PALACOS MV pro— 510(k) K213812

Clearance details

Applicant

Heraeus Medical GmbH

Product code

Code LOD

Device class

Class 2

Regulation

21 CFR 888.3027

Advisory panel

Orthopedic

Date received

2021-12-07

Decision date

2022-02-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Wehrheim, DE

• K254107 — Refobacin Bone Cement R (110034355)2026-04-15
• K250760 — SPECTRUM GV Bone Cement2025-04-02
• K241674 — OSTEOPAL® V2024-12-05
• K231556 — SPECTRUM® GV Bone Cement2023-12-20
• K211163 — Bone Cement Genta, Bone Cement HV, Bone Cement LV2023-01-09

• 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
• K210607 — PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro2021-07-09
• K202475 — PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G2020-11-23

Death

44

Injury

3,004

Malfunction

895

Other

4

Total

3,947

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 →

• Z-1083-2026 — Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog Number: 5150633; 5150635 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/AClass II·Ongoing·Heraeus Medical GmbH (Dental Division)·20251209

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K213812.