Cleared Special

K081106 - PERI-LOC PERIARTICULAR LOCKED PLATING S...

K081106 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 Special 510(k) pathway after a 61-day FDA review.

K081106 · Smith & Nephew, Inc. · Orthopedic device
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Jun 2008
Decision
61d
Days
Class 2
Risk

K081106 is an FDA 510(k) clearance for the PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM VOLAR DISTAL RADIUS LOCKING PLAT.... 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 June 18, 2008 after a review of 61 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number K081106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2008
Decision Date June 18, 2008
Days to Decision 61 days
Submission Type Special
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
61d faster than avg
Panel avg: 122d · This submission: 61d
Pathway characteristics
Modification to existing cleared device.

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 K081106.
ORTHOPEDIATRICS PEDIPLATES SYSTEM
K081407 · OrthoPediatrics Corp. · Jul 2008
ORTHOMESH
K073115 · Synthes (Usa) · Jul 2008
EVOLVE EPS SYSTEM
K081373 · Wrightmedicaltechnologyinc · Jul 2008
SYNTHES 3.5 MM LCP DISTAL TIBIA T PLATES
K080522 · Synthes (Usa) · May 2008
AAP BONE PLATES AND SCREW IMPLANTS
K072411 · Aap Implantate AG · Mar 2008
VARIAX DISTAL RADIUS TORX SCREWS
K080667 · Howmedica Osteonics Corp. · Mar 2008