(492 days)
Wise-Lock Tibia & Fibula System The Wise-Lock Tibia & Fibula System plates are intended for fracture fixations for the plates included in the system as follows:
3.5mm Wise-Lock Medial Distal Tibia Plate: Medial distal tibia plates are indicated for treating fractures of the tibia.
3.5mm Wise-Lock Proximal Tibia Plate:
3.5mm Wise-Lock Proximal Tibia Plate indicated for treating fractures of the tibia.
3.5mm Wise-Lock Medial Proximal Tibia Plate:
The 3.5mm Wise-Lock Medial Proximal Tibia Plates are indicated to buttress metaphyseal fractures of the medial tibia plateau, split type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia.
3.5mm Wise-Lock Posterior Medial Proximal Tibia Plate:
3.5mm Wise-Lock Posterior Medial Proximal Tibia Plates are indicated for internal fixation of posteromedial proximal tibia fractures including buttressing of fractures of the proximal, distal, and metaphyseal areas of the tibia.
3.5mm Wise-Lock Anterolateral Distal Tibia Plate: 3.5mm Wise-Lock Anterolateral Distal Tibia Plate indicated for treating fractures of the tibia.
3.5mm Wise-Lock Medial Distal Tibia Plate, Without Tab: The 3.5mm Wise-Lock Medial Distal Tibia Plate, Without Tab is indicated for fixation of complex intra-and extraarticular fractures and osteotomies of the distal tibia.
3.5mm Wise-Lock Low Profile Medial Distal Tibia Plate, Without Tab: The 3.5mm Wise-Lock Low Profile Medial Distal Tibia Plate, Without Tab is indicated for fixation of complex intra-and extra-articular fractures and osteotomies of the distal tibia.
3.5mm Wise-Lock Lateral Distal Fibula Plate:
The 3.5mm Wise-Lock Lateral Distal Fibula Plates are indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula.
3.5mm Wise-Lock Metaphyseal Plate For Medial Distal Tibia:
The 3.5mm Wise-Lock Metaphyseal Plate For Medial Distal Tibia is indicated for fractures, and non-unions of the metaphyseal and diaphyseal region of the distal fibula.
3.5mm Wise-Lock Pilon Plate:
The 3.5mm Wise-Lock Pilon Plate is indicated for fixation of complex intra-and extra-articular fractures and osteotomies of the distal tibia.
3.5mm Wise-Lock Pilon Plate, Cruciform:
3.5mm Wise-Lock Pilon Plate, Cruciform is indicated for fixation of complex intra-and extra-articular fractures and osteotomies of the distal tibia.
3.5mm Wise-Lock Z-type Distal Medial Tibial Plate: The 3.5mm Wise-Lock Z-type Distal Medial Tibial Plate is indicated for temporary internal fixation of osteotomies and fractures, including: Comminuted fractures Supracondylar fractures Intra-articular and extra-articular condylar fractures Non-unions, and
Malunions
3.5mm Wise-Lock Z-type Proximal Lateral Tibial Plate:
The 3.5mm Wise-Lock Z-type Proximal Lateral Tibial Plate is intended for fixation of fractures and osteotomies involving the tibia. The plate is indicated for the the follow:
Treatment of non-unions, malunions and fractures of the proximal tibia, including simple, comminuted lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and fractures with associated shaft fractures.
To buttress Metaphyseal fractures of the medial tibial plateau, split-type fractures of the medial split fractures with associated depressions and split of depression fractures of the medial tibia plateau.
The fixation of fractures of the distal tibia including, but not limited to, ankle fractures, intra articular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.
4.5/5.0mm Wise-Lock Proximal Lateral Tibia Plate:
The 4.5/5.0mm Wise-Lock Proximal Lateral Tibia Plate is indicated for treatment of nonunions, tibial osteotomies (4.5mm plate only), and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures.
4.5/5.0mm Wise-Lock Medial Proximal Tibia Plate:
The 4.5/5.0mm Wise-Lock Medial Proximal Tibia Plates are indicated to buttress metaphyseal fractures of the medial tibia plateau, split type fractures of the medial tibia plateau, medial split fractures with associated deplit or depression fractures of the medial tibia plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia. The 4.5mm version may also be used for fixation of nonunions and malunions of the medial proximal tibia shaft, as well as opening and closing wedge tibial osteotomies.
4.5/5.0mm Wise-Lock Proximal Tibia Plate:
4.5/5.0mm Wise-Lock Proximal Tibia Plate is indicated for treatment of non-unions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures.
AV-Wise Lock Ankle System
The AV-Wise Lock Ankle System is intended for fixation of the ankle in adults and adolescents (12-21) in which the growth plates have fused. Indications for plates included in the system are as follows:
Medial and Anteromedial Distal Tibia Plates are indicated for fixation of osteotomies, nonunions, nalunions, and replantations of bones and bone fragments of the diaphyseal regions of the distal tibia,
Distal Tibia T Plates and Distal Tibia L Plates are indicated to buttress partial articular fragments of the distal tibia, and
Lateral Distal Fibula Plates are indicated for fixation of osteotomies, malunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal fibula.
AV-Wise Lock Proximal Tibia Plates
The AV-Wise Lock Proximal Tibia Plates are indicated to treat fractures of the proximal tibia in adults and adolescents in which the growth plates have fused including: simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures. Plates can also be used for treatment of nonunions, malunions, tibial osteotomies.
The Tibia and Fibula System consists of three types of bone Plates system i.e. Wise-Lock Tibia & Fibula Plates, AV-Wise Lock Ankle Plates, AV-Wise Lock Proximal Tibia Plate and screws for implantation in the tibia and fibula bone to treat tibia and fibula bone fractures. The bone plates are available in Stainless steel and Titanium material and also in left and right directional configuration. There are 16 types of bone plates in Wise-lock tibia and fibula bone plates in AV-Wise Lock Ankle bone plates and 2 bone plates in AV-Wise Lock Proximal Tibia bone plate system. There are 25 types of bone screws associated with these bone plates.
These implants are sold in both non-sterile and sterile conditions.
Note- Non sterile products have to be sterilized before use. The system is indicated for use in adult patients only. All implants are for single use only.
The provided text is a 510(k) Premarket Notification for a medical device called the "Tibia and Fibula System." This type of document is submitted to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. The information required for your request (acceptance criteria and detailed study information) is typically not extensively detailed in a 510(k) summary, as the primary goal is to show equivalence.
However, based on the provided text, I can extract the following information concerning the acceptance criteria and the types of studies performed to show equivalence, rather than a detailed performance study proving efficacy against acceptance criteria. The document states that the new device is "substantially equivalent" to predicate devices, meaning it has the same intended use, technological characteristics, and performs as safely and effectively.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are implicitly defined by the material and performance standards the device claims to meet, and the "reported device performance" is the statement that the device conforms to these standards and exhibits equivalent performance to the predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Product Code: HWC (Primary), HRS | Identical as predicate device |
| Regulation Number: 21 CFR 888.3030 (Primary), 21 CFR 888.3040 | Identical as predicate device |
| Regulatory Class: Class II | Identical as predicate device |
| Indications for Use: Fracture treatment of Tibia and fibula bone | Identical as predicate device |
| Material: Titanium Alloy as per ASTM F136 and Stainless Steel as per ASTM F138. | Conform to the same material standard as predicate device (specifically, SS 304 for instruments per ASTM F899-20, SS 316L for Stainless Steel Implants, and Ti-6Al-4V Grade 5 for Titanium Implants per ASTM F136/ISO 5832-3, ASTM F138/ISO 5832-1) |
| Performance Standards: ASTM F382 and F543 | Identical as predicate device. Bench tests conducted to verify all design specifications and compliance with ASTM F382 (Metallic Bone Plates, including Four-Point Static Test and Four-Point Fatigue Test - Conforms) and ASTM F543 (Metallic Medical Bone Screws, including Driving Torque Test, Torsion Test, Axial Pull-out Test - Conforms). The results indicate the system is equivalent to a predicate device. |
| Sterilization: Gamma Sterilization Method and Non-Sterile | Identical as predicate device. Compliance with ISO 11137-1, -2, -3; ISO 17665-1, -2, -3; ISO 11140-1; ISO 11737-1, -2; ISO 11607-1, -2; ASTM F1980; ASTM F88/F88M; ASTM F1929. |
| Shelf-life: 5 Years (For Sterilized Product) | Identical as predicate device. Stability study performed to determine shelf life, following ASTM F1980, ASTM F88/F88M, and ASTM F1929. |
| Single Use/Reuse: Single Use | Identical as predicate device |
| Operating Principle: Plate fixed to bone by screws | Identical as predicate device |
| Dimensional Verification: Same dimensions as predicate devices | Identical as predicate device |
| Biocompatibility: Evaluated for biocompatibility according to ISO 10993-3 | Conforms |
| Bacterial Endotoxin: Endotoxin testing limit ≤ 20 EU/Device | Conforms. Limulus Amoebocyte Lysate (LAL) test performed. Test performed according to standard USP 32 chapter 85, USP Bacterial Endotoxin Test, and USP Medical Devices-Bacterial Endotoxin and Pyrogen Tests. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical studies with patients or data. The testing mentioned is bench testing on the physical devices (plates and screws). Therefore, the concept of data provenance (country, retrospective/prospective) and sample size in the traditional sense of medical image analysis or clinical trials is not applicable here. The "sample" would refer to the number of devices tested in the lab, which is not detailed in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this 510(k) summary. The ground truth in this context is defined by international and national standards for material properties and mechanical performance, not by expert medical assessment of cases.
4. Adjudication Method for the Test Set
This information is not applicable as there is no human adjudication of a test set in the methods described. The "adjudication" of performance is done by comparing test results against established engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes bench testing for mechanical properties and material equivalence, not human reader performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
No, a standalone (algorithm only) performance study was not done. This device is a physical medical implant (bone plate and screw system), not a software algorithm or AI device.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is based on established engineering standards (e.g., ASTM F382, ASTM F543, material standards like ASTM F136, ASTM F138, ASTM F899) and biological safety standards (e.g., ISO 10993-3 for biocompatibility, USP for bacterial endotoxin). This is a technical ground truth, not a clinical one derived from pathology or outcomes data in patients.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" as this device is a physical implant, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As stated above, there is no training set for this type of device.
§ 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.