KTTClass II

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

21 CFR 888.3030 / Orthopedic

KTT is the FDA product code for Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, a class II device type, regulated under 21 CFR 888.3030. As of 2026-09-10, FDA records hold 404 510(k) clearances under this code, the most recent dated 2026-06-11, and 89 recalls.

Classification record

Product code: KTT
Device name: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Regulation: 21 CFR 888.3030
Device class: Class II
Review panel: Orthopedic
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 404
Ingested recalls: 89

Clearances, product code KTT

By decision year

404 clearances under product code KTT with a decision year between 1979 and 2026, 2005 the highest year at 28.

Show the numbers

510(k) clearances under FDA product code KTT by decision year
Year	Clearances
1979	2
1981	1
1982	2
1983	1
1984	4
1985	6
1986	3
1987	8
1988	2
1989	3
1990	14
1991	4
1992	8
1993	3
1994	6
1995	7
1996	10
1997	10
1998	5
1999	8
2000	7
2001	15
2002	21
2003	21
2004	19
2005	28
2006	8
2007	9
2008	11
2009	11
2010	12
2011	10
2012	9
2013	7
2014	14
2015	12
2016	10
2017	11
2018	6
2019	8
2020	9
2021	10
2022	3
2023	7
2024	5
2025	10
2026	4

Applicants with the most clearances

Product code KTT

Applicants holding the most 510(k) clearances under product code KTT
Applicant	Clearances
Ebi, LLC	36
Synthes (USA) Products LLC	35
Howmedica Corp.	22
Howmedica Osteonics Corp	19
Smith & Nephew, Inc.	16
Orthofix SRL	11
Stryker Corp.	11
Wrightmedicaltechnologyinc	11
Zimmer GmbH	11
Alliance Medical Corp.	9

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 216 companies shown, in name order