(154 days)
The Apex K2™ Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate:
- . Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- . Rheumatoid arthritis;
- Correction of functional deformity: .
- Congenital dislocation; .
- Revision procedures where other treatments or devices have failed; .
- . Femoral neck and trochanteric fractures of the proximal femur.
The Apex K2™ Hip Stem consists of a rectangular tapered stem, modular necks that connect to the proximal end of the stem, and the modular heads that connect to the tapered trunion on the neck. This configuration allows the user to choose a combination of stem, neck, and head components to appropriately fit the anatomy of the patient. The various neck sizes allow for several length and lateral offset options for a given stem size. Several offset options are also available for the heads to allow further refinement of the lengths and offsets. The Apex K2 Hip Stem may be used in conjunction with the Apex Modular Acetabular Cup (K031110) for total hip arthroplasty.
The femoral stems (and modular necks) are manufactured from titanium alloy. The Apex K2 stems can be used with the cobalt chromium alloy heads and the alumina ceramic heads that are part of the Apex Modular hip system. The proximal metaphyseal region of each size femoral stem is circumferentially coated with unalloyed titanium applied by plasma spray, the same coating method used by the predicate Apex Modular hip stem. As in the predicate Apex Modular stem, the alignment pin in the stem is manufactured from wrought cobalt chromium alloy.
The provided text describes a 510(k) premarket notification for the Apex K2™ Hip Stem, seeking to demonstrate substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria with performance metrics. The information focuses on device description, intended use, and comparison to predicate devices. As such, the requested details regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information are not available in the provided text.
Specifically:
- Acceptance Criteria and Reported Device Performance: This information is not explicitly stated in terms of quantitative performance metrics for the Apex K2™ Hip Stem. The document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use.
- Sample size used for the test set and data provenance: No test set is described. The document pertains to a 510(k) submission, not a clinical study on the Apex K2™ Hip Stem with a specific test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set with corresponding ground truth is detailed.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document is for a hip stem, not an AI or diagnostic imaging device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document indicates that "Performance testing of the modularity was completed as per the relevant FDA guidance documents" and "Performance testing of the plasma sprayed unalloyed (CP) titanium coating was completed as per the relevant FDA guidance documents." This suggests engineering and material testing were performed, but the specific acceptance criteria and results of these tests are not detailed in the provided text. The submission is primarily about establishing substantial equivalence through comparison of features and characteristics to existing predicate devices.
§ 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.