(29 days)
The 44mm E1™ Acetabular Liner with 44mm Biolox® delta Option Ceramic Head or 44mm M2a Magnum™ Modular Head is 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 44mm Biolox® delta Option Ceramic Head 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)
Biomet Manufacturing Corp. is addinq a size 44mm liner to their line of E1™ Acetabular Liners to allow the surgeon more options. Additionally, the 44mm Biolox® delta Option Ceramic Head is added to the ceramic option line. The 44mm M²a Magnum™ may be used when a Co-Cr-Mo option is needed. This submission is a line extension of the previously cleared systems.
This document is a 510(k) Summary for a medical device (44mm E1™ Acetabular Liner with ceramic or modular heads) and does NOT contain information about acceptance criteria or a study proving the device meets said criteria.
The purpose of a 510(k) submission is to demonstrate that the device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove its performance against specific acceptance criteria in a study format often seen with AI/software devices. For traditional medical devices like hip implants, substantial equivalence is typically shown through demonstrating similar technological characteristics, materials, and intended use as a predicate device, often supported by non-clinical (e.g., mechanical) testing rather than clinical performance studies.
Therefore, I cannot extract the requested information from the provided text because it is not present. The document explicitly states:
- "Non-Clinical Testing: All parameters of the 'Guidance Document for the Preparation of PreMarket Notifications for Ceramic Ball Hip Systems' were met for the devices contained in this 510(k)." This indicates that the device met certain standards, but it doesn't provide the specific acceptance criteria or a "study" in the sense of a performance evaluation with reported metrics.
- "Clinical Testing: None provided." This confirms that there was no clinical study performed, which would be the typical place to find performance data, ground truth establishment, and details about sample sizes, experts, etc.
In summary, this document is a regulatory submission focused on demonstrating substantial equivalence, not a performance study report as you've outlined in your request.
§ 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.