Acute Innovations Sternal Fixation System

Q: What is the product code of K101170?

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.

FDA 510(k) K101170 · Acute Innovations, LLC

Substantially Equivalent

510(k) numberK101170

Submission

Device name: Acute Innovations Sternal Fixation System
Applicant: Acute Innovations, LLC
Hillsboro, OR, US
Received: April 26, 2010
Decision date: September 17, 2010
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

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)	Device	Applicant	Decision
K254087	MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction SystemKTT · Traditional	Synthes (USA) Products, LLC	06/11/2026SE
K260900	DYNEX® External Fixation SystemsKTT · Special	Vilex, LLC	04/17/2026SE
K260112	QuikFix External Fixator: Knee-Spanning PackKTT · Traditional	Stabiliz Orthopaedics, Inc.	03/23/2026SE
K253291	Excelsior SystemKTT · Traditional	Blue Ocean Global	01/20/2026SE
K253613	Monkey Rings External Ring Fixation SystemKTT · Special	Paragon 28, Inc.	12/19/2025SE
K253202	Hoffmann LRF SystemKTT · Traditional	Stryker GmbH	12/19/2025SE
K252555	Medusa Orthopedics Boa External Fixation SystemKTT · Traditional	Medusa Orthopedics, LLC	11/25/2025SE
K252625	The Response Ortho Smart Fixator - Hexapod SystemKTT · Traditional	Response Ortho Solutions, LLC	11/20/2025SE
K252106	External Fixation Mini Rail SystemKTT · Traditional	Paragon 28, Inc.	09/30/2025SE
K251862	External Fixation Bone DistractorKTT · Traditional	Paragon 28, Inc.	08/11/2025SE

More from Paragon 28, Inc.

510(k)	Device	Decision
K120163	Acute Innovations Biobridge Resorbable Plating SystemHRS · Special	02/17/2012SE
K113318	Acute Innovations Modular Ribloc SystemHRS · Traditional	01/12/2012SE
K081588	Re-Zorb Plating SystemHRS · Traditional	09/03/2008SE
K061206	Acute Bone ScrewHWC · Traditional	06/19/2006SE

Questions and answers

When was Acute Innovations Sternal Fixation System cleared by the FDA?

Acute Innovations Sternal Fixation System (K101170) received a 510(k) decision of Substantially Equivalent on September 17, 2010, 144 days after the submission was received.

What is the product code of K101170?

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.