Cleared Traditional

K920577 - HOWEDICA ZIRCONIA FEMORAL HEAD

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

K920577 · Howmedica Corp. · Orthopedic device
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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

FDA 510(k) Submission Details - K920577

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.

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 507
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K920577.
BIOPRO DRG CUSTOM HIP REPLACEMENT SYSTEM
K920145 · Biopro, Inc. · Oct 1992
CERAMIC FEMORAL HEAD
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FELDMUHLE CERAMIC HEAD
K920756 · Link America, Inc. · May 1992
KINAMED 22MM BIOCERAM-Z TOTAL HIP FEMORAL BALL
K915309 · Kinamed, Inc. · Feb 1992
KINAMED 28MM BIOCERAM-Z TOTAL HIP FEMORAL BALL
K915310 · Kinamed, Inc. · Feb 1992
ZIRCONIA CERAMIC MODULAR HEADS(TYPE I TAPER) MODIF
K913420 · Biomet, Inc. · Jan 1992