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510(k) Data Aggregation
K Number
K241180Device Name
Consensus Knee System with TiNbN
Manufacturer
Date Cleared
2025-01-14
(260 days)
Product Code
Regulation Number
888.3560Why did this record match?
Applicant Name (Manufacturer) :
Shalby Advanced Technologies
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The indications for use are:
A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis
B. Failed osteotomy or unicompartmental replacements
C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists
D. The non-porous (uncoated, coated with CoCr beads without Titanium, and uncoated with a TiNbN overcoat) components may only be used with cement
E. The porous coated (CoCr beads with Titanium) components may be used with or without cement
Device Description
The femoral implants are provided in left and right-side versions and designed to replicate the natural anatomy of the femur. They are available in a single variant only - CR, with sizes ranging from 1 to 6. The femoral implants have a R.P design, which offers surgeon an option for patients where a more minimal anatomic design is preferred. The femoral implants are manufactured using cast CoCrMo alloy (ASTM F75). A monolayer of TiNbN coating (thickness: 3 to 7 microns) is applied to the femoral implants.
The tibial baseplates are provided in left and right-side versions and designed to replicate the natural anatomy of the tibial baseplates are available in three variants – holed, pegged, and pegless, with sizes ranging from 0 to 6. The tibial baseplates are manufactured using cast CoCMo alloy (ASTM F75). A monolayer of TiNbN coating (thickness: 3 to 7 microns) is applied to the entire surface of the tibial baseplates.
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