Cleared Traditional

K983009 - BSM- BONE SUBSTITUTE MATERIAL

K983009 is an FDA 510(k) clearance for BSM- BONE SUBSTITUTE MATERIAL, manufactured by Etex Corp.. The device is a Class 2 Neurology device with product code GXP cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K983009 · Etex Corp. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
89d
Days
Class 2
Risk

K983009 is an FDA 510(k) clearance for the BSM- BONE SUBSTITUTE MATERIAL. Classified as Methyl Methacrylate For Cranioplasty (product code GXP), Class II - Special Controls.

Submitted by Etex Corp. (Cambridge, US). The FDA issued a Cleared decision on November 25, 1998 after a review of 89 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.

FDA 510(k) Submission Details - K983009

510(k) Number K983009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1998
Decision Date November 25, 1998
Days to Decision 89 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
60d faster than avg
Panel avg: 149d · This submission: 89d
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 44
Devices cleared under the same product code (GXP) and FDA review panel - the closest regulatory comparables to K983009.
PARALLAX CRANIOSET
K994022 · Parallax Medical, Inc. · Aug 2000
CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER
K990290 · Biomet, Inc. · Nov 1999
BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT
K991398 · Stryker Leibinger · Sep 1999
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