COPAL exchange G Hip and Knee Spacers— 510(k) K191016

Clearance details

Applicant

Heraeus Medical GmbH

Product code

Code KWY

Device class

Class 2

Regulation

21 CFR 888.3390

Advisory panel

Orthopedic

Date received

2019-04-17

Decision date

2019-11-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Werheim, DE

• K253357 — b-ONE® Bipolar Head2026-04-13
• K243634 — Maxx Libertas Bipolar Hip Head (Bipolar Hip)2025-08-25
• K231526 — CORAIL Cemented Femoral Stem2023-12-19
• K223441 — SpaceFlex Acetabular Cup2023-03-23
• K221794 — Vario-Cup System2022-07-20

• K241674 — OSTEOPAL® V2024-12-05
• K234028 — COPAL® exchange G hip spacer; COPAL® G+V2024-02-15
• K222570 — COPAL knee moulds2023-02-04
• K220492 — COPAL exchange G hip spacer2022-03-23
• K213812 — PALACOS MV pro2022-02-02

Death

3

Injury

2,049

Total

2,052

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 →