Cleared Traditional

K063098 - STATIC CRANIOPLASTY ORTHOSIS

K063098 is an FDA 510(k) clearance for STATIC CRANIOPLASTY ORTHOSIS, manufactured by Boston Brace Intl., Inc.. The device is a Class 2 Neurology device with product code OAN cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K063098 · Boston Brace Intl., Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
183d
Days
Class 2
Risk

K063098 is an FDA 510(k) clearance for the STATIC CRANIOPLASTY ORTHOSIS. Classified as Orthosis, Cranial, Laser Scan (product code OAN), Class II - Special Controls.

Submitted by Boston Brace Intl., Inc. (Avon, US). The FDA issued a Cleared decision on April 11, 2007 after a review of 183 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5970 - 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 Boston Brace Intl., Inc. devices

FDA 510(k) Submission Details - K063098

510(k) Number K063098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2006
Decision Date April 11, 2007
Days to Decision 183 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
35d slower than avg
Panel avg: 148d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OAN Device Classification - Class 2, Special Controls

Product Code OAN Orthosis, Cranial, Laser Scan
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5970
Definition A Cranial Orthosis Is A Device That Is Intended For Medical Purposes To Apply Pressure To Prominent Regions Of An Infant's Cranium In Order To Improve Cranial Symmetry And/or Shape. A Laser Scanning Accessory May Be Used To Create A Scan Of The Infant's Head. Indicated For Infants From 3 To 18 Months Of Age, With Moderate To Severe Nonsynostotic Positional Plagiocephaly, Including Infants With Plagiocephalic-, Brachycephalic-, And Scaphocephalic-shaped Heads.
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 - OAN Orthosis, Cranial, Laser Scan

All 18
Devices cleared under the same product code (OAN) and FDA review panel - the closest regulatory comparables to K063098.
STARBAND
K082950 · Orthomerica Products, Inc. · Dec 2008
STARLIGHT
K082945 · Orthomerica Products, Inc. · Oct 2008
STARLIGHT
K081994 · Orthomerica Products, Inc. · Sep 2008
CLARREN HELMET (ORTHOMERICA)
K021918 · Orthomerica Products, Inc. · Jul 2002
STARLIGHT
K021207 · Orthomerica Products, Inc. · Jul 2002
STARBAND CRANIAL ORTHOSIS
K011350 · Orthomerica Products, Inc. · Jul 2001