Cleared Traditional

K031217 - GMRS PRESS FIT STEMS WITH PUREFIX HA

K031217 is an FDA 510(k) clearance for GMRS PRESS FIT STEMS WITH PUREFIX HA, manufactured by Howmedica Osteonics. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K031217 · Howmedica Osteonics · Orthopedic device
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May 2003
Decision
36d
Days
Class 2
Risk

K031217 is an FDA 510(k) clearance for the GMRS PRESS FIT STEMS WITH PUREFIX HA. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Howmedica Osteonics (Allendale, US). The FDA issued a Cleared decision on May 23, 2003 after a review of 36 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 Howmedica Osteonics devices

FDA 510(k) Submission Details - K031217

510(k) Number K031217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2003
Decision Date May 23, 2003
Days to Decision 36 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
86d faster than avg
Panel avg: 122d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZO Device Classification - Class 2, Special Controls

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 477
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K031217.
STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD
K033944 · Stelkast Company · Mar 2004
DEPUY CERAMIC FEMORAL HEADS
K031803 · DePuy Orthopaedics, Inc. · Jul 2003
ALUMINA CERAMIC FEMORAL HEADS, 28 AND 32 MM
K030724 · Zimmer, Inc. · Jun 2003
ALUMINA V40 FEMORAL HEADS
K023901 · Howmedica Osteonics Corp. · Jan 2003
ASCENDENT ACETABULAR SYSTEM
K022985 · Sulzer Orthopedics, Inc. · Dec 2002
GMRS PRESS FIT STEMS WITH PUREFIX HA
K022403 · Howmedica Osteonics Corp. · Oct 2002