Cleared Special

EXCIA TOTAL HIP SYSTEM 36MM CERAMIC HEAD (K062684) - FDA 510(k) Clearance

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

K062684 · Aesculap, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Nov 2006
Decision
75d
Days
Class 2
Risk

K062684 is an FDA 510(k) clearance for the EXCIA TOTAL HIP SYSTEM 36MM CERAMIC HEAD. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on November 22, 2006 after a review of 75 days - a notably fast clearance 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Aesculap, Inc. devices

Submission Details

510(k) Number K062684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2006
Decision Date November 22, 2006
Days to Decision 75 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
47d faster than avg
Panel avg: 122d · This submission: 75d
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 Consultant

Aesculap AG
Kathy Racosky

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K062684.
TRIDENT II ACETABULAR SYSTEM
K063616 · Howmedica Osteonics Corp. · Dec 2006
MODIFICATION: TO DEPUY DELTA CERAMIC FEMORAL HEAD
K062748 · DePuy Orthopaedics, Inc. · Nov 2006
NOVATION SPLINED RDD FEMORAL STEMS
K063279 · Exactech, Inc. · Nov 2006
SYNERGY HIP SYSTEM
K061066 · Smith & Nephew, Inc. · Jul 2006
PATIENT MATCHED HIP STEM
K053246 · Smith & Nephew, Inc. · Jul 2006
36MM BIOLOX DELTA CERAMIC HEADS
K061312 · Biomet, Inc. · Jun 2006