Superfixation(Tm)

FDA 510(k) K863343 · Orthopaedic Device Corp.

Substantially Equivalent

510(k) numberK863343

Submission

Device name
Superfixation(Tm)
Applicant
Orthopaedic Device Corp.
Allendale, NJ, US
Received
August 29, 1986
Decision date
September 15, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3030
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code KTT

510(k)DeviceApplicantDecision
K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemKTT · Traditional Synthes (USA) Products, LLC06/11/2026SE
K260900DYNEX® External Fixation SystemsKTT · Special Vilex, LLC04/17/2026SE
K260112QuikFix External Fixator: Knee-Spanning PackKTT · Traditional Stabiliz Orthopaedics, Inc.03/23/2026SE
K253291Excelsior SystemKTT · Traditional Blue Ocean Global01/20/2026SE
K253613Monkey Rings External Ring Fixation SystemKTT · Special Paragon 28, Inc.12/19/2025SE
K253202Hoffmann LRF SystemKTT · Traditional Stryker GmbH12/19/2025SE
K252555Medusa Orthopedics Boa External Fixation SystemKTT · Traditional Medusa Orthopedics, LLC11/25/2025SE
K252625The Response Ortho Smart Fixator - Hexapod SystemKTT · Traditional Response Ortho Solutions, LLC11/20/2025SE
K252106External Fixation Mini Rail SystemKTT · Traditional Paragon 28, Inc.09/30/2025SE
K251862External Fixation Bone DistractorKTT · Traditional Paragon 28, Inc.08/11/2025SE

More from Paragon 28, Inc.

510(k)DeviceDecision
K870234P.T.H. Metal-Backed Acetabular CupJDL · Traditional 03/20/1987SE
K862460Femoral Hemi-Hip ProsthesisKWY · Traditional 10/06/1986SE
K855228Femoral Hemi-Hip ProsthesesKWL · Traditional 02/11/1986SE

Questions and answers

When was Superfixation(Tm) cleared by the FDA?

Superfixation(Tm) (K863343) received a 510(k) decision of Substantially Equivalent on September 15, 1986, 17 days after the submission was received.

What is the product code of K863343?

The FDA product code is KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, a Class II (moderate risk) device regulated under 21 CFR 888.3030.