Cleared Special

K062785 - LTD POLYAXIAL FIXATION SYSTEM

K062785 is an FDA 510(k) clearance for LTD POLYAXIAL FIXATION SYSTEM, manufactured by Us Spine. The device is a Class 2 Orthopedic device with product code KWP cleared through the Special 510(k) pathway after a 99-day FDA review.

K062785 · Us Spine · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
99d
Days
Class 2
Risk

K062785 is an FDA 510(k) clearance for the LTD POLYAXIAL FIXATION SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Us Spine (Apple Valley, US). The FDA issued a Cleared decision on December 26, 2006 after a review of 99 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K062785

510(k) Number K062785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2006
Decision Date December 26, 2006
Days to Decision 99 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
23d faster than avg
Panel avg: 122d · This submission: 99d
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 K062785.
ANATOMICA POSTERIOR CERVICAL FIXATION SYSTEM
K061943 · Anatomica AB · May 2007
EXPEDIUM SFX CROSS CONNECTOR SYSTEM
K070300 · Depuy Spine, Inc. · Apr 2007
C-JAWS CERVICAL COMPRESSIVE MINI FRAME
K062181 · Medicrea Technologies · Jan 2007
APEX SPINE SYSTEM
K062513 · Spinecraft, Inc. · Dec 2006
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K061591 · Medtronic Sofamor Danek, Inc. · Sep 2006
SYNTHES OC FUSION SYSTEM
K053418 · Synthes Spine Co.Lp · Sep 2006
K062785 · LTD POLYAXIAL FIXATION SYSTEM
Download PDF FDA Summary Us Spine