(88 days)
Not Found
Not Found
No
The device description and intended use clearly describe a manually operated surgical device for suture fixation, with no mention of AI or ML capabilities.
No.
The device is described as a surgical device for the fixation of soft tissue to bone, which aids in the repair of tendons and ligaments, but it does not directly treat a disease or condition itself.
No
The device is described as a "Titanium Fixation Device" intended for "arthroscopic and limited mini-open surgeries requiring soft tissue fixation to bone for repair of shoulder, hand/wrist, foot/ankle, knee, elbow, and pelvis." Its purpose is to fix suture to bone for repairs, not to diagnose a condition.
No
The device description explicitly states it is a "manually operated surgical device" constructed of "titanium" and "suture composed of #2 braided polyester," indicating it is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The provided information clearly states that this device is a "manually operated surgical device intended for suture fixation in the repair of tendons and ligaments" during surgical procedures. It is an implantable device used directly on the patient's body during surgery.
- Lack of Specimen Handling: There is no mention of this device being used to collect, prepare, or examine any specimens from the human body.
Therefore, based on the provided information, the Titanium Fixation Device is a surgical implant/device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Titanium Fixation Device is intended for arthroscopic and limited mini-open surgeries requiring soft tissue fixation to bone for repair of shoulder, hand/wrist, foot/ankle, knee, elbow, and pelvis.
Product codes (comma separated list FDA assigned to the subject device)
HWC, MBI
Device Description
The Arthrex, Inc. Titanium Fixation Device is a manually operated surgical device 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 medical devices and prior approved 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, elbow, and pelvis
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): 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.
Not Found
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
510(k) Summary
510(k) Number: Contact Person: Date Prepared:
100 38 1 Vernon C. Brown, Manager of Regulatory Affairs November 22, 2000
Trade/Proprietary Name: Titanium Fixation System
Fastener, fixation, non-degradable, soft tissue Classification Name: ANCHORLOK™ Soft Tissue Anchor System Wright Predicate Devices: Medical, Mitek Knotless Anchor Mitek Surgical Products, Straight-In Orthopedic fixation system, Influence, Inc., KSEA Flipptack 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 Titanium Fixation Device is intended for arthroscopic and limited mini-open surgeries requiring soft tissue fixation to bone for repair of shoulder, hand/wrist, foot/ankle, knee, elbow, and pelvis.
Description:
The Arthrex, Inc. Titanium Fixation Device is a manually operated surgical device 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 medical devices and prior approved implants of this type.
Substantial Equivalence:
The Arthrex, Inc. Titanium Fixation Device is substantially equivalent to predicate devices where the basic features and intended uses are the same. Minor differences between the Titanium Fixation Device 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.
00 0080
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Public Health Service
MAR - 9 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Vernon C. Brown Manager, Regulatory Affairs Arthrex. Inc. 2885 South Horseshoe Drive Naples, Florida 34104
Re: K003816
Trade Name: Arthrex Titanium Corkscrew, 3.5mm, 5.0mm, 6.5mm Regulatory Class: II Product Code: HWC and MBI Dated: December 8, 2000 Received: December 11, 2000
Dear Mr. Vernon:
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 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.
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 ( recting 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 - Mr. Vernon C. Brown
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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
le Mark n Millkusa
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
Indications for Use
The Titanium Corkscrew is intended for fixation of suture to bone. This product is intended for the following indications:
- Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder: Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Foot/Ankle: Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
- Medial Collateral Ligament Repair, Lateral Collateral Ligament Knee: Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
- Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Elbow: Radial Collateral Ligament Reconstruction
- Bladder Neck Suspension for female urinary incontinence due to Pelvis: urethral hyper mobility or intrinsic sphincter deficiency
Mark N. Milheusen
Division Sign-Off) Division of General, Restorative and Neurological Devices K003816
510(k) Number_