Cleared Traditional

K946026 - HOWMEDICA(R) 28MM ZIRCONIA FEMORAL HEADS

K946026 is an FDA 510(k) clearance for HOWMEDICA 28MM ZIRCONIA FEMORAL HEADS, manufactured by Howmedica, Inc.. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K946026 · Howmedica, Inc. · Orthopedic device
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Mar 1995
Decision
98d
Days
Class 2
Risk

K946026 is an FDA 510(k) clearance for the HOWMEDICA(R) 28MM ZIRCONIA FEMORAL HEADS. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Howmedica, Inc. (Rutherford, US). The FDA issued a Cleared decision on March 20, 1995 after a review of 98 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 Howmedica, Inc. devices

FDA 510(k) Submission Details - K946026

510(k) Number K946026 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 12, 1994
Decision Date March 20, 1995
Days to Decision 98 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 122d · This submission: 98d
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 511
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K946026.
STELKAST ALL POLYETHYLENE ACETABULAR CUP
K953169 · Stelkast Company · Aug 1995
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ZIRCONIA ARTICUL/EZE FEMORAL BALLS
K952088 · Depuy, Inc. · Jun 1995
OSTEONICS RESTORATION MONOLITHIC HIP STEM
K943774 · Osteonics Corp. · Mar 1995
NATURAL-HIP(TM) SYSTEM - CALCAR REPLCEMENT STEM
K945516 · Intermedics Orthopedics · Feb 1995
SENTRY TOTAL HIP
K945089 · Howmedica Corp. · Jan 1995