Cleared Traditional

K953268 - DUAL TAPER WEDGE PRESSED FIT FEMORAL CO...

K953268 is the FDA 510(k) clearance for DUAL TAPER WEDGE PRESSED FIT FEMORAL CO... by Stelkast Company. It is a Class 2 Orthopedic device (product code LWJ) cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K953268 · Stelkast Company · Orthopedic device
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Jan 1996
Decision
188d
Days
Class 2
Risk

K953268 is an FDA 510(k) clearance for the DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT. 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 January 17, 1996 after a review of 188 days - an extended review 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: 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 Stelkast Company devices

Submission Details

510(k) Number K953268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1995
Decision Date January 17, 1996
Days to Decision 188 days
Submission Type Traditional
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
66d slower than avg
Panel avg: 122d · This submission: 188d
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 K953268.
SRRS PRESSED FIT FEMORAL REVISION COMPONENT
K960908 · Stelkast Company · Aug 1996
INTERMOORE FRACTURE HIP STEM
K954854 · Intermedics Orthopedics · Feb 1996
LFIC OR FETTO HIP
K952776 · Zimmer, Inc. · Feb 1996
FOUNDATION TEXTURED STEM
K952297 · Encore Orthopedics, Inc. · Jul 1995
HOWMEDICA V40 22MM FEMORAL HEAD
K950541 · Howmedica Corp. · Mar 1995
COBALT CHROME GEMINI
K934909 · Depuy, Inc. · Apr 1994