HemiCAPWAVE®

Basic Information

• Brand Name: HemiCAPWAVE®
• Primary DI: M528PX110218W0
• Version / Model: PX11-0218-W
• Company Name: ARTHROSURFACE INCORPORATED
• Labeler DUNS: 144666109
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-15
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: f1ff6c80-2de5-4367-8cd0-2efc8e0fc87e

Device Description

Taper Post, 11mm Ø x 21.5mm LG, PFXL CE

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
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	888.3540	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58992	Partial-resurfacing knee femur prosthesis	A sterile implantable device, in the form of a small plug and stem, designed to treat focal lesions of the articular surface of the distal femur by excision of the lesion and uncemented fixation of the device in the surgically-prepared defect, with retention of the surrounding healthy articular cartilage. It is made of metal, may have a synthetic polymer articulating surface, and may be coated with a material intended to improve fixation and stability by promoting bone ingrowth. It is available in a range of sizes for treatment of different size lesions. Disposable devices associated with implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M528PX110218W0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K071413	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	11	Millimeter