Cleared Traditional

K051093 - OSTEOPORE PCL SCAFFOLD

K051093 is an FDA 510(k) clearance for OSTEOPORE PCL SCAFFOLD, manufactured by Osteopore, Inc.. The device is a Class 2 Neurology device with product code GXP cleared through the Traditional 510(k) pathway after a 323-day FDA review.

K051093 · Osteopore, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
323d
Days
Class 2
Risk

K051093 is an FDA 510(k) clearance for the OSTEOPORE PCL SCAFFOLD. Classified as Methyl Methacrylate For Cranioplasty (product code GXP), Class II - Special Controls.

Submitted by Osteopore, Inc. (Milpitas, US). The FDA issued a Cleared decision on March 17, 2006 after a review of 323 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Osteopore, Inc. devices

FDA 510(k) Submission Details - K051093

510(k) Number K051093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2005
Decision Date March 17, 2006
Days to Decision 323 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
175d slower than avg
Panel avg: 148d · This submission: 323d
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 35
Devices cleared under the same product code (GXP) and FDA review panel - the closest regulatory comparables to K051093.
STRYKER INJECTABLE CEMENT
K060763 · Stryker · Sep 2006
NORIAN CRS FAST SET PUTTY
K060443 · Synthes (Usa) · Apr 2006
NORIAN CRS BONE CEMENT
K060445 · Synthes (Usa) · Apr 2006
BONE SOURCE HAC RAPID SETTING CEMENT
K043334 · Stryker Instruments · Feb 2005
MIMIX MP BONE VOID FILLER
K043280 · Biomet, Inc. · Dec 2004
SYNTHES (USA) CHRONOS
K041350 · Synthes (Usa) · Jul 2004