AccessGUDID - DEVICE: ARCOS ONE-PIECE REVISION SYSTEM (00880304683235)

GUDID

Device Identifier (DI) Information

Brand Name: ARCOS ONE-PIECE REVISION SYSTEM
Version or Model: 11-304121
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11-304121
Company Name: Biomet Orthopedics, LLC

Primary DI Number: 00880304683235
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?
33581	Coated hip femur prosthesis, modular	A sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. 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
OQH	Hip, semi-constrained, cemented, metal/polymer + additive, cemented
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented
PBI	prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive
OQI	Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
KWL	Prosthesis, hip, hemi-, femoral, metal
KWY	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
OQG	Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented
LWJ	Prosthesis, hip, semi-constrained, metal/polymer, uncemented
KWZ	Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151603	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: 21 MM 210 MM TYPE 1 TAPER

Device Record Status

Public Device Record Key: 5255830e-5424-4107-84c1-dd858639edf3
Public Version Date: May 30, 2025
Public Version Number: 4
DI Record Publish Date: November 13, 2015