Cleared Traditional

K000021 - AESCULAP BONE WAX

K000021 · Aesculap, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
80d
Days
-
Risk

K000021 is an FDA 510(k) clearance for the AESCULAP BONE WAX. Classified as Wax, Bone (product code MTJ).

Submitted by Aesculap, Inc. (San Diego, US). The FDA issued a Cleared decision on March 24, 2000 after a review of 80 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.

FDA 510(k) Submission Details - K000021

510(k) Number K000021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2000
Decision Date March 24, 2000
Days to Decision 80 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
35d faster than avg
Panel avg: 115d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

MTJ Device Classification - Class 0,

Product Code MTJ Wax, Bone
Device Class -

Regulatory Peers - MTJ Wax, Bone

All 42
Devices cleared under the same product code (MTJ) and FDA review panel - the closest regulatory comparables to K000021.
SHARPOINT LUKENS BONE WAX
K050292 · Surgical Specialties Corp · Mar 2005
AOC BONE WAX
K041363 · Ceremed , Inc. · Jul 2004
CP MEDICAL BONE WAX
K024372 · Cp Medical · Jun 2003
AUTO SUTURE BONE WAX
K971680 · United States Surgical, A Division of Tyco Healthc · Oct 1997
LUKENS BONE WAX (GAMMA RADIATION)
K791495 · Lukens Corp. · Sep 1979
K000021 · AESCULAP BONE WAX
Download PDF FDA Summary Aesculap, Inc.