Cleared Traditional

K191708 - Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K191708 · Signature Orthopaedics Pty, Ltd. · Orthopedic device
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Aug 2020
Decision
415d
Days
Class 2
Risk

K191708 is an FDA 510(k) clearance for the Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Signature Orthopaedics Pty, Ltd. (Lane Cove West, AU). The FDA issued a Cleared decision on August 14, 2020 after a review of 415 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Signature Orthopaedics Pty, Ltd. devices

Submission Details

510(k) Number K191708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2019
Decision Date August 14, 2020
Days to Decision 415 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
293d slower than avg
Panel avg: 122d · This submission: 415d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

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