Cleared Traditional

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

K151382 is an FDA 510(k) clearance for Patient Contoured Implant-PEEK (PCI-PEEK), manufactured by KLS-Martin L.P.. The device is a Class 2 Neurology device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K151382

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
22d slower than avg
Panel avg: 149d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXN Device Classification - Class 2, Special Controls

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 56
Devices cleared under the same product code (GXN) and FDA review panel - the closest regulatory comparables to K151382.
Cranial PSI
K161090 · Ossdsign AB · Jan 2017
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K160707 · Fin-Ceramica Faenza S.P.A. · Dec 2016
BioArchitects Patient Specific Cranial/Craniofacial Plate
K151692 · Bioarchitects USA, LLC · Nov 2015
SPEEDY FLAP SYSTEM
K130447 · Jeil Medical Corporation · Dec 2014
OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE
K133082 · Osteosymbionics, LLC · May 2014
OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE
K121818 · Oxford Performance Materials · Feb 2013
K151382 · Patient Contoured Implant-PEEK (PCI-PEEK)
Download PDF FDA Summary KLS-Martin L.P.