(89 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a physical implant (suture anchor) and its associated tools and sutures. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
Yes
The device is described as an implantable suture anchor system used for the reattachment of soft tissue to bone, specifically for conditions like Bankart Repair, SLAP lesion repairs, rotator cuff tear repairs, and ligament reconstructions, which are therapeutic interventions.
No
This device is a suture anchor system intended for reattaching soft tissue to bone, serving as a mechanical fixation device rather than one that diagnoses conditions.
No
The device description clearly states it is a "sterile single use implantable suture anchor system" consisting of physical components like a suture anchor, suture, and inserter tool. This indicates it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for reattaching soft tissue to bone in various anatomical locations. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details a sterile, single-use implantable suture anchor system with sutures and an inserter tool. This aligns with a surgical device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis, monitoring, or prognosis.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic purposes. The Dunamis Suture Anchor is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Dunamis Suture Anchor suture anchors are intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder
Capsular Stabilization
- Bankart Repair
- Anterior Shoulder Instability
- SLAP lesion repairs
- Capsular Shift or capsulolabral reconstructions
Acromioclavicular separation repairs
Deltoid Repairs
Rotator Cuff tear repairs
Biceps tenodesis
Elbow, Wrist, and Hand
Ulnar or radial collateral ligament reconstructions
Lateral epicondylitis repair
Biceps tendon reattachment
Knee
Extra-capsular repairs:
- medial collateral ligament
- lateral collateral ligament
- posterior oblique ligament
Patellar realignment and tendon repairs: - vastus medialis obliquous advancement
Iliotibial band tenodesis
Foot and Ankle
Hallux valgus repairs
Medial or lateral instablility repairs/reconstructions
Achilles tendon repairs/reconstructions
Midfoot reconstructions
Metatarsal ligament/tendon repairs/reconstructions
Bunionectomy
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The Dunamis Suture Anchor is a sterile single use implantable suture anchor system designed to provide fixation and reattachment of soft tissue to bone. The system consists of the following components:
- · Suture Anchor
- · Teleflex Force Fiber Suture(s), USP Size 2, White & Blue, CoBraid Ultra High Molecular Weight Polyethylene
- · Inserter tool
The Dunamis Suture Anchor is packaged ready to use condition and provides aseptic O.R delivery. The system is provided complete and is not intended to be used or integrated with other bone anchor fixation implantable devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Elbow, Wrist, Hand, Knee, Foot and Ankle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 performance testing conducted demonstrates that the insertion and fixation properties of the Dunamis Suture Anchor are substantially equivalent to the predicate devices. Overall Performance Testing includes:
- Axial Pull-Out Strength
- Biocompatibility ●
- Sterilization Validation
- Ethylene Oxide Residuals ●
- . Sterile Barrier Packaging performance
- . Aging of Sterile Medical 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.
Smith & Nephew Osteoraptor 2.3 Suture Anchor K082215, Smith & Nephew Twinfix PK FT Suture Anchor K072785
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other, representing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 6, 2016
Dunamis LLC % Mr. Robert Dean Senior Consultant LexaMed 705 Front Street Toledo, Ohio 43605
Re: K160996
Trade/Device Name: Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 6.5mm Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: March 31, 2016 Received: April 8, 2016
Dear Robert Dean:
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
1
(21 CFR Part 807); labeling (21 CFR Parts 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.
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/Resourcesfor You/Industry/default.htm. 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 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 yours.
VincentJ. Devlin -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | ||
|---|---|---|
| Food and Drug Administration | ||
| Indications for Use | Form Approved: OMB No. 0910-0120 | |
| Expiration Date: January 31, 2017 | ||
| See PRA Statement below. | ||
| 510(k) Number (if known) | K160996 | |
| Device Name | ||
| Dunamis Suture Anchor PEEK | 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm | |
| Indications for Use (Describe) | ||
| The Dunamis Suture Anchor suture anchors are intended for use for the reattachment of soft tissue to bone for the following indications: | ||
| Shoulder | Elbow, Wrist, and Hand | |
| Capsular Stabilization | Ulnar or radial collateral ligament reconstructions | |
| - Bankart Repair | Lateral epicondylitis repair | |
| - Anterior Shoulder Instability | Biceps tendon reattachment | |
| - SLAP lesion repairs | ||
| - Capsular Shift or capsulolabral reconstructions | ||
| Acromioclavicular separation repairs | ||
| Deltoid Repairs | ||
| Rotator Cuff tear repairs | ||
| Biceps tenodesis | ||
| Knee | ||
| Extra-capsular repairs: | ||
| - medial collateral ligament | ||
| - lateral collateral ligament | ||
| - posterior oblique ligament | ||
| Patellar realignment and tendon repairs: | ||
| Foot and Ankle | - vastus medialis obliquous advancement | |
| Hallux valgus repairs | Iliotibial band tenodesis | |
| Medial or lateral instablility | ||
| repairs/reconstructions | ||
| Achilles tendon repairs/reconstructions | ||
| Midfoot reconstructions | ||
| Metatarsal ligament/tendon | ||
| repairs/reconstructions | ||
| Bunionectomy | ||
| 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) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | ||
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | ||
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | ||
| The burden time for this collection of information is estimated to average 79 hours per response, including the | ||
| time to review instructions, search existing data sources, gather and maintain the data needed and complete | ||
| and review the collection of information. Send comments regarding this burden estimate or any other aspect | ||
| of this information collection, including suggestions for reducing this burden, to: | ||
| Department of Health and Human Services | ||
| Food and Drug Administration | ||
| Office of Chief Information Officer | ||
| Paperwork Reduction Act (PRA) Staff | ||
| PRAStaff@fda.hhs.gov | ||
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of | ||
| information unless it displays a currently valid OMB number." | ||
| FORM FDA 3881 (8/14) | Page 1 of 1 | EF |
| PSC Pablishing Seeveres (301) 443-6 ? 40 |
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510(K) Summary
Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm
Date Prepared: June 1, 2016
-
A. Submitters Name:
Dr. Prithvi Raj Chavan Dunamis, LLC. 693 Sherling Lake Rd., Apt 122 Greenville, AL. 36037 (p) 731-217-2533 Email: dr.raj76@gmail.com -
B. Company Contact
Dr. Prithvi Raj Chavan Dunamis, LLC. 693 Sherling Lake Rd., Apt 122 Greenville, AL. 36037 -
C. Device Name
Trade Name: Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm Common Name: Suture Anchor Classification Name: fastener, fixation, non-degradable, soft tissue Product Code: MBI Regulation Number: 21CFR888.3040 -
Predicate Devices: The Dunamis Suture Anchor is substantially equivalent in Intended use and performance to the D. following legally marketed devices in commercial distribution: Smith & Nephew Osteoraptor 2.3 Suture Anchor K082215, Smith & Nephew Twinfix PK FT Suture Anchor K072785 .
-
E. Description of Device
The Dunamis Suture Anchor is a sterile single use implantable suture anchor system designed to provide fixation and reattachment of soft tissue to bone. The system consists of the following components:
- · Suture Anchor
- · Teleflex Force Fiber Suture(s), USP Size 2, White & Blue, CoBraid Ultra High Molecular Weight Polyethylene
- · Inserter tool
The Dunamis Suture Anchor is packaged ready to use condition and provides aseptic O.R delivery. The system is provided complete and is not intended to be used or integrated with other bone anchor fixation implantable devices.
- F. Intended Use
Indications
The Dunamis Suture Anchors are intended to be used for reattachment of soft tissue to bone for the following indications.
Shoulder
Capsular Stabilization Bankart Repair
4
- Anterior Shoulder Instability Repair SLAP lesion repairs Capsular Shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid Repairs Rotator Cuff tear repairs Biceps tenodesis Elbow Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment Foot and Ankle Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy Knee Extra-capsular repairs: medial collateral ligament lateral collateral ligament posterior oblique ligament Patellar realignment and tendon repairs: vastus medialis obliquous advancement Iliotibial band tenodesis
- G. Comparison of Technological Characteristics
The Dunamis Suture Anchor is substantially equivalent to the predicate device. The proposed and predicate devices are similar in design, operate on the same principles, have the same indications and intended use and exhibit similar fixation properties.
H. Summary Performance Data
The non-clinical performance testing conducted demonstrates that the insertion and fixation properties of the Dunamis Suture Anchor are substantially equivalent to the predicate devices. Overall Performance Testing includes:
- Axial Pull-Out Strength
- Biocompatibility ●
- Sterilization Validation
- Ethylene Oxide Residuals ●
- . Sterile Barrier Packaging performance
- . Aging of Sterile Medical Device