Search Results

The indications for the Corin TriFit TS 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 TriFit TS Hip is intended for cementless use only.

The Corin TriFit TS Hip is a double tapered-wedge blade stem design manufactured from Ti6Al4V Titanium alloy (ASTM F-136-08) with a layer of commercially pure titanium (BS ISO 5832-2: 1999) and calcium phosphate (BONIT®) coating (ASTM F1609-08) applied. The TriFit TS Hip is available in 11 sizes in standard and lateralized offsets with a 127° CCD angle. The device is intended to be used with Corin 12/14 modular taper heads.

The TriFit TS Hip is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

The Corin TriFit TS Hip Stem was originally cleared in K121563. The purpose of this submission is to modify the labeling to remove an indications for use for the TriFit TS Hip Stem, for clarity to ensure safe or effective use. The design and compatible components for use with the Corin TriFit TS Hip stem subject of this submission are identical to that of the predicate device K121563.

This document is a 510(k) premarket notification for a medical device called the Corin TriFit TS Hip. It is a submission to the FDA seeking approval to market the device based on its substantial equivalence to a legally marketed predicate device.

The provided document does not contain information about acceptance criteria and a study proving the device meets those criteria, as it is related to an AI/ML device. The Corin TriFit TS Hip is a physical medical device (hip prosthesis), and the submission focuses on its design, materials, intended use, and equivalence to a predicate device, rather than a performance study with acceptance criteria in the context of AI/ML.

Therefore, the requested information elements related to AI/ML device performance, such as sample sizes for test/training sets, expert consensus, MRMC studies, or standalone algorithm performance, are not applicable and not present in this document.

The document states:

• "Clinical testing was not necessary in this Traditional 510(k)." (Page 5, Section 13)

This indicates that clinical studies, which would typically contain acceptance criteria and performance data, were explicitly not required for this particular submission. The substantial equivalence was established based on non-clinical aspects like design, materials, coatings, and indications for use, as well as comparison to a previously cleared predicate device (Corin TriFit TS Hip Stem, K121563).

Ask a specific question about this device