COPAL exchange G hip spacer— 510(k) K220492

Clearance details

Applicant

Heraeus Medical GmbH

Product code

Code KWY

Device class

Class 2

Regulation

21 CFR 888.3390

Advisory panel

Orthopedic

Date received

2022-02-22

Decision date

2022-03-23

Decision

Substantially Equivalent

Clearance type

Special

Location

Wehrheim, DE

• K253357 — b-ONE® Bipolar Head2026-04-13
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• 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
• K213812 — PALACOS MV pro2022-02-02
• K210607 — PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro2021-07-09

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 →