Cleared Abbreviated

PORE-SI BONE GRAFT SUBSTITUTE (K040082) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K040082 · Apatech , Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
202d
Days
Class 2
Risk

K040082 is an FDA 510(k) clearance for the PORE-SI BONE GRAFT SUBSTITUTE. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Apatech , Ltd. (Waltham, US). The FDA issued a Cleared decision on August 4, 2004 after a review of 202 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3045 - the FDA orthopedic device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Apatech , Ltd. devices

Submission Details

510(k) Number K040082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2004
Decision Date August 04, 2004
Days to Decision 202 days
Submission Type Abbreviated
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 122d · This submission: 202d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code MQV Filler, Bone Void, Calcium Compound
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3045
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 Orthopedic devices follow this clearance model.

Regulatory Peers - MQV Filler, Bone Void, Calcium Compound

All 200
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K040082.
IGNITE BONE VOID FILLER KIT
K052913 · Wrightmedicaltechnologyinc · Nov 2005
SYNTHES (USA) CHRONOS
K043045 · Synthes (Usa) · Jan 2005
ALLOMATRIX TCP, ALLOMATRIX W/CASO4 FILLED TCP, AND ALLOMATRIX PLUS CBM
K041663 · Wrightmedicaltechnologyinc · Sep 2004
ALLOMATRIX PUTTY
K041168 · Wrightmedicaltechnologyinc · Aug 2004
NORIAN SRS FAST SET PUTTY
K041842 · Synthes (Usa) · Jul 2004
ALLOMATRIX C PUTTY, ALLOMATRIX CUSTOM PUTTY, ALLOMATRIX DR PUTTY, IGNITE SCAFFOLD, MODELS 860C, 86XC, 86DR, 860D, 860T
K040980 · Wrightmedicaltechnologyinc · Jul 2004