Cleared Traditional

K072818 - PERI-LOC PERIARTRICULAR LCK PIT SYS-PRO...

K072818 is the FDA 510(k) clearance for PERI-LOC PERIARTRICULAR LCK PIT SYS-PRO... by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K072818 · Smith & Nephew, Inc. · Orthopedic device
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Nov 2007
Decision
48d
Days
Class 2
Risk

K072818 is an FDA 510(k) clearance for the PERI-LOC PERIARTRICULAR LCK PIT SYS-PROX FEM PLATES/SCREWS.CALBE ACCESS. 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 November 19, 2007 after a review of 48 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 K072818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2007
Decision Date November 19, 2007
Days to Decision 48 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
74d faster than avg
Panel avg: 122d · This submission: 48d
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 K072818.
BIOFOAM BONE WEDGE
K073535 · Wrightmedicaltechnologyinc · Jan 2008
SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM
K073186 · Synthes (Usa) · Dec 2007
ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM
K072832 · DePuy Orthopaedics, Inc. · Dec 2007
4.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5MM CORTICAL & CANCELLOUS LOCKING SCREWS, RESPECTIVELY.
K072423 · DePuy Orthopaedics, Inc. · Nov 2007
SMALL FRAGMENT LOCKING PLATING SYSTEM
K072083 · DePuy Orthopaedics, Inc. · Oct 2007
SMALL BONE WEDGE
K070592 · Wrightmedicaltechnologyinc · Oct 2007