(99 days)
Biolox® delta Ceramic Heads are indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components in cases of:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Correction of functional deformity
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
- Revision procedures where other treatment or devices have failed.
Specific indications for compatible components that can be used with the above modular heads include:
Salvage/Oncology Hip and Total Femur System components are also indicated for cases of ligament deficiency, tumor resection, trauma and revision of unsuccessful osteotomy or arthrosis. (K974558, K002757, K021380, K033871)
Interlocking hip stems are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard type hip replacement prosthesis. (K990830, K042774)
Biolox® delta Option Ceramic Heads are designed to be the bearing surface of a total hip joint replacement. A highly polished spherical head in a variety of diameters articulates with a polyethylene liner acetabular component. The modular head attaches to a metallic femoral stem via a taper adapter. Adapters are available for either Biomet's Type I taper or Biomet's 12/14 taper in a variety of neck lengths.
This 510(k) premarket notification describes a medical device, the Biolox® delta Option Ceramic Heads, which is a component of a total hip joint replacement. The document focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting de novo clinical study data to meet specific acceptance criteria for a novel device.
Therefore, many of the requested categories (2-9) regarding specific study details, sample sizes, expert involvement, and ground truthing are not applicable or provided in this 510(k) submission. The core of this submission is non-clinical testing and comparison to predicates.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| All parameters of the "Guidance Document for the Preparation of Pre-Market Notifications for Ceramic Ball Hip Systems" were met. | "All parameters of the 'Guidance Document for the Preparation of Pre-Market Notifications for Ceramic Ball Hip Systems' were meet for the devices contained in this 510(k)." (This statement serves as the primary performance claim, indicating compliance with established non-clinical testing standards for ceramic hip systems). |
| Substantial Equivalence to Predicate Devices | The device is deemed "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices" (as per the FDA's letter) based on similar technology and meeting the guidance document for ceramic ball hip systems. |
Explanation of the "Acceptance Criteria" for this type of submission: In a 510(k) submission for substantial equivalence, the "acceptance criteria" are typically defined by regulatory guidance documents and the demonstration that the new device is as safe and effective as a legally marketed predicate device. For the Biolox® delta Option Ceramic Heads, fulfilling all parameters outlined in the "Guidance Document for the Preparation of Pre-Market Notifications for Ceramic Ball Hip Systems" serves as the primary acceptance criterion related to device performance and safety.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. No clinical test set data from human subjects is presented or required for this type of 510(k). The evaluation relies on non-clinical testing and comparison to predicates.
- Data Provenance: Not applicable. The "testing" mentioned is non-clinical, likely mechanical and material testing, rather than data from human subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. No expert ground truth establishment for a test set of human data is described as clinical testing was not provided.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This type of study was not conducted or presented. The submission explicitly states "Clinical Testing: None provided."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This medical device is a physical implant (ceramic hip head), not an algorithm or AI system.
7. Type of Ground Truth Used
- Not applicable. For this 510(k), the "ground truth" for the device's acceptability is established through conformity to regulatory guidance documents for ceramic hip systems (non-clinical testing) and demonstration of substantial equivalence to predicate devices with established safety and effectiveness records. There isn't a "ground truth" in the clinical sense (e.g., pathology, outcomes data) derived directly from a study for this submission.
8. Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that requires a training set.
9. 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.