Cleared Traditional

OSTEOMED CRANIAL FLAP FIXATION SYSTEM (K022277) - FDA 510(k) Clearance

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

K022277 · Osteomed Corp. · Neurology device
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Optimized for regulatory review, auditing and printing
Apr 2003
Decision
260d
Days
Class 2
Risk

K022277 is an FDA 510(k) clearance for the OSTEOMED CRANIAL FLAP FIXATION SYSTEM. Classified as Plate, Cranioplasty, Preformed, Non-alterable (product code GXN), Class II - Special Controls.

Submitted by Osteomed Corp. (Addison, US). The FDA issued a Cleared decision on April 1, 2003 after a review of 260 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5330 - the FDA neurology device 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Osteomed Corp. devices

Submission Details

510(k) Number K022277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2002
Decision Date April 01, 2003
Days to Decision 260 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 148d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXN Plate, Cranioplasty, Preformed, Non-alterable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5330
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 Neurology devices follow this clearance model.

Regulatory Peers - GXN Plate, Cranioplasty, Preformed, Non-alterable

All 25
Devices cleared under the same product code (GXN) and FDA review panel - the closest regulatory comparables to K022277.
CRAINFIX 2 TITANIUM CLAMP SYSTEM
K122353 · Aesculap, Inc. · Aug 2012
SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT
K053199 · Synthes (Usa) · Dec 2005
SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS
K033868 · Synthes (Usa) · Jun 2004
SYNTHES CRANIAL FLAP TWIST CLAMP
K991860 · Synthes (Usa) · Jul 1999
SYNTHES CRANIAL FLAP TUBE CLAMP
K992000 · Synthes (Usa) · Jul 1999
AESCULAP CRANIOFIX TITANIUM CLAMP SYSTEM
K972332 · Aesculap, Inc. · Jan 1998