(166 days)
Not Found
No
The summary describes a system of plates and screws for bone fixation and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as "plates used for fixation of fractures of the foot and ankle" and is indicated for "fixation of osteotomies, fusions, fractures, nonunions and replantations of small bones and small bone fragments." These uses are directly involved in treating or alleviating a disease, injury, or condition.
No
The device is a system of plates and screws intended for the fixation of osteotomies, fusions, fractures, nonunions, and replantations of small bones and fragments, which is a treatment rather than a diagnostic function.
No
The device description clearly states it is a collection of plates and screws made of materials like Stainless Steel and Titanium, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that this system is a collection of plates and screws used for the internal fixation of bones (osteotomies, fusions, fractures, etc.). This is a surgical implant, not a diagnostic tool that analyzes biological samples.
- Intended Use: The intended use describes the surgical procedures and anatomical locations where the device is used for bone fixation. It does not mention any analysis of biological specimens.
Therefore, this device falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HRS. HWC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot and ankle, clavicle, scapula, olecranon. humerus, hand, radius, ulna, pelvis, tibia, femur, fibula
Indicated Patient Age Range
The Synthes 2.7mm and 3.5mm Variable Angle LCP Midfoot/Hindfoot System is indicated for adults and adolescents (12-21 years).
The Synthes 3.5mm Low Profile Cortical Screws and the Synthes 3.5mm Cortex Screws are intended for 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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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 Parkway |
| West 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 |
| Predicate | |
| Device(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) |
.
ﺰ ﻟﻠﻌﺐ
47
1
| | 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: |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description: | • 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. |
| 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.
2
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
3
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
4
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