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510(k) Data Aggregation
(74 days)
The Citation TMZF HA Stem is indicated for cementless primary hip surgery in cases of non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity. Additionally it can be used in treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. It is also indicated for use in revision procedures where other treatments or devices have failed.
The Citation TMZF HA Stems are anatomic stems in a variety of lengths and distal diameters. The larger diameter stems have a rotated distal slot that contains distal flutes or grooves. This stem is intended for the reconstruction of the head and neck of the femoral joint. The device is intended for primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty. The stems can be used with any currently available Howmedica Osteonics acetabular components and V40 Femoral Heads that can be mated with a 5° 40' BG taper. The Citation TMZF HA Stems will be fabricated from TMZF Alloy. The stems are coated with a CP Titanium plasma spray coating and Pure-Fix™ HA.
This 510(k) submission is for the Citation TMZF HA Stem, a femoral component for hip arthroplasty. The device is not an AI/ML powered device, therefore, many of the requested categories are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | The Citation TMZF HA Stem is deemed substantially equivalent to the Meridian® Titanium Femoral Stem (K972228), Howmedica® Asymmetric Stem Femoral Component (K955871), and Osteonics® Omnifit® AD-HA Hip Stem Series (K941366) based on intended use, materials, design, and operational principles. |
| Fatigue Strength | Testing indicates that the addition of the HA coating over plasma spray has no effect on the stem fatigue strength. This implies the device maintains mechanical integrity comparable to its predicate devices without the HA coating. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable for this type of device. The evaluation is based on comparative analysis with predicate devices and material/mechanical testing, not a clinical test set with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. Ground truth as typically understood for AI/ML devices is not relevant here. Substantial equivalence is determined by regulatory bodies based on engineering and design principles, and comparison to existing legally marketed devices.
4. Adjudication Method for the Test Set
Not applicable. There was no "test set" in the sense of clinical data requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is not an AI/ML device, and an MRMC study is not relevant for the evaluation of a hip stem.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this submission is regulatory in nature. It centers on:
- Substantial equivalence: Demonstrated by comparing the device's intended use, materials, design, and operational principles to legally marketed predicate devices.
- Mechanical performance: Demonstrated through laboratory testing (e.g., fatigue testing) to ensure the device meets safety and performance standards, particularly concerning the effect of the HA coating.
8. The Sample Size for the Training Set
Not applicable. There is no AI/ML model or "training set" for physical medical devices of this nature.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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