Cleared Traditional

K021440 - BONESOURCE HAC

K021440 is the FDA 510(k) clearance for BONESOURCE HAC by Stryker Instruments. It is a Class 2 General & Plastic Surgery device (product code GXP) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K021440 · Stryker Instruments · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
88d
Days
Class 2
Risk

K021440 is an FDA 510(k) clearance for the BONESOURCE HAC. Classified as Methyl Methacrylate For Cranioplasty (product code GXP), Class II - Special Controls.

Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on August 2, 2002 after a review of 88 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 882.5300 - the FDA general and plastic surgery 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.

View all Stryker Instruments devices

Submission Details

510(k) Number K021440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2002
Decision Date August 02, 2002
Days to Decision 88 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 115d · This submission: 88d
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 General & Plastic Surgery 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 K021440.
BONESOURCE HAC FAST SETTING CEMENT
K032366 · Stryker Instruments · Oct 2003
BIOMET CRANIOFACIAL ACRYLIC CEMENT
K011399 · Biomet, Inc. · May 2003
QUICKSET MIMIX BONE VOID FILLER
K023718 · Walter Lorenz Surgical, Inc. · Dec 2002
FAST SET PUTTY
K012589 · Synthes (Usa) · Feb 2002
MODIFICATION TO: INJECTABLE MIMIX
K012569 · Biomet, Inc. · Dec 2001
CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER
K990290 · Biomet, Inc. · Nov 1999