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510(k) Data Aggregation
(70 days)
TAPERSET HIP SMALL STEMS
The TaperSet™ Hip System is designed for total or partial hip arthroplasty and is intended to be used with compatible components of the Consensus Hip System.
The indications for use are:
- A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
- B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
- C. Proximal femoral fractures.
- D. Avascular necrosis of the femoral head.
- E. Non-union of proximal femoral neck fractures.
- F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities.
The TaperSet™ hip stem is indicated for cementless use.
The TaperSet Hip System (THS) is a monolithic, titanium alloy tapered hip stem design with a proximal, plasma sprayed, porous CP Ti coating. The stem has a dual wedge geometry and is available in both standard and 7mm lateral offsets in sizes currently designated as 7.5mm to 24mm. The stems feature a neck shaft angle of 135° and a 12/14 Morse taper trunnion. The TaperSet Hip System is designed for total or partial hip arthroplasty and is intended to be used with compatible components of the Consensus Hip System. The stem is compatible with previously cleared CoCr heads, zirconia or Biolox delta ceramic heads, unipolar heads, bipolar heads. UHMWPE inserts and acetabular cups. The modification addressed here is the addition of two stems in sizes 5mm and 6mm.
The new stems are manufactured from forged titanium alloy (Ti-6AI-4V ELI, ASTM F620) and the proximal portion of the femoral stem component is plasma sprayed with commercially pure titanium (C. P. Ti. ASTM F1580). The new femoral stems are available in both standard and 7mm lateralized options and have the identical neck and taper design, and porous coating as the predicate TaperSet stems cleared under K102399 in design and indications.
The provided FDA 510(k) summary (K121935) describes the TaperSet Hip System Small Stems, which are orthopedic implants, not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device performance and study design are not applicable to this submission.
However, I can extract the relevant information regarding the acceptance criteria and the non-clinical study that demonstrates the device's performance based on mechanical testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| The stems were to achieve 5 million cycles of loading at a maximum load of 517 lbs. (2300 N) without failure in accordance with ASTM F2068-2009 and ISO 7206-4:2010(E). This applies to the worst-case configuration (the 5mm lateral femoral stem). | The submission states: "Based upon engineering analysis and testing of the design modification the new 5 & 6 mm femoral stems for the TaperSet Hip System by Consensus are substantially equivalent to devices currently marketed. Therefore, the device is as safe, as effective, and performs at least as safely and effectively as the legally marketed predicates." While not explicitly stating "passed," the determination of substantial equivalence, which is based on this testing, implies that the acceptance criteria were met. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document refers to testing of a "worst-case example," specifically "the 5mm lateral femoral stem." This implies that at least one of these stems was tested. The document also states "The stems were to achieve...", suggesting that multiple stems may have been tested to confirm consistency, but the exact number isn't specified beyond "the 5mm lateral femoral stem was determined to be the worst-case example per analysis report (R11-007)." The study is a non-clinical, laboratory-based mechanical test.
- Data Provenance: This is not applicable in the context of clinical data for a mechanical test. The testing was performed on newly manufactured devices to evaluate their mechanical properties.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This is not applicable as the study involves mechanical testing of an orthopedic implant, not the evaluation of a device by human experts or the establishment of a ground truth for diagnostic purposes. The "ground truth" here is the physical performance of the device under specific loading conditions, measured by engineering standards.
4. Adjudication Method for the Test Set
This is not applicable for a non-clinical mechanical test. The test results are determined by instrumentation and adherence to engineering standards, not through human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This is not an AI/ML device or a device that requires human interpretation of outputs.
6. If a Standalone Performance (i.e. algorithm only without human-in-the-loop performance) was Done
No. This is not an AI/ML device.
7. The Type of Ground Truth Used
The "ground truth" for this study is defined by established biomechanical and engineering standards for hip prostheses:
- ASTM F2068-2009 (Standard Specification for Femoral Prostheses – Mechanical Performance)
- ISO 7206-4:2010(E) (Implants for surgery — Partial and total hip joint prostheses — Part 4: Determination of endurance properties of stemmed femoral components)
The acceptance criteria (5 million cycles at 517 lbs/2300 N without failure) are directly derived from these standards.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/ML device.
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