(69 days)
KSEA Flipptack
Not Found
No
The device description and intended use clearly describe a manually operated surgical implant made of titanium and polyester suture, with no mention of software, algorithms, or any technology that would incorporate AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is described as a surgical implant intended for the repair of tendons and ligaments, specifically for soft tissue fixation to bone, which falls under the definition of a therapeutic device.
No
The device is a surgical implant intended for soft tissue fixation to bone for repair of various joints, not for diagnosing conditions.
No
The device description clearly states it is a manually operated surgical implant constructed of titanium and suture, which are physical components, not software.
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 fixing soft tissue to bone during various orthopedic procedures. This involves direct interaction with the patient's body during surgery.
- Device Description: The device is described as a "manually operated surgical implant" made of titanium and polyester suture. This is a physical implant used within the body.
- 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, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (within the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Arthrex Tenodesis Screw is intended for arthroscopic and limited mini-open surgeries requiring soft tissue fixation to bone for repair of shoulder, hand/wrist, foot/ankle, knee, and elbow.
The Arthrex Tenodesis Screw, 5.5 mm for fixation of tissue grafts is intended for interference fixation of soft tissue grafts in the shoulder, elbow, wrist, and ankle. These surgeries will be performed by both open and arthroscopic means.
- Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder. Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
- Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Elbow: Radial Collateral Ligament Reconstruction
- Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
- Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Foot/Ankle: Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
*This system is to be used in association with adequate post-operative immobilization.
Product codes
MBI
Device Description
The Arthrex Tenodesis Screw is a manually operated surgical implant intended for suture fixation in the repair of tendons and ligaments. The implant is constructed of titanium and the suture is composed of #2 braided polyester. These components are used in a wide variety of cleared medical devices and implants of this type.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, hand/wrist, foot/ankle, knee, and elbow, shoulder, elbow, wrist, and 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Talon Anchor Snap-Pak by Mitek Products, RC Multisuture Bone Anchor Model 4453 bv Innovasive Devices, Inc., Multitak SS Buttons by Bonutti Research, KSEA Flipptack by Karl Storz Endoscopy-America, and Acumed Suture Anchor by Acumed, Inc.
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
510(k) Summary
510(k) Number: KOHOOZ Contact Person: Ann Waterhouse, Regulatory Affairs Specialist Date Prepared: April 3, 2001
Trade/Proprietary Name: Tenodesis Screw
Classification Name: Fastener, fixation, non-degradable, soft tissue Predicate Devices: Talon Anchor Snap-Pak by Mitek Products, RC Multisuture Bone Anchor Model 4453 bv Innovasive Devices, Inc., Multitak SS Buttons by Bonutti Research, KSEA Flipptack by Karl Storz Endoscopy-America, and Acumed Suture Anchor by Acumed, Inc.
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Intended Use:
The Arthrex Tenodesis Screw is intended for arthroscopic and limited mini-open surgeries requiring soft tissue fixation to bone for repair of shoulder, hand/wrist, foot/ankle, knee, and elbow.
Description:
The Arthrex Tenodesis Screw is a manually operated surgical implant intended for suture fixation in the repair of tendons and ligaments. The implant is constructed of titanium and the suture is composed of #2 braided polyester. These components are used in a wide variety of cleared medical devices and implants of this type.
Substantial Equivalence:
The Arthrex, Inc. Tenodesis Screw is substantially equivalent to predicate devices where the basic features and intended uses are the same. Minor differences between the Tenodesis Screw and predicate devices do not raise any questions concerning safety and effectiveness and have no apparent effect on the performance, function, or intended use of this device.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes across its body.
Public Health Service
JUN 1 2 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Ann Waterhouse Regulatory Affairs Specialist Arthrex, Inc. 2885 South Horseshoe Drive Naples, Florida 34104
Re: K011007
Trade Name: Arthrex Tenodesis Screw, 5.5 mm Regulation Number: 888.3040 Regulatory Class: II Product Code: MBI Dated: April 3, 2001 Received: April 4, 2001
Dear Ms. Waterhouse:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
2
Page 2 - Ms. Ann Waterhouse
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
BBhlllellorff
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K011007
Device Name: Tenodesis Screw, 5.5 mm
Indications for Use:
The Arthrex Tenodesis Screw, 5.5 mm for fixation of tissue grafts is intended for interference fixation of soft tissue grafts in the shoulder, elbow, wrist, and ankle. These surgeries will be performed by both open and arthroscopic means.
- Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder. Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
- Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Elbow: Radial Collateral Ligament Reconstruction
- Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
- Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Foot/Ankle: Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
*This system is to be used in association with adequate post-operative immobilization.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mmkheunston an
(Division Sign-Off) Division of General. Restorative and Neurological Devices
(Option Format 3-10-98)
510(k) Number K011007