(263 days)
No
The document describes a system of bone plates and screws for fracture fixation and osteotomy, with no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes.
The device is intended to draw bone fragments together to facilitate healing, stabilize fractures, and aid in joint fusions and reconstruction in adult patients. These actions are directly aimed at treating or alleviating a medical condition (bone fractures and related orthopedic issues), fitting the definition of a therapeutic device.
No
The device, the BioPro Foot Plating Systems, is described as an implantable bone plate and screw system intended for fixation of bones and bone fragments to facilitate healing. It is a treatment device, not a diagnostic one.
No
The device description clearly states that the BioPro Foot Plating Systems consist of bone plate and locking screw implant components made of titanium, along with ancillary instrumentation. These are physical hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The BioPro Foot Plating Systems are described as bone plates and screws intended for the fixation of bone fragments in the foot and ankle to facilitate healing. This is a surgical implant used directly on the patient's body, not for testing specimens outside the body.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples, diagnostic testing, or providing information for diagnosis based on such testing.
Therefore, the BioPro Foot Plating Systems fall under the category of surgical implants or orthopedic devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
HRS, HWC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Foot (Phalanges and Metatarsals, Cuneiform, Cuboid, Navicular, Talus and Calcaneus), ankle (distal tibia, distal fibula)
Indicated Patient Age Range
Adult patient
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
NON-CLINICAL TESTING: An Engineering Analysis was performed to evaluate plate bending strength and bending stiffness. Also, an Engineering Analysis was performed to evaluate screw insertion/removal torque, yield torque, and axial pullout strength. A Biocompatability Risk Assessment was performed. Pyrogen bacterial endotoxin levels were evaluated using the LAL method.
CLINICAL TESTING: Clinical data was not submitted.
Key Metrics
Not Found
Predicate Device(s)
K072740 Mondeal-Extremity Bone Fixation - M2 System, K111678 OrthoSolutions – Extremity Fixation Implants for Osteosynthesis - FPS System, K001945 Synthes – Medial Distal Tibia Plate System, K091479, K142581, K140376, K141992, K090692, K100776, K141784, K001945 Synthes., K090675, K121651, K073460, K083213, K063672, K092812, K013248, K121651, K120359, K090692, K123000, K110908, K013248, K082807
Reference Device(s)
K922500 BioPro - PSL Total Hip System, K132510 BioPro - Infinity Plate Anchor System
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, wave-like appearance. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the profile graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 16, 2017
Biopro, Inc. % Al Lippincott Biomedical Engineer & Consultant To Biopro, Inc. Engineering Consulting Services, Inc. 3150 E. 200th St. Prior Lake, Minnesota 55372
Re: K162674 Trade/Device Name: BioPro Foot Plating Systems Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: May 3, 2017 Received: May 12, 2017
Dear Al Lippincott:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Vincent J. Devlin -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) NUMBER: K162674
DEVICE NAME: BioPro Foot Plating Systems
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.
Prescription Use XXXXXXXXXX Over-The-Counter-Use (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
K162674 Page 1/4
510(k) Summary
In Accordance with 21 CFR 807.92 of the Federal Code of Regulations
| NAME OF FIRM: | BioPro, Inc. |
|---|---|
| 2929 Lapeer Road | |
| Port Huron, MI 48060 | |
| www.bioproimplants.com | |
| 510(k) FIRM CONTACT: | Al Lippincott |
| Engineering Consulting Services, Inc. | |
| 3150 E. 200th St. | |
| Prior Lake, MN 55372 | |
| Tel. No. 952-492-5858 | |
| e-mail: allippincott@msn.com | |
| DATE: | May 3, 2017 |
| TRADE NAME: | BioPro Foot Plating Systems |
| COMMON NAME: | Plate, Fixation, Bone; Screw, Fixation, Bone. |
| CLASSIFICATION: | Single/multiple component metallic bone fixation applieances and |
| accessories, Class II (21CFR, Sec. 888.3030) | |
| Smooth or threaded metallic bone fixation faxtener, Class II | |
| (21CFR, Sec. 888.3040) | |
| DEVICE PRODUCT CODE: | HRS |
HWC SUBSEQUENT PRODUCT CODE:
SUBSTANTIALLY EQUIVALENT DEVICES:
| Forefoot System | Mid & Hindfoot System | Ankle Fracture System | |
|---|---|---|---|
| Primary Predicates | K072740 Mondeal- | ||
| Extremity Bone | |||
| Fixation - M2 System | K111678 OrthoSolutions – | ||
| Extremity Fixation Implants for | |||
| Osteosynthesis - FPS System | K001945 Synthes – Medial | ||
| Distal Tibia Plate System |
| Additional Predicates | K091479 & K142581 | K091479 & K142581 | K073460 & K083213 |
|---|---|---|---|
| Medartis – APTUS | |||
| Foot System | Medartis - APTUS Foot | ||
| System | Synthes – LCP Distal Fibula | ||
| Plate System | |||
| K140376 & K141992 | K140376 & K141992 Stryker | K063672 I.T.S. – Fibula | |
| Stryker – VariAx 2 | |||
| Foot Locking Plate | |||
| System | -VariAx 2 Foot Locking Plate | ||
| System | Plate Prolock with Angular | ||
| Stability System | |||
| K090692 Wright – | |||
| ORTHOLOC 2.0/2.4 | |||
| Plate System | K100776 Synthes – LCP | ||
| Variable Angle Midfoot System | K092812 & K013248 | ||
| Synthes - LCP Anterolateral | |||
| Distal Tibia Plate System | |||
| K100776 Synthes – | |||
| LCP Variable Angle | |||
| Forefoot System | K061808 Dacrco International, | ||
| Inc. - Darco Locking Bone Plate | |||
| System |
4
| Additional Predicates | Forefoot System | Mid & Hindfoot System | Ankle Fracture System |
|---|---|---|---|
| Continued: | |||
| K141784 | |||
| OrthoSolutions - | |||
| ULTOS Plating | |||
| System | K121651, K120359, K090692 | ||
| Wright - ORTHOLOC 3Di | |||
| Midfoot - Cotten, Evans, MTP, | |||
| Lapidus, Ankle Fusion Plating | |||
| Systems | K013248, K082807 | ||
| Synthes – LCP Distal Tibia | |||
| Plate & LCP Compression | |||
| Plate Systems & Ankle | |||
| Arthrodesis Plates | |||
| K001945 Synthes. – | |||
| Medial Distal Tibia | |||
| Plates | K123000 Integra - Total Foot | ||
| System - MOWO & Rearfoot | |||
| K090675 Smith & | |||
| Nephew - VLP Foot | |||
| Plating/Screw System | K110908 Medartis Ag - Aptus | ||
| Foot 3.5 System | |||
| K121651 Wright - | |||
| ORTHOLOC 3Di | |||
| Flatfoot System |
| Reference Predicates: | K922500 BioPro -
PSL Total Hip System
K132510 BioPro -
Infinity Plate Anchor
System |
| ----------------------- | ------------------------------------------------------------------------------------------------- |
|---|
DEVICE DESCRIPTION: 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.
5
A full set of Ancillary Instrumentation (Depth Gauge, Drill Guides, Drill DEVICE DESCRIPTION: 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.
6
The intended use of the BioPro Foot Plating Systems is to draw two or INTENDED USE: 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 Plating 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, nonunions, malunions, reconstruction of medium/large bones, revision surgeries and replantations in an adult patient.
The Mid & Hindfoot Plating 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. NON-CLINICAL TESTING: An Engineering Analysis was performed to evaluate plate bending strength and bending stiffness. Also, an Engineering Analysis was performed to evaluate screw insertion/removal torque, yield torque, and axial pullout strength. A Biocompatability Risk Assessment was performed. Pyrogen bacterial endotoxin levels were evaluated using the LAL method. CLINICAL TESTING: Clinical data was not submitted. SUMMARY OF TECH-The BioPro Foot Plating Systems is similar in Material, Design NOLOGICAL and Indications to Predicate Systems legally marketed in the US. CHARACTERISTICS
CONCLUSIONS: Based on the similarity in Material, Geometry, Design, and Indications for Use, as well as all Engineering Analysis, the BioPro Foot Plating Systems have been demonstrated to be Substantially Equivalent (SE) to the Predicate Devices.