Cleared Traditional

K151382 - Patient Contoured Implant-PEEK (PCI-PEEK)

K151382 is the FDA 510(k) clearance for Patient Contoured Implant-PEEK (PCI-PEEK) by KLS-Martin L.P.. It is a Class 2 Neurology device (product code GXN) cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K151382 · KLS-Martin L.P. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2015
Decision
171d
Days
Class 2
Risk

K151382 is an FDA 510(k) clearance for the Patient Contoured Implant-PEEK (PCI-PEEK). Classified as Plate, Cranioplasty, Preformed, Non-alterable (product code GXN), Class II - Special Controls.

Submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on November 9, 2015 after a review of 171 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5330 - the FDA neurology device 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all KLS-Martin L.P. devices

Submission Details

510(k) Number K151382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2015
Decision Date November 09, 2015
Days to Decision 171 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 148d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXN Plate, Cranioplasty, Preformed, Non-alterable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5330
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 Neurology devices follow this clearance model.

Regulatory Peers - GXN Plate, Cranioplasty, Preformed, Non-alterable

All 30
Devices cleared under the same product code (GXN) and FDA review panel - the closest regulatory comparables to K151382.
OsteoFab Patient Specific Cranial Device
K180064 · Oxford Performance Materials, Inc. · Jul 2018
CustomizedBone Service
K180513 · Fin-Ceramica Faenza S.P.A. · May 2018
Longeviti PMMA Static Cranial Implant
K170410 · Longeviti Neuro Solutions, LLC · Mar 2018
CRAINFIX 2 TITANIUM CLAMP SYSTEM
K122353 · Aesculap, Inc. · Aug 2012
PATIENT CONTOURED MESH-PEEK (PCM-P)
K072707 · KLS-Martin L.P. · Dec 2007
KLS MARTIN QUICK DISC
K062857 · KLS-Martin L.P. · Nov 2006