Cleared Traditional

K050292 - SHARPOINT LUKENS BONE WAX

K050292 · Surgical Specialties Corp · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
30d
Days
-
Risk

K050292 is an FDA 510(k) clearance for the SHARPOINT LUKENS BONE WAX. Classified as Wax, Bone (product code MTJ).

Submitted by Surgical Specialties Corp (Reading, US). The FDA issued a Cleared decision on March 9, 2005 after a review of 30 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 Surgical Specialties Corp devices

FDA 510(k) Submission Details - K050292

510(k) Number K050292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2005
Decision Date March 09, 2005
Days to Decision 30 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
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

MTJ Device Classification - Class 0,

Product Code MTJ Wax, Bone
Device Class -

Regulatory Peers - MTJ Wax, Bone

All 26
Devices cleared under the same product code (MTJ) and FDA review panel - the closest regulatory comparables to K050292.
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K971680 · United States Surgical, A Division of Tyco Healthc · Oct 1997