Cleared Traditional

COATED ZT PROXIMAL SLEEVE (K934412) - FDA 510(k) Clearance

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

K934412 · Joint Medical Products Corp. · Orthopedic device
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Jun 1994
Decision
266d
Days
Class 2
Risk

K934412 is an FDA 510(k) clearance for the COATED ZT PROXIMAL SLEEVE. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Joint Medical Products Corp. (Stamford, US). The FDA issued a Cleared decision on June 3, 1994 after a review of 266 days - an extended review cycle.

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 Joint Medical Products Corp. devices

Submission Details

510(k) Number K934412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1993
Decision Date June 03, 1994
Days to Decision 266 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
144d slower than avg
Panel avg: 122d · This submission: 266d
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 325
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K934412.
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INFINITY REVISION HIP STEM
K942115 · Wrightmedicaltechnologyinc · Sep 1994
OSTEONICS SCREWLESS ACETABULAR COMPONENTS
K935875 · Osteonics Corp. · Jul 1994
HOWMEDICA ACETABULAR SHELL W/SCREW HOLES
K933102 · Howmedica Corp. · May 1994
TRILOGY ACETABULAR SYSTEM
K934765 · Zimmer, Inc. · Apr 1994
POROCOAT POROUS COATING/AML PROXIMALLY-COATED STEM
K933787 · Depuy, Inc. · Apr 1994