(120 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 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.
This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, and IMN Instruments System. This submission encompasses multiple systems that have similar intended use and will be used together during the surgical procedure.
T2 Alpha Femur Antegrade GT/PF Nailing System: The T2 Alpha Femur Antegrade GT/PF Nailing System is a fracture fixation system and includes sterile implants (intramedullary nails in various diameter and sizes, compression screw, set screws and end caps) as well as non-sterile instruments (targeting devices). The femoral nails, compression screw and end caps are made of titanium alloy (Ti6Al4V ELI) as per ASTM F136. The set screws are manufactured from titanium alloy (Ti6Al4V ELI) as per ASTM F136 and PEEK.
IMN Screws System: The IMN Screws System includes locking screws that are inserted through the intramedullary nail to stabilize the nail-bone construct. The locking screws are made of titanium alloy (Ti6Al4V ELI) as per ASTM F136.
IMN Instruments System: The IMN Instruments System includes instruments that support the implantation and extraction of intramedullary nails and screws.
This FDA 510(k) summary describes the substantial equivalence of the Stryker Trauma GmbH devices: T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, and IMN Instruments System, to predicate devices. The document details performance data, but does not provide specific acceptance criteria or reported device performance in a table format, nor does it detail a study proving the device meets acceptance criteria in the way one might expect for a diagnostic or AI device. Instead, the studies aim to demonstrate mechanical equivalence and biocompatibility to existing, legally marketed predicate devices.
Here's an attempt to extract and synthesize the requested information, noting where specific details are not provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria with corresponding reported device performance values in a table format for clinical efficacy or diagnostic accuracy. Instead, the "acceptance criteria" are implied by the successful completion of various non-clinical tests demonstrating equivalence to predicate devices, biocompatibility, and MR Conditional status.
| Test Type | Implied Acceptance Criterion | Reported Device Performance (Summary) |
|---|---|---|
| T2 Alpha Femur Antegrade GT/PF Nailing System | ||
| Fatigue strength testing | Equivalent mechanical performance to predicate devices (K102992, K101438, K083497) | Demonstrated equivalence in mechanical performance to predicate devices. |
| Mechanical properties (ASTM F1264) | Compliance with ASTM F1264 standards and equivalence to predicate devices. | Demonstrated equivalence in mechanical performance to predicate devices. |
| Cut-out testing | Mechanical performance equivalent to predicate devices. | Demonstrated equivalence in mechanical performance to predicate devices. |
| MR Conditional Status | Meet MR safety standards to be deemed "MR Conditional". | Demonstrated as MR Conditional. |
| Biocompatibility | Compliance with ISO 10993-1 for biological safety. | Demonstrated as biocompatible. |
| Bacterial Endotoxin Testing | Meet specified endotoxin limit for sterile implants. | Met the specified endotoxin limit. |
| IMN Screws System | ||
| Mechanical properties (ASTM F543) | Compliance with ASTM F543 standards and equivalence in mechanical performance to predicate device (K003018). | Demonstrated equivalence in mechanical performance to the predicate device. |
| MR Conditional Status | Meet MR safety standards to be deemed "MR Conditional". | Demonstrated as MR Conditional. |
| Biocompatibility | Compliance with ISO 10993-1 for biological safety. | Demonstrated as biocompatible. |
| Bacterial Endotoxin Testing | Meet specified endotoxin limit. | Met the specified endotoxin limit. |
| IMN Instruments System | ||
| Biocompatibility | Compliance with ISO 10993-1 for biological safety. | Demonstrated as biocompatible. |
2. Sample Size Used for the Test Set and Data Provenance
This is a non-clinical submission for mechanical and biocompatibility testing of medical devices (intramedullary nails, screws, and instruments). Therefore, the concept of a "test set" in the context of clinical data or diagnostic accuracy (e.g., patient samples) does not apply. The tests described are bench tests or laboratory assessments of materials and mechanical functionality.
- Sample Size for Tests: Not explicitly detailed for each specific test. The document generally states "Non-clinical testing was performed..."
- Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory setting. The country of origin for the data is implied to be Germany, where the manufacturer (Stryker Trauma GmbH) is located. The tests are "retrospective" in the sense that they are performed on manufactured components rather than gathered from prospective clinical trials.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to a non-clinical submission for mechanical and biocompatibility testing. Ground truth in this context refers to established material standards (e.g., ASTM F136, ASTM F543, ASTM F1264) and biological safety guidelines (ISO 10993-1). Experts would be involved in designing and conducting these tests and interpreting the results against these standards, but not in establishing a "ground truth" derived from clinical judgment, pathology, or outcomes in the way one would for a diagnostic device.
4. Adjudication Method for the Test Set
This concept is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies or diagnostic accuracy studies where there might be disagreement among human readers or observers about a clinical finding or ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was performed or mentioned. The device is an orthopedic implant system and associated instruments, not an AI or diagnostic tool where human reader performance (with or without AI assistance) would be relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical implant and instrument system, not an algorithm or software requiring standalone performance testing.
7. Type of Ground Truth Used
The "ground truth" for the non-clinical tests described is based on:
- Mechanical Standards: ASTM F1264, ASTM F543, and the mechanical properties of the predicate devices. The goal is to demonstrate equivalence to these established standards and predicate devices.
- Biocompatibility Standards: International Standard ISO 10993-1.
- Material Standards: ASTM F136 for titanium alloys, and characteristics of PEEK.
- Endotoxin Limits: Specified endotoxin limits for sterile devices.
8. Sample Size for the Training Set
Not applicable. This is a non-clinical submission for physical medical devices. There is no AI algorithm or "training set" involved.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reason as 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.