(54 days)
Not Found
No
The device description and intended use clearly describe a mechanical suture anchor system and associated instruments, with no mention of software, algorithms, or data processing that would indicate the presence of AI/ML.
No
The device is a suture anchor system used for fixation of tissue to bone, not a therapeutic device designed to treat or cure a disease or condition. It aids in surgical repair.
No
The device is a medical implant (suture anchor) used for fixation of soft tissue to bone during surgical procedures. Its intended use is therapeutic, not diagnostic.
No
The device description clearly describes a physical, implantable suture anchor made of titanium, along with associated instruments for implantation. This is a hardware device, not software.
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, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description and intended use of the Titan Ti Suture Anchor System clearly indicate it is a surgical implant used to fix soft tissue to bone within the body during various orthopedic procedures. It is a physical device used for mechanical support and repair, not for analyzing biological samples.
The information provided focuses on the surgical application and physical characteristics of the anchor, not on any diagnostic testing performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Titan Ti Suture Anchor System is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist and elbow in the following procedures:
- Shoulder· Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps 비 Tendodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, 트 Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament/Tendon Repair, Bunionectomy;
- Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, ■ Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodosis;
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament I Reconstruction, Radial Collateral Ligament Reconstruction,
- Elbow Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial 내 Collateral Ligament Reconstruction, Lateral Epicondylitis repair;
- 미 Hip: Capsular Repair, Acetabular Labral Repair
Product codes
MBI
Device Description
The ArthroCare Titan Ti Suture Anchor is a fully-threaded, self-tapping, titanium corkscrew shape anchor available in 5.5mm and 6.5mm diameter sizes. The suture anchor comes preconfigured with Magnum Wire® sutures and is mounted on a disposable delivery driver The device is supplied sterile and is available with or without needles. The optional Titan instruments are used to facilitate implantation and removal of the Titan Ti Suture Anchor
· 5.5mm Titan Ti Suture Anchor with #2 Magnum Wire with Needles
· 5.5mm Titan Ti Suture Anchor with #2 MagnumWire
· 6.5mm Titan Ti Suture Anchor with #2 Magnum Wire with Needles
· 6.5mm Titan Ti Suture Anchor with #2 Magnum Wire
· Titan Bone Punch
· Titan Removal Tool Driver
· Titan Removal Tool Capture Sleeve
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, foot/ankle, hip, knee, hand/wrist, elbow
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
111397
510(k) Summary
ArthroCare Corporation TitanTM Ti Suture Anchor System
General Information Submitter Name/Address:
ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936 2951580 Establishment Registration Number: Valerie Defiesta-Ng Contact Person: Director, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, CA 94085-2936 (408) 735-6426 Date Prepared: May 18, 2011 Device Description · 5.5mm Titan Ti Suture Anchor Trade Name: with #2 Magnum Wire with Needles · 5.5mm Titan Ti Suture Anchor with #2 MagnumWire · 6.5mm Titan Ti Suture Anchor with #2 Magnum Wire with Needles · 6.5mm Titan Ti Suture Anchor with #2 Magnum Wire · Titan Bone Punch · Titan Removal Tool Driver · Titan Removal Tool Capture Sleeve Smooth or Threaded Metallic Bone Generic/Common Name: Fixation Fastener (21 CFR 888.3040) Class II, 21 CFR 888.3040 Classification Name: Product Code MBI Predicate Devices Arthrocare Titan Ti Suture Anchor K092133 (11/5/2009) K101184 (5/18/2010) Arthrocare Titan Ti Suture Anchor System
p. 1 of 2
1
KI1397
Product Description
The ArthroCare Titan Ti Suture Anchor is a fully-threaded, self-tapping, titanium corkscrew shape anchor available in 5.5mm and 6.5mm diameter sizes. The suture anchor comes preconfigured with Magnum Wire® sutures and is mounted on a disposable delivery driver The device is supplied sterile and is available with or without needles. The optional Titan instruments are used to facilitate implantation and removal of the Titan Ti Suture Anchor
Intended Uses/Indications for Use
The Titan Ti Suture Anchor System is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist and elbow in the following procedures:
- Shoulder· Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps 비 Tendodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, 트 Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament/Tendon Repair, Bunionectomy;
- Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, ■ Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodosis;
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament I Reconstruction, Radial Collateral Ligament Reconstruction,
- Elbow Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial 내 Collateral Ligament Reconstruction, Lateral Epicondylitis repair;
- 미 Hip: Capsular Repair, Acetabular Labral Repair
Substantial Equivalence
The Titan Ti Suture Anchor system design and technology is substantially equivalent to the existing Titan Ti Suture Anchor devices cleared in K101184 and K092133 The addition of polyethylene tubing to improve shaft design does not raise new questions regarding the safety and effectiveness of the Titan Ti Suture Anchor system. The proposed system is safe and effective as the predicate device.
Summary of Safety and Effectiveness
The proposed modifications to the Titan Ti Suture Anchor System are not substantial changes, and do not significantly affect the safety or efficacy of the predicate device.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread. The eagle is facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
ArthroCare Corporation % Ms.Valerie Defiesta Regulatory Affairs Director 680 Vaqueros Avenue Sunnyvale, California 94085-3523
JUL 1 2 2011
Re: K111397
Trade/Device Name: Titan Ti Suture Anchor System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: June 30, 2011 Received: July 1, 2011
Dear Ms. Defiesta:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Valerie Defiesta
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
E. Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number:
Kj1/397
Device Name:
ArthroCare® Titan™ Ti Suture Anchor System
Indications for Use:
The Titan Ti Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist and elbow in the following procedures:
- Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps l Tendodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, 요 Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament/Tendon Repair, Bunionectomy;
- Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, 미 Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodosis;
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament 트 Reconstruction, Radial Collateral Ligament Reconstruction;
- Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial 트 Collateral Ligament Reconstruction, Lateral Epicondylitis repair;
- Hip: Capsular Repair, Acetabular Labral Repair 트
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 | |
| Subpart D) |
AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
| (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) | |
|---|---|
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
| for M. Melkerson | |
| (Division Sign-Off) | |
| Division of Surgical, Orthopedic, | |
| and Restorative Devices | |
| 510(k) Number | K111397 |
510(k) Number