Cleared Traditional

K032110 - PROCLASS PRESS FIT HIP STEM

K032110 is the FDA 510(k) clearance for PROCLASS PRESS FIT HIP STEM by Stelkast Company. It is a Class 2 Orthopedic device (product code LWJ) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K032110 · Stelkast Company · Orthopedic device
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Sep 2003
Decision
75d
Days
Class 2
Risk

K032110 is an FDA 510(k) clearance for the PROCLASS PRESS FIT HIP STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (product code LWJ), Class II - Special Controls.

Submitted by Stelkast Company (Mcmurray, US). The FDA issued a Cleared decision on September 22, 2003 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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 Stelkast Company devices

Submission Details

510(k) Number K032110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2003
Decision Date September 22, 2003
Days to Decision 75 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 122d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented

All 57
Devices cleared under the same product code (LWJ) and FDA review panel - the closest regulatory comparables to K032110.
BETACONE HIP PROSTHESIS SYSTEM
K051826 · Waldemar Link GmbH & Co. KG · Nov 2005
EXCIA TOTAL HIP SYSTEM
K042344 · Aesculap, Inc. · Mar 2005
MODULAR PLUS HIP STEM
K032709 · Plus Orthopedics · Sep 2003
MODIFICATION TO MODULAR PLUS REVISION STEM
K030971 · Plus Orthopedics · Apr 2003
GLOBAL MODULAR REPLACEMENT SYSTEM ADAPTER
K023692 · Howmedica Osteonics Corp. · Mar 2003
DEPUY SUMMIT BASIC PRESS-FIT HIP STEM
K030122 · DePuy Orthopaedics, Inc. · Feb 2003