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• Versafitcup CC TRIO

The Versafitcup CC Trio and the Versafitcup CC Trio No-Hole are designed for cementless use in total hip arthroplasty in primary or revision surgery.

The patient should be skeletally mature.

The patient's condition should be due to one or more of:

• Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis.
• Avascular necrosis of the femoral head.
• Acute traumatic fracture of the femoral head or neck.
• Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.

• Quadra-P and Quadra-P Collared

The hip prosthesis Quadra-P and Quadra-P Collared are designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. The Quadra-P Cemented is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery. Hip Replacement is indicated in the following cases:

• Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia.
• Avascular necrosis of the femoral head.
• Acute traumatic fracture of the femoral head or neck.
• Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

• AMIStem-H, AMIStem-H Collared, AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared

The hip prosthesis AMIStem-H, AMIStem-H collared, AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared are designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. The AMIStem-C is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery.

Hip Replacement is indicated in the following cases:

• Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia.
• Avascular necrosis of the femoral head.
• Acute traumatic fracture of the femoral head or neck.
• Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

• MiniMAX

The MiniMax is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. Hip Replacement is indicated in the following cases:

• Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia.
• Avascular necrosis of the femoral head.
• Acute traumatic fracture of the femoral head or neck.
• Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

• Quadra-H and Quadra-R

The hip prosthesis Quadra -S, Quadra-H and Quadra-R is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. The hip prosthesis Quadra-C is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery. Hip Replacement is indicated in the following cases:

• Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia.
• Avascular necrosis of the femoral head.
• Acute traumatic fracture of the femoral head or neck.
• Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

The Quadra-C size 0 implant should not be implanted in patients with a mass of 65 kg or greater.

• SMS and SMS Collared

The hip prosthesis SMS and SMS Collared are designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. Hip Replacement is indicated in the following cases:

• Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia.
• Avascular necrosis of the femoral head.
• Acute traumatic fracture of the femoral head or neck.
• Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

• Mpres

The Mpres stem is a cementless neck preserving stem designed for use in total or partial hip arthroplasty for primary or revision surgery.

Total Hip Arthroplasty with the Mpres stem is indicated in the following cases:

• Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polyarthritis or congenital hip dysplasia.
• Avascular necrosis of the femoral head.
• Acute traumatic fracture of the femoral head.
• Failure of previous hip surgery:
  • Conservative hip surgery,
  • Internal fixation,
  • Arthrodesis,
  • Hip resurfacing replacement.

Partial hip arthroplasty with the Mpres stem is indicated in the following cases:

• Acute traumatic fracture of the femoral head.
• Avascular necrosis of the femoral head.
• Primary pathology involving the femoral head but with a non-deformed acetabulum.

• Mpact Acetabular Shell

The Mpact implants are designed for cementless use in total hip arthroplasty in primary or revision surgery.

The patient should be skeletally mature.

The patient's condition should be due to one or more of:

• Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis.
• Avascular necrosis of the femoral head.
• Acute traumatic fracture of the femoral head or neck.
• Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.

The aim of this submission is to seek clearance for the addition of a new coating supplier for the following coatings:

• Titanium + Hydroxyapatite coating;
• Hydroxyapatite coating;
• Porous Titanium coating for Mpact devices; and
• Titanium coating for Mpact T sizes devices.

The already FDA cleared devices affected by the change are listed in Table 1 below.

N/A

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The hip prosthesis AMIS-K Long is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery.

Total hip replacement is indicated in the following cases:
· Severely painful and/or disabled joint as a result of arthritis, rheumatoid polyarthritis or congenital hip dysplasia

• Avascular necrosis of the femoral head
• · Acute traumatic fracture of the femoral head or neck
  · Failure of previous hip surgery: joint reconstruction, arthrodesis, partial hip arthroplasty, hip resurfacing replacement, or total hip arthroplasty.

Partial hip arthroplasty is indicated in the following cases:
· Acute traumatic fracture of the femoral head or neck

• · Non-union of femoral neck fracture
• · Avascular necrosis of the femoral head.
• · Primary pathology involving the femoral head but with a non-deformed acetabulum.

The AMIS-K Long cemented stem is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery.

The AMIS-K Long is a straight, double-tapered cemented stem whose primary stability is ensured by bone cement.

The AMIS-K Long implants in this submission are comprised of the following size: from #2 to #5 with 2 different stem body size for #2, #3 and #4, 1 different stem body size for #5. Stem length: 200 - 250 - 300 mm (for each size).

The AMIS-K Long implants are part of the Medacta Total Hip Prosthesis system.

The Medacta Total Hip Prosthesis system consists of femoral stemoral heads, and acetabular components.

The AMIS-K Long are cemented stems manufactured from high nitrogen stainless steel (ISO 5832-9) with a mirror polished surface.

The acetabular components consist of metal cups and liners made of ultra-high molecular weight polyethylene (UHMWPE), or Highcross highly crosslinked ultra-high polyethylene (HXUHMWE). Acetabular components include the Mpact DM (K143453), VersafitCup (K083116 and K092265), VersafitCup CC Trio (K103352, K120531 and K122911), Mpact (K103721 and K132879), Mpact 3D Metal (K171966), and Medacta Bipolar Head (K091967).

The AMIS-K Long implants can be combined with the CoCr Ball Heads (K072857 and K080885). Endo Head (K111145), or MectaCer BIOLOX® Forte (K073337) or MectaCer BIOLOX® Delta Femoral Heads (K112115).

The provided text is a 510(k) summary for a medical device (Amis K Long hip prosthesis), which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the context of AI/ML or diagnostic performance.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria in the context of AI/ML performance. Specifically:

• No acceptance criteria for AI/ML performance are listed. The acceptance criteria mentioned refer to non-clinical performance tests for the physical hip prosthesis (e.g., pull-off strength, fatigue testing).
• No study proving AI/ML device performance is described. The document explicitly states "No clinical studies were conducted." and describes non-clinical mechanical tests.
• The requested elements (sample size, data provenance, expert qualifications, etc.) are not applicable in this context as the document is about a physical implant, not an AI/ML diagnostic or assistive device.

The study described in the document primarily focuses on non-clinical mechanical tests to validate the physical properties of the hip prosthesis, such as pull-off strength, range of motion, and fatigue. These tests adhere to established international standards (ASTM, EN ISO, ISO).

In summary, the provided text does not contain the information necessary to answer the questions about acceptance criteria and a study proving device performance as they relate to AI/ML or diagnostic accuracy.

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