(30 days)
The KMTI Hip Replacement System is indicated for patients suffering from:
- 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 using other techniques; and
- Revision procedures where other treatment or devices have failed.
Qualifiers:
The KMTI A400 Hip System is intended for cementless applications unless used with the KMTI Cemented Hip Stem.
The KMTI Porous Coated Acetabular Shell System is intended for cementless applications. In addition, the KMTI Porous Coated Acetabular Shell and Universal liners can be used with the Kyocera Corporation ("KYOCERA") Initia Total Hip System femoral stem mated with KYOCERA CoCr (28-40mm) or BIOCERAM AZUL (28-40mm) femoral head.
The Cemented Hip Stem is intended for cemented applications.
The KMTI Tesera Trabecular Technology (T3) Acetabular Shell System is intended for cementless applications. In addition, the KMTI T3 Acetabular Shell and Universal liners can be used with the KYOCERA Initia femoral stem mated with KYOCERA CoCr (28-40mm) or BIOCERAM AZUL (28-40mm) femoral head.
The Bipolar Head is for use in conjunction with KMTI femoral heads and femoral stems. Bipolar outer heads are not for use with acetabular shells and liners.
The Renovis Surgical Hip Joint Replacement System (K112897) includes multiple subsystem offerings, including:
K132312: Renovis Tesera Trabecular Technologies (T3) Acetabular Shell System
K141676: Renovis Porous Acetabular Cup System
Renovis Surgical Technologies is now wholly owned by Kyocera International, Inc. (San Diego, CA) as Kyocera Medical Technologies, Inc. ("KMTI"). The subject of this Special 510k Premarket Notification are additional KMTI offerings which include the use of components of the K160895 Kyocera Medical Corporation, Japan Initia Total Hip System (now Kyocera Corporation, Japan; "KCJ") that may be used with the KMTI K132312 T3 acetabular shell, K141676 porous acetabular shell and KMTI universal acetabular liners.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device (hip replacement system). This type of document is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific performance acceptance criteria through clinical studies or AI algorithm evaluations.
Therefore, this document does not contain the information required to answer the questions about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.
The document primarily focuses on:
- Device Name: Kyocera Medical Technologies, Inc. (KMTI) Hip Replacement System, including the Tesera Trabecular Technologies (T3) Acetabular Shell System and Porous Acetabular Cup System.
- Regulatory Information: Class II device, regulation number, product codes, and predicates.
- Indications for Use: Specifies the conditions for which the hip replacement system is intended.
- Substantial Equivalence: States that there are no changes in intended use, implant materials, manufacturing, packaging, or sterilization, and that the equivalence of certain components has been demonstrated.
- Compliance: Mentions assessment under Design Controls and compliance with ISO and ASTM standards for mechanical testing.
There is no mention of AI, software algorithms, or clinical studies that would involve establishing ground truth with experts, performing multi-reader multi-case studies, or evaluating standalone algorithm performance. The "performance" discussed in this document refers to the mechanical and biological performance of the implant, typically evaluated through bench testing and material analyses to ensure safety and effectiveness, rather than a diagnostic or predictive AI algorithm's performance.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.