Cleared Traditional

FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System, and Osprey™ Anterior Cervical Plate System (K231460) - FDA 510(k) Clearance

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

K231460 · K&J Consulting Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2023
Decision
58d
Days
Class 2
Risk

K231460 is an FDA 510(k) clearance for the FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate S.... Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by K&J Consulting Corp. (Lansdale, US). The FDA issued a Cleared decision on July 16, 2023 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all K&J Consulting Corp. devices

Submission Details

510(k) Number K231460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2023
Decision Date July 16, 2023
Days to Decision 58 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
64d faster than avg
Panel avg: 122d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 244
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K231460.
Skyway Anterior Cervical Plate System
K231766 · Kyocera Medical Technologies Inc. (KMTI) · Sep 2023
Sapphire X3 Anterior Cervical Plate System
K231593 · Spinal Elements, Inc. · Aug 2023
CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System
K231839 · L & K Biomed Co., Ltd. · Jul 2023
CODA™ Anterior Cervical Plate System
K230993 · Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech · Jun 2023
Zevo Anterior Cervical Plate System
K231090 · Medtronic Sofamor Danek USA, Inc. · Jun 2023
Axis Anterior Cervical Plate System
K231145 · Southern Medical (Pty) , Ltd. · Jun 2023