(166 days)
The Synthes 2.7 and 3.5 mm Variable Angle LCP Midfoot System is indicated for fixation of osteotomies, fusions, fractures, nonunions and replantations of small bones and small bone fragments in adult and adolescent (12 -21 years) patients, including the foot and ankle, and particularly in osteopenic bone.
The Synthes 3.5mm Low Profile Cortical Screws are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, hand, radius, ulna, pelvis, tibia, femur, fibula, and foot in adults, and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by the screw fixation.
The Synthes 3.5mm Cortex Screws are intended to be used as stand-alone bone screws, or in a platescrew system for internal bone fixation for bone fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, hand, radius, ulna, pelvis, tibia, and foot in adults, and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by the screw fixation.
The system is a collection of plates used for fixation of fractures of the foot and ankle in adults and adolescents (12-21) in which the growth plates have fused or in which the growth plates will not be crossed by the plate system. The complete system includes the following plate types:
• 2.4mm/2.7mm Variable Angle Locking Talus Plate
• 2.7mm Variable Angle Locking Calcaneal Plate
• 2.7mm Variable Angle Locking Anterolateral Calcaneal Plate
• 3.5mm Variable Angle Locking Compression Medial Column Fusion Plate
The system accepts various screw fixation options such as existing cortical, locking, variable angle locking, low profile, cannulated locking, cannulated conical and metaphyseal screws. The plates are low profile in design and offered in variations of Stainless Steel, Commercially Pure Titanium-Grade 4, and Titanium Alloy (TAN). When used in conjunction with a plate system, the system indications apply to the entire construct, including the screws.
This document describes the Synthes 2.7mm and 3.5mm Variable Angle LCP Midfoot/Hindfoot System. The device is a collection of plates and screws used for the fixation of fractures and other bone conditions in the foot and ankle. The submission is a Traditional 510(k) seeking substantial equivalence to several predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative sense as might be found for a software algorithm's performance metrics. Instead, the study's goal was to demonstrate substantial equivalence to predicate devices through mechanical testing and engineering analyses. The acceptance criteria implied are that the device's performance in these tests should be equal to or greater than the predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Fatigue strength of the plates and screw systems | Demonstrated "equal to or greater strength" compared to predicate devices |
| Engineering analyses of the plates and screw systems | Completed, demonstrating "equal to or greater strength" compared to predicate devices |
| Similar indications for use | Yes, explicitly stated |
| Similar design characteristics | Yes, explicitly stated |
| Similar performance characteristics (beyond fatigue strength) | Yes, explicitly stated |
2. Sample Size Used for the Test Set and Data Provenance:
The study primarily involved mechanical fatigue strength testing and engineering analyses of the plates and screw systems. The document does not specify the exact number of samples or specimens used for these tests. Data provenance is not applicable in the context of mechanical testing of physical devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. The study is a mechanical and engineering evaluation of a medical device, not a diagnostic or AI-based system requiring expert-established ground truth.
4. Adjudication Method for the Test Set:
Not applicable, as this was a mechanical and engineering study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs. Without AI Assistance:
Not applicable. This device is a bone fixation system, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a bone fixation system.
7. The Type of Ground Truth Used:
For the mechanical testing, the "ground truth" would be the measured physical properties (e.g., fatigue life, strength) of the tested devices compared against the known properties of the predicate devices. For the engineering analyses, the "ground truth" would be derived from established engineering principles and material science data.
8. The Sample Size for the Training Set:
Not applicable. This is a mechanical device, not an AI system that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
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K131186 page 1 of 2
Attachment 3: Revised 510(k) Summary
The following is a summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.
| Sponsor Information | |
|---|---|
| Date Prepared | August 29, 2013 |
| Company Name | Synthes |
| Address | 1301 Goshen ParkwayWest Chester, PA 19380 |
| Contact Person | Rebecca G. Reiter |
| Title | Regulatory Affairs Specialist |
| Phone | (610) 719-1268 |
| Fax | 484-356-9682 |
| Device Information | |
| Proprietary Name | Synthes 2.7mm and 3.5mm Variable Angle LCP Midfoot/Hindfoot System |
| Device | Plate, fixation, bone |
| Regulation | Single/multiple component metallic bone fixation appliances and accessories |
| Description | Screw, fixation, bone |
| Product Code | HRS. HWC |
| Submission Type | Traditional 510(k) |
| Regulation | 888.3030, 888.3040 |
| Device Class | Class II |
| PredicateDevice(s): | Synthes Cortical Screws (K112583)Synthes 3.5mm Low Profile Cortical Screws (K111230)Arthrex Low Profile Screws (K103705)Synthes Locking Calcaneal Plates (K991407)Synthes 2.4/2.7 VA LCP Forefoot/Midfoot System (K100776)Synthes 2.4mm/2.7mm Locking Talus Plate (K071264)Stryker Foot Plating System (K063875) |
.
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47
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| The system is a collection of plates used for fixation of fractures of the foot andankle in adults and adolescents (12-21) in which the growth plates have fused orin which the growth plates will not be crossed by the plate system. The completesystem includes the following plate types: | |
|---|---|
| DeviceDescription: | • 2.4mm/2.7mm Variable Angle Locking Talus Plate• 2.7mm Variable Angle Locking Calcaneal Plate• 2.7mm Variable Angle Locking Anterolateral Calcaneal Plate• 3.5mm Variable Angle Locking Compression Medial Column FusionPlate |
| The system accepts various screw fixation options such as existing cortical,locking, variable angle locking, low profile, cannulated locking, cannulatedconical and metaphyseal screws. The plates are low profile in design and offeredin variations of Stainless Steel, Commercially Pure Titanium-Grade 4, andTitanium Alloy (TAN). When used in conjunction with a plate system, the systemindications apply to the entire construct, including the screws. | |
| Intended Use |
The Synthes 2.7mm and 3.5mm Variable Angle LCP Midfoot/Hindfoot System is indicated for fixation i of osteotomies, fusions, fractures, nonunions and replantations of small bones and small bone fragments in adult and adolescent (12 -21 years) patients, including the foot and ankle, and particularly in osteopenic bone.
The Synthes 3.5mm Low Profile Cortical Screws and the Synthes 3.5mm Cortex Screws are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions of the clavicle, scapula, olecranon. humerus, hand, radius, ulna, pelvis, tibia, femur, fibula, and foot in adults, and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by the screw fixation.
Substantial Equivalence
Both the Synthes 2.7mm and 3.5mm Variable Angle LCP MidfootHindfoot System and predicate systems have similar indications, design characteristics, and performance characteristics. Fatigue strength testing, as well as engineering analyses were completed for the plates included in the Synthes 2.7mm and 3.5mm Variable Angle LCP Midfoot/Hindfoot System, demonstrating equal to or greater strength in comparison to the predicate devices and constructs.
The subject Synthes 3.5mm Low Profile Cortex and Synthes 3.5mm Cortex Screws share the same indications for use, product technology. and design characteristics. No design changes have been made to the Synthes 3.5mm Cortex and 3.5mm Low Profile cortex screws. No new questions of safety and efficacy are raised as a result of the expanded indications statements.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure, rendered in a bold, black line.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 8, 2013
Synthes (USA) Products, LLC Ms. Rebecca Reiter Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K131186
Trade/Device Name: Synthes 2.7mm and 3.5mm Variable Angle LCP Midfoot/Hindfoot System 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: August 29, 2013 Received: September 3, 2013
Dear Ms. Reiter:
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
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Page 2 - Ms. Rebecca Reiter
CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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 yours.
Image /page/3/Picture/7 description: The image shows the text "Erin | Keith" in a simple, bold font. The name "Erin" is on the left, followed by a vertical bar, and then the name "Keith" on the right. The text is black against a white background.
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 Statement
510(k): K131186
Device Name: Synthes 2.7mm and 3.5mm Variable Angle LCP MidfootHindfoot System
Indications for Use:
The Synthes 2.7 and 3.5 mm Variable Angle LCP Midfoot System is indicated for fixation of osteotomies, fusions, fractures, nonunions and replantations of small bones and small bone fragments in adult and adolescent (12 -21 years) patients, including the foot and ankle, and particularly in osteopenic bone.
The Synthes 3.5mm Low Profile Cortical Screws are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, hand, radius, ulna, pelvis, tibia, femur, fibula, and foot in adults, and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by the screw fixation.
The Synthes 3.5mm Cortex Screws are intended to be used as stand-alone bone screws, or in a platescrew system for internal bone fixation for bone fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, hand, radius, ulna, pelvis, tibia, and foot in adults, and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by the screw fixation.
Prescription Use X (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth L. Frank -S
Division of Orthopedic 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.