Cleared Traditional

K920577 - HOWEDICA ZIRCONIA FEMORAL HEAD

K920577 is the FDA 510(k) clearance for HOWEDICA ZIRCONIA FEMORAL HEAD by Howmedica Corp.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K920577 · Howmedica Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1992
Decision
95d
Days
Class 2
Risk

K920577 is an FDA 510(k) clearance for the HOWEDICA ZIRCONIA 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 Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on May 15, 1992 after a review of 95 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 Corp. devices

Submission Details

510(k) Number K920577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1992
Decision Date May 15, 1992
Days to Decision 95 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 122d · This submission: 95d
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 419
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K920577.
OSTEONICS ZIRCONIA C-TAPER FEMORAL BEARING HEAD
K915396 · Osteonics Corp. · Oct 1992
BIOPRO DRG CUSTOM HIP REPLACEMENT SYSTEM
K920145 · Biopro, Inc. · Oct 1992
CERAMIC FEMORAL HEAD
K920593 · Dow Corning Wright · Aug 1992
ZIRCONIA CERAMIC MODULAR HEADS(TYPE I TAPER) MODIF
K913420 · Biomet, Inc. · Jan 1992
EXACTECH CERAMIC FEMORAL HEAD COMPONENT
K914574 · Exactech, Inc. · Jan 1992
ZIMMER(R) CERAMIC FEMORAL HEADS 28MM DIAMETER
K914676 · Zimmer, Inc. · Jan 1992