(21 days)
The PROFEMUR® LX Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis;
- correction of functional deformity; and,
- revision procedures where other treatments or devices have failed
The design features of the PROFEMUR® LX Hip Stem are summarized below:
- Manufactured from titanium alloy (Ti6A14V) .
- Offered in one medial flare option .
- Tri-planar proximal geometry with plasma sprayed surface .
- Cylindrical, splined, and slotted distal stem with glassbead surface .
- Threaded hole with slot impaction mechanism .
- Polished distal tip and collar .
- Table of Acceptance Criteria and Reported Device Performance:
| Feature/Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence | The PROFEMUR® LX Hip Stem is "substantially equivalent" to predicate devices. |
| Indications for Use | Identical to predicate devices. |
| Design Features | Substantially equivalent to predicate devices. |
| Fundamental Scientific Technology | Unchanged relative to predicate devices. |
| Safety and Effectiveness | Adequately supported by substantial equivalence information, materials information, and analysis data. |
Note: This 510(k) summary primarily focuses on demonstrating substantial equivalence to predicate devices rather than defining and meeting specific, quantitative acceptance criteria for a novel device.
-
Sample Size for Test Set and Data Provenance:
- Sample Size: Not applicable. The submission does not describe a clinical study with a "test set" in the traditional sense for evaluating device performance against pre-defined metrics. Instead, it relies on demonstrating substantial equivalence to existing, legally marketed devices.
- Data Provenance: Not applicable. The submission does not refer to data from a clinical trial or observational study for a test set.
-
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. No "ground truth" was established for a test set as there was no independent evaluation of the device's clinical performance in the manner of a new device requiring such a study. The evaluation focused on equivalence to predicate devices already on the market.
-
Adjudication Method for the Test Set:
- Not applicable. No test set requiring adjudication was described.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is not mentioned or implied in the provided document. The submission is for a hip stem, a medical implant, and does not involve AI or image reading.
-
Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
- Not applicable. This device is a hip stem and does not involve an algorithm or AI.
-
Type of Ground Truth Used:
- Not applicable in the context of a new device performance study. The "ground truth" for the submission is the established safety and effectiveness of the predicate devices based on their prior regulatory clearance.
-
Sample Size for the Training Set:
- Not applicable. There is no mention of a "training set" as this is not an AI/algorithm-based device.
-
How the Ground Truth for the Training Set was Established:
- Not applicable. There is no mention of a "training set" or corresponding ground truth establishment.
Study Proving the Device Meets Acceptance Criteria:
The "study" that proves the PROFEMUR® LX Hip Stem meets its "acceptance criteria" is the Premarket Notification (510(k)) process itself, which demonstrates Substantial Equivalence to legally marketed predicate devices.
The key aspects of this "study" are:
- Comparison to Predicate Devices: The submission explicitly states:
- "The indications for use of the PROFEMUR® LX Hip Stem are identical to the predicate devices."
- "The design features of the PROFEMUR® LX Hip Stem are substantially equivalent to those of the predicate devices."
- "The fundamental scientific technology of the modified device has not changed relative to the predicate devices."
- Supporting Information: "The safety and effectiveness of the PROFEMUR® LX Hip Stem are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification." While the specific "materials information and analysis data" are not detailed in this summary, they would typically include engineering analyses, material testing, mechanical testing (e.g., fatigue strength, static strength), and biocompatibility assessments to show that the new device performs as safely and effectively as the predicate devices.
- FDA Review: The FDA's letter (K053588) confirms that "[We] have determined the devices are substantially equivalent... to legally marketed predicate devices."
Therefore, the "study" is a regulatory review of comparative data and evidence demonstrating that the PROFEMUR® LX Hip Stem is as safe and effective as predicate devices already on the market, rather than a clinical trial or performance study against pre-defined quantitative metrics for a novel technology.
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented 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. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without 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 an uncemented 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 an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.