Cleared Traditional

BIODHOC (K024185) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K024185 · Future Medical Systems, SA · Orthopedic device
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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

Submission Details

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.

Device Classification

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 68
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K024185.
ARTHREX BIO-PIN
K050259 · Arthrex, Inc. · May 2005
HUMERAL STAPLE
K041355 · Smith & Nephew, Inc. · Jul 2004
HANSSON PIN SYSTEM
K033968 · Howmedica Osteonics Corp. · Feb 2004
ACE NANCY NAIL
K032687 · DePuy Orthopaedics, Inc. · Oct 2003
2MM PEDIATRIC FLEX NAIL
K022531 · Biomet, Inc. · Aug 2002
RESORBABLE BONE PINS
K011522 · Biomet, Inc. · Jul 2001