(113 days)
I'm sorry, I cannot find any Predicate Device(s) K/DEN numbers in the given input "Not Found".
Not Found
No
The device description and intended use clearly define a mechanical suture anchor and its application in surgical procedures. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
Explanation: The device is intended for the fixation of suture (soft tissue) to bone in various surgical procedures, which directly addresses an injury or condition, classifying it as a therapeutic device.
No.
The provided text describes the Titan Ti Suture Anchor as a device intended for surgical fixation of suture to bone in various joints, such as the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow. It functions as a mechanical fastener during surgical procedures, not to diagnose a condition.
No
The device description clearly describes a physical, implantable suture anchor made of titanium, which is a hardware component.
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 used to fix soft tissue to bone within the body. This is a therapeutic and structural function, not a diagnostic one performed on samples outside the body.
- Device Description: The description details a physical implant (suture anchor) and its delivery system. This aligns with a surgical device, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Titan Ti Suture Anchor does not fit this description.
N/A
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.
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K092133 p.1 of 2 .
510(k) Summary
NOV - 5 2009
ArthroCare® Corporation Titan™ Ti Suture Anchor
:
General Information Submitter Name/Address:
Establishment Registration Number:
Contact Person:
Date Prepared:
Device Description Trade Name:
Generic/Common Name:
Tissue
Classification Name:
Device Classification:
680 Vaqueros Avenue Sunnyvale, CA 94085-3523
ArthroCare Corporation
2951580
Valerie Defiesta-Ng Director, Regulatory Affairs
July 13, 2009
Titan Ti Suture Suture Anchor
Screw, Fixation, Bone; Fastener, Fixation, Nondegradable, Soft
Smooth or Threaded Metallic Bone Fixation Fastener (21 CFR 888.3040)
Class II, 21 CFR 888.3040 Product Code MBI and HWC
Predicate Devices
Arthrex Corkscrew FT Suture Anchor Arthrex Corkscrew FT Suture Anchor Arthrex Corkscrew FT III Suture Anchor Arthrex Corkscrew, Corkscrew FT, Bio-Corkscrew, and Bio Corkscrew FT Suture Anchor(s)
K050358 cleared 04/15/05) K061665 (cleared 07/25/06) K062679 (cleared 09/27/06) K061863 (cleared 10/19/06)
Product Description
The 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 MagnumWire® sutures and is mounted on a disposable delivery driver. The device is supplied sterile and is available with or without needles.
1
Intended Uses/Indications for Use
The Titan Ti Suture 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 미 Tendodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, . 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 . Reconstruction, Radial Collateral Ligament Reconstruction;
- Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial 해 Collateral Ligament Reconstruction, Lateral Epicondylitis repair;
- 1 Hip: Capsular Repair, Acetabular Labral Repair
Substantial Equivalence
In establishing substantial equivalence to the predicate devices. ArthroCare compared the indications for use, dimensional specifications, and performance specifications of the subject device and the predicate device. Additionally, performance testing has been completed to demonstrate the substantial equivalence of the Titan Ti Suture Anchor to the predicate device. The performance testing and device comparison demonstrate that the subject devices are substantially equivalent to the predicate devices, and is safe and effective for its intended use.
Summary of Safety and Effectiveness
The Titan Ti Suture Anchor, as described in this premarket notification 510(k), is substantially equivalent to the predicate devices. The differences in performance specifications, and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The bird is positioned above a wavy line, possibly symbolizing water or movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
ArthroCare Corporation c/o Ms. Valerie Defiesta-Ng Director, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085-3523
NOV - 5 2009
Re: K092133
Trade/Device Name: Titan™ Ti Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MBI Dated: October 20, 2009 Received: October 21, 2009
· Dear Ms. Defiesta-Ng:
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
3
Page 2 - Ms. Valerie Defiesta-Ng
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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Sincerely yours,
Mark McMilleon
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
Titan™ Ti Suture Anchor Device Name
KOGZI33 510(k) Number:
Indications for Use:
The Titan Ti Suture 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 . Tendodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; '
- 비 Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, 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 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 .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109)
OR
Over-the-Counter Use
Onetta for mxn
(Division Sign) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number KD92133