Cleared Traditional

K192883 - Spartan Hip Stem

K192883 is the FDA 510(k) clearance for Spartan Hip Stem by Signature Orthopaedics Pty, Ltd.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K192883 · Signature Orthopaedics Pty, Ltd. · Orthopedic device
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Aug 2020
Decision
300d
Days
Class 2
Risk

K192883 is an FDA 510(k) clearance for the Spartan 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 August 5, 2020 after a review of 300 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. 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 K192883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2019
Decision Date August 05, 2020
Days to Decision 300 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
178d slower than avg
Panel avg: 122d · This submission: 300d
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 K192883.
SMS Cementless Stem
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Cemented Origin Hip Stem
K201951 · Signature Orthopaedics Pty, Ltd. · Jul 2020
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