Cleared Traditional

LUKENS BONE WAX (GAMMA RADIATION) (K791495) - FDA 510(k) Clearance

K791495 · Lukens Corp. · General & Plastic Surgery device

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Sep 1979

Decision

52d

Days

Risk

K791495 is an FDA 510(k) clearance for the LUKENS BONE WAX (GAMMA RADIATION). Classified as Wax, Bone (product code MTJ).

Submitted by Lukens Corp. (Mchenry, US). The FDA issued a Cleared decision on September 24, 1979 after a review of 52 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lukens Corp. devices

Submission Details

510(k) Number	K791495 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 03, 1979
Decision Date	September 24, 1979
Days to Decision	52 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

63d faster than avg

Panel avg: 115d · This submission: 52d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	MTJ Wax, Bone
Device Class	-

Regulatory Peers - MTJ Wax, Bone

All 41

Devices cleared under the same product code (MTJ) and FDA review panel - the closest regulatory comparables to K791495.

Permatage Flowable, Settable Hemostatic Bone Paste

K261439 · Orthocon, Inc. · Jun 2026

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

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K791495

Lukens Corp.

Mchenry, IL · US

Regulatory profile

11 submissions 11 cleared

100% clearance rate · Active in General & Plastic Surgery

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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