Cleared Traditional

PL8 Wrist Reconstruction Plate (K180150) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K180150 · Citieffe S.R.L. · Orthopedic device
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Aug 2018
Decision
195d
Days
Class 2
Risk

K180150 is an FDA 510(k) clearance for the PL8 Wrist Reconstruction Plate. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Citieffe S.R.L. (Calderara Di Reno, IT). The FDA issued a Cleared decision on August 2, 2018 after a review of 195 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Citieffe S.R.L. devices

Submission Details

510(k) Number K180150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2018
Decision Date August 02, 2018
Days to Decision 195 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 122d · This submission: 195d
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 698
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K180150.
AOS Small Fragment Plating System Lite
K181035 · Advanced Orthopaedic Solutions, Inc. (Aos) · Aug 2018
EVOS Wrist Fracture Plating System
K181533 · Smith & Nephew, Inc. · Aug 2018
APTUS® Proximal Humerus System
K181425 · Medartis AG · Aug 2018
CoLink™ Afx Plating System
K181113 · In2bones USA, LLC · Jun 2018
AlignX Ankle Fusion System
K181067 · Extremity Medical, LLC · May 2018
Omni Foot Plating System
K180808 · Extremity Medical, LLC · May 2018