KWHClass II

Prosthesis, Toe, Constrained, Polymer

21 CFR 888.3720 / Orthopedic

KWH is the FDA product code for Prosthesis, Toe, Constrained, Polymer, a class II device type, regulated under 21 CFR 888.3720. As of 2026-09-10, FDA records hold 21 510(k) clearances under this code, the most recent dated 2020-02-13, and 2 recalls.

Classification record

Product code: KWH
Device name: Prosthesis, Toe, Constrained, Polymer
Regulation: 21 CFR 888.3720
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: 21
Ingested recalls: 2

Clearances, product code KWH

By decision year

21 clearances under product code KWH with a decision year between 1978 and 2020, 2002 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code KWH by decision year
Year	Clearances
1978	1
1980	2
1982	1
1983	1
1989	1
1991	1
1995	2
1998	1
2000	1
2002	4
2003	1
2011	1
2016	1
2018	1
2019	1
2020	1

Applicants with the most clearances

Product code KWH

Applicants holding the most 510(k) clearances under product code KWH
Applicant	Clearances
Nexa Orthopedics, Inc.	4
Dow Corning Corp. Healthcare Industries Materials	2
In2bones USA, LLC	2
Osteomed	2
Sgarlato Laboratories, Inc.	2
Biomedics	1
Biomet Manufacturing Corp	1
BRM Extremities SRL	1
Fusion Orthopedics, LLC	1
Ortho-Pro, LLC	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 26 companies shown, in name order