Cleared Traditional

K071082 - STRYKER MODULAR HIP SYSTEM

K071082 is the FDA 510(k) clearance for STRYKER MODULAR HIP SYSTEM by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K071082 · Howmedica Osteonics Corp. · Orthopedic device
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Sep 2007
Decision
149d
Days
Class 2
Risk

K071082 is an FDA 510(k) clearance for the STRYKER MODULAR HIP 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 September 13, 2007 after a review of 149 days - within the typical 510(k) review window.

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 K071082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2007
Decision Date September 13, 2007
Days to Decision 149 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
27d slower than avg
Panel avg: 122d · This submission: 149d
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 K071082.
BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS
K073102 · Biomet Manufacturing Corp · Nov 2007
BIOLOX DELTA CERAMIC FEMORAL HEAD
K071535 · Zimmer, Inc. · Nov 2007
DEPUY DELTA TS CERAMIC FEMORAL HEADS
K071830 · DePuy Orthopaedics, Inc. · Sep 2007
DEPUY CORAIL AMT DYSPLASIA HIP PROSTHESIS
K070554 · DePuy Orthopaedics, Inc. · Sep 2007
UNIVERSAL TAPER DELTA FEMORAL HEAD
K070885 · Howmedica Osteonics Corp. · May 2007
EXACTECH NOVATION CROWN CUP AND LINERS
K070479 · Exactech, Inc. · Mar 2007