Cleared Traditional

MODULAR CERAMIC FEMORAL HEAD (K936256) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K936256 · Stelkast Company · Orthopedic device
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Nov 1994
Decision
319d
Days
Class 2
Risk

K936256 is an FDA 510(k) clearance for the MODULAR CERAMIC FEMORAL HEAD. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Stelkast Company (Pittsburgh, US). The FDA issued a Cleared decision on November 14, 1994 after a review of 319 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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. Elevated predicate reliance profile. 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 K936256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1993
Decision Date November 14, 1994
Days to Decision 319 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
197d slower than avg
Panel avg: 122d · This submission: 319d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 291
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K936256.
CDH HIP STEM
K945096 · Howmedica Corp. · Jan 1995
HOWMEDICA ALUMINA FEMORAL HEAD
K945091 · Howmedica Corp. · Jan 1995
ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD
K944601 · Zimmer, Inc. · Jan 1995
ZIRCONIA CERAMIC MODULAR HEADS (ASTRO MET)
K943586 · Biomet, Inc. · Oct 1994
SOLUTION BOWED FEMORAL HIP PROTSTHESIS
K933942 · Depuy, Inc. · Oct 1994
5/8 POROCOAT AML HIP POROCOAT POROUS COATING
K941847 · Depuy, Inc. · Jul 1994