Cleared Traditional

K913420 - ZIRCONIA CERAMIC MODULAR HEADS(TYPE I T...

K913420 is an FDA 510(k) clearance for ZIRCONIA CERAMIC MODULAR HEADS(TYPE I T..., manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K913420 · Biomet, Inc. · Orthopedic device
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Jan 1992
Decision
175d
Days
Class 2
Risk

K913420 is an FDA 510(k) clearance for the ZIRCONIA CERAMIC MODULAR HEADS(TYPE I TAPER) MODIF. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 16, 1992 after a review of 175 days - an extended review cycle.

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 Biomet, Inc. devices

FDA 510(k) Submission Details - K913420

510(k) Number K913420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1991
Decision Date January 16, 1992
Days to Decision 175 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
53d slower than avg
Panel avg: 122d · This submission: 175d
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 435
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K913420.
HOWEDICA ZIRCONIA FEMORAL HEAD
K920577 · Howmedica Corp. · 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
EXACTECH CERAMIC FEMORAL HEAD COMPONENT
K914574 · Exactech, Inc. · Jan 1992
ZIMMER(R) CERAMIC FEMORAL HEADS 28MM DIAMETER
K914676 · Zimmer, Inc. · Jan 1992
KINAMED CTN STEM
K914237 · Kinamed, Inc. · Dec 1991