Cleared Traditional

K141502 - HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTY (FDA 510(k) Clearance)

K141502 · Orthocon, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2014
Decision
119d
Days
-
Risk

K141502 is an FDA 510(k) clearance for the HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTY. Classified as Wax, Bone (product code MTJ).

Submitted by Orthocon, Inc. (Irvington, US). The FDA issued a Cleared decision on October 3, 2014 after a review of 119 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

Submission Details

510(k) Number K141502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2014
Decision Date October 03, 2014
Days to Decision 119 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
5d slower than avg
Panel avg: 114d · This submission: 119d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 K141502.
Montage- XT Settable, Resorbable Hemostatic Bone Putty
K232998 · Orthocon, Inc. · Oct 2023
MONTAGE Settable, Resorbable Hemostatic Bone Putty
K213418 · Orthocon, Inc. · Aug 2023
Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste
K231386 · Orthocon, Inc. · Jul 2023
Meril-Bonewax
K200452 · M/s. Meril Endo Surgery Private Limited. · Mar 2023
MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty
K220315 · Orthocon, Inc. · Mar 2022
HBP7 Settable Hemostatic Bone Putty
K202363 · Orthocon, Inc. · Jan 2021