Cleared Special

K042986 - MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM

K042986 is an FDA 510(k) clearance for MODIFICATION TO SYNTHES (USA) (SYNTHES)..., manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code GXR cleared through the Special 510(k) pathway after a 19-day FDA review.

K042986 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
19d
Days
Class 2
Risk

K042986 is an FDA 510(k) clearance for the MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM. Classified as Cover, Burr Hole (product code GXR), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on November 17, 2004 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 882.5250 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K042986

510(k) Number K042986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2004
Decision Date November 17, 2004
Days to Decision 19 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 122d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

GXR Device Classification - Class 2, Special Controls

Product Code GXR Cover, Burr Hole
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5250
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 Orthopedic devices follow this clearance model.

Regulatory Peers - GXR Cover, Burr Hole

All 28
Devices cleared under the same product code (GXR) and FDA review panel - the closest regulatory comparables to K042986.
CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM
K101235 · Neos Surgery S.L · Oct 2010
AESCULAP PEEK CRANIOFIX
K091692 · Aesculap, Inc. · Aug 2010
CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM
K071138 · Prosurg, Inc. · Aug 2007
SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP
K041611 · Synthes (Usa) · Sep 2004
AESCULAP ABSORBABLE CRANIOFIX
K040080 · Aesculap, Inc. · Mar 2004
SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED)
K031654 · Synthes (Usa) · Aug 2003
K042986 · MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM
Download PDF FDA Summary Synthes (Usa)