Cleared Special

DEPUY SUMMIT BASIC PRESS-FIT HIP STEM (K030122) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K030122 · DePuy Orthopaedics, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Feb 2003
Decision
22d
Days
Class 2
Risk

K030122 is an FDA 510(k) clearance for the DEPUY SUMMIT BASIC PRESS-FIT HIP STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (product code LWJ), Class II - Special Controls.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 5, 2003 after a review of 22 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all DePuy Orthopaedics, Inc. devices

Submission Details

510(k) Number K030122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2003
Decision Date February 05, 2003
Days to Decision 22 days
Submission Type Special
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
100d faster than avg
Panel avg: 122d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

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 24
Devices cleared under the same product code (LWJ) and FDA review panel - the closest regulatory comparables to K030122.
EXCIA
K061699 · Aesculap, Inc. · Aug 2006
EXCIA TOTAL HIP SYSTEM
K042344 · Aesculap, Inc. · Mar 2005
GLOBAL MODULAR REPLACEMENT SYSTEM ADAPTER
K023692 · Howmedica Osteonics Corp. · Mar 2003
PRO-FEMUR R
K003016 · Wrightmedicaltechnologyinc · Dec 2000
ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH L-SERIES PRESS-FIT
K002141 · Exactech, Inc. · Aug 2000
HOWMEDICA OSTEONICS FEMORAL HEADS
K993601 · Howmedica Osteonics Corp. · Nov 1999