(263 days)
The intended use of the BioPro Foot Plating Systems is to draw two or more aligned bone fragments together to facilitate healing in an adult patient and is composed of the following bone plate categories:
I. Forefoot System:
The BioPro Forefoot Plating System is Indicated for Use in fixation of small bones and small bone fragments in the foot (Phalanges and Metatarsals) for stabilization of fractures, joint fusions, osteotomies , nonunions, malunions, reconstruction of small bones, revision surgeries and replantations in an adult patient. The Forefoot System is not for Spinal Use.
II. Mid & Hindfoot System:
The BioPro Mid & Hindfoot Plating System is Indicated for Use in fixation of medium/large bones and medium/large bone multi-fragments in the foot (Cuneiform, Cuboid, Navicular, Talus and Calcaneus) for stabilization of fractures, joint fusions, osteotomies, malunions, reconstruction of medium/large bones, revision surgeries and replantations in an adult patient.
The Mid & Hindfoot System is not for Spinal Use.
III. Ankle Fracture System:
The BioPro Ankle Fracture System is Indicated for Use in:
1). Fixation of fractures of the distal tibia included, but not limited to, ankle fractures, perarticular fractures, corrective osteotomies, non-unions, intra- and extra- articular and distal tibia fractures with a shaft extension, and malleolar fractures;
2). In intra- and extra articular fractures, osteotomies, medial malleolar fractures and non-unions of the metaphyseal and diaphyseal region of the distal fibula;
3). In distal tibia/fibula long bones which include the metaphyseal and diaphyseal regions of the tibia and fibula in the ankle.
The Ankle Fracture System is not for Spinal Use.
The BioPro Foot Plating Systems consists of Predicate Foot and Ankle Bone Plate and Locking Screw implant components found with many companies with orthopedic markets in the United States. These Foot Bone Plate Systems fracture fixation & osteotomy implant devices consist of the following categories:
-
- Forefoot System
-
- Mid & Hindfoot System
-
- Ankle Fracture System
A brief and concise description of each system is as follows:
- The BioPro Forefoot System is designed to address a variety of indications in forefoot reconstruction fixation/osteotomy surgery. The system is composed of many locking plate types which include: 1). Straight Fracture Plates, 2). T-Shaped Fracture Plates, 3). Y-Shape Fracture Plates, 4). L-Shaped Fracture Plates, 5). Cloverleaf Fracture Plates, 6). TMT 1 Medial Fusion Plates, 7). Open Wedge Fusion Plates, 8). MTP Fusion Plates, 9). MTP Fusion Revision Plates, and 10). Dorsal TMT 1 Step Fusion Plates, - in various plate lengths, Right & Left versions. The System will incorporate both Cortical Locking Screws and standard Cortical Screws in 2.0mm, 2.5mm, 3.0mm and 3.5mm sizes in various lengths. All plates are composed of Medical Grade CP Titanium material (to ASTM F67) with an Anodized Type II surface treatment. All screws are composed of Medical Grade 6-4 Alloyed Titanium material (to ASTM F136) color anodized for sizing.
A full set of Ancillary Instrumentation (Depth Gauge, Drill Guides, Drill Bits, Screwdrivers, Retractors, Bending Irons, K-wire with stop, Distraction/ Compression Device and MTP Fusion Reamers) is available with the system. The BioPro Forefoot System is offered both EO STERILE and Non-sterile for single-use.
- The BioPro Mid & Hindfoot System is designed to address a variety of indications in midfoot & hindfoot reconstruction fixation/osteotomy surgery. The system is composed of many locking plate types which include:
1). Straight Fracture/Fusion Plates, 2). T-Shaped Fracture/Fusion Plates, 3). L-Shaped Fracture/Fusion Plates, 4). Cloverleaf Fracture/Fusion Plates, 5). X-Shaped Fracture/Fusion Plates, 6). Retangular Fracture/Fusion Plates, 7). Cotton Osteotomy Plates, 8). Dwyer Step Plates, 9). Evans Osteotomy Plates, 10.) Plantar TMT Plates, 11). Distal Medial & 3 - 4 Column Plates and 11). ORIF & Standard Calcaneal Plates - in various plate lengths, Right & Left versions.
The System will incorporate both Cortical Locking Screws and standard Cortical Screws in 3.0mm, 3.5mm and 4.0mm sizes in various lengths. All plates are composed of Medical Grade CP Titanium material (to A.STM F67) with an Anodized Type II surface treatment. All screws are composed of Medical Grade 6-4 Alloyed Titanium material (to ASTM F136) color anodized for sizing.
A full set of Ancillary Instrumentation (Depth Gauge, Drill Guides, Drill Bits, Screwdrivers, Retractors, Reduction Forcepts, Bending Pliers, Osteotomes, K-Wires with stop and Distraction/Compression Device) is available with the system.
The BioPro Mid & Hindfoot System is offered both EO STERILE and Non-sterile for single-use.
- The BioPro Ankle Fracture System is designed to address a variety of indications in ankle reconstruction mid-shaft and distal tibia/fibula fixation surgery. The system is composed of many locking plate types which include:
1). Distal Fibula Plates, 2). Medial Distal Tibia Plates, 3). AnteroLateral Distal Tibia Plates, 4). Posterior Distal Tibia T-Plates, 5). Straight Low Contact Plates, and 6). Straight 1/3 Tubular Plates - in various plate shapes, lengths, Right & Left versions. The System will incorporate both Cortical Locking Screws and standard Cortical Screws in 2.8mm, 3.0mm, 3.5mm and 4.0mm sizes in various lengths. All plates are composed of either Medical Grade CP Titanium (to ASTM F67) or 6-4 Alloyed Titanium (to ASTM F136) materials with an Anodized Type II surface treatment. All screws are composed of Medical Grade 6-4 Alloyed Titanium material (to ASTM F136) color anodized for sizing. A full set of Ancillary Instrumentation (Depth Gauge, Drill Guides, Drill Bits, Screwdrivers, Retractors, Reduction Forcepts, Bending Pliers, Osteotomes, K-Wires with stop, and Distraction/Compression Device) is available with the system. The BioPro Ankle Fracture System is offered both EO STERILE and Non-sterile for single-use.
The provided text describes a 510(k) premarket notification for the BioPro Foot Plating Systems, asserting its substantial equivalence to legally marketed predicate devices. This type of submission relies on demonstrating similarity to existing devices and typically does not include a clinical study or acceptance criteria related to device performance in a clinical setting in the way an AI/software device would. Instead, the "acceptance criteria" here refer to regulatory requirements and engineering performance tests.
Therefore, the following information will be based on the provided text, which states what was done to support the claim of substantial equivalence for a hardware medical device, rather than the performance of an AI model.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Performance (Plates): | Demonstrated plate bending strength met requirements. |
| Mechanical Performance (Plates): | Demonstrated plate bending stiffness met requirements. |
| Mechanical Performance (Screws): | Evaluated screw insertion/removal torque. |
| Mechanical Performance (Screws): | Evaluated screw yield torque. |
| Mechanical Performance (Screws): | Evaluated screw axial pullout strength. |
| Biocompatibility: | Risk assessment performed. |
| Sterility/Pyrogenicity (if applicable): | Pyrogen bacterial endotoxin levels evaluated using LAL method. |
| Material Composition: | Plates composed of Medical Grade CP Titanium (ASTM F67) or 6-4 Alloyed Titanium (ASTM F136). |
| Material Composition: | Screws composed of Medical Grade 6-4 Alloyed Titanium (ASTM F136). |
| Indications for Use: | For fixation of small/medium/large bones and fragments in the foot (Forefoot, Mid & Hindfoot, Ankle Fracture Systems). |
| Substantial Equivalence: | Demonstrated substantial equivalence in Material, Geometry, Design, and Indications for Use to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "CLINICAL TESTING: Clinical data was not submitted."
Therefore, there are no "test sets" or "data provenance" in the context of clinical performance for this device, as it is a hardware device seeking 510(k) clearance based on substantial equivalence to existing devices, supported by non-clinical engineering analyses. The "test set" would refer to the mechanical test samples.
- Sample size for mechanical testing: Not specified in the provided text. The document refers to "An Engineering Analysis" which implies that samples of the plates and screws were subjected to mechanical tests.
- Data provenance: Not applicable in the context of clinical data. The mechanical testing would have been performed in a laboratory setting by the manufacturer or a contract lab.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. "Ground truth" in this context typically refers to clinical diagnosis or outcome data, which was not used for this submission. The "ground truth" for the engineering analyses would be established by validated test methods and engineering standards.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring adjudication. Mechanical tests follow predefined protocols and analysis methods, not expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This is a hardware medical device, not a diagnostic AI/software device. MRMC studies are not relevant here.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
No. This is a hardware medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the submission is the mechanical and material specifications outlined in recognized standards (e.g., ASTM F67, ASTM F136) and internal engineering requirements for plate strength, stiffness, screw torque, and pullout strength. The biological ground truth for biocompatibility is established through risk assessment and LAL testing for endotoxin levels, adhering to relevant standards. The ultimate "ground truth" for regulatory approval is the demonstration of substantial equivalence to predicate devices based on these engineering and material properties and intended use.
8. The Sample Size for the Training Set
Not applicable. This is a hardware medical device, not an AI/software device that requires a training set. The design of the device is based on engineering principles and knowledge of existing predicate devices.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for an AI model, there is no ground truth established in this manner. The design and validation relied on established engineering standards, material science, and comparisons to legally marketed predicate devices.
§ 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.