Cleared Traditional

K243715 - Synthes Patient Specific Implants

K243715 is an FDA 510(k) clearance for Synthes Patient Specific Implants, manufactured by Synthes GmbH. The device is a Class 2 Neurology device with product code GXN cleared through the Traditional 510(k) pathway after a 345-day FDA review.

K243715 · Synthes GmbH · Neurology device
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Nov 2025
Decision
345d
Days
Class 2
Risk

K243715 is an FDA 510(k) clearance for the Synthes Patient Specific Implants. Classified as Plate, Cranioplasty, Preformed, Non-alterable (product code GXN), Class II - Special Controls.

Submitted by Synthes GmbH (Zuchwil, CH). The FDA issued a Cleared decision on November 12, 2025 after a review of 345 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Synthes GmbH devices

FDA 510(k) Submission Details - K243715

510(k) Number K243715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2024
Decision Date November 12, 2025
Days to Decision 345 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
197d slower than avg
Panel avg: 148d · This submission: 345d
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 55
Devices cleared under the same product code (GXN) and FDA review panel - the closest regulatory comparables to K243715.
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