(30 days)
No
The device description and intended use are purely mechanical, describing a suture anchor and its applications. There is no mention of any software, algorithms, or data processing that would suggest the use of AI/ML.
Yes
The device is described with specific indications for use in repairing and reconstructing various ligaments and tendons in multiple anatomical sites, which aligns with the function of a therapeutic device.
No
The device is an implantable suture anchor used for tissue fixation and repair, not for diagnosing medical conditions.
No
The device description clearly states it is a physical suture anchor made of PEEK material with preloaded suture and an insertion device. This is a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Arthrex Knotless SutureTak Anchor is a physical implant made of PEEK material with suture, intended for surgical fixation of suture or tissue within the body. The listed indications are all surgical procedures involving the musculoskeletal system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
This device is a surgical implant used for mechanical support and fixation during orthopedic procedures.
N/A
Intended Use / Indications for Use
The Arthrex Knotless SutureTak Anchor is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repairs, 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 Reconstructions, 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
Hip: Capsular Repair, Acetabular Labral repair
Product codes
MBI, HWC, GAT
Device Description
The Arthrex Knotless SutureTak Anchor is a tap-in ribbed suture anchor comprised of PEEK material and preloaded with UHMWPE looped suture and assembled to an insertion device. The proposed anchor is being offered in a 3 mm diameter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, foot/ankle, knee, hand/wrist, elbow, and hip. Foot, ankle, knee, hand, wrist, elbow, shoulder, and hip.
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
The mechanical testing demonstrates that the proposed device meets or exceeds the established minimum acceptance criteria for tensile (pull-out) strength for the desired indications.
Key Metrics
Not Found
Predicate Device(s)
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
/20155 Page 1/2
Arthrex SPECIAL 510(k): Arthrex Knotless SutureTak Anchor
1 510(k) Summary of Safety and Effectiveness
| Date Summary Prepared | January 17, 2012 |
|---|---|
| Purpose of Submission | To obtain clearance of the Arthrex Knotless SutureTak Anchor devices. |
| Manufacturer/Distributor/Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | Christina Flores |
| Regulatory Affairs Specialist | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643.5553, ext. 1819 | |
| Fax: 239/598.5508 | |
| Email: christina.flores@arthrex.com | |
| Trade Name | Knotless SutureTak Anchor |
| Common Name | fastener, fixation, nondegradable, soft tissue |
| Product Code - Classification Name | MBI - 21 CFR 888.3040 fastener, fixation, nondegradable, soft tissue |
| HWC - 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener | |
| GAT - 21 CFR 878.5000: Nonabsorbable poly(ethylene terephthalate) surgical suture | |
| Predicate Devices | K061863 Arthrex 3 mm PEEK SutureTak |
| Device Description and Intended Use | The Arthrex Knotless SutureTak Anchor is a tap-in ribbed suture anchor comprised of PEEK material and preloaded with UHMWPE looped suture and assembled to an insertion device. The proposed anchor is being offered in a 3 mm diameter. |
The Arthrex Knotless SutureTak Anchor is intended to be used for suture or soft tissue fixation to bone in shoulder, foot/ankle, knee, hand/wrist, elbow, and hip. These indications are identical to those cleared in K061863 with the exception of the removal of the Skull and Pelvis indications.
The Arthrex Knotless SutureTak Anchor is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP |
i
Page 8 of 19
1
120155 Page 2/2
Arthrex SPECIAL 510(k): Arthrex Knotless SutureTak Anchor
| | | Lesion Repair, Biceps Tenodesis, Acromio-
Clavicular Separation Repair, Deltoid Repair,
Capsular Shift or Capsulolabral Reconstruction | |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | Hand/Wrist: | Scapholunate Ligament Reconstruction, Carpal
Ligament Reconstructions,
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 | |
| | Hip: | Capsular Repair, Acetabular Labral repair | |
| Substantial Equivalence
Summary | The Arthrex Knotless SutureTak Anchor is substantially
equivalent to the predicate devices in which the basic features
and intended uses are the same. Any differences between the
Knotless SutureTak Anchor and the predicates are considered
minor and do not raise questions concerning safety and
effectiveness. | | |
| | | The mechanical testing demonstrates that the proposed device
meets or exceeds the established minimum acceptance criteria for
tensile (pull-out) strength for the desired indications. | |
| | | Based on the indication for use, technological characteristics, and
summary of data submitted, Arthrex, Inc. has determined that the
Arthrex Knotless SutureTak Anchor is substantially equivalent
to currently marketed predicate devices. | |
2
Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The text is black and the background is white.
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized abstract symbol resembling an eagle or bird in flight, positioned to the right. Encircling the symbol is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", arranged in a circular fashion.
FEB 1 7 2012
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Arthrex, Inc. % Ms. Christina Flores 1370 Creekside Boulevard Naples, FL 34108-1945
Re: K120155
Trade/Device Name: Arthrex Knotless SutureTak Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI, HWC, GAT Dated: January 17th, 2012 Received: January 18th, 2012
Dear Ms. Flores:
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.
3
Page 2 – Ms. Christina Flores
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/default.htm.
Sincerely vours.
Erin L. Keith
Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Arthrex SPECIAL 510(k): Arthrex Knotless SutureTak Anchor
3 Indications for Use Form
Indications for Use
K120155 510(k) Number (if known): .
Device Name:
Arthrex Knotless SutureTak Anchor
Indications For Use:
The Arthrex Knotless SutureTak Anchor is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:
| Elbow: | Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction |
|---|---|
| Shoulder: | Rotator Cuff Repairs, 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 Reconstructions, 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 |
| Hip: | Capsular Repair, Acetabular Labral repair |
Prescription Use _ X _ AND/OR Over-The-Counter Use __
(Per 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
PAGE 1 of 1
Concurrence of CDRH, Office of Device Evaluation (ODE)
PAGE 1 of 1
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
PAGET OF TO
510(k) Number K120155