Cleared Traditional

K043406 - VERTEBROPLASTIC RADIOPAQUE BONE CEMENT

K043406 is the FDA 510(k) clearance for VERTEBROPLASTIC RADIOPAQUE BONE CEMENT by Depuy Spine, Inc.. It is a Class 2 Orthopedic device (product code NDN) cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K043406 · Depuy Spine, Inc. · Orthopedic device
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Jul 2005
Decision
217d
Days
Class 2
Risk

K043406 is an FDA 510(k) clearance for the VERTEBROPLASTIC RADIOPAQUE BONE CEMENT. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Depuy Spine, Inc. (Raynham, US). The FDA issued a Cleared decision on July 15, 2005 after a review of 217 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3027 - the FDA orthopedic 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Depuy Spine, Inc. devices

Submission Details

510(k) Number K043406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2004
Decision Date July 15, 2005
Days to Decision 217 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 122d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NDN Cement, Bone, Vertebroplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3027
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 - NDN Cement, Bone, Vertebroplasty

All 44
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K043406.
EBI VERTEBROPLASTY SYSTEMS
K060148 · Ebi, L.P. · Mar 2006
PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS
K053180 · Arthrocare Corp. · Jan 2006
VERTEFIX VERTEBROPLASTY PROCEDURE SET
K042691 · Cook, Inc. · Nov 2005
PARALLAX ACRYLIC RESIN WITH TRACERS TA
K050864 · Arthrocare Corp. · Jun 2005
CONCORD Radiopaque Bone Cement
K042168 · Globus Medical, Inc. · Jan 2005
PARALLAX ACRYLIC RESIN WITH TRACERS, MODEL KP-PAR-003
K042947 · Arthrocare Corp. · Dec 2004