Cleared Traditional

K071261 - ISOBAR SEMI-RIGID DUAL DAMPENER (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K071261 · Scient'X · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
349d
Days
Class 2
Risk

K071261 is an FDA 510(k) clearance for the ISOBAR SEMI-RIGID DUAL DAMPENER. Classified as Posterior Metal/polymer Spinal System, Fusion (product code NQP), Class II - Special Controls.

Submitted by Scient'X (Maitland, US). The FDA issued a Cleared decision on April 17, 2008 after a review of 349 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Scient'X devices

Submission Details

510(k) Number K071261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2007
Decision Date April 17, 2008
Days to Decision 349 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
227d slower than avg
Panel avg: 122d · This submission: 349d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.