Cleared Traditional

K960180 - 22 MM COCR HEAD & POLYETHLENE LINER

K960180 is the FDA 510(k) clearance for 22 MM COCR HEAD & POLYETHLENE LINER by Stelkast Company. It is a Class 2 Orthopedic device (product code LPH) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K960180 · Stelkast Company · Orthopedic device
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Optimized for regulatory review, auditing and printing
May 1996
Decision
107d
Days
Class 2
Risk

K960180 is an FDA 510(k) clearance for the 22 MM COCR HEAD & POLYETHLENE LINER. 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 May 2, 1996 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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 K960180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1996
Decision Date May 02, 1996
Days to Decision 107 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
15d faster than avg
Panel avg: 122d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 446
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K960180.
FOUNDATION FORGED, TEXTURED & POROUS STEMS W/BIOLOX CERAMIC HEADS
K955563 · Encore Orthopedics, Inc. · Aug 1996
FENNING FEMORAL COMPONENT
K960303 · Biomet, Inc. · Jun 1996
HEMISPHERE ACETABULAR CUP
K960660 · Ortho Development Corp. · May 1996
MODULAR ACETABULAR SHELL II
K955739 · Intermedics Orthopedics · Mar 1996
DEPUY POROCOAT HPS II HIP PROSTHESIS W/ARTICUL-EZE TAPER
K960172 · Depuy, Inc. · Mar 1996
HOWMEDICA ASYMMETRIC STEM FEMORAL COMPONENT
K955871 · Howmedica Corp. · Mar 1996