Cleared Traditional

K990290 - CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER

K990290 is an FDA 510(k) clearance for CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC ..., manufactured by Biomet, Inc.. The device is a Class 2 Neurology device with product code GXP cleared through the Traditional 510(k) pathway after a 293-day FDA review.

K990290 · Biomet, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
293d
Days
Class 2
Risk

K990290 is an FDA 510(k) clearance for the CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER. Classified as Methyl Methacrylate For Cranioplasty (product code GXP), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on November 18, 1999 after a review of 293 days - an extended review 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: 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 Biomet, Inc. devices

FDA 510(k) Submission Details - K990290

510(k) Number K990290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1999
Decision Date November 18, 1999
Days to Decision 293 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
145d slower than avg
Panel avg: 148d · This submission: 293d
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 38
Devices cleared under the same product code (GXP) and FDA review panel - the closest regulatory comparables to K990290.
FAST SET PUTTY
K012589 · Synthes (Usa) · Feb 2002
MODIFICATION TO: INJECTABLE MIMIX
K012569 · Biomet, Inc. · Dec 2001
PARALLAX CRANIOSET
K994022 · Parallax Medical, Inc. · Aug 2000
BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT
K991398 · Stryker Leibinger · Sep 1999
BSM- BONE SUBSTITUTE MATERIAL
K983009 · Etex Corp. · Nov 1998
MEDPOR SURGICAL GRANULE IMPLANTS
K982040 · Porex Surgical, Inc. · Sep 1998