Cleared Traditional

K012589 - FAST SET PUTTY

K012589 is the FDA 510(k) clearance for FAST SET PUTTY by Synthes (Usa). It is a Class 2 Neurology device (product code GXP) cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K012589 · Synthes (Usa) · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
181d
Days
Class 2
Risk

K012589 is an FDA 510(k) clearance for the FAST SET PUTTY. Classified as Methyl Methacrylate For Cranioplasty (product code GXP), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on February 7, 2002 after a review of 181 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 Synthes (Usa) devices

Submission Details

510(k) Number K012589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2001
Decision Date February 07, 2002
Days to Decision 181 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
33d slower than avg
Panel avg: 148d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 24
Devices cleared under the same product code (GXP) and FDA review panel - the closest regulatory comparables to K012589.
BIOMET CRANIOFACIAL ACRYLIC CEMENT
K011399 · Biomet, Inc. · May 2003
QUICKSET MIMIX BONE VOID FILLER
K023718 · Walter Lorenz Surgical, Inc. · Dec 2002
BONESOURCE HAC
K021440 · Stryker Instruments · Aug 2002
MODIFICATION TO: INJECTABLE MIMIX
K012569 · Biomet, Inc. · Dec 2001
CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER
K990290 · Biomet, Inc. · Nov 1999
CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL
K873689 · Dentsply Intl. · Oct 1987