(29 days)
The indications for use of these internal fixation devices include:
- Fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, comminuted proximal femoral shaft fractures
- Femoral fixation required as a result of pathological disease
- Temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur
- Open and closed femoral fractures
- Pseudoarthrosis and correction osteotomy
- Pathologic fractures, impending pathologic fractures and tumor resections
- Ipsilateral femur fractures
- Fractures proximal to a total knee arthroplasty
- Nonunions and malunions
- Fractures involving osteopenic and osteoporotic bone
The indications for use of this internal fixation device include:
- Open and closed tibial fractures
- Pseudoarthrosis and correction osteotomy
- Pathologic fractures, impending pathologic fractures, and tumor resections
- Fractures involving osteopenic and osteoporotic bone
- Nonunion and malunion
The End Cap Lower Extremity and the Nail Holding Screw Tibia / Femur PF may also be used in conjunction with the T2 Alpha Femur Antegrade GT/PF Nailing System.
The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization.
The IMN Instruments System is intended to enable the implantation of intramedullary nail and screw.
A Special 510(k) submission is being supplied to the U.S. FDA to gain clearance for modifications to the existing T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System and IMN Instruments System previously cleared in K180436. Modifications include an increase of shelf-life from 5 years to 10 years for the sterile implants and a change of dimensional specifications for the Advanced Locking Screw, Targeting Arm Femur GT and Targeting Arm Femur PF.
The T2 Alpha Femur Antegrade GT/PF Nailing System previously cleared in K180436 is a fracture fixation system and includes sterile implants (femoral nails in various diameter and sizes, compression screw femur, set screws and end caps) as well as non-sterile instruments (targeting devices).
The T2 Alpha Tibia Nailing System previously cleared in K180436 is a fracture fixation system and includes sterile implants (tibial nails in various diameter, compression screw tibia and end caps) as well as non-sterile instruments (targeting devices).
The IMN Screws System previously cleared in K180436 includes bone screws (locking screws and advanced locking screws) that are inserted through the intramedullary nail to stabilize the nail-bone construct.
The IMN Instruments System includes the distal targeting device femur antegrade previously cleared in K180436. There are also associated surgical instruments (class I devices) that support the implantation and extraction of intramedullary nails and screws.
This document describes a Special 510(k) Premarket Notification for modifications to existing intramedullary nailing systems (T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, and IMN Instruments System). The submission's purpose is to demonstrate substantial equivalence to the previously cleared predicate device (K180436) for these modifications.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (for modifications) | Reported Device Performance (supporting modifications) |
|---|---|
| Maintain packaging integrity and functionality for increased shelf-life. | Packaging testing performed using methods consistent with the predicate device. |
| No new worst-case scenarios identified through risk analysis. | Risk analysis (per DIN EN ISO 14971) demonstrated no new worst case. |
| Verification and validation methods for modifications are the same as for the original predicate device. | Same verification and validation methods applied as for the predicate (K180436). |
| Device remains as safe and effective as the predicate device. | Risk analysis demonstrated the subject device is as safe and effective as the predicate device. |
| Dimensional specifications meet established criteria. | Specification review and dimensional analysis performed using the same protocol as the original submission. |
| Acceptance criteria for dimensional changes are not altered from original device. | Acceptance criteria were not altered from those used for the original device. |
| No additional types of evaluation needed for dimensional changes. | No additional types of evaluation are needed for dimensional changes. |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states: "No clinical testing of the T2 Alpha Femur Antegrade GT/PF Nailing System has been conducted." This indicates that there was no "test set" in the context of clinical performance evaluation. The data provenance supporting the modifications (shelf-life increase and dimensional changes) would be from in-house engineering and quality testing, likely conducted by Stryker Trauma GmbH in Schoenkirchen, Germany. These are likely retrospective data based on existing product infrastructure.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
As no clinical testing was conducted and the performance data primarily relates to engineering and quality assessments for modifications, there is no mention of "experts" establishing ground truth in the context of a clinical test set. The validation would have been performed by qualified engineers and quality control personnel within Stryker Trauma GmbH.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set requiring adjudication by experts was used for this Special 510(k) submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned or performed. The submission is for modifications to an existing device, and clinical efficacy was not under evaluation, nor was comparison with human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable, as this device is a physical medical implant system, not a software algorithm or AI-powered device.
7. Type of Ground Truth Used:
The "ground truth" for this submission's modifications primarily relies on:
- Engineering specifications and data: For dimensional changes, ensuring the modified components still meet their intended design parameters.
- Packaging integrity and sterility data: For the shelf-life extension, ensuring the packaging maintains sterility and functionality over the new extended period.
- Risk analysis methodology: As per DIN EN ISO 14971, to confirm that the changes do not introduce new hazards or increase existing risks.
These are established through internal quality and engineering testing, not clinical outcomes, pathology, or expert consensus on patient data.
8. Sample Size for the Training Set:
Not applicable, as this is a physical medical device and not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, for the reasons stated above.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.