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KWL

Prosthesis, Hip, Hemi-, Femoral, Metal

Product code
KWL
Device name
Prosthesis, Hip, Hemi-, Femoral, Metal
Device class
Class 2
21 CFR
21 CFR 888.3360
Medical specialty
Orthopedic
Marketing pathway
510(K)
Flag
Implant
510(k) clearances (last 3 years)
6
Summaries archived here
6 (direct download)
510(k) clearances (all years, FDA)
108 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (6)

Last three years. Most recent: 2026-07-24.

NumberDecision dateApplicantDevice nameSummary
K2622902026-07-24Osteoremedies, LLCREMEDY POLY+PLUS SNAP FIT Acetabular CupPDF
K2605362026-05-15Depuy Ireland UCProstalac Hip System, SmartSet V+G Dual Antibiotic B…PDF
K2536752025-12-23Osteoremedies, LLCOsteoRemedies Hip Spacer SystemPDF
K2523262025-08-06Tecres S.P.A.InterSpace GV Hip SpacerPDF
K2428652025-06-12Biocomposites, Ltd.Synicem Hip Spacer; Synicem Knee Spacer; Synicem Sho…PDF
K2340282024-02-15Heraeus Medical GmbHCOPAL® exchange G hip spacer; COPAL® G+VPDF

6 summaries are archived here for direct download.

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