Cleared Special

K081106 - PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM VOLAR DISTAL RADIUS LOCKING PLATE FOR THE UPPER EXTREMITY-ASTM F139

K081106 is an FDA 510(k) clearance for PERI-LOC PERIARTICULAR LOCKED PLATING S..., manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Special 510(k) pathway after a 61-day FDA review.

K081106 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K081106

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.

HRS Device Classification - Class 2, Special Controls

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 1332
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K081106.
ORTHOMESH
K073115 · Synthes (Usa) · Jul 2008
EVOLVE EPS SYSTEM
K081373 · Wrightmedicaltechnologyinc · Jul 2008
MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS
K073556 · Medxpert GmbH · Jun 2008
SYNTHES 3.5 MM LCP DISTAL TIBIA T PLATES
K080522 · Synthes (Usa) · May 2008
DISTAL HUMERAL PLATES WITH ANGULAR STABILITY
K080184 · I.T.S. Implantat-Technologie-Systeme GmbH · Mar 2008
AAP BONE PLATES AND SCREW IMPLANTS
K072411 · Aap Implantate AG · Mar 2008
K081106 · PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM VOLAR DISTAL RADIUS LOCKING PLATE FOR THE UPPER EXTREMITY-ASTM F139
Download PDF FDA Summary Smith & Nephew, Inc.