OVOClass III

Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation

Unknown

OVO is the FDA product code for Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation, a class III device type. FDA's definition for this code reads: "Intended as a primary joint replacement prosthesis in total hip arthroplasty". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: OVO
Device name: Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation
FDA definition: Intended as a primary joint replacement prosthesis in total hip arthroplasty.
Device class: Class III
Review panel: Unknown
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

Recent clearances

Product code OVO

FDA records hold no clearances under product code OVO.

Recent recalls

Product code OVO

FDA records show no recalls under product code OVO.

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)