Cleared Traditional

K061774 - NFIX II PEDICLE SCREW SYSTEM

K061774 is an FDA 510(k) clearance for NFIX II PEDICLE SCREW SYSTEM, manufactured by N-Spine, Inc.. The device is a Class 2 Orthopedic device with product code NQP cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K061774 · N-Spine, Inc. · Orthopedic device
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Dec 2006
Decision
173d
Days
Class 2
Risk

K061774 is an FDA 510(k) clearance for the NFIX II PEDICLE SCREW SYSTEM. Classified as Posterior Metal/polymer Spinal System, Fusion (product code NQP), Class II - Special Controls.

Submitted by N-Spine, Inc. (San Diego, US). The FDA issued a Cleared decision on December 13, 2006 after a review of 173 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all N-Spine, Inc. devices

FDA 510(k) Submission Details - K061774

510(k) Number K061774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received June 23, 2006
Decision Date December 13, 2006
Days to Decision 173 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 122d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NQP Device Classification - Class 2, Special Controls

Product Code NQP Posterior Metal/polymer Spinal System, Fusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition This Device Is A Posterior Spinal System That Contains Polymer And Metal Components. This Spinal System Is To Be Used With Bone Graft And Is An Adjunct To Fusion In The Treatment Of Acute And Chronic Instabilities Or Deformities Of The Thoracic, Lumbar, And Sacral Spine.
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 - NQP Posterior Metal/polymer Spinal System, Fusion

All 12
Devices cleared under the same product code (NQP) and FDA review panel - the closest regulatory comparables to K061774.
TRANSITION STABILIZATION SYSTEM
K073439 · Globus Medical, Inc. · Feb 2009
DYNESYS TOP-LOADING SPINAL SYSTEM
K073347 · Zimmer Spine, Inc. · Feb 2008
ZIMMER DTO IMPLANT
K071879 · Zimmer Spine, Inc. · Oct 2007
CD HORIZON SPINAL SYSTEM
K061304 · Medtronic Sofamor Danek · Jul 2006
DYNESYS SPINAL SYSTEM WITH HA COATED SCREWS
K060638 · Zimmer Spine, Inc. · Apr 2006
MODIFICATION TO DYNESYS SPINAL SYSTEM
K043565 · Zimmer Spine, Inc. · Mar 2005