Cleared Traditional

K040734 - MODIFICATION TO RESTORATION MODULAR SYSTEM

K040734 is an FDA 510(k) clearance for MODIFICATION TO RESTORATION MODULAR SYSTEM, manufactured by Howmedica Osteonics Corp.. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K040734 · Howmedica Osteonics Corp. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 2004
Decision
156d
Days
Class 2
Risk

K040734 is an FDA 510(k) clearance for the MODIFICATION TO RESTORATION MODULAR SYSTEM. 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 Corp. (Mahwah, US). The FDA issued a Cleared decision on August 25, 2004 after a review of 156 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 Howmedica Osteonics Corp. devices

FDA 510(k) Submission Details - K040734

510(k) Number K040734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2004
Decision Date August 25, 2004
Days to Decision 156 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
34d slower than avg
Panel avg: 122d · This submission: 156d
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 508
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K040734.
SECUR-FIT HA AND SECUR-FIT PLUS HIP STEMS
K041170 · Howmedica Osteonics Corp. · Nov 2004
NOVATION 12/14 PRESS-FIT FEMORAL STEM
K042842 · Exactech, Inc. · Nov 2004
CLS SPOTORNO STEM
K042249 · Zimmer Austin, Inc. · Sep 2004
MS-30 FEMORAL STEM STANDARD AND LATERAL
K040803 · Zimmer, Inc. · Apr 2004
MODIFICATION TO DEPUY CERAMIC FEMORAL HEAD
K040644 · DePuy Orthopaedics, Inc. · Apr 2004
STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD
K033944 · Stelkast Company · Mar 2004