Cleared Traditional

K162829 - Medline UNITE Ankle Fracture Plating Sy...

K162829 is the FDA 510(k) clearance for Medline UNITE Ankle Fracture Plating Sy... by Medline Industries, Inc.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K162829 · Medline Industries, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
63d
Days
Class 2
Risk

K162829 is an FDA 510(k) clearance for the Medline UNITE® Ankle Fracture Plating System. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on December 9, 2016 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 Medline Industries, Inc. devices

Submission Details

510(k) Number K162829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2016
Decision Date December 09, 2016
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 915
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K162829.
AxSOS 3 Ti
K162439 · Stryker GmbH · Feb 2017
ORTHOLOC® 3Di Ankle Fracture Plating System
K163044 · Wrightmedicaltechnologyinc · Jan 2017
VLP MINI-MOD 2.0mm Column Plates
K163086 · Smith & Nephew, Inc. · Dec 2016
aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5
K161696 · Aap Implantate AG · Nov 2016
LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5
K161747 · Aap Implantate AG · Nov 2016
EVOS Small Fragment Plating System
K162078 · Smith & Nephew, Inc. · Nov 2016