(50 days)
Not Found
Not Found
No
The summary describes a family of implants made from titanium alloy and polymers for suture or tissue fixation. There is no mention of any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No
The device is described as an implant used for suture or tissue fixation in various anatomical locations for repair and reconstruction, which does not inherently qualify it as a therapeutic device in a broad sense. Therapeutic devices are typically those that directly treat or alleviate symptoms of a disease or condition, which is not the primary stated function here beyond providing structural support for healing.
No
This device is an implantable medical device used for surgical fixation and reconstruction, which are therapeutic rather than diagnostic purposes.
No
The device description explicitly states it is comprised of titanium alloy, PLLA, and PLDLA implants, which are hardware components.
Based on the provided information, the Arthrex Tak™ Family is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes the device as being used for "suture or tissue fixation" in various anatomical locations. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as "titanium alloy implants, poly (L-lactide) or PLLA implants and poly (L-lactide-Co-D, L-lactide) or PLDLA implants." These are physical implants designed to be placed within the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of the Arthrex Tak™ Family does not involve the analysis of such specimens.
Therefore, the Arthrex Tak™ Family is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Arthrex Tak™ Family is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and in select maxillofacial applications. Specific indications are listed below:
| Skull: | Stabilization and fixation of oral cranio-maxillofacial skeletal bone, mandible and maxillofacial bones, Lateral Canthoplasty, Repair of Nasal Vestibular Stenosis, Brow Lift, Temporomandibular Joint (TMJ) reconstruction, soft tissue attachment to the parietal temporal ridge, frontal, zygoma, and perioorbital bones of the skull |
|---|---|
| Elbow: | Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction |
| Shoulder: | Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction |
| Hand/Wrist: | Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers |
| Foot/Ankle: | Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction |
| Knee: | Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis |
Product codes (comma separated list FDA assigned to the subject device)
HWC, MAI, MBI
Device Description
The Arthrex Tak™ Family is comprised of titanium alloy implants, poly (L-lactide) or PLLA implants and poly (L-lactide-Co-D, L-lactide) or PLDLA implants. They are offered in several different shapes and sizes. They are offered sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, ankle, knee, hand, wrist, elbow, shoulder, and in select maxillofacial applications.
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
MAY 1 2 2005 510(k) Summary
| 510(k) Number: | K050749 |
|---|---|
| Company: | Arthrex, Inc. |
| Address: | 1370 Creekside Blvd., Naples, FL 34108-1945 |
| Telephone: | (239) 643-5553 |
| Facsimile: | (239) 598-5508 |
| Contact: | Ann Waterhouse |
| Device Name: | Arthrex TakTM Family |
| Classification: | Screw, Fixation, Bone |
| Product Code: | HWC, MAI, MBI (21 CFR 888.3040 and 888.3030) |
Description:
The Arthrex Tak™ Family is comprised of titanium alloy implants, poly (L-lactide) or PLLA implants and poly (L-lactide-Co-D, L-lactide) or PLDLA implants. They are offered in several different shapes and sizes. They are offered sterile.
Indications for Use:
The Arthrex Tak™ Family is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and in select maxillofacial applications. Specific indications are listed below:
| Skull: | Stabilization and fixation of oral cranio-maxillofacial skeletal bone,
mandible and maxillofacial bones, Lateral Canthoplasty, Repair of
Nasal Vestibular Stenosis, Brow Lift, Temporomandibular Joint
(TMJ) reconstruction, soft tissue attachment to the parietal temporal
ridge, frontal, zygoma, and perioorbital bones of the skull |
|-------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Elbow: | Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament
Reconstruction |
| Shoulder: | Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps
Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair,
Capsular Shift or Capsulolabral Reconstruction |
| Hand/Wrist: | Scapholunate Ligament Reconstruction, Carpal Ligament
Reconstruction, Repair/Reconstruction of collateral ligaments,
Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP
joints for all digits, digital tendon transfers |
| Foot/Ankle: | Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair,
Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital
tendon transfers, Mid-foot reconstruction |
| Knee: | Medial Collateral Ligament Repair, Lateral Collateral Ligament
Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair,
Iliotibial Band Tenodesis |
1
$$
\xi \bigcirc \bigcirc \bigcirc \xi \bigcirc \xi
$$
Substantial Equivalence:
By definition, substantial equivalence means that a device has the same intended use and technical characteristics as the predicate device, or has the intended use and different technological characteristics, but can be demonstrated to be as safe and effective as the predicate device for the previously cleared indications for use as well as the expanded indications noted in the above statement. These expanded indications do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the materials used in construction of these devices are well characterized and have been used in predicate devices with similar indications.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings or feathers. The eagle is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
MAY 1 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Ann Waterhouse, RAC Senior Regulatory Affairs Specialist Arthrex Incorporated 1370 Creekside Boulevard Naples, Florida 34108
Re: K050749 Trade/Device Name: Arthex Tak™ Family Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, MAI, MBI Dated: March 22, 2005 Received: March 23, 2005
Dear Ms. Waterhouse:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); 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.
3
Page 2- Ms. Ann Waterhouse, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) I ins letter will anow you to ough mationing of substantial equivalence of your device to a legally premarket notification: "The PDT Intention for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your acon 2011 276-0120 . Also, please note the regulation entitled, comact the Office of Comphalled as (21) = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = other general information on your responsibilities under the Act from the Division of Small other general information on your responser Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Oolisa.http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Stupt Rlurde
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: Arthrex Tak™ Family
Indications for Use:
The Arthrex Tak™ Family is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and in select maxillofacial applications. Specific indications are listed below:
- Stabilization and fixation of oral cranio-maxillofacial skeletal bone, Skull. mandible and maxillofacial bones, Lateral Canthoplasty, Repair of Nasal Vestibular Stenosis, Brow Lift, Temporomandibular Joint (TMJ) reconstruction, soft tissue attachment to the parietal temporal ridge, frontal, zygoma, and perioorbital bones of the skull Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Elbow: Reconstruction Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder:
- Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Hand/Wrist: Scapholunate Ligament Reconstruction. Carpal Ligament
- Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers
- Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Foot/Ankle: Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
- Medial Collateral Ligament Repair, Lateral Collateral Ligament Knee: Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Concurrence of CDRH, Office of Device Evaluation (ODE)
page 1 of 1 - 1
Division of General, Restorative, and Neurological Devices
510(k) Number K050749
1 2