Cleared Traditional

K043260 - ORTHOCON LLC ORTHOSTAT HEMOSTATIC BONE ...

K043260 · Orthocon, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
261d
Days
-
Risk

K043260 is an FDA 510(k) clearance for the ORTHOCON LLC ORTHOSTAT HEMOSTATIC BONE PUTTY. Classified as Wax, Bone (product code MTJ).

Submitted by Orthocon, LLC (Colts Neck, US). The FDA issued a Cleared decision on August 12, 2005 after a review of 261 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Orthocon, LLC devices

FDA 510(k) Submission Details - K043260

510(k) Number K043260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2004
Decision Date August 12, 2005
Days to Decision 261 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 115d · This submission: 261d
Pathway characteristics
Predicate-based equivalence.

MTJ Device Classification - Class 0,

Product Code MTJ Wax, Bone
Device Class -

Regulatory Peers - MTJ Wax, Bone

All 33
Devices cleared under the same product code (MTJ) and FDA review panel - the closest regulatory comparables to K043260.
ORTHOCON HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY
K063330 · Orthocon, Inc. · Nov 2006
OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31
K060987 · Cp Medical · Nov 2006
AOC BONE WAX OSTENE, OSTEOTENE AND CERETENE
K052528 · Ceremed , Inc. · Oct 2005
AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERETENE, MODEL BW-12
K050440 · Ceremed , Inc. · Mar 2005
SHARPOINT LUKENS BONE WAX
K050292 · Surgical Specialties Corp · Mar 2005
AOC BONE WAX
K041363 · Ceremed , Inc. · Jul 2004