(242 days)
The indications for the Corin MetaFix Hip as a total hip arthroplasty, and when used in combination with a Corin hemi arthroplasty head, as a hip hemi-arthroplasty, include:
• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• Correction of functional deformity
• Treatment of non-union and femoral neck fractures
• Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH)
The MetaFix Hip is intended for cementless use only.
The Metafix Hip is a tapered stem manufactured from titanium (Ti6Al4V) with a layer of hydroxyapatite (HA) Coating applied. The Metafix™ Hip is available in a 135° standard offset (collared and collarless), 135° lateralized high offset (collarless), a 125° standard offset (collared and collarless), a 125° short neck (collared) and a 135° short neck (collared). The device is intended to be used with 12/14 modular taper heads.
This is a 510(k) premarket notification for a medical device called the Corin MetaFix Hip Stem, not an AI/ML device. Therefore, the requested information about acceptance criteria and studies proving the device meets them, particularly regarding AI performance, is not applicable.
The document states:
- "Clinical testing was not necessary in this Traditional 510(k)." (Page 4, Section 13)
- The submission is primarily to "modify the labeling to remove an indications for use for the MetaFix Hip Stem, for clarity to ensure safe or effective use." (Page 4)
- The device design and compatible components are "identical to that of the predicate device" (K082525, K120362, K121439, K130634, K131952 and K153381). (Page 4)
- The substantial equivalence is based on similarities in "design, materials, coating, sizes and similar in terms of intended use/indications for use." (Page 4, Section 11)
Therefore, the information for establishing acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details as they relate to an AI/ML device's performance are not provided in this document. The FDA's review concluded substantial equivalence based on non-clinical data and comparison to predicate devices, which is typical for traditional 510(k) submissions of non-AI devices.
§ 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.