PIXNot classified

Elbow Joint Metal/Polymer, Constrained, Porous Coated, Uncemented Prosthesis

Unknown

PIX is the FDA product code for Elbow Joint Metal/Polymer, Constrained, Porous Coated, Uncemented Prosthesis. FDA's definition for this code reads: "An elbow joint metal/polymer constrained uncemented prosthesis is a device intended to be implanted to replace an elbow joint". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code: PIX
Device name: Elbow Joint Metal/Polymer, Constrained, Porous Coated, Uncemented Prosthesis
FDA definition: An elbow joint metal/polymer constrained uncemented prosthesis is a device intended to be implanted to replace an elbow joint.
Device class: Not classified
Review panel: Unknown
Submission type: Contact ODE
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code PIX

FDA records hold no clearances under product code PIX.

Recent recalls

Product code PIX

Z-0532-2020Class IIElevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.Zimmer Biomet, Inc. / initiated 2019-08-21 / 217240

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)