(160 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a physical interference screw, with no mention of software, algorithms, or AI/ML capabilities.
No.
The Dunamis Interference Screw is used for reattaching tissues and bones during surgical procedures, primarily acting as a fixation device rather than directly treating a disease or condition to restore health.
No.
The provided text describes an interference screw indicated for reattachment of tissues during surgical procedures, which is a therapeutic rather than a diagnostic function.
No
The device description and intended use clearly describe a physical interference screw used for surgical procedures, not a software application. The performance studies also focus on the mechanical properties of a physical implant.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description and intended use of the Dunamis Interference Screw clearly state that it is a surgical implant used for the reattachment of tissues and bone during various orthopedic procedures. It is a physical device implanted into the body, not a test performed on a sample outside the body.
The information provided focuses on the mechanical properties, biocompatibility, and surgical applications of the screw, which are characteristic of a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Dunamis Interference Screw are indicated for the reattachment of ligament, tendon, soft tissue, or bone to bone during cruciate ligament reconstruction surgeries of the knee. All screws with a diameters of 9mm or less and a length of 25mm or less are also intended for use in the following procedures:
Knee
• ACL Repairs
• PCL Repairs
• Extra-capsular repairs
– Medial collateral ligament
– Lateral collateral ligament
– Posterior oblique ligament
• Patellar realignment and tendon repairs
– Vastus medialis obliquous advancement
• Iliotibial band tenodesis
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
Foot and Ankle
• Hallux valgus repairs
• Medial or lateral instability repairs/reconstructions
• Achilles tendon repairs/reconstructions
• Midfoot reconstructions
• Metatarsal ligament/tendon repairs/reconstructions
• Bunionectomy
• Flexor Hullucis Longus (FLH)
• Tendon Transfers
Elbow, Wrist, and Hand
• Biceps tendon reattachment
• Ulnar or radial collateral ligament reconstructions
• Lateral epicondylitis repair
• Scapholunate ligament reconstruction
• Tendon Transfers
• Carpometacarpal Joint Arthroplasty
• Carpal Ligament Reconstruction
Product codes
MBI
Device Description
Reattachment of ligament, tendon, soft tissue, or bone, shoulder, foot, ankle, knee, elbow and hand/wrist.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee, Foot and Ankle, Shoulder, Elbow, Wrist, and Hand
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 performance testing conducted demonstrates that the insertion and fixation properties of the Dunamis Interference Screw are substantially equivalent to the Smith & Nephew Biosure PK Interference Screw (K083635).
Overall Performance Testing includes:
• Torsional Yield Strength, Maximum Torque and Breaking Angle
• Insertion and Removal Torque
• Axial Push-Out Strength
• Self-Tapping force
• 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 Biosure PK Interference Screw 510(k) K083635.
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 & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 14, 2015
Dunamis LLC % Mr. Robert O. Dean Senior Regulatory Consultant LexaMed 705 Front Street Toledo, Ohio 43605
Re: K151220
Trade/Device Name: Dunamis Interference Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: May 1, 2015 Received: Mav 7. 2015
Dear Mr. 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 (21 CFR 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
1
forth in the quality systems (OS) 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 yours,
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 Form
Indications for Use:
510(k) Number (if known): K151220
Device Name: Dunamis Interference Screw
The Dunamis Interference Screw are indicated for the reattachment of ligament, tendon, soft tissue, or bone to bone during cruciate ligament reconstruction surgeries of the knee. All screws with a diameters of 9mm or less and a length of 25mm or less are also intended for use in the following procedures:
| Knee | Foot and Ankle |
|---|---|
| • ACL Repairs | • Hallux valgus repairs |
| • PCL Repairs | • Medial or lateral instability |
| repairs/reconstructions | |
| • Extra-capsular repairs | • Achilles tendon repairs/reconstructions |
| – Medial collateral ligament | • Midfoot reconstructions |
| – Lateral collateral ligament | • Metatarsal ligament/tendon |
| repairs/reconstructions | |
| – Posterior oblique ligament | • Bunionectomy |
| • Patellar realignment and tendon repairs | • Flexor Hullucis Longus (FLH) |
| – Vastus medialis obliquous advancement | • Tendon Transfers |
| • Iliotibial band tenodesis | |
| Shoulder | Elbow, Wrist, and Hand |
| • Capsular stabilization | • Biceps tendon reattachment |
| – Bankart repair | • Ulnar or radial collateral ligament |
| reconstructions | |
| – Anterior shoulder instability | • Lateral epicondylitis repair |
| – SLAP lesion repairs | • Scapholunate ligament reconstruction |
| – Capsular shift or capsulolabral | |
| reconstructions | • Tendon Transfers |
| • Acromioclavicular separation repairs | • Carpometacarpal Joint Arthroplasty |
| • Deltoid repairs | • Carpal Ligament Reconstruction |
| • Rotator cuff tear repairs |
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
3
Section 4 510(K) Summary of Safety and Effectiveness - R2
Dunamis Interference Screw 8mm, 9mm, 10mm, 11mm x 25mm
Date Prepared: October 07, 2015
-
A. Submitters Name:
Dunamis, LLC. 693 Sherling Lake Rd. Greenville, AL. 36037 -
B. Company Contact
Dr. Prithvi Raj Chavan Dunamis, LLC. 693 Sherling Lake Rd. Greenville, AL. 36037 334-239-0774 www.Dunamismedical.com -
C. Device Name
Trade Name: Dunamis Interference Screw Common Name: Screw, Fixation, Bone Classification Name: Smooth or threaded metallic bone fixation fastener Product Code: MBI Regulation Number: 21CFR888.3040 -
D. Predicate Devices: The Dunamis Interference Screw is substantially equivalent in Intended use and performance to the following legally marketed devices in commercial distribution: Smith & Nephew Biosure PK Interference Screw 510(k) K083635.
-
E. Description of Device
Reattachment of ligament, tendon, soft tissue, or bone, shoulder, foot, ankle, knee, elbow and hand/wrist.
- F. Intended Use:
The Dunamis Interference Screw are indicated for the reattachment of ligament, tendon, soft tissue, or bone to bone during cruciate ligament reconstruction surgeries of the knee. All screws with a diameter of 9 mm or less and a length of 25 mm or less are also intended for use in the following procedures:
Knee
- · ACL Repairs
- · PCL Repairs
- · Extra-capsular repairs
- Medial collateral liqament
- -Lateral collateral ligament
- । Posterior oblique ligament
- · Patellar realignment and tendon repairs
- Vastus medialis obliquous advancement —
- · Iliotibial band tenodesis
4
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
Foot and Ankle
- · Hallux valgus repairs
- · Medial or lateral instability repairs/reconstructions
- · Achilles tendon repairs/reconstructions
- · Midfoot reconstructions
- · Metatarsal ligament/tendon repairs/reconstructions
- Bunionectomy
- · Flexor Hullucis Longus (FLH)
- · Tendon Transfers
Elbow. Wrist. and Hand
- · Biceps tendon reattachment
- · Ulnar or radial collateral ligament reconstructions
- · Lateral epicondylitis repair
- · Scapholunate ligament reconstruction
- · Tendon Transfers
- · Carpometacarpal Joint Arthroplasty
- Carpal Ligament Reconstruction
- G. Comparison of Technological Characteristics
The Dunamis Interference Screw is substantially equivalent in intended use, technological characteristics, and is safe and effective as its currently marketed predicate device, Smith & Nephew Biosure PK Interference Screw (K083635).
H. Summary Performance Data
The performance testing conducted demonstrates that the insertion and fixation properties of the Dunamis Interference Screw are substantially equivalent to the Smith & Nephew Biosure PK Interference Screw (K083635).
Overall Performance Testing includes:
- · Torsional Yield Strength, Maximum Torque and Breaking Angle
- · Insertion and Removal Torque
- · Axial Push-Out Strength
- · Self-Tapping force
- · Biocompatibility
- · Sterilization Validation
- · Ethylene Oxide Residuals
- · Sterile Barrier Packaging performance
- · Aging of Sterile Medical Device