Cleared Traditional

Z-SERIES MODULAR TOTAL HIP SYSTEM (K032729) - FDA 510(k) Clearance

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

K032729 · Osteoimplant Technology, Inc. · Orthopedic device
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Dec 2003
Decision
91d
Days
Class 2
Risk

K032729 is an FDA 510(k) clearance for the Z-SERIES MODULAR TOTAL HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Osteoimplant Technology, Inc. (Hunt Valley, US). The FDA issued a Cleared decision on December 3, 2003 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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 Osteoimplant Technology, Inc. devices

Submission Details

510(k) Number K032729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2003
Decision Date December 03, 2003
Days to Decision 91 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 122d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 325
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K032729.
DEPUY PINNACLE ACETABULAR CUP SYSTEM, ESL MARATHON POLYETHYLENE LINERS, AND DEPUY ULTIMA UNIPOLAR FEMORAL HEADS
K033273 · DePuy Orthopaedics, Inc. · May 2004
SPECTRUM MODULAR SYSTEM
K033893 · DePuy Orthopaedics, Inc. · Mar 2004
PINNACLE REVISION SYSTEM
K033338 · DePuy Orthopaedics, Inc. · Jan 2004
EXACTECH 12/14 ALUMINA FEMORAL HEAD
K032964 · Exactech, Inc. · Nov 2003
VERSYS BEADED FULLCOAT CALCAR HIP PROSTHESIS
K033034 · Zimmer, Inc. · Nov 2003
ZIMMER M/L TAPER HIP PROSTHESIS, 7711 SERIES
K032726 · Zimmer, Inc. · Oct 2003