Cleared Traditional

K953339 - BONESOURCE HYDROXYAPATITE CEMENT (HAC)

K953339 is an FDA 510(k) clearance for BONESOURCE HYDROXYAPATITE CEMENT (HAC), manufactured by Osteogenics, Inc.. The device is a Class 2 Neurology device with product code GXP cleared through the Traditional 510(k) pathway after a 346-day FDA review.

K953339 · Osteogenics, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
346d
Days
Class 2
Risk

K953339 is an FDA 510(k) clearance for the BONESOURCE HYDROXYAPATITE CEMENT (HAC). Classified as Methyl Methacrylate For Cranioplasty (product code GXP), Class II - Special Controls.

Submitted by Osteogenics, Inc. (Richardson, US). The FDA issued a Cleared decision on June 27, 1996 after a review of 346 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 Osteogenics, Inc. devices

FDA 510(k) Submission Details - K953339

510(k) Number K953339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1995
Decision Date June 27, 1996
Days to Decision 346 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
198d slower than avg
Panel avg: 148d · This submission: 346d
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 32
Devices cleared under the same product code (GXP) and FDA review panel - the closest regulatory comparables to K953339.
MEDPOR SURGICAL GRANULE IMPLANTS
K982040 · Porex Surgical, Inc. · Sep 1998
NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORIAN CRANIAL REPAIR SYSTEM (CRS) BONE CEMENT- 10CC
K973789 · Norian Corp. · May 1998
BONESOURCE HYDROXYAPATITE CEMENT (HAC)
K964537 · Osteogenics, Inc. · Jan 1997
CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL
K873689 · Dentsply Intl. · Oct 1987