Cleared Special

K052247 - NEX-LINK SPINAL FIXATION SYSTEM VARIABLE CROSSLINK, MODEL 721-XX

K052247 is an FDA 510(k) clearance for NEX-LINK SPINAL FIXATION SYSTEM VARIABL..., manufactured by Abbott Spine, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Special 510(k) pathway after a 27-day FDA review.

K052247 · Abbott Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
27d
Days
Class 2
Risk

K052247 is an FDA 510(k) clearance for the NEX-LINK SPINAL FIXATION SYSTEM VARIABLE CROSSLINK, MODEL 721-XX. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Abbott Spine, Inc. (Austin, US). The FDA issued a Cleared decision on September 14, 2005 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 - K052247

510(k) Number K052247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2005
Decision Date September 14, 2005
Days to Decision 27 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
95d faster than avg
Panel avg: 122d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 421
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K052247.
SYNTHES PANGEA SYSTEM
K052123 · Synthes (Usa) · Sep 2005
MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM
K052376 · Medtronic Sofamor Danek · Sep 2005
VERTEX RECONSTRUCTION SYSTEM
K052402 · Medtronic Sofamor Danek · Sep 2005
MODIFICATION TO XIA SPINAL SYSTEM
K052181 · Stryker Spine · Sep 2005
VERTEBRON PSS PEDICLE SCREW SYSTEM
K051716 · Vertebron, Inc. · Sep 2005
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K052180 · Medtronic Sofamor Danek · Aug 2005
K052247 · NEX-LINK SPINAL FIXATION SYSTEM VARIABLE CROSSLINK, MODEL 721-XX
Download PDF FDA Summary Abbott Spine, Inc.