Cleared Traditional

K953268 - DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT

K953268 is an FDA 510(k) clearance for DUAL TAPER WEDGE PRESSED FIT FEMORAL CO..., manufactured by Stelkast Company. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K953268

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.

LWJ Device Classification - Class 2, Special Controls

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 73
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