Cleared Traditional

K873154 - TREACE MAGNUM OTO-TOOL SYSTEM

K873154 is the FDA 510(k) clearance for TREACE MAGNUM OTO-TOOL SYSTEM by Treace Medical, Inc.. It is a Class 2 Ear, Nose, Throat device (product code ERL) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K873154 · Treace Medical, Inc. · Ear, Nose, Throat device
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Sep 1987
Decision
24d
Days
Class 2
Risk

K873154 is an FDA 510(k) clearance for the TREACE MAGNUM OTO-TOOL SYSTEM. Classified as Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (product code ERL), Class II - Special Controls.

Submitted by Treace Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on September 4, 1987 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4250 - the FDA ear, nose and throat device framework. 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 Treace Medical, Inc. devices

Submission Details

510(k) Number K873154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1987
Decision Date September 04, 1987
Days to Decision 24 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 89d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ERL Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - ERL Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece

All 58
Devices cleared under the same product code (ERL) and FDA review panel - the closest regulatory comparables to K873154.
STRYKER TOTAL PERFORMANCE SYSTEM
K943569 · Stryker Corp. · Jan 1995
APEX UNIVERSAL DRIVE SYSTEM
K944476 · Linvatec Corp. · Nov 1994
STRYKER MICRODEBRIDER SYSTEM
K940710 · Stryker Corp. · May 1994
TREACE DRILL SYSTEM
K862807 · Treace Medical, Inc. · Aug 1986
MICRO-AIRE OTO/NEURO DRILL SYSTEM
K854331 · Micro-Aire Surgical Instruments, Inc. · Jan 1986
MICRO-AIRE STAPES DRILL SYSTEM
K854332 · Micro-Aire Surgical Instruments, Inc. · Jan 1986