Cleared Special

PROTRACT PRESS FIT HIP STEM-HA COATED (K010241) - FDA 510(k) Clearance

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

K010241 · Stelkast Company · Orthopedic device
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Feb 2001
Decision
14d
Days
Class 2
Risk

K010241 is an FDA 510(k) clearance for the PROTRACT PRESS FIT HIP STEM-HA COATED. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Stelkast Company (Pittsburgh, US). The FDA issued a Cleared decision on February 8, 2001 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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 K010241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2001
Decision Date February 08, 2001
Days to Decision 14 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
108d faster than avg
Panel avg: 122d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

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 K010241.
PERFECTA AND EXTEND
K004032 · Wrightmedicaltechnologyinc · Feb 2001
AML HIP PROSTHESIS
K003800 · DePuy Orthopaedics, Inc. · Feb 2001
MODIFICATION TO EXACTECH ACUMATCH INTEGRATED HIP SYSTEM, M-SERIES HIGH OFF-SET NECK SEGMENT, M-SERIES LOW OFF-SET NECK S
K010120 · Exactech, Inc. · Feb 2001
TRIOLOGY ACETABULAR SYSTEM 46MM LARGE HEAD LINERS, MODEL 6310
K003478 · Zimmer, Inc. · Feb 2001
REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS
K002747 · Smith & Nephew, Inc. · Dec 2000
TRILOGY ACETABULAR SYSTEM LARGE HEAD LINER, MODEL 6353
K002960 · Zimmer, Inc. · Dec 2000