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Monolithic cementless stems are indicated for use in partial or total hip arthroplasty and they are intended for press-fit (uncemented) use.

When used in total hip arthroplasty, monolithic cementless stems are with modular heads and compatible acetabular cups.

When used in partial hip arthroplasty, they are intended for use with bipolar heads.

Hip arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

· non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and dysplasia;

• rheumatoid arthritis;

· revisions in cases of good remaining femoral bone stock;

· treatment of femoral head and neck fractures.

The C2 femoral stem is intended for partial or total hip arthroplasty in cementless use in primary or revision cases. It is a monolithic collarless stem available in 14 sizes for both standard and lateralized versions and 8 sizes in revision version.

When used in total hip arthroplasty C2 femoral stems are coupled to previously cleared Limacorporate components:

• . Biolox Delta femoral heads or Limacorporate Femoral Heads articulating with Limacorporate Cemented Cups or
• Biolox Delta heads or Limacorporate Femoral Heads articulating with Delta TT ● Acetabular System.

When used in partial hip arthroplasty the C2 femoral stem is coupled to previously cleared Limacorporate Lock Bipolar Heads.

The C2 femoral stem is made of Ti6Al4V conforming to the specifications ASTM F1472 - ISO 5832-3. The stem is characterized by a 12/14 conical taper to be coupled to Limacorporate Femoral Heads, Biolox Delta femoral heads or Lock Bipolar Heads. In addition necks are mirror-polished to reduce abrasion of the UHMWPE cups in case of abnormal contact. The stem has a rectangular section and is characterized by a "V" shaped A-P profile to improve adaptability to the most common bone morphologies and to facilitate insertion of the stem in the canal.

The C2 femoral stem is suitable for both first implant and revision versions. The first implant versions are available in standard and lateralized versions with different CCD angles (131° and 134°), offsets and stem lengths.

This document is a 510(k) premarket notification for a medical device called the "C2 femoral stem." It is a submission to the FDA to demonstrate substantial equivalence to previously marketed devices. Therefore, it does not describe an AI/ML powered device, an acceptance criteria table with reported device performance, or a study to prove an AI/ML device meets acceptance criteria.

The document details the device's intended use, description, and comparison to predicate devices, and refers to non-clinical testing for fatigue resistance as part of demonstrating substantial equivalence.

Here's the information that is available in the document, which primarily focuses on the regulatory submission process for a traditional medical device:

1. A table of acceptance criteria and the reported device performance:
* Not Applicable. This document is for a traditional medical device (a femoral stem implant), not an AI/ML powered device. Therefore, no acceptance criteria for AI/ML performance metrics (like sensitivity, specificity, AUC) are presented.
* The document mentions fatigue resistance tests according to ISO 7206-4 and ISO 7206-6. It states, "The tests results demonstrated the device's ability to perform under expected clinical conditions." However, no specific quantitative acceptance criteria or reported performance values (e.g., cycles to failure, load limits) are provided in this summary.

2. Sample size used for the test set and the data provenance:
* Not Applicable for an AI/ML test set. For the non-clinical fatigue testing, the document states, "All mechanical tests were performed on worst case components or constructs." The specific number of samples (e.g., number of stems tested) for these mechanical tests is not disclosed in this summary. Data provenance is not relevant in the context of these physical component tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not Applicable. This is not an AI/ML device requiring expert-established ground truth.

4. Adjudication method for the test set:
* Not Applicable. This is not an AI/ML device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
* Not Applicable. This is not an AI/ML device and therefore no MRMC study was conducted or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not Applicable. This is not an AI/ML device.

7. The type of ground truth used:
* For the non-clinical fatigue testing, the "ground truth" would be the engineering specifications and ISO standards (ISO 7206-4, ISO 7206-6) for fatigue performance. Meeting these standards demonstrates the device's mechanical integrity.

8. The sample size for the training set:
* Not Applicable. This is not an AI/ML device, so there is no training set.

9. How the ground truth for the training set was established:
* Not Applicable. This is not an AI/ML device.

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The Minima S System is indicated for use in partial or total hip arthroplasty and is intended for press-fit (uncemented) use. When used in total hip arthroplasty, the Minima S Stems are intended for use with compatible femoral heads and acetabular components. When used in partial hip arthroplasty, the Minima S stems are intended for use with Lock Bipolar Heads. Hip arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

• non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia;
• rheumatoid arthritis;
• treatment of femoral head and neck fractures; .
• revisions in cases of good remaining femoral bone stock.

The Minima S System is intended for partial or total hip arthroplasty in cementless use. It is a monolithic collarless stem available in 9 sizes (#4-#12) in standard and lateralized versions.
When used in total hip arthroplasty Minima S stems are coupled to:

• Biolox Delta femoral heads (object of this submission) or Limacorporate Femoral Heads (K112158) articulating with Limacorporate Cemented Cups (K112158) or
• Biolox Delta heads (object of this submission) or Limacorporate Femoral Heads (K112158) articulating with Delta TT Acetabular System (K112898).
  When used in partial hip arthroplasty the Minima S femoral stem is coupled to Lock Bipolar Heads (Limacorporate K112158).
  The Minima S stem is made of Ti6Al4V and it has a plasma sprayed titanium coating in the proximal area (ASTM F1472 - ISO 5832-3). The stem is characterized by a 12/14 conical taper to be coupled to Limacorporate Femoral Heads, Biolox Delta femoral heads or Lock Bipolar Heads. In addition necks are lowered to reduce accidental contact between stem and acetabular cups and they are mirror-polished to reduce abrasion of the UHMWPE cups in case of abnormal contact. The stem has a rectangular section and is characterized by a "V" shaped A-P profile to improve adaptability to the most common bone morphologies and to facilitate insertion of the stem in the canal.
  The Minima S System stems is available in standard and lateralized versions with different CCD angles (131° and 134°), offsets and stem lengths.
  Biolox Delta Heads devices are used by surgeons to replace the head of the femur during total or partial hip surgery. They are characterized by a spherical shape and are coupled with the acetabular cup (K112158, K112898) inserted in the acetabulum, in total hip replacement, or with Lock Bipolar Heads (K112158) in partial hip replacement.
  Biolox Delta heads are coupled with the Minima S stems by means of a 12/14 Morse taper. Biolox Delta heads are made of Biolox Delta ceramic and are available with 28, 32 and 36 mm of diameters and in sizes (offsets) S, M, L and XL (XL size available only for head size 36).

This document is a 510(k) premarket notification for the Minima S System, a hip replacement device. It primarily focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting the results of a primary clinical study for the Minima S System itself. As such, information regarding acceptance criteria, device performance, and study design elements typically found in a clinical trial report is not present in this document for the Minima S System.

However, the document does describe non-clinical testing performed to demonstrate substantial equivalence. Based on the provided text, here's an analysis of the relevant sections, acknowledging that many requested fields cannot be filled due to the nature of this submission:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states that the non-clinical tests demonstrated the devices' ability to perform under expected clinical conditions, implying that the acceptance criteria for these tests were met. However, the specific quantitative pass/fail criteria (e.g., maximum deflection, number of cycles survived, minimum pull-out force values, specific burst pressure) are not detailed in this summary.

Information Not Available or Not Applicable Based on the Provided Document:

The following information is specifically requested for "the study that proves the device meets the acceptance criteria." Since this document details a 510(k) submission based on substantial equivalence and non-clinical testing, and explicitly states "Clinical testing was not necessary," most of the requested fields related to clinical studies, human reader performance, and ground truth establishment from patient data are not applicable and are therefore left blank or marked as "N/A."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Sample Size: Not specified for the non-clinical tests. Non-clinical mechanical tests typically use a smaller number of physical samples (e.g., n=3 or n=6 per test condition) rather than a "test set" of patient data.
   • Data Provenance: N/A (Non-clinical mechanical testing).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No clinical test set requiring expert ground truth in this document).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (No clinical test set requiring adjudication in this document).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document refers to a hip replacement system, not an AI diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This document refers to a hip replacement system, not an AI diagnostic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A. For the non-clinical tests, the "ground truth" would be the engineering specifications and performance limits defined by the referenced ISO standards and FDA guidance documents.

8. The sample size for the training set: Not applicable. This document refers to non-clinical testing for a physical medical device, not a machine learning model.

9. How the ground truth for the training set was established: Not applicable. This document refers to non-clinical testing for a physical medical device.

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