HRZClass III

Prosthesis, Knee, Hinged (Metal-Metal)

21 CFR 888.3480 / Orthopedic

HRZ is the FDA product code for Prosthesis, Knee, Hinged (Metal-Metal), a class III device type, regulated under 21 CFR 888.3480. FDA's definition for this code reads: "PMAs to be filed by 12/26/96 (61 FR 50710 (9/27/96))". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: HRZ
Device name: Prosthesis, Knee, Hinged (Metal-Metal)
FDA definition: PMAs to be filed by 12/26/96 (61 FR 50710 (9/27/96))
Regulation: 21 CFR 888.3480
Device class: Class III
Review panel: Orthopedic
Submission type: PMA
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

Microport Orthopedics Inc.

Recent clearances

Product code HRZ

FDA records hold no clearances under product code HRZ.

Recent recalls

Product code HRZ

FDA records show no recalls under product code HRZ.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)