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BENCOX Total Hip System is intended for cementless use in total or partial hip arthroplasty in primary or revision surgery for the following conditions:

· non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis;

· Inflammatory degenerative joint disease, such as rheumatoid arthritis;

· Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques;

· patients with failed previous surgery where pain, deformity, or dysfunction persists;

· revision of previously failed total hip arthroplasty.

The Additional components being added to the BENCOX THR System are:

• Instrumentation (Head trial, Bencox Hybrid PE Liner Trial - STD/ELV, Bencox Mirabo PE Liner Trial - STD/ELV, Shell Trial, Bipolar Cup Trial, Bipolar Cup Trial Ring, Head Impacting Part, Liner Impacting Part)

The Bencox Hip Instrumentation is a set of accessories to be used with Bencox Hip Implants. The instruments are designed to be simple, conventional, and accurate and all parts of which are used for their respective procedures by qualified orthopedic surgeons. The parts of the instruments are made of Propylux and/or SUS along with colorants which are biocompatible and used in medical industry for decades and cleared for use in previous premarket notifications of Corentec.

The Trials are used to match the different anatomical structures of the hip joint and the Impacting Parts are used to combine the components together. These instruments are reusable devices that must be sterilized prior to use.

The trials and impacting parts of this submission are made of Propylux and/or SUS conforming to ASTM D4101: Standard Classification System and Basis for Specification for Polypropylene Injection and Extrusion Materials, and ASTM F899:

Standard Specification for Wrought Stainless Steels for Surgical Instruments, respectively.

The provided document is a 510(k) premarket notification for a medical device, the BENCOX THR System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's performance against specific acceptance criteria through a clinical study.

Therefore, the document does not contain the following information:

• A table of acceptance criteria and reported device performance.
• Sample size used for a test set or its data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
• Information on standalone (algorithm-only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a test set.
• Sample size for a training set.
• How ground truth for a training set was established.

Explanation from the document:

The document states under "Non-Clinical Testing":
"The designs, dimensions and function of additional instruments are similar with predicate devices under K162127. Additional performance testing is unnecessary since the trial is not implanted."

And under "Clinical Testing":
"Clinical testing for BENCOX THR System Instrumentation were not required as a basis for substantial equivalence."

This explicitly indicates that no clinical performance studies, which would typically involve testing against acceptance criteria, were conducted or required for this 510(k) submission. The basis for clearance is the demonstrated substantial equivalence to predicate devices through technical characteristics and non-clinical engineering analysis (e.g., dimensions).

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