(69 days)
The indications for use for total hip arthroplasty include:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late-stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or inadequate for other reconstructive techniques, such as cementless fixation, as indicated by deficiencies of the acetabulum.
The Exeter X3 RimFit Cup is intended for cemented use only.
This submission covers the subject Exeter X3 RimFit Cups, terminally sterilized by gas plasma (GP) or ethylene oxide (EtO).
The Exeter X3-GP RimFit Cup, terminally sterilized by gas plasma (GP), was previously cleared in K193429 and K111848. It features three subcomponents: a cup manufactured from X3 UHMWPE, a radiopaque wire manufactured from Rex 734 Stainless Steel (Orthinox), and cement spacers manufactured from SG-10 PMMA.
The Exeter X3-EtO RimFit Cup, terminally sterilized by ethylene oxide (EtO), was previously cleared in K193429. It features three subcomponents: a cup manufactured from X3 UHMWE, a radiopaque wire manufactured from Rex 734 Stainless Steel (Orthinox), and cement spacers manufactured from TS2270 PMMA.
The subject Exeter X3-GP RimFit Cup and Exeter X3-EtO RimFit Cup are compatible for use with Stryker Orthopaedics V40 femoral heads, universal taper femoral heads, and C-Taper femoral heads as previously cleared in K111848.
The purpose of the submission is to modify the labeling to remove a contraindication for obesity.
This document is a 510(k) premarket notification for the "Exeter® X3® RimFit® Cup" by Howmedica Osteonics Corp., dba Stryker Orthopaedics. The submission's primary purpose is to modify the labeling by removing a contraindication for obesity, stating that obesity should be a warning rather than a contraindication.
1. A table of acceptance criteria and the reported device performance:
This document describes a labeling modification (removing obesity as a contraindication) for an already cleared device. Therefore, a table of acceptance criteria with specific performance metrics for the device itself is not provided and is not applicable to this submission. The submission asserts that the device is substantially equivalent to predicates, meaning its performance has already been established and accepted. The device's performance is implicitly accepted as meeting the performance of the predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No new test set was used, and therefore no sample size or data provenance information is provided for the device performance itself, as this submission is not about new performance data. The decision to remove obesity as a contraindication is based on interpretation of FDA guidance regarding labeling, not new clinical or non-clinical testing of the device's physical performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. No new test set or ground truth on device performance was established for this labeling modification. The decision regarding the change in contraindication/warning for obesity is based on regulatory guidance and medical judgment, not expert review of a specific test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No new test set requiring adjudication was performed.
5. 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 is not an AI/software device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical prosthetic device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the labeling modification, the "ground truth" or basis for the change is the FDA Device Labeling Guidance #G91-1, which guides the classification of contraindications versus warnings. The manufacturer's interpretation of this guidance led to the proposed change.
8. The sample size for the training set:
Not applicable. There is no "training set" in the context of this device and submission, as it relates to updating labeling based on regulatory interpretation, not developing a new performance model.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set, there is no ground truth establishment for it.
§ 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.