Cleared Traditional

BETA HIP PROSTHESIS (K953337) - FDA 510(k) Clearance

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

K953337 · Zimmer, Inc. · Orthopedic device
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Jan 1996
Decision
189d
Days
Class 2
Risk

K953337 is an FDA 510(k) clearance for the BETA HIP PROSTHESIS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 22, 1996 after a review of 189 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 Zimmer, Inc. devices

Submission Details

510(k) Number K953337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1995
Decision Date January 22, 1996
Days to Decision 189 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
67d slower than avg
Panel avg: 122d · This submission: 189d
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 324
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K953337.
HOWMEDICA ASYMMETRIC STEM FEMORAL COMPONENT
K955871 · Howmedica Corp. · Mar 1996
DEPUY VISION AML HIP PROTHESIS
K953694 · Depuy, Inc. · Feb 1996
DEPUY VISION SOLUTION HIP PROSTHESIS
K953703 · Depuy, Inc. · Feb 1996
TRILOGY ACETABULAR COMPONENT 7MM OFFSET
K954698 · Zimmer, Inc. · Jan 1996
DEPUY ADVANTAGE HIP FEMORAL PROSTHESIS WITH POROCOAT
K954811 · Depuy, Inc. · Jan 1996
A-B ACETABULAR COMPONENT
K954417 · Biomet, Inc. · Dec 1995