Cleared Traditional

K181693 - SMS Femoral Stem (FDA 510(k) Clearance)

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

K181693 · Medacta International S.A. · Orthopedic device
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Nov 2018
Decision
154d
Days
Class 2
Risk

K181693 is an FDA 510(k) clearance for the SMS Femoral Stem. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Medacta International S.A. (Castel San Pietro (Ch), CH). The FDA issued a Cleared decision on November 28, 2018 after a review of 154 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 Medacta International S.A. devices

Submission Details

510(k) Number K181693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2018
Decision Date November 28, 2018
Days to Decision 154 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
32d slower than avg
Panel avg: 122d · This submission: 154d
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 528
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K181693.
Avenir® Müller Stem
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K252401 · Implantcast GmbH · Mar 2026
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K253171 · Maxx Orthopedics, Inc. · Jan 2026
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K243021 · Signature Orthopaedics Pty, Ltd. · Aug 2025
Z1 Hip System
K251906 · Zimmer, Inc. · Jul 2025