Cleared Traditional

K042415 - MENDEC SPINE

K042415 is an FDA 510(k) clearance for MENDEC SPINE, manufactured by Tecres S.P.A.. The device is a Class 2 Orthopedic device with product code NDN cleared through the Traditional 510(k) pathway after a 275-day FDA review.

K042415 · Tecres S.P.A. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
275d
Days
Class 2
Risk

K042415 is an FDA 510(k) clearance for the MENDEC SPINE. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Tecres S.P.A. (Bethesda, US). The FDA issued a Cleared decision on June 9, 2005 after a review of 275 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 Tecres S.P.A. devices

FDA 510(k) Submission Details - K042415

510(k) Number K042415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2004
Decision Date June 09, 2005
Days to Decision 275 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
153d slower than avg
Panel avg: 122d · This submission: 275d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NDN Device Classification - Class 2, Special Controls

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 53
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K042415.
VERTEFIX VERTEBROPLASTY PROCEDURE SET
K042691 · Cook, Inc. · Nov 2005
VERTEBROPLASTIC RADIOPAQUE BONE CEMENT
K043406 · Depuy Spine, Inc. · Jul 2005
PARALLAX ACRYLIC RESIN WITH TRACERS TA
K050864 · Arthrocare Corp. · Jun 2005
RADIOPAQUE BONE CEMENT
K043518 · Cardinalhealth · May 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