KWY

Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Product code
KWY
Device name
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Device class
Class 2
21 CFR
21 CFR 888.3390
Medical specialty
Orthopedic
Marketing pathway
510(K)
Flag
Implant
510(k) clearances (last 3 years)
3
Summaries archived here
3 (direct download)
510(k) clearances (all years, FDA)
99 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2026-04-13.

NumberDecision dateApplicantDevice nameSummary
K2533572026-04-13B-One Ortho, Corp.b-ONE® Bipolar HeadPDF
K2436342025-08-25Maxx Orthopedics, Inc.Maxx Libertas Bipolar Hip Head (Bipolar Hip)PDF
K2315262023-12-19Depuy Ireland UCCORAIL Cemented Femoral StemPDF

3 summaries are archived here for direct download.

Official FDA classification page: KWY
Classification and pathway per current FDA publications. Data from openFDA (CC0).