Cleared Traditional

K052871 - STRYKER CUSTOM TI IMPLANT

K052871 is an FDA 510(k) clearance for STRYKER CUSTOM TI IMPLANT, manufactured by Stryker Leibinger. The device is a Class 2 Neurology device with product code GXN cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K052871 · Stryker Leibinger · Neurology device
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Dec 2005
Decision
66d
Days
Class 2
Risk

K052871 is an FDA 510(k) clearance for the STRYKER CUSTOM TI IMPLANT. Classified as Plate, Cranioplasty, Preformed, Non-alterable (product code GXN), Class II - Special Controls.

Submitted by Stryker Leibinger (Kalamazoo, US). The FDA issued a Cleared decision on December 16, 2005 after a review of 66 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 Stryker Leibinger devices

FDA 510(k) Submission Details - K052871

510(k) Number K052871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2005
Decision Date December 16, 2005
Days to Decision 66 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 148d · This submission: 66d
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 48
Devices cleared under the same product code (GXN) and FDA review panel - the closest regulatory comparables to K052871.
BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
K062819 · Bioplate, Inc. · Dec 2006
KLS MARTIN QUICK DISC
K062857 · KLS-Martin L.P. · Nov 2006
PATIENT CONTOURED MESH (PCM)
K062570 · KLS-Martin L.P. · Oct 2006
SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT
K053199 · Synthes (Usa) · Dec 2005
SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS
K033868 · Synthes (Usa) · Jun 2004
SPIN DOWN RAPIDFLAP
K031034 · Walter Lorenz Surgical, Inc. · May 2003