · Smith & Nephew, Inc. · Nov 2016
OSS/Arcos IM Total Femur Rod
K152621 · Biomet, Inc. · Oct 2015