(58 days)
Not Found
No
The device description and performance studies focus on mechanical properties, biocompatibility, and sterilization, with no mention of AI or ML.
Yes
The Coronet Soft Tissue Fixation System is used for fixation of tissue to bone and tissue to tissue for various repairs and reconstructions, which are therapeutic interventions.
No
Explanation: The device is described as a "Soft Tissue Fixation System" intended for "fixation of tissue to bone and tissue to tissue," and its function is to implant an anchor and soft tissue washer with suture. This is a therapeutic/surgical device for structural repair, not a device used to diagnose a condition.
No
The device description clearly states it consists of a physical implant (anchor, soft tissue washer, suture) and an inserter, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "fixation of tissue to bone and tissue to tissue." This describes a surgical implant used for mechanical support and repair within the body.
- Device Description: The description details a physical implant (anchor, washer, suture) and tools for its insertion (inserter, drill bit). These are all components of a surgical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze biological samples. This device is implanted inside the body for structural support.
N/A
Intended Use / Indications for Use
Coronet Soft Tissue Fixation System is intended for fixation of tissue to bone and tissue to tissue.
This product is intended for the following indications:
- Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps O Tenodesis, Acromio-clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux o Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
- Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar o Tendon Repair, Posterior Oblique Ligament Repair
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar and Radial Ligament o Reconstruction
- Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar and Radial о Ligament Reconstruction
Product codes
MBI
Device Description
The Coronet Soft Tissue Fixation System consists of a single-use, sterile implant used to fixate tissue to bone and tissue to tissue. The implant consists of an anchor and soft tissue washer interconnected via a continuous loop of suture. The implant comes pre-assembled to an inserter, which facilitates concurrent placement of the anchor and soft tissue washer. A drill bit is provided to allow for the creation of a properly sized pilot hole in the bone implantation site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot/Ankle, Knee, Hand/Wrist, Elbow
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)
Bench Testing:
Static pullout testing
Cyclic testing
Insertion testing
Fatigue limit testing
Human Factors:
End-user validation
Biocompatibility Testing:
Cytotoxicity
Sensitization
Irritation
Pyrogen testing
MEM elution testing
Acute system injection
Intramuscular implantation
Sterilization validation:
Bioburden
Relative resistance
EO residual testing
Endotoxin (LAL) validation
MR Compatibility:
Induced displacement testing
Induced torque testing
Induced heating testing
Image artifact testing
Packaging:
Package integrity tests
Accelerated aging
Benchtop testing comparing Coronet to the ZipE and TwinLoop predicates demonstrates the Coronet system is substantially equivalent and introduces no new for different questions of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K162429, K070882, K013806, K130033
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
March 4, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
CoNextions Medical % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, Pennsylvania 19103
Re: K200028
Trade/Device Name: Coronet Soft Tissue Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: January 6, 2020 Received: January 6, 2020
Dear Ms. Hogan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for
Laura Rose. Ph.D. Acting Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Coronet Soft Tissue Fixation System
Indications for Use (Describe)
Coronet Soft Tissue Fixation System is intended for fixation of tissue to tissue to tissue.
This product is intended for the following indications:
- Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-clavicular ● Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- . Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valqus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
- Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, ● Posterior Oblique Ligament Repair
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar and Radial Ligament Reconstruction ●
- Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar and Radial Ligament Reconstruction ●
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K200028 510(k) SUMMARY CoNextions Medical's Coronet Soft Tissue Fixation System
Applicant Information
| Manufacturer: | CoNextions Medical, Inc
150 North Wright Brothers Drive, Suite 560
Salt Lake City, Utah 84116
Ph: 201.419.0118
F: 801.436.5369 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Matthew Swift, Director of Marketing |
| Date Prepared: | March 2, 2020 |
| Device Information | |
| Proprietary Name: | Coronet Soft Tissue Fixation System |
| Common Name: | Soft Tissue Fixation Device |
| Classification Name: | MBI (888.3040) Fastener, fixation, nondegradable, soft tissue |
| Predicate Devices: | K162429 ZipE Knotless Tissue Repair and Attachment Devices,
Ziptek LLC. (Primary)
K070882 TwinLoopTM-PEEK Anchor, Stryker, Inc.
K013806 Synthes ® Metallic Spiked Washer, Depuy Synthes, Inc.
K130033 ToggleLocTM System, Zimmer Biomet, Inc. |
Device Description
The Coronet Soft Tissue Fixation System consists of a single-use, sterile implant used to fixate tissue to bone and tissue to tissue. The implant consists of an anchor and soft tissue washer interconnected via a continuous loop of suture. The implant comes pre-assembled to an inserter, which facilitates concurrent placement of the anchor and soft tissue washer. A drill bit is provided to allow for the creation of a properly sized pilot hole in the bone implantation site.
Intended Use/Indications for Use
Coronet Soft Tissue Fixation System is intended for fixation of tissue to bone and tissue to tissue.
This product is intended for the following indications:
- Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps O Tenodesis, Acromio-clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
4
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux o Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
- Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar o Tendon Repair, Posterior Oblique Ligament Repair
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar and Radial Ligament o Reconstruction
- Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar and Radial о Ligament Reconstruction
Technological Characteristics
Coronet Soft Tissue Fixation System is substantially equivalent to other legally marketed bone anchor devices. Specifically, use of an anchor for bone attachment with a washer for soft tissue attachment is substantially equivalent to the ZipE® Knotless Tissue Repair and Attachment Device from Ziptek LLC (K162429). Coronet and the ZipE device are similar in design, and have same intended use, same specific indications, similar technological characteristics and similar principles of operation. The anchor component of Coronet is equivalent to the TwinLoop™-PEEK Anchor from Stryker, Inc. (K070882), which has the same intended use, similar specific indications, similar technological characteristics and similar principles of operation. The soft tissue washer component of Coronet is equivalent to the Synthes® Spiked Metallic Washer from Depuy Synthes, Inc (K013806) which has a similar intended use and similar technological characteristics and principles of operation. Benchtop testing comparing Coronet to the ZipE and TwinLoop predicates demonstrates the Coronet system is substantially equivalent and introduces no new for different questions of safety or effectiveness.
Performance Data
| Testing Category | Specific Tests Performed |
|---|---|
| Bench Testing | Static pullout testing |
| Cyclic testing | |
| Insertion testing | |
| Fatigue limit testing | |
| Human Factors | End-user validation |
| Biocompatibility Testing | Cytotoxicity |
| Sensitization | |
| Irritation | |
| Pyrogen testing | |
| MEM elution testing | |
| Acute system injection | |
| Intramuscular implantation | |
| Sterilization validation | Bioburden |
| Relative resistance | |
| EO residual testing | |
| Endotoxin (LAL) validation | |
| MR Compatibility | Induced displacement testing |
| Induced torque testing | |
| Induced heating testing |
The following non-clinical testing was conducted on Coronet Soft Tissue Fixation System.
5
| Image artifact testing | |
|---|---|
| Packaging | Package integrity tests |
| Accelerated aging |
Conclusions
The Coronet Soft Tissue Fixation System is substantially equivalent to predicate devices with respect to its indications for use, design, and function. The minor technological differences between Coronet and the predicate devices raise no new or different questions of safety or effectiveness and do not adversely impact the performance or function of the device as confirmed by performance testing. Thus, Coronet is substantially equivalent to the predicates.