Cleared Special

K092015 - PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM

K092015 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 24-day FDA review.

K092015 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
24d
Days
Class 2
Risk

K092015 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 July 30, 2009 after a review of 24 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 - K092015

510(k) Number K092015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2009
Decision Date July 30, 2009
Days to Decision 24 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
98d faster than avg
Panel avg: 122d · This submission: 24d
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 K092015.
AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 3MM LOCKING INSERTS
K092419 · Howmedica Osteonics Corp. · Sep 2009
WAVEON WRX BONE FIXATION SYSTEM
K090304 · Sonoma Orthopedic Products, Inc. · Aug 2009
OPTILOCK PERIARTICULAR PLATING
K092078 · Biomet Trauma · Aug 2009
LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE,
K091294 · DePuy Orthopaedics, Inc. · Jul 2009
ADKINS STRUT
K091058 · Biomet Microfixation, Inc. · Jul 2009
TRIMED STERILE PRODUCT
K091156 · TriMed, Inc. · Jul 2009
K092015 · PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM
Download PDF FDA Summary Smith & Nephew, Inc.