Cleared Traditional

K914574 - EXACTECH CERAMIC FEMORAL HEAD COMPONENT

K914574 is an FDA 510(k) clearance for EXACTECH CERAMIC FEMORAL HEAD COMPONENT, manufactured by Exactech, Inc.. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K914574 · Exactech, Inc. · Orthopedic device
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Jan 1992
Decision
90d
Days
Class 2
Risk

K914574 is an FDA 510(k) clearance for the EXACTECH CERAMIC FEMORAL HEAD COMPONENT. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on January 13, 1992 after a review of 90 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 Exactech, Inc. devices

FDA 510(k) Submission Details - K914574

510(k) Number K914574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1991
Decision Date January 13, 1992
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 K914574.
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
ZIMMER(R) CERAMIC FEMORAL HEADS 28MM DIAMETER
K914676 · Zimmer, Inc. · Jan 1992
KINAMED CTN STEM
K914237 · Kinamed, Inc. · Dec 1991
BIOPRO ZIRALLOY MODULAR FEMORAL HEADS
K912641 · Biopro, Inc. · Nov 1991