AccessGUDID - DEVICE: OSS™ Orthopedic Salvage System (00880304568426)

GUDID

Device Identifier (DI) Information

Brand Name: OSS™ Orthopedic Salvage System
Version or Model: 110008542
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 110008542
Company Name: Biomet Orthopedics, LLC

Primary DI Number: 00880304568426
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?
33692	Rotating hinged total knee prosthesis	A sterile implantable artificial substitute for a knee joint typically designed to replace all the articulating surfaces of the joint [total knee arthroplasty (TKA)] because of major loss of stabilizing structures or bone around the knee, often from tumour resection, or to replace a dysfunctional knee prosthesis (revision); it is designed with a mechanism for joint rotation and its major components are connected for stability typically about a transverse axis posterior of the rotational axis. It typically includes femoral, tibial, and patellar components that articulate and with parts made of metal, ceramic, and/or polyethylene (PE); it may be implated with or without bone cement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KRO	PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
KWZ	Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
KWY	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
KWT	PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
MEH	Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K002757	000
K021260	000
K051479	000
K051570	000
K060131	000
K080330	000
K123501	000
K131393	000
K140509	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
No Device Sizes

Device Record Status

Public Device Record Key: 59752c8d-8305-4c88-92b5-0d85ca4e7e66
Public Version Date: May 30, 2025
Public Version Number: 7
DI Record Publish Date: October 24, 2015