COPAL® exchange G hip spacer; COPAL® G+V— 510(k) K234028

Clearance details

Applicant

Heraeus Medical GmbH

Product code

Code KWL

Device class

Class 2

Regulation

21 CFR 888.3360

Advisory panel

Orthopedic

Date received

2023-12-20

Decision date

2024-02-15

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Wehrheim, DE

• K262290 — REMEDY POLY+PLUS SNAP FIT Acetabular Cup2026-07-24
• K260536 — Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement2026-05-15
• K253675 — OsteoRemedies Hip Spacer System2025-12-23
• K252326 — InterSpace GV Hip Spacer2025-08-06
• K242865 — Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer2025-06-12

• K241674 — OSTEOPAL® V2024-12-05
• K222570 — COPAL knee moulds2023-02-04
• K220492 — COPAL exchange G hip spacer2022-03-23
• K213812 — PALACOS MV pro2022-02-02
• K210607 — PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro2021-07-09

Injury

523

Total

523

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →