Cleared Traditional

K072707 - PATIENT CONTOURED MESH-PEEK (PCM-P)

K072707 is an FDA 510(k) clearance for PATIENT CONTOURED MESH-PEEK (PCM-P), 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 85-day FDA review.

K072707 · KLS-Martin L.P. · Neurology device
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Dec 2007
Decision
85d
Days
Class 2
Risk

K072707 is an FDA 510(k) clearance for the PATIENT CONTOURED MESH-PEEK (PCM-P). 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 December 19, 2007 after a review of 85 days - a notably fast clearance 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: 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 KLS-Martin L.P. devices

FDA 510(k) Submission Details - K072707

510(k) Number K072707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2007
Decision Date December 19, 2007
Days to Decision 85 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
63d faster than avg
Panel avg: 148d · This submission: 85d
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 54
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