(73 days)
The ULTIMA and ULTIMA LX Femoral Hip Stem is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
The ULTIMA and ULTIMA LX Cemented Femoral stem is indicated for use only with PMMA bone cement.
The ULTIMA and ULTIMA LX Cemented stem is a femoral component for use in total or partial hip arthroplasty procedures. It is designed to be implanted with Polymethylmethacrylate bone cement (PMMA) and used in conjunction with a total hip acetabular component and modular hip head. The ULTIMA and ULTIMA LX Femoral Hip Stems can be used in either the right or left hip.
The stem body design is derived from that of the primary ULTIMA stems K#924379. These stems will be offered in both a collared and collarless (ULTIMA LX) design, with either a polished or grit blast finish and a larger proximal slot. The stems have also been designed with a proximal slot to allow the surgeon an additional instrumentation choice during the seating of the implant.
Both the ULTIMA and ULTIMA LX femoral components are available with either a neck angle of a 135 (centralized) or a neck angle of 130 (medialized) to allow for more accurate anatomical head positioning for the patient. The ULTIMA and ULTIMA LX femoral components can be utilized with the P.F.C. Modular Hip Heads (previously cleared K# 893872) of various neck heads diameters (22.225, 26, 28, and 32 mm) and three neck lengths of standard, +5 mm and +10 mm. The 28 mm head and the 32 mm head are also available with a neck length of -3 mm and -5 mm, respectively.
The provided text is a 510(k) premarket notification for a medical device (ULTIMA® and ULTIMA® LX Cemented Femoral Stem). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics in the way a new, novel AI/software as a medical device (SaMD) would.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details cannot be extracted from this document. This document does not describe a study that "proves the device meets acceptance criteria" in the context of an AI/SaMD, but rather demonstrates its substantial equivalence to a previously cleared device.
The information provided confirms:
- Device Name: ULTIMA® and ULTIMA® LX Cemented Femoral Stem
- Intended Use: Total or partial hip replacement procedures for various conditions (rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, etc.).
- Substantial Equivalence: The device is stated to be substantially equivalent to the ULTIMA Total Hip System Cemented Femoral Stem (cleared under #K924379) based on similar materials, intended use, design, manufacture, packaging, and sterilization.
- Regulatory Class: Class II (21 CFR 888.3350)
- Product Code: 87 JDI
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.