Cleared Traditional

K140622 - DVR DORSAL PLATE

K140622 is the FDA 510(k) clearance for DVR DORSAL PLATE by Biomet, Inc.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K140622 · Biomet, Inc. · Orthopedic device
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May 2014
Decision
63d
Days
Class 2
Risk

K140622 is an FDA 510(k) clearance for the DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on May 13, 2014 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory 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, Inc. devices

Submission Details

510(k) Number K140622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2014
Decision Date May 13, 2014
Days to Decision 63 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 122d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 Orthopedic devices follow this clearance model.

Regulatory Peers - HRS Plate, Fixation, Bone

All 918
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K140622.
APTUS ULNA SHORTENING 2.5
K141232 · Medartis AG · Jun 2014
ACUMED HAND FRACTURE SYSTEM
K141383 · Acumed, LLC · Jun 2014
SALVATION 3DI PLATING SYSTEM
K140792 · Wrightmedicaltechnologyinc · May 2014
AAP LOQTEC(R) OLECRANON PLATE
K140607 · Aap Implantate AG · May 2014
EVOS MINI-FRAGMENT PLATING SYSTEM
K140814 · Smith & Nephew, Inc. · May 2014
MATRIXRIB FIXATION SYSTEM
K133616 · Synthes USA Products, LLC · May 2014