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.

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:

1. Forefoot System
1. Mid & Hindfoot System
1. 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.

AI/ML Overview

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.

Summary

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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

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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

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Indications for Use

510(k) NUMBER: K162674

DEVICE NAME: BioPro Foot Plating Systems

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)

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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 andaccessories, 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 BoneFixation - M2 System	K111678 OrthoSolutions –Extremity Fixation Implants forOsteosynthesis - FPS System	K001945 Synthes – MedialDistal Tibia Plate System

K091479 & K142581	K091479 & K142581	K073460 & K083213
Medartis – APTUSFoot System	Medartis - APTUS FootSystem	Synthes – LCP Distal FibulaPlate System
K140376 & K141992	K140376 & K141992 Stryker	K063672 I.T.S. – Fibula
Stryker – VariAx 2Foot Locking PlateSystem	-VariAx 2 Foot Locking PlateSystem	Plate Prolock with AngularStability System
K090692 Wright –ORTHOLOC 2.0/2.4Plate System	K100776 Synthes – LCPVariable Angle Midfoot System	K092812 & K013248Synthes - LCP AnterolateralDistal Tibia Plate System
K100776 Synthes –LCP Variable AngleForefoot System	K061808 Dacrco International,Inc. - Darco Locking Bone PlateSystem

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Additional Predicates	Forefoot System	Mid & Hindfoot System	Ankle Fracture System
Continued:
	K141784OrthoSolutions -ULTOS PlatingSystem	K121651, K120359, K090692Wright - ORTHOLOC 3DiMidfoot - Cotten, Evans, MTP,Lapidus, Ankle Fusion PlatingSystems	K013248, K082807Synthes – LCP Distal TibiaPlate & LCP CompressionPlate Systems & AnkleArthrodesis Plates
	K001945 Synthes. –Medial Distal TibiaPlates	K123000 Integra - Total FootSystem - MOWO & Rearfoot
	K090675 Smith &Nephew - VLP FootPlating/Screw System	K110908 Medartis Ag - AptusFoot 3.5 System
	K121651 Wright -ORTHOLOC 3DiFlatfoot System

Reference Predicates:	K922500 BioPro -PSL Total Hip SystemK132510 BioPro -Infinity Plate AnchorSystem
-----------------------	-------------------------------------------------------------------------------------------------

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:

1. Forefoot System
1. Mid & Hindfoot System
1. 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.

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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:

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:

Non-sterile for single-use.

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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.

Regulation Number and Section

§ 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.