JDHClass III

Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal

21 CFR 888.3380 / Orthopedic

JDH is the FDA product code for Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal, a class III device type, regulated under 21 CFR 888.3380. As of 2026-09-10, FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code: JDH
Device name: Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal
Regulation: 21 CFR 888.3380
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: 1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code JDH.

Recent clearances

Product code JDH

FDA records hold no clearances under product code JDH.

Recent recalls

Product code JDH

Z-0721-05Outer cannula has the potential to separate from the head/flange assembly, leading to ineffective ventilation, which could result...Nellcor Puritan Bennett / initiated 2004-12-09 / 323 units shipped to US Field Personnel or Healthcare facilities.

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)