(90 days)
No
The device description and performance studies focus on the mechanical properties and material safety of a surgical anchor system, with no mention of AI or ML.
Yes
The device is used for soft-tissue to bone fixation in various parts of the body to repair anatomical structures, which is a therapeutic function.
No
The device is described as an "Anchor System" intended for "soft-tissue to bone fixation" in various joints, used for surgical repairs like "Rotator Cuff Repair" or "ACL/PCL Reconstruction." This indicates it is a surgical implant used for treatment, not for diagnosing conditions.
No
The device description clearly states it consists of physical components made of PEEK (poly-ether-ether-ketone) and is intended for surgical implantation. It is a hardware device, not software.
Based on the provided information, the Stryker All-PEEK Knotless Anchor System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "soft-tissue to bone fixation" in various anatomical locations. This is a surgical procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical implant (screws and eyelets) used to anchor soft tissue to bone. This is a therapeutic device, not a diagnostic one.
- Performance Studies: The performance studies focus on mechanical properties like tensile strength and insertion testing, as well as biocompatibility (pyrogenicity and endotoxins). These are relevant to the safety and effectiveness of a surgical implant, not a diagnostic test.
- 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.
In summary, the Stryker All-PEEK Knotless Anchor System is a surgical implant used for fixation, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Stryker All-PEEK Knotless Anchor System is intended to be used for soft-tissue to bone fixation in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip.
It is indicated for use in the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair and Bunionectomy
K.nee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Secondary Fixation for ACL/PCL Reconstruction or Repair
Hand/Wrist: Scapholunate Ligament Reconstruction. Ulnar or Radial Collateral Ligament Reconstruction
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Reconstruction, Lateral Epicondylitis Repair
Hip: Capsular Repair, Acetabular Labral Repair.
Product codes
MBI
Device Description
The Stryker All-PEEK Knotless Anchor System (herein referred to as the proposed device(s)) consists of poly-ether-ether-ketone (PEEK) cannulated screws with a separate eyelet. The anchor system is designed for insertion of the eyelet and screw into bone either directly or by using instrumentation for creation of a pilot hole. Alternatively, screws may be used without the eyelet for suture fixation in a pre-drilled pilot hole by means of a cannulated screwdriver. Screws and eyelets may be provided either preloaded on respective disposable screwdrivers and inserters, or separately for manual loading. A suture threader is included with the eyelet inserter to facilitate loading of suture through the eyelet. Anchor systems are provided sterile and are packaged in single-use sterile barrier systems (SBS) that include one or more screws with or without evelets.
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, hip
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)
Non-clinical benchtop testing was performed to evaluate the performance characteristics of the Stryker All-PEEK Knotless Anchor System, including ultimate tensile strength (UTS) and insertion testing. The proposed devices demonstrated equivalent or higher pull-out strength to the predicate devices, and no new issues of safety and effectiveness were identified.
Testing was also performed on the final finished devices for material-mediated pyrogenicity and bacterial endotoxins, with passing results below the required limits.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue rectangle with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 23, 2018
Stryker Katie Farraro Senior Regulatory Affairs Specialist 5900 Optical Court San Jose, California 95138
Re: K181083
Trade/Device Name: Stryker All-PEEK Knotless 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: April 23, 2018 Received: April 24, 2018
Dear Ms. Farraro:
We have reviewed vour 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. Isting of devices, good manufacturing practice, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract hability 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 forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurence D. Coyne -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K181083
Device Name Stryker All-PEEK Knotless Anchor System
Indications for Use (Describe)
The Stryker All-PEEK Knotless Anchor System is intended to be used for soft-tissue to bone fixation in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip.
It is indicated for use in the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair and Bunionectomy
K.nee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Secondary Fixation for ACL/PCL Reconstruction or Repair
Hand/Wrist: Scapholunate Ligament Reconstruction. Ulnar or Radial Collateral Ligament Reconstruction
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Reconstruction, Lateral Epicondylitis Repair
Hip: Capsular Repair, Acetabular Labral Repair
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ------------------------------------------------------------------------------------------------- |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|
| ------------------------------------------------------------------------------------------------ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(k) Summary
I. SUBMITTER
Stryker Endoscopy 5900 Optical Ct San Jose, CA 95138
| Contact Person: | Katie Farraro, Senior Regulatory Affairs Specialist
Phone: 408-754-2285
Fax: 408-754-2507 |
|-----------------|-------------------------------------------------------------------------------------------------|
| Date Prepared: | June 22, 2018 |
II. DEVICE
| Name of Device: | Stryker All-PEEK Knotless Anchor System |
|---|---|
| Common or Usual Name: | Suture, Fastener, Fixation, Nondegradable, Soft Tissue |
| Classification Name: | Smooth or threaded metallic bone fixation fastener (21 |
| CFR 888.3040) | |
| Regulatory Class: | II |
| Product Code: | MBI |
III. PREDICATE AND REFERENCE DEVICE
Predicate Device: Arthrex SwiveLock Anchors Company Name: Arthrex 510(k) Number: K151342
Reference Device: Stryker ReelX STT Suture Anchor System Company Name: Stryker 510(k) Number: K120824
There has been one Class II recall for the predicate device due to eyelet breakage during insertion of six product configurations. The recall was initiated by the firm in March 2017.
There have been no design-related recalls for the reference device.
IV. DEVICE DESCRIPTION
The Stryker All-PEEK Knotless Anchor System (herein referred to as the proposed device(s)) consists of poly-ether-ether-ketone (PEEK) cannulated screws with a separate
4
eyelet. The anchor system is designed for insertion of the eyelet and screw into bone either directly or by using instrumentation for creation of a pilot hole. Alternatively, screws may be used without the eyelet for suture fixation in a pre-drilled pilot hole by means of a cannulated screwdriver. Screws and eyelets may be provided either preloaded on respective disposable screwdrivers and inserters, or separately for manual loading. A suture threader is included with the eyelet inserter to facilitate loading of suture through the eyelet. Anchor systems are provided sterile and are packaged in single-use sterile barrier systems (SBS) that include one or more screws with or without evelets.
V. INTENDED USE
The Stryker All-PEEK Knotless Anchor System is intended to be used for soft-tissue to bone fixation in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip.
It is indicated for use in the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Secondary Fixation for ACL/PCL Reconstruction or Repair
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Reconstruction, Lateral Epicondylitis Repair
Hip: Capsular Repair, Acetabular Labral Repair
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The proposed All-PEEK Knotless Anchor System is identical to the predicate device in terms of intended use, indications for use, raw material intended for implantation, general anchor system design features, and operational principle. It is equivalent in terms of
5
other technological characteristics and performance attributes. The minor differences between the proposed and predicate device do not raise new questions of safety and effectiveness, and these devices are substantially equivalent based on the criteria described in 21 CFR §807.100.
VII. PERFORMANCE DATA
Non-clinical benchtop testing was performed to evaluate the performance characteristics of the Stryker All-PEEK Knotless Anchor System, including ultimate tensile strength (UTS) and insertion testing. The proposed devices demonstrated equivalent or higher pull-out strength to the predicate devices, and no new issues of safety and effectiveness were identified.
Testing was also performed on the final finished devices for material-mediated pyrogenicity and bacterial endotoxins, with passing results below the required limits.
VIII. CONCLUSIONS
The information presented within this traditional premarket submission demonstrates that the Stryker All-PEEK Knotless Anchor System is substantially equivalent to the predicate device and will perform as safely and effectively within the intended use.