FDA.reportPublic FDA data

STELLAR Knee

Primary DI
00850046497018
Brand
STELLAR Knee
Company
POLARISAR, INC.
Model
Revision 03
Catalog number
80-0002
Device description
Kit, Total Knee, Right
Published
2025-03-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850046497018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850046497018008500464970188500464970180850046497018

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
035071717
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850046497179STELLAR Knee Marker Kit80-000680-00062025-06-16
00850046497186TruFix Pin Kit80-000580-00052025-06-16
00850046497193Right Femur - Left Tibia Arm Assembly50-001450-00142025-06-16
00850046497209Left Femur - Right Tibia Arm Assembly50-001550-00152025-06-16
00850046497001STELLAR KneeRevision 0380-00012025-03-03
00850046497025STELLAR KneeRevision 0080-00032025-03-03
00850046497032STELLAR KneeRevision 0150-00052025-03-03
00850046497049STELLAR KneeRevision 0230-00162025-03-03
00850046497056STELLAR KneeRevision 0230-00172025-03-03
00850046497063STELLAR KneeRevision 0230-00202025-03-03
00850046497070STELLAR KneeRevision 0130-00212025-03-03
00850046497087STELLAR KneeRevision 0130-00222025-03-03
00850046497100STELLAR KneeSoftware Version 1.2.270-00012025-03-03
00850046497117STELLAR KneeRevision 0180-00042025-03-03
00850046497124STELLAR KneeRevision 0080-0004-STREAM2025-03-03
00850046497131STELLAR KneeSoftware Version 2.0.10770-00032025-03-03
00850046497148STELLAR KneeRevision 0180-00072025-03-03
00850046497155STELLAR KneeRevision 0180-0007-STREAM2025-03-03
00850046497162STELLAR KneeRevision 0180-0007-OBSERVER2025-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862656117NewtonExactech, Inc.OLO2026-05-27
10885862656124NewtonExactech, Inc.OLO2026-05-27
10885862656131NewtonExactech, Inc.OLO2026-05-27
10885862656148NewtonExactech, Inc.OLO2026-05-27
10885862656155NewtonExactech, Inc.OLO2026-05-27
10885862656162NewtonExactech, Inc.OLO2026-05-27
10885862656179NewtonExactech, Inc.OLO2026-05-27
07613327594829Common Shoulder DriverMAKO SURGICAL CORP.OLO2026-05-21
07613327595543MakoMAKO SURGICAL CORP.OLO2026-05-21
07640221373021PERLA NAVSpineArt SAOLO2026-05-07
07640221373052PERLA NAVSpineArt SAOLO2026-05-07
07640221373069PERLA NAVSpineArt SAOLO2026-05-07
07640221373113PERLA NAVSpineArt SAOLO2026-05-07
07640221373120PERLA NAVSpineArt SAOLO2026-05-07
07640221373137PERLA NAVSpineArt SAOLO2026-05-07
07640221373144PERLA NAVSpineArt SAOLO2026-05-07
07640221373151PERLA NAVSpineArt SAOLO2026-05-07
07640221373168PERLA NAVSpineArt SAOLO2026-05-07
07640221373175PERLA NAVSpineArt SAOLO2026-05-07
07640221373182PERLA NAVSpineArt SAOLO2026-05-07
07640221373199PERLA NAVSpineArt SAOLO2026-05-07
07640221373205PERLA NAVSpineArt SAOLO2026-05-07
07640221373212PERLA NAVSpineArt SAOLO2026-05-07
07640221373229PERLA NAVSpineArt SAOLO2026-05-07
07640221373236PERLA NAVSpineArt SAOLO2026-05-07
07640221373243PERLA NAVSpineArt SAOLO2026-05-07
07640221373250PERLA NAVSpineArt SAOLO2026-05-07
07640221373267PERLA NAVSpineArt SAOLO2026-05-07
07640221373274PERLA NAVSpineArt SAOLO2026-05-07
07640221373281PERLA NAVSpineArt SAOLO2026-05-07