PALACOS®

Basic Information

• Brand Name: PALACOS®
• Primary DI: 04260102135970
• Version / Model: R pro
• Catalog Number: 5075299
• Company Name: Heraeus Medical GmbH
• Labeler DUNS: 333623937
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-01
• Public Version: 7
• Public Version Date: 2023-06-16
• Public Version Status: Update
• Public Device Record Key: 7a44ea71-dbb0-446c-b19f-323a28c6f5cd

Device Description

The PALACOS® R pro system consists of a mixing and application system prefilled with PALACOS® powder and monomer liquid. PALACOS® R pro is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LOD	Bone Cement	Orthopedic	888.3027	2
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	888.4210	1
KIH	Dispenser, Cement	Orthopedic	888.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35217	Orthopaedic cement, non-antimicrobial	A substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic implants to the living bone. It may also be intended for use as a filler in the case of bone pathologies (e.g., to stabilize and reinforce vertebral body structures in vertebroplasty and kyphoplasty). It is typically made from methylmethacrylate, polymethylmethacrylate (PMMA), esters of methacrylic acid or copolymers containing polymethylmethacrylate and polystyrene. This device does not contain an antimicrobial agent. After application, this device cannot be reused.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260102135970	GS1
Package	04260102135994	GS1	Pallet	108	In Commercial Distribution
Package	04260102135987	GS1	Paper Carton	12	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K150119	000
K202475	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 25 Degrees Celsius