(140 days)
The MP Reconstruction System is intended for revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur. The MP Reconstruction System is indicated for the following conditions:
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Revision arthroplasty due to juxta-articular bone defects.
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Revision of loosened femoral prosthesis components involving extensive bone resorption of the proximal femur and widening of the medullary cavity or marked thinning of proximal femoral cortical bone.
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Revision of loosened femoral prosthesis components by peri-/subprosthetic fracture.
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Deformed proximal femur due to fractures or osteotomies.
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Correction of bone deficiencies, e.g. due to tumors.
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Large post-revision and post-trauma segmental bone defects.
The MP Reconstruction System is for cementless use. Only cemented labeled modular stems are indicated for cemented use.
This 510k adds Cemented Stems to the MP Reconstruction System. The MP Reconstruction System is a modular hip prosthesis system and consists of Prosthesis Heads, Stems, Neck Segments, Proximal Spacers, and Expansion Bolts. The modular components are interchangeable allowing for independent positioning. The Prosthesis Stems are available in a variety of diameters and lengths. Neck Segments are available in a variety of CCD angles and sizes. Proximal Spacers are available in two different heights and can be used independently or combined to add leg length. Expansion Bolts are used to secure the Neck Segments and Proximal Spacers, when used, to the Prosthesis Stems.
The cementless prosthesis stems are tapered with a microporous surface, and include longitudinal fluting. The cemented prosthesis stems have a rounded triangular shape with an anatomic bow at the distal tip.
The MP Reconstruction Prosthesis Stems (cementless) and Neck Segments are produced of Titanium Aluminum Vanadium alloy (Ti-6Al-4V). Cemented Stems, Proximal Spacers and Expansion Bolts are made of Cobalt Chromium Molybdenum casting alloy (CoCrMo) materials.
This document pertains to the 510(k) premarket notification for the MP Reconstruction System, specifically focusing on the addition of cemented stems.
Here's an analysis of the provided information regarding acceptance criteria and performance studies:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance and Conclusion |
|---|---|---|
| Mechanical Performance | Femoral stem fatigue resistance (per ISO 7206-4) | Passed. The results demonstrated substantial equivalence to predicate devices. |
| Material Composition | Material identity to predicate and reference devices | Confirmed. Subject device materials are identical to those used in predicate and reference device systems (CoCrMo for cemented stems, Ti-6Al-4V for cementless stems and neck segments). |
| Design | Substantial equivalence in design | Confirmed. Performance testing demonstrated substantial equivalence in design, with differences (CoCrMo material, rounded triangular shape, narrower distal tip for cemented stems) not changing intended use or fundamental scientific technology. |
| Indications for Use | Same as primary predicate | Confirmed. The subject device has the same indications for use as the primary predicate device. |
| Clinical Performance | Not specified for this submission | No clinical performance testing was required. |
2. Sample Size Used for the Test Set and Data Provenance:
The document primarily describes non-clinical performance testing (mechanical testing). Therefore, the concept of a "test set" in the context of clinical data or patient samples is not applicable here.
- Sample Size: Not applicable. The testing refers to physical specimens of the femoral stems. The number of specimens tested for femoral stem fatigue (ISO 7206-4) is not explicitly stated but would be defined by the ISO standard for such tests.
- Data Provenance: Not applicable in the context of patient data. The testing involves laboratory-controlled mechanical tests of device components.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. For non-clinical mechanical testing, "ground truth" is established by the specifications of engineering standards (e.g., ISO 7206-4) and the physical properties of the materials and design. The evaluation is performed by engineers and technicians against these established standards.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or image-based evaluations involving human interpretation. This submission relies on objective mechanical test results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "There was no clinical performance testing required for this device."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is a medical device (hip prosthesis), not an AI algorithm or software device.
7. The Type of Ground Truth Used:
The "ground truth" for this medical device's performance is established through compliance with recognized international standards (e.g., ISO 7206-4) for mechanical properties, and comparison to the characteristics and performance of the legally marketed predicate devices.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the same reason as above.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.