Cleared Traditional

MS-30 LATERAL FEMORAL STEM (K020713) - FDA 510(k) Clearance

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

K020713 · Sulzer Orthopedics, Inc. · Orthopedic device
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May 2002
Decision
70d
Days
Class 2
Risk

K020713 is an FDA 510(k) clearance for the MS-30 LATERAL 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 Sulzer Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on May 14, 2002 after a review of 70 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sulzer Orthopedics, Inc. devices

Submission Details

510(k) Number K020713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2002
Decision Date May 14, 2002
Days to Decision 70 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
52d faster than avg
Panel avg: 122d · This submission: 70d
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 292
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K020713.
RESTORATION MODULAR SYSTEM
K022549 · Howmedica Osteonics Corp. · Sep 2002
ACCOLADE C FEMORAL STEMS
K022555 · Howmedica Osteonics Corp. · Aug 2002
TOTAL HIP FEMORAL HEAD - 12/14 TAPER
K021673 · Smith & Nephew, Inc. · Jun 2002
2 PIECE MODULAR HIP STEM
K013106 · Howmedica Osteonics Corp. · Apr 2002
DEPUY FEMORAL HEADS
K011533 · DePuy Orthopaedics, Inc. · Jan 2002
ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER
K013989 · Smith & Nephew, Inc. · Dec 2001