Cleared Traditional

K944601 - ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD

K944601 is the FDA 510(k) clearance for ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD by Zimmer, Inc.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K944601 · Zimmer, Inc. · Orthopedic device
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Jan 1995
Decision
115d
Days
Class 2
Risk

K944601 is an FDA 510(k) clearance for the ZIMMER ZIRCONIA 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 Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 12, 1995 after a review of 115 days - within the typical 510(k) review window.

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. 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 K944601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1994
Decision Date January 12, 1995
Days to Decision 115 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
7d faster than avg
Panel avg: 122d · This submission: 115d
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 435
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K944601.
APC FEMORAL COMPONENT
K945095 · Howmedica Corp. · Jan 1995
CDH HIP STEM
K945096 · Howmedica Corp. · Jan 1995
HOWMEDICA ALUMINA FEMORAL HEAD
K945091 · Howmedica Corp. · Jan 1995
HOWMEDICA SENTRY S TOTAL HIP SYSTEM
K935913 · Howmedica, Inc. · Dec 1994
APR II NON POROUS HIP STEM
K944209 · Intermedics Orthopedics · Dec 1994
ZIRCONIA CERAMIC FEMORAL HEAD
K935921 · Smith & Nephew Richards, Inc. · Nov 1994