Cleared Special

EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS (K050398) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K050398 · Exactech, Inc. · Orthopedic device
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Nov 2005
Decision
275d
Days
Class 2
Risk

K050398 is an FDA 510(k) clearance for the EXACTECH ZIRAMIC ZIRCONIA 12/14 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 Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on November 18, 2005 after a review of 275 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Exactech, Inc. devices

Submission Details

510(k) Number K050398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2005
Decision Date November 18, 2005
Days to Decision 275 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
153d slower than avg
Panel avg: 122d · This submission: 275d
Pathway characteristics
Modification to existing cleared device.

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 290
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K050398.
ACUMATCH 12/14 C-SERIES CEMENTED FEMORAL STEMS (SIZE 1-6), ACUMATCH 12/14 L-SERIES CEMENTED FEMORAL STEMS (SIZE 1-5)
K052787 · Exactech, Inc. · Dec 2005
SMITH & NEPHEW PLATFORM HIP STEM
K052275 · Smith & Nephew, Inc. · Dec 2005
ACUMATCH M-SERIES LPB 12/14 FEMORAL STEM
K051858 · Exactech, Inc. · Dec 2005
V40 BIOLOX DELTA CERAMIC FEMORAL HEADS
K052718 · Howmedica Osteonics Corp. · Oct 2005
EXACTECH 12/14 ALUMINA FEMORAL HEADS 36 MM
K051682 · Exactech, Inc. · Jul 2005
MODIFICATION TO V-40/C-TAPER ADAPTER SLEEVE
K051737 · Howmedica Osteonics Corp. · Jul 2005