Cleared Traditional

K102762 - ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATOR

K102762 · Orthocon, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
144d
Days
-
Risk

K102762 is an FDA 510(k) clearance for the ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATOR. Classified as Wax, Bone (product code MTJ).

Submitted by Orthocon, Inc. (Irvington, US). The FDA issued a Cleared decision on February 15, 2011 after a review of 144 days - within the typical 510(k) review window.

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, Inc. devices

FDA 510(k) Submission Details - K102762

510(k) Number K102762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2010
Decision Date February 15, 2011
Days to Decision 144 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
29d slower than avg
Panel avg: 115d · This submission: 144d
Pathway characteristics
Predicate-based equivalence.

MTJ Device Classification - Class 0,

Product Code MTJ Wax, Bone
Device Class -

Regulatory Peers - MTJ Wax, Bone

All 40
Devices cleared under the same product code (MTJ) and FDA review panel - the closest regulatory comparables to K102762.
SKAFFOLD CIS
K111538 · Skeletal Kinetics, LLC · Oct 2011
MP 719
K111524 · Marine Polymer Technologies, Inc. · Jul 2011
SYNTHES HEMOSTATIC BONE PUTTY (HBP)
K103822 · Synthes USA Products, LLC · May 2011
OSTENE CT, AOC CT, OSTEOTENE, CERETENE
K102071 · Ceremed , Inc. · Oct 2010
OSTENE CT, AOC CT, OSTEOTENE, CERETENE
K091636 · Ceremed , Inc. · Jun 2009
ORTHOSTAT
K091121 · Orthocon, Inc. · Apr 2009