Cleared Traditional

K061943 - ANATOMICA POSTERIOR CERVICAL FIXATION SYSTEM

K061943 is an FDA 510(k) clearance for ANATOMICA POSTERIOR CERVICAL FIXATION S..., manufactured by Anatomica AB. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 319-day FDA review.

K061943 · Anatomica AB · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K061943

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.

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 354
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K061943.
LDR SPINE EASYSPINE POSTERIOR OSTEOSYNTHESIS SYSTEM
K070341 · Ldr Spine USA · Aug 2007
POLARIS BE RODS
K071377 · Biomet Spine · Aug 2007
THEKEN ATOLL CERVICO-THORACIC SYSTEM
K070638 · Theken Spine, LLC · May 2007
EXPEDIUM SFX CROSS CONNECTOR SYSTEM
K070300 · Depuy Spine, Inc. · Apr 2007
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K061591 · Medtronic Sofamor Danek, Inc. · Sep 2006
SYNTHES OC FUSION SYSTEM
K053418 · Synthes Spine Co.Lp · Sep 2006