Cleared Traditional

ANATOMICA POSTERIOR CERVICAL FIXATION SYSTEM (K061943) - FDA 510(k) Clearance

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

K061943 · Anatomica AB · Orthopedic device
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May 2007
Decision
319d
Days
Class 2
Risk

K061943 is an FDA 510(k) clearance for the ANATOMICA POSTERIOR CERVICAL FIXATION SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Anatomica AB (Washington, US). The FDA issued a Cleared decision on May 25, 2007 after a review of 319 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 Anatomica AB devices

Submission Details

510(k) Number K061943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2006
Decision Date May 25, 2007
Days to Decision 319 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
197d slower than avg
Panel avg: 122d · This submission: 319d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 99
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K061943.
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K070742 · Medtronic Sofamor Danek · Sep 2007
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K061579 · Medtronic Sofamor Danek · Aug 2006
BASIS SPINAL SYSTEM
K060081 · Medtronic Sofamor Danek · Feb 2006
MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM
K052734 · Medtronic Sofamor Danek · Oct 2005