Cleared Special

K082516 - PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM HEXALOBULAR BONE SCREWS

K082516 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 HWC cleared through the Special 510(k) pathway after a 15-day FDA review.

K082516 · Smith & Nephew, Inc. · Orthopedic device
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Sep 2008
Decision
15d
Days
Class 2
Risk

K082516 is an FDA 510(k) clearance for the PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM HEXALOBULAR BONE SCREWS. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on September 17, 2008 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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

FDA 510(k) Submission Details - K082516

510(k) Number K082516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2008
Decision Date September 17, 2008
Days to Decision 15 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
107d faster than avg
Panel avg: 122d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 927
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K082516.
ORTHOPEDIATRICS BONE SCREWS
K082949 · OrthoPediatrics Corp. · Nov 2008
DARCO SMALL SCREW
K082320 · Wrightmedicaltechnologyinc · Nov 2008
OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE, MODEL OM-6500
K081893 · Arthrocare Corp. · Oct 2008
EXTREMITY MEDICAL COMPRESSION SCREW
K081934 · Extremity Medical, LLC · Aug 2008
BIOPRO GO-EZ SCREW
K081149 · Biopro, Inc. · Aug 2008
MERETE 3.0 AND 3.5 MM LOCKING SCREWS
K081513 · Merete Medical GmbH · Jul 2008