(154 days)
No
The device description and performance studies focus on mechanical properties and materials, with no mention of AI/ML terms or functionalities.
Yes
The device is described as providing fixation and stabilization during the healing process following trauma, which aligns with the definition of a therapeutic device.
No
Explanation: The device is intended to provide fixation and stabilize the ankle syndesmosis during healing, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it consists of physical components: UHMWPE suture and titanium alloy buttons.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for providing fixation during the healing process following trauma to the Ankle Syndesmosis. This is a therapeutic or surgical intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The device is described as a system of sutures and buttons intended to stabilize syndesmotic trauma. This is a physical implant used within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is a surgical implant used to treat an injury.
N/A
Intended Use / Indications for Use
The GRAVITY™ Syndesmosis LP System is intended to provide fixation during the healing process following trauma to the Ankle Syndesmosis (Syndesmosis disruptions) and as an adjunct in connection with trauma hardware for ankle fractures such as Weber B and C.
Product codes (comma separated list FDA assigned to the subject device)
HTN, HRS
Device Description
The subject GRAVITY™ Syndesmosis LP is a sterile, single-use, device intended to stabilize syndesmotic trauma of the ankle. The subject system consists of UHMWPE suture tensioned between two titanium alloy buttons.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ankle Syndesmosis
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing and analysis demonstrated substantial equivalence in side by side construct static and dynamic tensile testing. Bacterial endotoxin levels on the final finished form of the device were evaluated using LAL pyrogen testing.
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.
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.
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Wright Medical Technology, Inc. Michael Mullins Regulatory Affairs Specialist 1023 Cherry Road Memphis. Tennessee 38117
June 30, 2017
Re: K170249
Trade/Device Name: GRAVITY™ Syndesmosis LP Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HTN. HRS Dated: May 23, 2017 Received: May 24, 2017
Dear Mr. Mullins:
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
1
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 (QS) 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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Indications for Use
510(k) Number (if known) K170249
Device Name GRAVITY™ Syndesmosis LP
Indications for Use (Describe)
The GRAVITY™ Syndesmosis LP System is intended to provide fixation during the healing process following trauma to the Ankle Syndesmosis (Syndesmosis disruptions) and as an adjunct in connection with trauma hardware for ankle fractures such as Weber B and C.
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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1023 Cherry Road Memphis, TN 38117 USA
901 867 9971 800 238 7117 wright.com
510(K) SUMMARY
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the GRAVITY Syndesmosis LP.
| (a)(1). Submitted By: | Wright Medical Technology, Inc.
1023 Cherry Road
Memphis, TN 38117 |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | June 27, 2017 |
| Contact Person: | Michael Mullins
Regulatory Affairs Specialist
Fax – (901) 867-4190 |
| (a)(2). Proprietary Name: | GRAVITY ™ Syndesmosis LP |
| Common Name: | Washer, Bolt Nut
Plate, Fixation, Bone |
| Classification Name and Reference: | 21 CFR 888.3030 – Class II |
| Device Product Code, Device Panel: | HTN – Orthopedic
HRS – Orthopedic |
| (a)(3). Predicate Device: | Primary: K043248-Arthrex TightRope ™
Reference: K083070-Biomet ToggleLoc ™
Reference: K163044-ORTHOLOC 3Di
Ankle Fracture Plating System
Reference: K113871-PRODENSE (ABS instruments) |
(a)(4). Device Description
The subject GRAVITY™ Syndesmosis LP is a sterile, single-use, device intended to stabilize syndesmotic trauma of the ankle. The subject system consists of UHMWPE suture tensioned between two titanium alloy buttons.
(a)(5). INTENDED USE
The GRAVITY™ Syndesmosis LP System is intended to provide fixation during the healing process following trauma to the Ankle Syndesmosis disruptions) and as an adjunct in connection with trauma hardware for ankle fractures such as Weber B and C.
Attachment 2-1
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(a)(6). Technological Characteristics Comparison
The subject GRAVITY™ Syndesmosis LP is technologically substantially equivalent to predicate devices in material, component design (i.e. suture, buttons), surgical technique, and construct design.
(b)(1). Substantial Equivalence – Non-Clinical Evidence
Performance testing and analysis demonstrated substantial equivalence in side by side construct static and dynamic tensile testing. Bacterial endotoxin levels on the final finished form of the device were evaluated using LAL pyrogen testing.
(b)(2). Substantial Equivalence - Clinical Evidence
N/A
(b)(3). Substantial Equivalence - Conclusions
The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate device.