(259 days)
The MUTARS® Proximal Femur Replacement System is a modular hip replacement system offering various components that can be combined to replace the hip joint and address major bone defects with various options depending upon the size and location of the defects of each patient.
The MUTARS® Proximal Femur System is intended for cemented use in total hip arthroplasty or hemiarthroplasty for the following indications:
· Proximal femur replacement in oncology cases where radical resection and replacement of bone is required.
· Limb salvage procedures including surgical intervention for severe trauma, failed previous prosthesis, and/or oncology indications, where radical resection and replacement of the bone is required.
Use of this prosthesis is generally only indicated in skeletally mature patients.
The purpose of this Traditional 510(k) is to expand the MUTARS® Cemented Femoral Stems and MUTARS® Proximal Femur Replacement System with a line extension to the existing stems. The new stems are available with longer lengths (160 and 200mm).
This is a 510(k) premarket notification for a medical device, specifically the MUTARS® femoral stem cemented 160 mm and 200 mm. Such notifications focus on demonstrating "substantial equivalence" to a legally marketed predicate device rather than establishing new acceptance criteria and proving performance against them in the same way one might for a novel device or software.
In this context, the "acceptance criteria" for the new device are implicitly that it performs comparably or acceptably to the predicate device, as demonstrated through adherence to relevant standards and performance testing.
Here's a breakdown of the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Performance (Fatigue Strength): The device should withstand anticipated physiological loads without failure, demonstrated by meeting or exceeding the requirements of ISO 7206-4 for distal stem fatigue testing. | "All necessary testing has been performed for the worst-case MUTARS® femoral stem cemented 160 mm and 200 mm to assure substantial equivalence to the predicates and to demonstrate the subject devices perform as intended." |
"- Distal Stem Fatigue Testing (ISO 7206-4)"
"All performance testing conducted for the MUTARS® femoral stem cemented 160 mm and 200 mm met the predetermined acceptance criteria or were otherwise considered acceptable." |
| Biocompatibility: Materials should be biocompatible and not elicit adverse biological responses. | While not explicitly detailed in the provided snippets, a 510(k) submission for an implantable device would typically include or reference biocompatibility testing to relevant ISO standards (e.g., ISO 10993 series). The statement "All necessary testing has been performed" implies this was addressed. |
| Material Properties: The materials used in the device should meet specified mechanical and chemical properties. | Not explicitly detailed in the provided snippets, but implied by the "All necessary testing" statement and comparison to the predicate device. |
| Design Equivalence/Similarity: The design features should be comparable to the predicate device for the intended use. | "The MUTARS® femoral stem cemented 160 mm and 200 mm subject to this submission possess the same intended use and technological characteristics as the predicate device system components." |
| Dimensional Specifications: The device dimensions (e.g., length) should meet manufacturing specifications and be within the expected range for the intended application (extension to 160mm and 200mm lengths). | The submission is for a "line extension to the existing stems" with "new stems... available with longer lengths (160 and 200mm)." This implies the dimensional specifications for these new lengths are defined and were adhered to. The testing of "worst-case" further supports this. |
| Manufacturing Quality: The device should be manufactured under a Quality System (QS) Regulation (21 CFR Part 820). | The FDA letter explicitly states, "Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820)..." and references design controls, nonconforming product, and corrective/preventive action. This is a regulatory requirement for acceptance of the device into the market. |
The crucial phrase indicating acceptance criteria were met is: "All performance testing conducted... met the predetermined acceptance criteria or were otherwise considered acceptable."
Regarding the study that proves the device meets the acceptance criteria:
The document describes performance testing conducted on the device.
- Type of Study: This was a bench testing study, specifically focused on Distal Stem Fatigue Testing (ISO 7206-4). This standard is designed to assess the endurance of femoral components of hip prostheses under simulated physiological loading conditions.
- Proof of Meeting Criteria: The conclusion states that "All performance testing conducted for the MUTARS® femoral stem cemented 160 mm and 200 mm met the predetermined acceptance criteria or were otherwise considered acceptable." This directly confirms the device performed as required by the established standard and internal criteria.
The remaining sections are not applicable to the provided document, as this is a mechanical medical device (femoral stem for hip replacement) and not an AI/software device. Therefore, questions related to sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details are not relevant to this 510(k) submission for a physical implant.
Specifically:
- Sample size used for the test set and the data provenance: Not applicable. For mechanical testing like fatigue, the sample size is determined by the testing standard (e.g., ISO 7206-4) and statistical requirements for demonstrating meeting performance thresholds. The data provenance is from the specific test laboratory where the bench tests were conducted.
- Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth in this context refers to engineering specifications and performance standards, not diagnostic interpretations by experts.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done... effect size: Not applicable as this is not an AI/software imaging device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used: For mechanical devices, the "ground truth" is defined by established engineering principles, material science, and international performance standards (like ISO 7206-4).
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
§ 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.