(90 days)
The T2 Tibial Nailing System is intended to provide temporary stabilization of various types of fractures, malunions and nonunion of the tibia. The nails are inserted or closed technique and can be statically, dynamically and compressed locked. The T2 Tibial Nailing System is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following: Open and closed tibial fractures, Pseudoarthrosis and correction osteotomy, Pathologic fractures, impending pathologic fractures, and tumor resections, Nonunion and malunion.
The T2 Femoral Nail is indicated for long bone fracture fixation specifically femoral fracture fixation which may include the following: Open and closed femoral fractures, Pseudoarthrosis and correction osteotomy, Pathologic fractures, impending pathologic fractures, and tumor resections, Supracondylar fractures, including those with intra-articular extension, Ipsilateral femur fractures, Fractures proximal to a total knee arthroplasty, Fractures distal to hip joint, Nonunions and malunions.
The T2 Supracondylar Nail System is indicated for: Open and closed femoral fractures, Pseudoarthrosis and correction osteotomy, Pathologic fractures, impending pathologic fractures, and tumor resections, Supracondylar fractures including those with intra-articular extension, Fractures distal to total hip prosthesis, Nonunions and malunions.
The T2 Recon Nail is indicated for: Subtrochanteric fractures, Intertrochanteric fractures, Ipsilateral neck/shaft fractures, 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.
The T2 Greater Trochanter Nail is indicated for long bone fracture fixation, which may include the following: Open and closed femoral fractures, Pseudarthrosis and correction osteotomy, Pathologic fractures, impending pathologic fractures, and tumor resections, Ipsilateral femur fractures, Fractures proximal to a total knee arthroplasty, Nonunions and malunions.
The T2 Ankle Arthrodesis Nail is intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include: Post-traumatic or primary Arthrosis, Previously infected arthrosis (second degree), Revision of Failed Ankle Arthrodesis, Failed Total Ankle Replacement, Avascular Necrosis of the Talus (requiring tibiocalcaneal arthrodesis), Neuroarthropathy or Neuromuscular Deformity or other neuromuscular disease with severe deformity or instability of the ankle, Rheumatoid Arthritis with severe deformity such as rheumatoid hindfoot, Osteoarthritis, Nonunions or Pseudarthrosis of hindfoot and distal tibia, Malunited tibial pilon fracture, Charcot foot, Severe endstage degenerative arthritis, Severe defects after tumor resection, Pantalar arthrodesis.
The T2 Arthrodesis Nail is intended for long bone internal fixation, which may include the following: Aseptic failed total knee arthroplasty, Open and closed femoral fractures, Pseudoarthrosis and correction osteotomy, Pathological fractures, impending pathological fractures, and tumor resections, Ipsilateral femur fractures, Failed external fixation, nonunions and malunions, Periarticular fractures where repair is not possible, Knee arthrodesis.
The T2 Tibial Nailing System is a cylindrical tube manufactured from titanium alloy and slightly bowed to accommodate the shape of the tibia. Locking screws, compression screws and an end cap are manufactured from titanium alloy and are used with the nails. The T2 Tibial Nailing System is available in three versions, each differing from the other only in diameter, length and number and orientation of screw holes.
The T2 Femoral Nail is a cylindrical, cannulated titanium alloy tube, slightly bowed to accommodate the shape of the femur. The T2 Femoral Nail may be inserted into the femoral canal using either a retrograde or antegrade surgical approach.
The T2 Supracondylar Nails are retrograde nails with a one-piece round profiled shaft design. The nails are cannulated and have a closed-section design with proximal rounded end. The T2 Supracondylar Nail is available in two versions: Short and Long. The T2 Supracondylar nails are available in lengths from 170 mm to 440 mm and in diameters from 9 mm to 14 mm. The T2 Supracondylar Nail System offers nails in varying lengths, a combination of locking screws, condyle screws, nuts and end caps.
The T2 Recon Nail System is a family of nails for various types of femoral fractures. The system includes Recon Nails in various lengths and diameters (both left and right versions), Lag Screws, Locking Screws, end caps, an Antegrade Set Screw and other accessories for use with the nails.
The T2 Greater Trochanter Nail (GTN) is a cylindrical, cannulated titanium alloy tube, slightly bowed to accommodate the shape of the femur. The T2 GTN may be inserted into the femoral canal using either a retrograde or antegrade surgical approach.
The T2 Ankle Arthrodesis Nail is a fluted, cannulated, titanium alloy nail and has a compression screw to provide internal compression of the upper ankle joint. The nail is inserted using an open or closed technique and can be locked in static, dynamic or compression mode. The T2 Ankle Arthrodesis Nail and accessories are intended for single use only. The T2 Ankle Arthrodesis Nail is available in left and right version in diameters 10 mm to 13 mm with the length ranging from 150 mm to 480 mm in increments of either 20mm or 50 mm. It has a 5 "lateral bend.
The T2 Arthrodesis Nails have a one-piece round profiled shaft design. The nails are cannulated and have a closed-section design with distal rounded end. The T2 Arthrodesis Nail is available in lengths from 540 mm to 780 mm in 40 mm increments, and in diameters from 10 mm to 15 mm.
This document describes the Stryker GmbH T2 Nail Systems, which are intramedullary fixation rods. The submission is a Traditional 510(k) Premarket Notification (K200880).
Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria described for this device are not explicitly enumerated in a numerical or pass/fail table format within the provided excerpt. Instead, the "acceptance criteria" are implied by the nature of a 510(k) submission, which aims to demonstrate substantial equivalence to existing legally marketed predicate devices.
The reported device performance is demonstrated by showing that the newer components (IMN Locking Screws) perform equal to or higher than the previously cleared components (T2 Locking Screw) in various test disciplines.
| Acceptance Criteria (Implied for Substantial Equivalence in a 510(k)) | Reported Device Performance (Summary) |
|---|---|
| Functional Equivalence (e.g., locking mechanism performance) | IMN Locking Screw performance shown to be equal or higher than T2 Locking Screw in various test disciplines. |
| Construct Strength (Nail + Screw combination) | Equal or higher construct strength of IMN Locking Screw (Ø5 mm) in combination with T2 nails. |
| Material Compatibility (with existing T2 nails) | Interface compatibility of IMN Locking Screws (Ø 5 mm) with all T2 nails was shown. |
| Mechanical Properties (e.g., dynamic fatigue strength) | For T2 Femoral Nails, new Student's t-tests re-confirmed substantial equivalence to predicates, including the 09mm Synthes Solid Femoral Nail (K923580). |
| Intended Use Equivalence | Substantially equivalent to predicate devices regarding intended use for all T2 Nail Systems. |
| Design Equivalence | Substantially equivalent to predicate devices regarding design for all T2 Nail Systems. |
| Operational Principles Equivalence | Substantially equivalent to predicate devices regarding operational principles for all T2 Nail Systems. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a numerical sample size for the "computational assessment" or "various test disciplines." It mentions "constructs of T2 nails and IMN Locking Screws" were compared to "constructs of T2 nails used with T2 Locking Screw." For the T2 Femoral Nail System, "new Student t-tests were performed with the corrected data input" and "the 09mm Synthes Solid Femoral Nail (K923580), which was tested in the same manner and statistically compared to the T2 Femoral Nails." These phrases imply testing was conducted on an unspecified number of physical or computational models.
- Data Provenance: The data appears to be from retrospective testing and analysis, as it refers to comparisons with "previously cleared" components and "reevaluation of the dynamic fatigue strength testing." There is no mention of country of origin for the data; typically, such non-clinical testing would be conducted in the manufacturer's R&D facilities or contracted labs, likely within the regions where the manufacturing or development is centered (e.g., Switzerland, as per the Sponsor's address, and/or the US).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This submission relies on non-clinical (benchtop) testing and computational assessment, not clinical data or expert visual assessment of medical images for ground truth. Therefore, the concept of "experts" establishing ground truth for a test set in the way it would apply to AI/imaging devices is not directly applicable here. The "ground truth" is defined by the objective, measurable mechanical properties and performance characteristics established through engineering principles and testing standards. Regulatory bodies (like the FDA) evaluate this data.
4. Adjudication Method for the Test Set
Not applicable, as this is non-clinical testing. Adjudication methods like "2+1" or "3+1" are typically used for clinical study data where multiple human readers are involved in assessing outcomes or classifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not conducted. The submission explicitly states: "Clinical testing was not required for this submission." MRMC studies are typically performed for diagnostic or AI devices where human reader performance is a key variable. This device is a mechanical implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a mechanical implant (intramedullary fixation rod), not an algorithm or AI. The performance demonstrated is intrinsic to the device's physical and mechanical properties.
7. The Type of Ground Truth Used
The ground truth for this device's performance is established by objective, measurable mechanical properties and performance characteristics derived from:
- Computational assessments (e.g., "IMN Screws DOF 25-039 Functional Interface Analysis-Locking Screws").
- Mechanical testing (e.g., "dynamic fatigue strength testing").
- Statistical comparisons against predicate devices ("Student t-tests").
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set. The data presented is from verification and validation testing of a mechanical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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.