HTSClass I

Knife, Orthopedic

21 CFR 888.4540 / Orthopedic

HTS is the FDA product code for Knife, Orthopedic, a class I device type, regulated under 21 CFR 888.4540. As of 2026-09-10, FDA records hold 9 510(k) clearances under this code, the most recent dated 1994-02-22, and 3 recalls.

Classification record

Product code: HTS
Device name: Knife, Orthopedic
Regulation: 21 CFR 888.4540
Device class: Class I
Review panel: Orthopedic
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 9
Ingested recalls: 3

Clearances, product code HTS

By decision year

9 clearances under product code HTS with a decision year between 1977 and 1994, 1987 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code HTS by decision year
Year	Clearances
1977	1
1984	1
1987	4
1988	1
1994	2

Applicants with the most clearances

Product code HTS

Applicants holding the most 510(k) clearances under product code HTS
Applicant	Clearances
Arthropedics, Inc.	4
Acufex Microsurgical, Inc.	1
Associated Medical Products Co.	1
Karlin Technology, Inc.	1
Medtech Industries, Inc.	1
Richard Wolf Medical Instruments Corp.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 109 companies shown, in name order