Cleared Traditional

K143450 - Ackermann Intervertebral Body Fusion Device

K143450 is an FDA 510(k) clearance for Ackermann Intervertebral Body Fusion Device, manufactured by Ackermann Instrumente GmbH. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K143450 · Ackermann Instrumente GmbH · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
288d
Days
Class 2
Risk

K143450 is an FDA 510(k) clearance for the Ackermann Intervertebral Body Fusion Device. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Ackermann Instrumente GmbH (Rietheim, Weilheim, DE). The FDA issued a Cleared decision on September 16, 2015 after a review of 288 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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.

FDA 510(k) Submission Details - K143450

510(k) Number K143450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2014
Decision Date September 16, 2015
Days to Decision 288 days
Submission Type Traditional
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
166d slower than avg
Panel avg: 122d · This submission: 288d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ODP Device Classification - Class 2, Special Controls

Product Code ODP Intervertebral Fusion Device With Bone Graft, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
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 Consultant

Ferguson Medical International Device Consultants, LLC
Frank Ferguson

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 352
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K143450.
RT2 Trabeculite Titanium Cervical Cage System
K150455 · Rhausler, Inc. · Nov 2015
Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C(HA) Cervical Intervertebral Body Fusion Devices
K150788 · Meditech Spine, LLC · Oct 2015
Hedgehog Cervical Interbody Fusion Device
K143685 · Vertera, Inc. · Sep 2015
CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System
K150619 · Orthofix, Inc. · Sep 2015
Xenco Medical Cervical Interbody System (Argus)
K152302 · Xenco Medical, LLC · Sep 2015
Genesys Spine Apache Cervical Interbody Fusion System
K150812 · Genesys Spine · Sep 2015