(238 days)
The VerSys Epoch FullCoat Hip Prosthesis is indicated for:
- Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur.
- Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.
- Patients suffering from disability due to previous fusion.
- Patients with acute femoral neck fractures.
This device is intended for cementless use only.
The VerSys Epoch FullCoat Hip stem is an addition to the currently marketed VerSys Epoch FullCoat proximal femoral hip implant family. It is a set of fully porous coated implants that are comprised of Zimaloy™, a cobalt chromium molybdenum (CoCrMo) alloy core surrounded by a layer of injection molded polyetheretherketone (PEEK) encased in a layer of commercially pure titanium fiber metal (FM). The stem is designed to replace the proximal femur in a total hip arthroplasty. It features a 12/14 Morse-type taper to accommodate the attachment of modular femoral heads. The proximal geometry of the device is trapezoidal and comes in two options Reduced Neck Length (RNL) with 125° and 135° angles and Low Head Center (LHC) with a 125° angle.
This document describes the VerSys® Epoch® FullCoat Hip System. The provided text is a 510(k) summary for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical study results for novel device categories.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Substantial Equivalence to Predicate Device (K052321) | Mechanical testing indicated that the device is substantially equivalent to the legally marketed predicate. |
| Similar Intended Use | The subject device has the same intended use as the predicate. |
| Similar Physical and Performance Characteristics | The subject device has similar physical and performance characteristics to the predicate. |
| Similar Manufacturing Processes | The subject device is manufactured using similar processes to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. The submission relies on mechanical testing for substantial equivalence, not a clinical test set from human subjects.
- Data Provenance: Not applicable. The data is non-clinical, related to mechanical testing.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
- Not applicable. Ground truth from human experts is not relevant for this type of mechanical testing submission.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set or human adjudication was involved.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This type of study is not relevant for a hip implant submission focused on mechanical substantial equivalence.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
- Mechanical Performance Data: The ground truth for this submission is based on mechanical testing data comparing the subject device to its predicate. The "ground truth" essentially refers to established engineering and material science principles and the performance of the legally marketed predicate device.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of this device and submission type.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There is no training set for this device.
Summary of the Study Proving Acceptance Criteria:
The Zimmer, Inc. submission for the VerSys® Epoch® FullCoat Hip System (K073499) relies on non-clinical mechanical testing to demonstrate substantial equivalence to its predicate device, the VerSys® Epoch® FullCoat Hip System (K052321).
The study primarily assessed:
- Mechanical Performance: The mechanical testing indicated that the subject device is substantially equivalent to the predicate.
- Intended Use: The device shares the same intended use as the predicate.
- Physical and Performance Characteristics: The device exhibits similar physical and performance characteristics to the predicate.
- Manufacturing Processes: The device is manufactured using similar processes as the predicate.
The report explicitly states: "Clinical data and conclusions were not needed for this device." This indicates that for this specific type of device modification (an "addition to the currently marketed... hip implant family"), the FDA deemed non-clinical mechanical testing sufficient to establish substantial equivalence to a previously cleared device. The acceptance criterion was therefore to demonstrate substantial equivalence in these non-clinical aspects to the predicate.
§ 888.3320 Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis is a two-part 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with a cemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with a cemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with a cemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.