(89 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a physical suture anchor and its insertion tool. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
This device is designed to secure soft tissue to bone during reconstructive surgery, which is a therapeutic intervention aimed at restoring function and structure.
No
This device is a surgical implant (suture anchor) used to secure soft tissue to bone during reconstructive surgery, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components made of PEEK, UHMWPE, ABS, and stainless steel, along with sutures. This indicates a hardware-based medical device, not a software-only one.
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 used to "secure soft tissue to bone during reconstructive surgery." This is a surgical procedure performed directly on a patient's body.
- Device Description: The description details a physical implantable device (bone screw, suture anchor, sutures) and an insertion tool. These are all components used in a surgical setting.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or disease. IVDs are designed for diagnostic purposes, not for surgical repair.
- Performance Studies: The performance studies focus on the mechanical strength, biocompatibility, and sterilization of the device, which are relevant to a surgical implant, not a diagnostic test.
In summary, the Stabilynx Suture Anchor is a surgical implant used for tissue repair, not a device used to perform in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The Stabilynx Suture Anchor is a soft tissue anchor which will be used to secure soft tissue to bone during reconstructive surgery. The anchor is intended for use in such procedures as:
• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Acromio-Clavicular Separation Repair, Capsular Shift/Capsulolabral Reconstruction, Biceps Tendonesis, Deltoid Repair
• Knee: Extra Capsular Repairs (Medial Collateral Ligament, Lateral Ligament, Posterior Oblique Ligament), Illiotibial Band Tendonesis, Patellar Tendon Repair
• Elbow, Wrist, Hand: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Biceps Tendon Reattachment
• Foot and Ankle: Medial Instability Repair/Reconstruction, Lateral Instability Repair/Reconstruction, Achilles Tendon Repair/Reconstruction, Midfoot Reconstruction, Hallux Valgus Reconstruction
Product codes
MBI
Device Description
The Stabilynx PEEK Suture Anchor consists of an ethylene oxide sterilized, implantable, poly-ether-etherketone (PEEK) bone screw and ultra high molecular weight polyethylene (UHMWPE) suture anchor is supplied pre-mounted on a disposable Insertion Tool, which consists of a non-patient contact, acrylonitrile butadiene styrene (ABS) handle molded over an externally-communicating, stainless steel shaft. The anchor comes pre-loaded with two (2) high-strength, polyethylene, non-absorbable sutures. The Stabilynx PEEK Suture Anchor design allows a surgeon to create at least one contiguous suture link between one or more adjacent suture anchors after the suture anchors have been inserted into bone. The suture anchor is designed such that one or both of the pre-loaded sutures may be exchanged with one or more sutures connected to an adjacent suture anchor(s).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Knee, Elbow, Wrist, Hand, Foot, Ankle, bone
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)
Bench Testing: Verification tests included: a) Dimensional and Visual Inspections; b) Suture Loop Exchange Force; c) Fixation Strength with and without Cycle Loading; d) Inserter and Anchor Torque Strength; e) Suture Knot-Pull Tensile Strength; and, f) Repair Suture Bifurcated Loop Strength. These tests were conducted on ethylene oxide sterilized units at baseline and on devices subjected to accelerated aging conditions equivalent to three (3) months. Passing results were obtained for all design verification tests.
Biocompatibility Testing: The biocompatibility evaluation for the Stabilynx PEEK Suture Anchor was conducted in accordance with the requirements defined in ISO 10993-1 "Biological Evaluation of Medical Devices" and FDA's guidance ("Use of International Standard ISO 10993", draft document issued on 24 April 2013 and BlueBook Memorandum #G95-1 dated 01 May 1995). Testing included the following: 1) Cytotoxicity; and, 2) Systemic Toxicity. The device is comprised of: 1) an inserter shaft that is considered a tissue/bone contacting component for a duration of
§ 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing right, stacked on top of each other, with flowing lines extending from the bottom profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 15, 2014
Stabilynx, Incorporated Mr. Mike Rosenthal Vice President, Engineering Operations 3475-0 Edison Wav Menlo Park, California 94025
Re: K142643
Trade/Device Name: Stabilynx PEEK Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: September 15, 2014 Received: September 17, 2014
Dear Mr. Rosenthal:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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/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 Industry and Consumer Education 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,
Lori A. Wiggins -S
for Mark N. Melkerson Director Department of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Stabilynx PEEK Suture Anchor
Indications for Use (Describe)
The Stabilynx Suture Anchor is a soft tissue anchor which will be used to secure soft tissue to bone during reconstructive surgery. The anchor is intended for use in such procedures as:
• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Acromio-Clavicular Separation Repair, Capsular Shift/Capsulolabral Reconstruction, Biceps Tendonesis, Deltoid Repair
· Knee: Extra Capsular Repairs (Medial Collateral Ligament, Lateral Ligament, Posterior Oblique Ligament), Illiotibial Band Tendonesis, Patellar Tendon Repair
· Elbow, Wrist, Hand: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Biceps Tendon Reattachment
· Foot and Ankle: Medial Instability Repair/Reconstruction, Lateral Instability Repair/Reconstruction, Achilles Tendon Repair/Reconstruction, Midfoot Reconstruction, Hallux Valgus Reconstruction
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Section 6: 510(k) Summary (21 CFR § 807.92(c))
I: SUBMITTER INFORMATION
| Submitter: | Stabilynx, Inc.
3475-0 Edison Way
Menlo Park, CA 94025 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mike Rosenthal
Vice President, Engineering Operations, Stabilynx
Phone: 650.503.3329
Fax: 650.618.1440
Email: mrosenthal@d3dc.com |
| Date Summary Prepared: | 15 September 2014 |
II: SUBJECT DEVICE INFORMATION
| Device Trade Name: | Stabilynx PEEK Suture Anchor |
|---|---|
| Common Name: | Fastener, Fixation, Nondegradable, Soft Tissue |
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
| (21 CFR §888.3040) | |
| Product Code: | MBI |
III: PREDICATE DEVICE INFORMATION
Stryker PEEK Zip Suture Anchor (K070758) Predicate Device:
No recalls, market withdrawals or safety alerts were identified in FDA's database for the above referenced predicate device.
No reference devices were used in this submission.
IV: DEVICE DESCRIPTION:
The Stabilynx PEEK Suture Anchor consists of an ethylene oxide sterilized, implantable, poly-ether-etherketone (PEEK) bone screw and ultra high molecular weight polyethylene (UHMWPE) suture anchor is supplied pre-mounted on a disposable Insertion Tool, which consists of a non-patient contact, acrylonitrile butadiene styrene (ABS) handle molded over an externally-communicating, stainless steel shaft. The anchor comes pre-loaded with two (2) high-strength, polyethylene, non-absorbable sutures. The Stabilynx PEEK Suture Anchor design allows a surgeon to create at least one contiguous suture link between one or more adjacent suture anchors after the suture anchors have been inserted into bone. The suture anchor is designed such that one or both of the pre-loaded sutures may be exchanged with one or more sutures connected to an adjacent suture anchor(s).
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V. INDICATIONS FOR USE:
The Stabilynx Suture Anchor is a soft tissue anchor which will be used to secure soft tissue to bone during reconstructive surgery. The anchor is intended for use in such procedures as:
- . Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Acromio-Clavicular Separation Repair, Capsular Shift/Capsulolabral Reconstruction, Biceps Tendonesis, Deltoid Repair
- . Knee: Extra Capsular Repairs (Medial Collateral Ligament, Lateral Collateral Ligament, Posterior Oblique Ligament), Illiotibial Band Tendonesis, Patellar Tendon Repair
- . Elbow, Wrist, Hand: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Biceps Tendon Reattachment
- . Foot and Ankle: Medial Instability Repair/Reconstruction, Lateral Instability Repair/Reconstruction, Achilles Tendon Repair/Reconstruction, Midfoot Reconstruction, Hallux Valgus Reconstruction
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:
The primary technological principle for the subject and predicate devices is to anchor suture to bone so that the suture may be used to secure soft tissue to bone. The subject and predicate devices accomplish this function by similar means. At a high level, the subject and predicate devices are based on the following same technological elements:
- . PEEK implantable bone screw and non-absorbable sutures
- Ability to secure soft tissue to bone during reconstructive procedures
The following technological differences exist between the subject and predicate devices:
- Sutures in the subject device contain suture loops at either end
- Suture loops of the subject device enable contiguous linking of adjacent suture anchors
VII. PERFORMANCE DATA:
The following performance data were provided in support of the substantial equivalence determination.
Bench Testing
Verification tests included: a) Dimensional and Visual Inspections; b) Suture Loop Exchange Force; c) Fixation Strength with and without Cycle Loading; d) Inserter and Anchor Torque Strength; e) Suture Knot-Pull Tensile Strength; and, f) Repair Suture Bifurcated Loop Strength. These tests were conducted on ethylene oxide sterilized units at baseline and on devices subjected to accelerated aging conditions equivalent to three (3) months. Passing results were obtained for all design verification tests.
Biocompatibility Testing
The biocompatibility evaluation for the Stabilynx PEEK Suture Anchor was conducted in accordance with the requirements defined in ISO 10993-1 "Biological Evaluation of Medical Devices" and FDA's guidance ("Use of International Standard ISO 10993", draft document issued on 24 April 2013 and BlueBook Memorandum #G95-1 dated 01 May 1995). Testing included the following: 1) Cytotoxicity; and, 2) Systemic Toxicity. The device is comprised of: 1) an inserter shaft that is considered a tissue/bone
5
contacting component for a duration of