Cleared Traditional

K024372 - CP MEDICAL BONE WAX (FDA 510(k) Clearance)

K024372 · Cp Medical · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
170d
Days
-
Risk

K024372 is an FDA 510(k) clearance for the CP MEDICAL BONE WAX. Classified as Wax, Bone (product code MTJ).

Submitted by Cp Medical (Portland, US). The FDA issued a Cleared decision on June 19, 2003 after a review of 170 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 Cp Medical devices

Submission Details

510(k) Number K024372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2002
Decision Date June 19, 2003
Days to Decision 170 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
56d slower than avg
Panel avg: 114d · This submission: 170d
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 K024372.
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