Cleared Special

MODIFICATION TO PROVIDENT HIP SYSTEM (K001745) - FDA 510(k) Clearance

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

K001745 · Stelkast Company · Orthopedic device
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Jul 2000
Decision
49d
Days
Class 2
Risk

K001745 is an FDA 510(k) clearance for the MODIFICATION TO PROVIDENT HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (product code LWJ), Class II - Special Controls.

Submitted by Stelkast Company (Pittsburgh, US). The FDA issued a Cleared decision on July 27, 2000 after a review of 49 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 Stelkast Company devices

Submission Details

510(k) Number K001745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2000
Decision Date July 27, 2000
Days to Decision 49 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 122d · This submission: 49d
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 25
Devices cleared under the same product code (LWJ) and FDA review panel - the closest regulatory comparables to K001745.
DEPUY SUMMIT BASIC PRESS-FIT HIP STEM
K030122 · DePuy Orthopaedics, Inc. · Feb 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
OSTEONICS EXTENDED FEMORAL BEARING HEAD
K982936 · Osteonics Corp. · Oct 1998
PERFECTA REVISION HIP SYSTEM
K955553 · Wrightmedicaltechnologyinc · Oct 1996