Cleared Traditional

K153095 - ROP Resorbable Hemostasis Material (FDA 510(k) Clearance)

K153095 · Resorbable Orthopedic Products, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
114d
Days
-
Risk

K153095 is an FDA 510(k) clearance for the ROP Resorbable Hemostasis Material. Classified as Wax, Bone (product code MTJ).

Submitted by Resorbable Orthopedic Products, LLC (Addison, US). The FDA issued a Cleared decision on February 17, 2016 after a review of 114 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 Resorbable Orthopedic Products, LLC devices

Submission Details

510(k) Number K153095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2015
Decision Date February 17, 2016
Days to Decision 114 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
At panel average
Panel avg: 114d · This submission: 114d
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 K153095.
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K202363 · Orthocon, Inc. · Jan 2021