Cleared Traditional

K040734 - MODIFICATION TO RESTORATION MODULAR SYSTEM

K040734 is the FDA 510(k) clearance for MODIFICATION TO RESTORATION MODULAR SYSTEM by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (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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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

Submission Details

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.

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 433
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K040734.
CORAIL AMT HIP PROSTHESIS
K042992 · DePuy Orthopaedics, Inc. · Feb 2005
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
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