Cleared Traditional

K022277 - OSTEOMED CRANIAL FLAP FIXATION SYSTEM

K022277 is an FDA 510(k) clearance for OSTEOMED CRANIAL FLAP FIXATION SYSTEM, manufactured by Osteomed Corp.. The device is a Class 2 Neurology device with product code GXN cleared through the Traditional 510(k) pathway after a 260-day FDA review.

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

FDA 510(k) Submission Details - K022277

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
Combination Product No
PCCP Authorized No
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.

GXN Device Classification - Class 2, Special Controls

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 55
Devices cleared under the same product code (GXN) and FDA review panel - the closest regulatory comparables to K022277.
SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT
K053199 · Synthes (Usa) · Dec 2005
SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS
K033868 · Synthes (Usa) · Jun 2004
SPIN DOWN RAPIDFLAP
K031034 · Walter Lorenz Surgical, Inc. · May 2003
STRYKER LEIBINGER CRANIAL FIXATION SYSTEM
K030378 · Stryker Instruments · Mar 2003
MODIFICATION OF THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
K020088 · Bioplate, Inc. · Feb 2002
THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
K013050 · Bioplate, Inc. · Dec 2001