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The indications for use for TaperSet™ Hip System are:

The TaperSet™ Hip System is designed for total hip arthroplasty and is intended to be used with compatible components of the Consensus Hip System including the CS2™ Acetabular Cup System.

The indications for use are:

A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
C. Proximal femoral fractures.
D. Avascular necrosis of the femoral head.
E. Non-union of proximal femoral neck fractures.
F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities.

The TaperSet™ hip stem is indicated for cementless use.

The Consensus acetabular cup components are intended for cemented or cementless use. The CS2 Ti plasma coated acetabular shell is intended for cementless use. The Consensus all-poly acetabular cup is intended for cemented use.

The intended use or indications for use of the TaperSet™ Hip System are similar to its original clearance K102399 except the removal of 'partial hip arthroplasty" as the DAA surgical technique is only applicable to the total hip system.

Shalby Advanced Technologies, Inc. has created the DAA surgical technique for its cleared TaperSet™ Hip System including hip implants – TaperSet Femoral Stems™ and CS2™ Acetabular Components as well as other compatible components.

There have been no changes made to the TaperSet™ Femoral Stems and CS2™ Acetabular Components or any other compatible components from their previous clearances in developing the DAA surgical technique.

The TaperSet™ Femoral Stems are available in sizes ranging from 5 to 24mm in standard and 7mm lateralized neck options. The TaperSet™ Femoral Stems with Reduced Distal Profile (RDP) are available in sizes ranging from 10.5 to 24mm in standard and 7mm lateralized neck options. The femoral stems are manufactured from wrought or forged titanium alloy (Ti-6Al-4V), except the 5 and 6mm femoral stems which are manufactured from forged titanium alloy (Ti-6Al-4V) only, and the proximal portion is plasma sprayed with commercially pure titanium.

The CS2™ Acetabular Components include acetabular shells and mating liners. The acetabular shells and liners have matching circumferential scallops that rotationally secure the insert in the shell and allow for dialing the insert in a desired orientation. The shells with screw holes have anatomically placed holes, which accommodate optional screws for additional fixation. The shells are manufactured from titanium alloy (Ti-6Al-4V) and are porous coated with either commercially pure titanium sintered or diffusion bonded irregular beads or commercially pure titanium plasma spray. The acetabular shells coated with titanium irregular beads are available in six configurations (1) Hemispherical with three screw holes, (2) Hemispherical with eight to ten screw holes, (3) Hemispherical without screw holes, (4) Flared rim with three screw holes, (5) Flared rim with eight to ten screw holes, and (6) Flared rim without screw holes. The acetabular shells with titanium plasma spray are available in one configuration: hemispherical with three screw holes. The acetabular shells are available in sizes ranging from 42 to 68mm.

The CS2™ and CS2™ PLUS acetabular liners are manufactured from highly cross-linked UHMWPE or highly cross-linked UHMWPE blended with Vitamin-E (VitalitE). The CS2 acetabular liners made from highly cross-linked UHMWPE are available in two configurations: (1) Rimmed neutral and (2) Rimmed hooded. The CS2™ acetabular inserts made from VitalitE are available in four configurations: (1) Rimmed neutral, (2) Rimmed hooded, (3) Rimless neutral, and (4) Rimless hooded. The CS2™ PLUS acetabular inserts are designed with a +5mm lateralized offset and are available in two configurations: (1) Rimmed neutral and (2) Rimmed hooded.

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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

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.

The provided text describes the regulatory clearance for the "Consensus Knee System with TiNbN" and discusses its substantial equivalence to predicate devices, primarily focusing on the addition of a TiNbN coating. However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria related to AI/software performance.

The text is a 510(k) summary for a medical device (knee prosthesis), which focuses on demonstrating substantial equivalence to existing devices. The "tests" mentioned are non-clinical, primarily material and mechanical tests (biocompatibility, wear performance, fatigue, range of motion) conducted for the physical implant and its new coating, not for any AI or software component.

Therefore, I cannot provide the requested information, as the input document does not contain details about:

• Acceptance criteria for AI/software performance.
• A study validating AI/software performance.
• Sample sizes for test sets (in the context of AI/software).
• Expert involvement in establishing ground truth for AI/software.
• Adjudication methods for AI/software test sets.
• MRMC studies.
• Standalone AI algorithm performance.
• Types of ground truth for AI/software.
• Training set sample sizes or ground truth establishment for an AI/software component.

The document is about a physical medical device (a knee implant), not an AI/software device.

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