Orthopedic Salvage System (OSS)

Basic Information

• Brand Name: Orthopedic Salvage System (OSS)
• Primary DI: 00880304674523
• Version / Model: 151850
• Catalog Number: 151850
• Company Name: Biomet Orthopedics, LLC
• Labeler DUNS: 129278169
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-24
• Public Version: 5
• Public Version Date: 2023-02-03
• Public Version Status: Update
• Public Device Record Key: 695e9872-98e5-4da5-98e5-79a6c0e40b2f

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
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED	Orthopedic	888.3358	2
KRO	PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER	Orthopedic	888.3510	2
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented	Orthopedic	888.3350	2
KWY	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented	Orthopedic	888.3390	2
KWT	PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED	Orthopedic	888.3650	2
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented	Orthopedic	888.3353	2
MEH	Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate	Orthopedic	888.3353	2
KWZ	Prosthesis, hip, constrained, cemented or uncemented, metal/polymer	Orthopedic	888.3310	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48067	Knee arthroplasty wedge	An implantable device designed to augment the implantation of a knee femur or tibia prosthesis by serving as a space-filler adjacent to the prosthesis, typically to replace lost bone and increase bone contact area and aid stability. It is typically made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo) or titanium (Ti)].	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00880304674523	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K002757	000
K021260	000
K051479	000
K051570	000
K060131	000
K080330	000
K123501	000
K140509	000
K141331	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			LARGE SIZE