Cleared Traditional

K113079 - SYNTHES HEMOSTATIC BONE PUTTY (FDA 510(k) Clearance)

K113079 · Synthes (Usa) Products, LLC/Norian Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
57d
Days
-
Risk

K113079 is an FDA 510(k) clearance for the SYNTHES HEMOSTATIC BONE PUTTY. Classified as Wax, Bone (product code MTJ).

Submitted by Synthes (Usa) Products, LLC/Norian Corporation (West Chester, US). The FDA issued a Cleared decision on December 13, 2011 after a review of 57 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 Synthes (Usa) Products, LLC/Norian Corporation devices

Submission Details

510(k) Number K113079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2011
Decision Date December 13, 2011
Days to Decision 57 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
57d faster than avg
Panel avg: 114d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MTJ Wax, Bone
Device Class -

Regulatory Peers - MTJ Wax, Bone

All 40
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