Cleared Traditional

K213208 - Twist Drills (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K213208 · Biomet Microfixation · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2021
Decision
85d
Days
Class 2
Risk

K213208 is an FDA 510(k) clearance for the Twist Drills. Classified as Drills, Burrs, Trephines & Accessories (simple, Powered) (product code HBE), Class II - Special Controls.

Submitted by Biomet Microfixation (Jacksonville, US). The FDA issued a Cleared decision on December 23, 2021 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4310 - the FDA neurology 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 Biomet Microfixation devices

Submission Details

510(k) Number K213208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2021
Decision Date December 23, 2021
Days to Decision 85 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 148d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HBE Drills, Burrs, Trephines & Accessories (simple, Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4310
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 Neurology devices follow this clearance model.

Regulatory Consultant

MRC Global, LLC
Danielle Besal

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HBE Drills, Burrs, Trephines & Accessories (simple, Powered)

All 64
Devices cleared under the same product code (HBE) and FDA review panel - the closest regulatory comparables to K213208.
Surgify Halo (54.085.SHD.U1)
K253627 · Surgify Medical OY · Mar 2026
Hubly Drill (H100)
K250815 · Hubly, Inc. · Nov 2025
GREEN
K252060 · Phasor Health, LLC · Oct 2025
UniBur
K252662 · Nakanishi, Inc. · Sep 2025
Surgify Halo (54.085.SHD.H1)
K251433 · Surgify Medical OY · Jun 2025
Surgify Halo (54.085.SHD.H1)
K250380 · Surgify Medical OY · Mar 2025