(196 days)
Not Found
No
The device description and performance studies focus on mechanical properties and equivalence to a predicate device, with no mention of AI/ML algorithms or data processing.
Yes
The device is described as a "Syndesmosis Repair Kit" intended to "provide fixation during the healing process following a syndesmotic trauma," which clearly indicates its role in treating an injury.
No
The device is described as a repair kit intended to provide fixation during the healing process, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components including bone anchors (stainless steel screw, PEEK T-nut), a distribution bridge (UHMWPE suture, threaded PEEK rod), and a clipper. This indicates a hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide fixation during the healing process following a syndesmotic trauma." This describes a surgical implant used in vivo (within the body) to stabilize a joint.
- Device Description: The description details a physical implant made of materials like stainless steel, PEEK, and UHMWPE suture, designed to be surgically placed.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The Tarsus Synde-Lock Syndesmosis Repair Kit is a surgical implant used for orthopedic repair.
N/A
Intended Use / Indications for Use
The Tarsus Synde-Lock Syndesmosis Repair Kit is intended to provide fixation during the healing process following a syndesmotic trauma.
Product codes (comma separated list FDA assigned to the subject device)
HWC, HTN
Device Description
The Synde-Lock™ Syndesmosis Repair Kit contains an implant designed as two bone anchors, one a stainless steel screw and the other a PEEK T-nut, connected by a distribution bridge comprised of UHMWPE suture and a threaded PEEK rod. The stainless steel screw is pre-threaded with the UHMWPE suture section of the distribution bridge. The PEEK T-nut engages the threads of the PEEK section of the distribution bridge allowing the effective length of the bridge to be shortened. A clipper is also contained in the kit to cut away excess distribution bridge material, once the implant is in place. The Tarsus Synde-Lock Syndesmosis Repair Kit is intended to provide fixation during the healing process following a syndesmotic trauma.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 non-clinical tests performed by the company include lateral displacement testing, external rotation testing, fatigue testing with lateral tensile to failure, and external rotation to failure. Both synthetic bone analog and cadaveric bone were used for testing. The test results demonstrate that the Synde-Lock™ Syndesmosis Repair Kit is substantially equivalent to the legally marketed predicate 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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
5. 510(k) Summary
| General Information | JAN 2 3 2012 | |
|---|---|---|
| Date Compiled | January 21, 2012 | |
| Classification | Class II, 21 CFR § 888.3040 Smooth or threaded metallic bone fixation fastener | |
| Primary Product code HWC | ||
| Class II, 21 CFR § 888.3030, Single/multiple component metallic bone fixation | ||
| appliances and accessories | ||
| Secondary Product code HTN | ||
| Trade Name | Synde-Lock™ Syndesmosis Repair Kit | |
| Submitter | Tarsus Medical, Inc. | |
| 465 Fairchild Drive | ||
| Suite 230 | ||
| Mountain View, CA 94043 | ||
| Contact | Nicholas Mourlas | |
| President and CEO | ||
| Tel: (650) 237-0070 | ||
| Fax: (650) 237-0071 |
Intended Use
The Tarsus Synde-Lock Syndesmosis Repair Kit is intended to provide fixation during the healing process following a syndesmotic trauma.
Predicate Device TightRope Syndesmosis Device Plus Manufactured by Arthrex
Device Description
The Synde-Lock™ Syndesmosis Repair Kit contains an implant designed as two bone anchors, one a stainless steel screw and the other a PEEK T-nut, connected by a distribution bridge comprised of UHMWPE suture and a threaded PEEK rod. The stainless steel screw is pre-threaded with the UHMWPE suture section of the distribution bridge. The PEEK T-nut engages the threads of the PEEK section of the distribution bridge allowing the effective length of the bridge to be shortened. A clipper is also contained in the kit to cut away excess distribution bridge material, once the implant is in place. The Tarsus Synde-Lock Syndesmosis Repair Kit is intended to provide fixation during the healing process following a syndesmotic trauma.
Materials
The Synde-Lock™ Syndesmosis Device is comprised of 316 LVM stainless steel conforming to ASTM F138-08, Ultra High Molecular Weight Polyethylene (UHMWPE) suture conforming to USP 33, and Polyetheretherketone (PEEK) conforming to ASTM F2026-08.
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Testing
The non-clinical tests performed by the company include lateral displacement testing, external rotation testing, fatigue testing with lateral tensile to failure, and external rotation to failure. Both synthetic bone analog and cadaveric bone were used for testing. The test results demonstrate that the Synde-Lock™ Syndesmosis Repair Kit is substantially equivalent to the legally marketed predicate device.
Summary of Substantial Equivalence
Tarsus Medical, Inc. believes the Synde-Lock™ Syndesmosis Repair Kit is substantially equivalent to the predicate product. The intended use, method of operation, methods of construction and materials used, are either identical or substantially equivalent to the existing legally marketed product.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Tarsus Medical, Inc. % Nicholas J. Mourlas, Ph.D. 465 Fairchild Drive, Suite 230 Mountain View, CA 94043
JAN 2 3 2012
Re: K111971
Trade/Device Name: Synde-Lock™ Syndesmosis Repair Kit Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, HTN Dated: December 8, 2011 Received: December 12, 2011
Dear Dr. Mourlas:
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 (reporting of medical
3
Page 2 - Nicholas J. Mourlas, Ph.D.
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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. Indications for Use Statement
| 510(k) Number
| (if known): | This application | $K 1 l q 7 l$ |
|---|---|---|
| ------------------------------ | ------------------ | ----------------- |
Synde-Lock™ Syndesmosis Repair Kit Device Name:
The Tarsus Synde-Lock Syndesmosis Repair Kit is intended to provide fixation during Indications for Use: the healing process following a syndesmotic trauma.
Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Per 21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
T. N. Shepard
for (Division Sigh-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111971