(91 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and fixation strength of a physical suture anchor system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
A therapeutic device is used to treat a disease, injury, or other condition. This device is a soft-tissue fixation device used for soft-tissue to bone fixation, which is a structural repair rather than a therapeutic treatment.
No
The device is described as an "All Suture Anchor System" intended for "soft-tissue to bone fixation". Its function is to fix tissues, not to diagnose a condition.
No
The device description clearly states it is a "soft-tissue fixation device with a push-in design, provided preloaded on a disposable inserter" and is "composed of a sheath structure that contains one or more working sutures." This describes a physical, implantable medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "soft-tissue to bone fixation" in various anatomical locations. This is a surgical procedure, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a physical implantable device ("soft-tissue fixation devices with a push-in design") used for mechanical fixation. This is not consistent with the nature of IVD devices, which are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
The ICONIX All Suture Anchor System is a surgical implant used for musculoskeletal repair.
N/A
Intended Use / Indications for Use
The ICONIX All Suture Anchor System is intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder. Specific Indications are listed below.
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 Repair
- Hand/Wrist: Scaphulolunate 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 Repair
- 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, Gluteal Tendon Repair
The ICONIX All Suture Anchors are intended for single use only.
Product codes
MBI
Device Description
This Traditional 510(k) is being supplied to the U.S. FDA to expand the indications of the Stryker All Suture Anchors (K120509) (currently marketed as the ICONIX All Suture Anchor System) to include Gluteal Tendon Repair of the Hip. The ICONIX All Suture Anchors are softtissue fixation devices with a push-in design, provided preloaded on a disposable inserter. They are composed of a sheath structure that contains one or more working sutures. As the anchor is deployed, the sheath bunches and fixates in bone. There have been no design modifications to the ICONIX All Suture Anchors since the original clearance (K120509).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, ankle, knee, hip, hand, wrist, elbow and shoulder
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
Non-Clinical Testing: In order to support the additional indication, non-clinical comparative bench testing was performed to verify the fixation strength of the ICONIX All Suture Anchors. Cyclic testing followed by ultimate tensile strength was evaluated in order to support the efficacy of the ICONIX All Suture Anchors as compared to the predicate devices identified within this premarket notification. The results of this evaluation indicate that the ICONIX All Suture Anchors provide statistically equivalent fixation strength to the predicate devices, and will be functional within the intended use.
Clinical Testing: Clinical testing was not required for this submission.
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
Image /page/0/Picture/2 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase, and there is a small circle above and to the right of the "r". The word is black against a white background.
| Endoscopy
| 510(k) Summary of Safety and Effectiveness | |
|---|---|
| Proprietary Name: | ICONIX All Suture Anchor System |
| Common Name: | Fastener, Fixation, Nondegradable, Soft Tissue |
| Classification Name and Reference: | Smooth or threaded metallic bone fixation fastener |
| 21 CFR §888.3040 | |
| Proposed Regulatory Class: | Class II |
| Product Codes: | MBI: Fastener, Fixation, Nondegradable, Soft Tissue |
| Device Owner: | Stryker Endoscopy |
| 5900 Optical Court | |
| San Jose, CA 95138 | |
| For Information Contact: | Kelly Kucharczyk |
| Regulatory Affairs Specialist | |
| Howmedica Osteonics Corp. | |
| 3201 E. 3rd Ave | |
| Denver, CO 80210 | |
| Phone: (303) 336-7285; Fax (303) 370-5775 | |
| Email: kelly.kucharczyk@stryker.com | |
| Legally Marketed Devices to Which | |
| Substantial Equivalence Is Claimed: | K120509 – Stryker All Suture Anchors |
| K110545 - Smith & Nephew Next Generation Fully | |
| Threaded PEEK Suture Anchor (marketed as the | |
| Healicoil PK Suture Anchor) | |
| Date Prepared: | November 26, 2013 |
Description
This Traditional 510(k) is being supplied to the U.S. FDA to expand the indications of the Stryker All Suture Anchors (K120509) (currently marketed as the ICONIX All Suture Anchor System) to include Gluteal Tendon Repair of the Hip. The ICONIX All Suture Anchors are softtissue fixation devices with a push-in design, provided preloaded on a disposable inserter. They are composed of a sheath structure that contains one or more working sutures. As the anchor is deployed, the sheath bunches and fixates in bone. There have been no design modifications to the ICONIX All Suture Anchors since the original clearance (K120509).
Intended Use
The ICONIX All Suture Anchor System is intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder. Specific Indications are listed below.
1
Indications
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 Repair
- Hand/Wrist: Scaphulolunate 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 Repair
- 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, Gluteal Tendon Repair
The ICONIX All Suture Anchors are intended for single use only.
Summary of Technologies
The ICONIX All Suture Anchors are substantially equivalent in design, materials of construct, performance attributes, and operational principles to its currently marketed predicate devices, the Stryker All Suture Anchors (currently marketed as the ICONIX All Suture Anchor System) and the Smith and Nephew Next Generation Fully Threaded PEEK Suture Anchor (currently marketed as the Healicoil PK Suture Anchor).
Non-Clinical Testing
In order to support the additional indication, non-clinical comparative bench testing was performed to verify the fixation strength of the ICONIX All Suture Anchors. Cyclic testing followed by ultimate tensile strength was evaluated in order to support the efficacy of the ICONIX All Suture Anchors as compared to the predicate devices identified within this premarket notification. The results of this evaluation indicate that the ICONIX All Suture Anchors provide statistically equivalent fixation strength to the predicate devices, and will be functional within the intended use.
Clinical Testing
Clinical testing was not required for this submission.
Conclusion
Based on the information discussed above, the ICONIX All Suture Anchors are as safe, as effective, and perform as well or better to the predicate devices listed within this submission.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 28, 2014
Stryker Endoscopy Ms. Kelly Kucharczyk Regulatory Affairs Specialist 5900 Optical Court San Jose. California 95138
Re: K133671
Trade/Device Name: ICONIX All 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: November 26, 2013 Received: December 4, 2013
Dear Ms. Kucharczyk:
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. Kelly Kucharczyk
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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,
Vincent到
- for
and and the first the state of the states
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K133671
Device Name: ICONIX All Suture Anchor System
Elbow: Biceps Tendon Re-attachment, 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 Repair
- Hand/Wrist: Scaphulolunate 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 Repair
- 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. Gluteal Tendon Repair
The ICONIX All Suture Anchors are intended for single use only.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)
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Image /page/4/Picture/14 description: The image shows the logo for the FDA's Division of Orthopedic Devices. The text "Casey L. Hanley, Ph.D." is written above a horizontal line, and the text "Division of Orthopedic Devices" is written below the line. The FDA logo is on the right side of the image.
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