FDA.reportPublic FDA data

ORTHOPEDIC SALVAGE SYSTEM (OSS)

Primary DI
00880304030763
Brand
ORTHOPEDIC SALVAGE SYSTEM (OSS)
Company
Biomet Orthopedics, LLC
Model
CP111279
Catalog number
CP111279
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020970000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020970000MODIFICATION TO ONCOLOGY SALVAGE SYSTEM (OSS)Biomet, Inc.2002-04-04JDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304030763PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304030763008803040307638803040307630880304030763

GMDN Terms#

Term, Definition table
TermDefinition
Diaphysis prosthesisAn artificial substitute for the diaphysis (shaft) of a humerus, femur, or tibia intended to be implanted for the long-term stabilization of segmental bone defects (e.g., due to osteomyelitis, trauma, bone tumours, or non-healed fractures after osteosynthesis/revision arthroplasty). It is a modular device that typically includes a resection element (spacer), intramedullary nails (inserted into the intramedullary canal), screws, and connectors all made of metal [e.g., titanium (Ti)]; components are both sterile and non-sterile. Instruments for implantation are typically included and implantation may be performed with or without bone cement.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
129278169
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024706828Mini Baseplate Sizer Cannulated HandleSSI008562SSI0085622026-03-19
00889024706835Mini Baseplate Sizer 0 degree On-axis HandleSSI008561SSI0085612026-03-19
00887868551611StageOne Select4311904311902026-03-17
00887868551628StageOne Select4311914311912026-03-17
00887868551635StageOne Select4311924311922026-03-17
00887868551642StageOne Select4311934311932026-03-17
00887868551659StageOne Select4311944311942026-03-17
00887868551666StageOne Select4311954311952026-03-17
00887868551673StageOne Select4311964311962026-03-17
00887868551680StageOne Select4311974311972026-03-17
00887868551697StageOne Select4311984311982026-03-17
00887868551703STAGEONE SELECT4311994311992026-03-17
00889024706774Biomet®32-34169232-3416922026-03-12
00889024706781Biomet®32-14815332-1481532026-03-12
00889024706798Biomet®32-14815132-1481512026-03-12
00889024706804Biomet®32-34169732-3416972026-03-12
00889024706811Biomet®32-14814932-1481492026-03-12
00889024706484Vanguard®32-34702132-3470212026-02-27
00880304009615BMP CABLE CUTTER4980104980102020-05-23
00880304387676OPEN END CUTTER4980234980232020-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862661012N/AExactech, Inc.JDI2026-03-19
10885862661166N/AExactech, Inc.JDI2026-03-19
10885862661173N/AExactech, Inc.JDI2026-03-19
10885862663221N/AExactech, Inc.JDI2026-03-19
04719886912524Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886912951Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886912968Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886912975Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886912982Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886912999Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886913002Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886913019Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886913026Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886913033Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886913040Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886913064Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
00889024703292OSS™ Orthopedic Salvage SystemBiomet Orthopedics, LLCJDI2025-12-02
00889024703315OSS™ Orthopedic Salvage SystemBiomet Orthopedics, LLCJDI2025-12-02
00889024703339OSS™ Orthopedic Salvage SystemBiomet Orthopedics, LLCJDI2025-12-02
10885862658210EXACTECHExactech, Inc.JDI2025-11-14
10885862658326EXACTECHExactech, Inc.JDI2025-11-14
04719872162568UCP StemUNITED ORTHOPEDIC CORP.JDI2025-09-15
04719872162926UCP StemUNITED ORTHOPEDIC CORP.JDI2025-09-15
04719872169017UCP StemUNITED ORTHOPEDIC CORP.JDI2025-09-15
04719872169024UCP StemUNITED ORTHOPEDIC CORP.JDI2025-09-15
04719872169031UCP StemUNITED ORTHOPEDIC CORP.JDI2025-09-15
00810008120859LibertasMAXX ORTHOPEDICS, INC.JDI2025-07-23
00810008120866LibertasMAXX ORTHOPEDICS, INC.JDI2025-07-23
00810008120873LibertasMAXX ORTHOPEDICS, INC.JDI2025-07-23
00810008120880LibertasMAXX ORTHOPEDICS, INC.JDI2025-07-23