Cleared Traditional

K024185 - BIODHOC

K024185 is an FDA 510(k) clearance for BIODHOC, manufactured by Future Medical Systems, SA. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 392-day FDA review.

K024185 · Future Medical Systems, SA · Orthopedic device
Download Printable Device Report (PDF)
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Jan 2004
Decision
392d
Days
Class 2
Risk

K024185 is an FDA 510(k) clearance for the BIODHOC. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Future Medical Systems, SA (Glen Burnie, US). The FDA issued a Cleared decision on January 15, 2004 after a review of 392 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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. Elevated predicate reliance profile. 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 Future Medical Systems, SA devices

FDA 510(k) Submission Details - K024185

510(k) Number K024185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2002
Decision Date January 15, 2004
Days to Decision 392 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
270d slower than avg
Panel avg: 122d · This submission: 392d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTY Device Classification - Class 2, Special Controls

Product Code HTY Pin, Fixation, Smooth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HTY Pin, Fixation, Smooth

All 140
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K024185.
HUMERAL STAPLE
K041355 · Smith & Nephew, Inc. · Jul 2004
ARTHROTEK LACTONAIL
K040500 · Arthrotek, Inc. · May 2004
HANSSON PIN SYSTEM
K033968 · Howmedica Osteonics Corp. · Feb 2004
ACE NANCY NAIL
K032687 · DePuy Orthopaedics, Inc. · Oct 2003
INION OTPS BIODEGRADABLE PIN
K031712 · Inion , Ltd. · Aug 2003
K-FIX
K022597 · New Deal, S.A. · Nov 2002