(41 days)
The OrthoPediatrics Locking Proximal Femur System Cortical Screws are intended for temporary internal fixation and stabilization of long bone fractures and osteotomies, mal-unions, and non-unions, in pediatric and small stature adults. Specific indications include: intertrochanteric derotation and Varus osteotomies, femoral neck and pertrochanteric fractures, and intertrochanteric valgus osteotomies.
The OrthoPediatrics Locking Proximal Femur System Cortical Screws are a line extension to expand the current offering to allow for longer cortical screws. The screws are part of one system that combines implants (plates and screws) and instruments. The additional cortical screw sizes include the following: 55mm, 60mm, 65mm, 70mm, 75mm, and 80mm.
The FDA 510(k) summary for the OrthoPediatrics Locking Proximal Femur System Cortical Screws (K162307) describes the device as a line extension to an existing system, adding longer cortical screws. The submission focuses on demonstrating substantial equivalence to a predicate device (K111086).
Based on the provided document, here's a breakdown of the acceptance criteria and the study conducted to prove the device meets these criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Intended Use | The proposed device's intended use must be the same as the predicate device: temporary internal fixation and stabilization of long bone fractures and osteotomies, mal-unions, and non-unions, in pediatric and small stature adults. | The proposed Locking Proximal Femur System Cortical Screws are intended for temporary internal fixation and stabilization of long bone fractures and osteotomies, mal-unions, and non-unions, in pediatric and small stature adults, which is the same as the predicate device. |
| Indications for Use | The proposed device's specific indications for use must be identical to the predicate device: intertrochanteric derotation and Varus osteotomies, femoral neck and pertrochanteric fractures, and intertrochanteric valgus osteotomies. | The proposed Locking Proximal Femur System Cortical Screws Indications for Use are identical to the predicate devices. |
| Material Equivalence | The proposed device's implant material must be identical to the predicate system's screws (medical grade BIODUR stainless steel meeting ASTM 2229-07 standard). | The proposed Locking Proximal Femur System Cortical Screws use the identical implant material as the predicate system's screws (medical grade BIODUR stainless steel which meets ASTM 2229-07 standard). |
| Design Features | The proposed device's design features must be similar to the predicate system's screws, accommodating differences like screw length and change from cannulated to solid. Safety and performance should remain equivalent. | The proposed Locking Proximal Femur System Cortical Screws incorporate similar design features as the predicate system's screws with the difference being the length of the screw and the change from cannulated to solid. The submission implies that these differences do not introduce new risks or reduce performance. |
| Sterilization | The proposed device's sterilization state must be identical to the predicate device (non-sterile). | The proposed Locking Proximal Femur System Cortical Screws are provided non-sterile, which is identical to the predicate device. |
| Performance (Non-Clinical) | Engineering analysis must demonstrate substantial equivalence between the subject device and the predicate device, implying that the mechanical performance (e.g., strength, durability, fixation capability) is maintained despite changes in length and cannulation. | Engineering analysis was performed to show substantial equivalence between the subject device and predicate device. The document does not provide specific metrics or results from this engineering analysis, but states that the activities were "verification activities." It also concludes "No new risks have been identified." |
| Clinical Performance | No clinical performance criteria were explicitly defined for this 510(k) as the submission claims substantial equivalence without new clinical data. The expectation is that clinical performance would be equivalent to the predicate. | Clinical Tests - None provided as a basis for substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of this 510(k). The submission relies on engineering analysis rather than a test set of data from patients or a defined clinical/biomedical dataset. No specific number of samples (e.g., implants tested) from the engineering analysis is provided in the summary.
- Data Provenance: Not applicable for a clinical or retrospective/prospective study. The provenance is from engineering analysis data generated by the manufacturer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. There was no test set requiring expert ground truth establishment in a clinical or image-based context. The "ground truth" for the engineering analysis would be the established engineering and materials standards (e.g., ASTM 2229-07) and the performance characteristics of the predicate device.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring adjudication was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study was not conducted nor mentioned. This device is a bone fixation screw, not an AI or diagnostic imaging device that would typically involve a multi-reader study.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This is not an algorithm or AI device. The "standalone" performance refers to the device's mechanical integrity as an implant. The engineering analysis conducted would assess this, but it's not described as a "standalone study" in the AI/algorithm sense.
7. Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Engineering and Material Standards: Compliance with ASTM 2229-07 for material (BIODUR stainless steel).
- Predicate Device Characteristics: The known, legally marketed characteristics and performance of the K111086 OrthoPediatrics Locking Proximal Femur System, which serves as the benchmark for substantial equivalence.
- Design Specifications: The detailed design of the new screws compared to the predicate.
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that involves a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/machine learning device.
Summary of the "Study" to Prove Acceptance Criteria:
The "study" conducted to prove the device meets acceptance criteria was an engineering analysis. This analysis compared the proposed Locking Proximal Femur System Cortical Screws (which are a line extension with longer screw sizes and a change from cannulated to solid design) to the predicate device (K111086).
The rationale for substantial equivalence was based on demonstrating similar:
- Intended Use
- Indications for Use
- Materials (medical grade BIODUR stainless steel meeting ASTM 2229-07 standard)
- Sterilization (provided non-sterile)
- Design Features (with considerations for the length and cannulation differences, implying these differences do not compromise performance).
The submission explicitly states:
- "Engineering analysis was performed to show substantial equivalence between the subject device and predicate device."
- "Clinical Tests - None provided as a basis for substantial equivalence."
The conclusion is that OrthoPediatrics believes the new screws are substantially equivalent to the predicate based on these similarities and the results of the verification activities (i.e., the engineering analysis), and that no new risks have been identified.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.