Cleared Traditional

K992905 - CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM

K992905 is an FDA 510(k) clearance for CODMAN CRANIOSORB ABSORBABLE FIXATION S..., manufactured by Codman & Shurtleff, Inc.. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 337-day FDA review.

K992905 · Codman & Shurtleff, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
337d
Days
Class 2
Risk

K992905 is an FDA 510(k) clearance for the CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on August 1, 2000 after a review of 337 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - the FDA dental device regulatory 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 Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Codman & Shurtleff, Inc. devices

FDA 510(k) Submission Details - K992905

510(k) Number K992905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1999
Decision Date August 01, 2000
Days to Decision 337 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
210d slower than avg
Panel avg: 127d · This submission: 337d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEY Device Classification - Class 2, Special Controls

Product Code JEY Plate, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
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 Dental devices follow this clearance model.

Regulatory Peers - JEY Plate, Bone

All 238
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K992905.
NEWGEN SYSTEM
K002619 · Stryker Instruments · Nov 2000
MACROPOREMX MANDIBULAR FIXATION SYSTEM
K000696 · Macropore Biosurgery, Inc. · Oct 2000
MODIFICATION TO BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
K002879 · Bioplate, Inc. · Oct 2000
THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
K001530 · Bioplate, Inc. · Jul 2000
BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM
K000836 · Bionx Implants, Inc. · Jun 2000
LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM
K001238 · Walter Lorenz Surgical, Inc. · May 2000