Cleared Traditional

K944601 - ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD

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

K944601 · Zimmer, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K944601

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.

LZO Device Classification - Class 2, Special Controls

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 512
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