AccessGUDID - DEVICE: Arcos Modular Revision Hip System (00880304475144)

GUDID

Device Identifier (DI) Information

Brand Name: Arcos Modular Revision Hip System
Version or Model: 11-301815
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11-301815
Company Name: Biomet Orthopedics, LLC

Primary DI Number: 00880304475144
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 129278169 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
34191	Coated femoral stem prosthesis, modular	A sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is composed of two or more separate segments designed to be joined, typically made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MEH	Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
KWY	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented
KWZ	Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
MAY	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
KWA	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)
JDL	Prosthesis, hip, semi-constrained (metal cemented acetabular component)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K100469	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 15 MM 200 MM

Device Record Status

Public Device Record Key: db3659f0-14da-49b6-bcb7-87a77d381eac
Public Version Date: May 30, 2025
Public Version Number: 5
DI Record Publish Date: October 24, 2015