Cleared Traditional

K062216 - PERI-LOC PERIARTICULAR LOCKED PLATING S...

K062216 is the FDA 510(k) clearance for PERI-LOC PERIARTICULAR LOCKED PLATING S... by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K062216 · Smith & Nephew, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Sep 2006
Decision
45d
Days
Class 2
Risk

K062216 is an FDA 510(k) clearance for the PERI-LOC PERIARTICULAR LOCKED 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 Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on September 15, 2006 after a review of 45 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 Smith & Nephew, Inc. devices

Submission Details

510(k) Number K062216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2006
Decision Date September 15, 2006
Days to Decision 45 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
77d faster than avg
Panel avg: 122d · This submission: 45d
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 904
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K062216.
EBI OPTILOCK UPPER EXTREMITY PLATING SYSTEM
K062494 · Ebi, L.P. · Oct 2006
SYNTHES LCP DISTAL FEMUR PLATES
K062564 · Synthes (Usa) · Oct 2006
ARTHREX RETROBUTTON, 15MM, 60MM, RETROBUTTON, LONG, 15MM, 60MM
K062747 · Arthrex, Inc. · Sep 2006
SYNTHES 3.5MM SPRING PLATE
K061973 · Synthes (Usa) · Sep 2006
SYNTHES LCP ANKLE ARTHRODESIS PLATES
K061940 · Synthes (Usa) · Sep 2006
KLS MARTIN STERNAL TALON
K051165 · KLS-Martin L.P. · Sep 2006