(69 days)
Not Found
No
The device description and performance studies focus on mechanical properties and surgical repair techniques, with no mention of AI or ML.
Yes
The device is intended for the repair of ankle syndesmosis disruptions, which is a therapeutic intervention.
No
The device is described as a "SyndesMetrics Syndesmosis Repair System" intended for "repair in the ankle" and "fixation," which are therapeutic functions, not diagnostic ones. There is no mention of it being used to detect or identify a condition.
No
The device description clearly states it consists of physical components: a Fibular Anchor, a Tibial Anchor, and suture. It also mentions being marketed with previously cleared UHMWPE OrthoTape.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "repair in the ankle including indications for: Ankle syndesmosis fixation... and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures." This describes a surgical implant used to physically stabilize a joint, not a test performed on a sample from the body to diagnose a condition.
- Device Description: The device consists of "Fibular Anchor and a Tibial Anchor which are connected by a length of suture." This is a description of a physical implant, not a reagent, instrument, or system used for in vitro testing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing diagnostic information about a disease or condition
Therefore, the SyndesMetrics Syndesmosis Repair System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SyndesMetrics Syndesmosis Repair System is intended for repair in the ankle including indications for: Ankle syndesmosis fixation (syndesmosis disruptions), and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures.
Product codes (comma separated list FDA assigned to the subject device)
HTN
Device Description
The SyndesMetrics Syndesmosis Repair System consists of a Fibular Anchor and a Tibial Anchor which are connected by a length of suture. The implant is marketed with previously cleared ultra-high molecular weight polyethylene (UHMWPE) 3.5mm OrthoTape® (K150438) which is provided sterile packaged from Teleflex, Inc.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle
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)
The performance of the SyndesMetrics Syndesmosis Repair System was characterized through the following tests:
- Insertion Testing
- Pullout Strength Testing
- Fatigue Testing
Clinical data were not needed to support the safety and effectiveness of the subject device.
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.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
Mortise Medical LLC Robert Hoy Director of Research 124 South 600 West Suite 100 Logan, Utah 84321
November 8, 2017
Re: K172620
Trade/Device Name: SyndesMetrics Syndesmosis Repair System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HTN Dated: August 31, 2017 Received: August 31, 2017
Dear Robert Hoy:
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 of medical device-related 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
1
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 (DICE) 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 (DICE) 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
2
Indications for Use
510(k) Number (if known)
Device Name SyndesMetrics Syndesmosis Repair System
Indications for Use (Describe)
The SyndesMetrics Syndesmosis Repair System is intended for repair in the ankle including indications for:
Ankle syndesmosis fixation (syndesmosis disruptions), and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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5. 510(k) Summary
| Device Trade Name: | SyndesMetrics Syndesmosis Repair System |
|---|---|
| Manufacturer: | Mortise Medical LLC |
| 124 South 600 West, Suite 100 | |
| Logan, UT 84321 | |
| Contact: | Mr. Robert Hoy |
| Director of Research | |
| Phone: (614) 448-6358 | |
| Fax: (435) 213-4878 | |
| bob@surgicalfrontiers.com | |
| Date Prepared: | October 26, 2017 |
| Common Name: | Single/multiple component metallic bone fixation |
| appliances and accessories | |
| Classification: | 21 CFR 888.3030 |
| Class: | II |
| Product Code: | HTN |
Indications for Use:
The SyndesMetrics Syndesmosis Repair System is intended for repair in the ankle including indications for:
Ankle syndesmosis fixation (syndesmosis disruptions), and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures.
Device Description:
The SyndesMetrics Syndesmosis Repair System consists of a Fibular Anchor and a Tibial Anchor which are connected by a length of suture. The implant is marketed with previously cleared ultra-high molecular weight polyethylene (UHMWPE) 3.5mm OrthoTape® (K150438) which is provided sterile packaged from Teleflex, Inc.
Predicate Devices:
The Arthrex, Inc. TightRope Syndesmosis Device (K043248) serves as the primary predicate device, and the JuggerLoc Bone to Bone System (K141219) serves as a reference predicate device.
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Technological Characteristics Comparison:
The SyndesMetrics Syndesmosis Repair System and the predicates are similar in design, function, material, size and performance. Each subject and predicate device is designed to repair syndesmosis disruptions. Further, the subject device and TightRope Syndesmosis Device predicate device both consist of two cortical bone anchors and a length of suture material there between. The SyndesMetrics Syndesmosis Repair System subject device implants and the TightRope Syndesmosis Device predicate device implants are manufactured from titanium alloy and stainless steel materials with well-established biocompatibility and a long history of use in many previously cleared permanent implants. In addition, the subject and primary predicate device are for use with UHMWPE suture material.
Side-by-side mechanical performance testing demonstrates that the design differences between the SyndesMetrics Syndesmosis Repair System subject devices and the TightRope Syndesmosis Device predicate device raise no new safety and effectiveness questions.
Nonclinical Testing:
All necessary testing has been performed for the worst-case SyndesMetrics Syndesmosis Repair System to assure substantial equivalence to its predicates and to demonstrate the subject devices perform as intended. All testing was performed on test units representative of finished devices. The performance of the SyndesMetrics Syndesmosis Repair System was characterized through the following tests:
- Insertion Testing ●
- Pullout Strength Testing
- Fatigue Testing ●
Clinical data were not needed to support the safety and effectiveness of the subject device.
Substantial Equivalence:
The Mortise Medical LLC SyndesMetrics Syndesmosis Repair System is substantially equivalent to the Arthrex, Inc. TightRope Syndesmosis Device (K043248) and the JuggerLoc Bone to Bone System (K141219) with respect to its indications for use, design, material, size, performance and function.