Cleared Traditional

K072601 - OSTEOSYMBIONICS PATIENT SPECIFIC CRANIA...

K072601 is an FDA 510(k) clearance for OSTEOSYMBIONICS PATIENT SPECIFIC CRANIA..., manufactured by Osteosymbionics, LLC. The device is a Class 2 Neurology device with product code GXP cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K072601 · Osteosymbionics, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
87d
Days
Class 2
Risk

K072601 is an FDA 510(k) clearance for the OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT. Classified as Methyl Methacrylate For Cranioplasty (product code GXP), Class II - Special Controls.

Submitted by Osteosymbionics, LLC (Cleveland, US). The FDA issued a Cleared decision on December 10, 2007 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5300 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Osteosymbionics, LLC devices

FDA 510(k) Submission Details - K072601

510(k) Number K072601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2007
Decision Date December 10, 2007
Days to Decision 87 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
61d faster than avg
Panel avg: 148d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXP Device Classification - Class 2, Special Controls

Product Code GXP Methyl Methacrylate For Cranioplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5300
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 - GXP Methyl Methacrylate For Cranioplasty

All 29
Devices cleared under the same product code (GXP) and FDA review panel - the closest regulatory comparables to K072601.
DB-CMF
K182742 · Dimensional Bioceramics, LLC · Jun 2019
DirectInject
K143661 · Stryker · Sep 2015
NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY
K102018 · Synthes USA Products, LLC · Sep 2010
MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280
K071791 · Codman & Shurtleff, Inc. · Jul 2007
STRYKER INJECTABLE CEMENT
K060763 · Stryker · Sep 2006
NORIAN CRS FAST SET PUTTY
K060443 · Synthes (Usa) · Apr 2006