Cleared Traditional

K973789 - NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORIAN CRANIAL REPAIR SYSTEM (CRS) BONE CEMENT- 10CC

K973789 is an FDA 510(k) clearance for NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE ..., manufactured by Norian Corp.. The device is a Class 2 Neurology device with product code GXP cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K973789 · Norian Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
224d
Days
Class 2
Risk

K973789 is an FDA 510(k) clearance for the NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORIAN CRANIAL REPAIR.... Classified as Methyl Methacrylate For Cranioplasty (product code GXP), Class II - Special Controls.

Submitted by Norian Corp. (Cupertino, US). The FDA issued a Cleared decision on May 18, 1998 after a review of 224 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 Norian Corp. devices

FDA 510(k) Submission Details - K973789

510(k) Number K973789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1997
Decision Date May 18, 1998
Days to Decision 224 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
76d slower than avg
Panel avg: 148d · This submission: 224d
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 31
Devices cleared under the same product code (GXP) and FDA review panel - the closest regulatory comparables to K973789.
CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER
K990290 · Biomet, Inc. · Nov 1999
BSM- BONE SUBSTITUTE MATERIAL
K983009 · Etex Corp. · Nov 1998
MEDPOR SURGICAL GRANULE IMPLANTS
K982040 · Porex Surgical, Inc. · Sep 1998
BONESOURCE HYDROXYAPATITE CEMENT (HAC)
K964537 · Osteogenics, Inc. · Jan 1997
CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL
K873689 · Dentsply Intl. · Oct 1987