(143 days)
No
The summary describes a system of plates, screws, and washers for bone fracture treatment. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on mechanical properties, not algorithmic performance.
Yes
The device is described as a system of plates, screws, and washers intended to treat fractures and non-unions of bones, which are medical conditions, aligning with the definition of a therapeutic device.
No
The device description and intended use state that it is a system of plates, screws, and washers used to treat (fix) fractures and non-unions, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states it is a "system of plates, screws and washers," which are physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use of the In2Bones USA LLC, Fracture and Correction System clearly state that it is a system of plates, screws, and washers used for the internal fixation of bone fractures and non-unions. This is a surgical procedure performed directly on the body, not a test performed on a sample outside the body.
The device is a surgical implant used to stabilize and repair bones, which falls under the category of medical devices, but not specifically in vitro diagnostics.
N/A
Intended Use / Indications for Use
The In2Bones USA LLC, Fracture and Correction System plates and screws are intended to treat fractures and non-unions of the 5th metatarsal.
The Fracture and Correction System lag screws are intended to be used as screws, or in a plate-screw system for internal bone fraction for bone fractures, fusionies and non-unions of various bones, including humerus, radius, uha, tibia, calcaneus, fibula, and small bones (metacarpals, metatarsals, and phalanges).
Product codes
HRS, HWC, HTN
Device Description
The In2Bones Fracture and Correction System is a system of plates, screws and washers used to treat fracture and reconstruction of the bones of the extremities.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
5th metatarsal, humerus, radius, ulna, tibia, calcaneus, fibula, metacarpals, metatarsals, and phalanges.
Indicated Patient Age Range
Not Found
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
Testing including pyrogenicity, static driving torque, static pullout, static torsion, static bending and fatigue bending were performed. The results of the testing demonstrate that the device is substantially equivalent to the predicate devices identified.
Key Metrics
Not Found
Predicate Device(s)
K123241 Arthrex Fracture Plates, K983495 Syntec Taichung Non-Sterile Bone Plate and Screw Implants, K131920 In2Bones SAS I.B.S. Osteosynthesis Screw, K160174 In2Bones SAS I.B.S. 2.0 Osteosynthesis Screw
Reference Device(s)
Not Found
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.
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Image /page/0/Picture/2 description: The image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002.
In2bones USA, LLC % Christine Scifert Managing Partner MRC-X. LLC 6075 Poplar Avenue, Suite 500 Memphis. Tennessee 38119
July 14, 2017
Re: K170518 Trade/Device Name: In2bones Fracture and Correction 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, HTN Dated: June 2, 2017 Received: June 6, 2017
Dear Christine Scifert:
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
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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 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.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on last page.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K170518
Device Name
In2Bones Fracture and Correction System
Indications for Use (Describe)
The In2Bones USA LLC, Fracture and Correction System plates and screws are intended to treat fractures and non-unions of the 5th metatarsal.
The Fracture and Correction System lag screws are intended to be used as screws, or in a plate-screw system for internal bone fraction for bone fractures, fusionies and non-unions of various bones, including humerus, radius, uha, tibia, calcaneus, fibula, and small bones (metacarpals, metatarsals, and phalanges).
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Pg.1/2 K170518
510(k) Summary of Safety and Effectiveness
Summary of 510(k) safety and effectiveness information upon which the substantial equivalence determination is based:
- I. Submitter Date Prepared: July 11, 2017 Device Submitter: In2Bones USA, LLC 6060 Poplar Avenue, Suite 380 Memphis, TN 38119 Phone: 901-260-7931 Contact Person: Christine Scifert II. Device Proprietary Name: In2Bones Fracture and Correction System Common Name: Plate, Fixation, Bone Screw, Fixation, Bone Regulation Number/ 21 CFR 888.3030: Single/multiple component metallic Name: bone fixation appliances and accessories 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II HRS, HWC, HTN Product Code: Review Panel: Orthopedic III. Predicate Device
| Predicate Device: | K123241 Arthrex Fracture Plates |
|---|---|
| K983495 Syntec Taichung Non-Sterile Bone Plate and Screw | |
| Implants | |
| K131920 In2Bones SAS I.B.S. Osteosynthesis Screw | |
| K160174 In2Bones SAS I.B.S. 2.0 Osteosynthesis Screw |
IV. Device Description
The In2Bones Fracture and Correction System is a system of plates, screws and washers used to treat fracture and reconstruction of the bones of the extremities.
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- V. Intended Use and Indications for Use
The In2Bones USA LLC, Fracture and Correction System plates and screws are intended to treat fractures, fusions, osteotomies and non-unions of the 5th metatarsal.
The Fracture and Correction System lag 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 various bones, including humerus, radius, ulna, tibia, calcaneus, fibula, and small bones (metacarpals, metatarsals, and phalanges).
- VI. Comparison of technological characteristics with the predicate devices
The In2Bones USA Fracture and Correction System and the legally marketed predicate devices have the same intended use and similar indications for use, similar dimensions, geometry and materials. The In2Bones device and the predicates are available in multiple sizes and various shapes. The plates are attached to bone using various diameter and length screws. The In2Bones USA Fracture and Correction System implants are made from titanium alloy.
VII. Performance Data
Testing including pyrogenicity, static driving torque, static pullout, static torsion, static bending and fatigue bending were performed. The results of the testing demonstrate that the device is substantially equivalent to the predicate devices identified.
VIII. Conclusions
The In2Bones USA Fracture and Correction System when compared to the predicates have similar intended use and indications for use, technological characteristics, and principals of operation as the predicate devices. Thus, the In2Bones USA Fracture and Correction System design characteristics do not raise any new types of questions of safety or effectiveness and thus is substantially equivalent to the predicate devices.