(86 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a physical implant (anchor system) and do not mention any software, algorithms, or data processing that would involve AI or ML.
Yes
The device is intended for "bone fixation" and listed "procedures" related to musculoskeletal repair (e.g., Rotator Cuff Repair, Achilles Tendon Repair), indicating it directly treats or restores function to a diseased or injured body part.
No
This device is an anchor system intended for bone fixation in various parts of the body. Its purpose is to provide mechanical support for repairs, not to diagnose medical 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, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "bone fixation in the shoulder, foot/ ankle, knee, hand/wrist, elbow, and hip" and lists various surgical procedures. This describes a device used in vivo (within the body) for structural support and repair.
- Device Description: The description details a system of screws and eyelets made of PEEK, designed for insertion into bone. This further confirms its use as an implantable or surgically placed device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing. IVDs are typically used in laboratories or point-of-care settings to analyze biological samples.
Therefore, the Stryker Omega PEEK Knotless Anchor System is a surgical implant/device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Stryker Omega PEEK Knotless Anchor System is intended 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 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, Meniscal Root Repair
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction
Elbow: Biceps Tendon Reattachment, Temis Elbow Repair, Unar or Radial Collateral Reconstruction, Lateral Epicondylitis Repair
Hip: Capular Repair, Acetabular Labral Repair
Product codes
MBI
Device Description
The Stryker Omega PEEK Knotless Anchor System consists of poly-ether-ether-ketone ("PEEK") cannulated screws with a separate PEEK 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 eyelets.
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, and 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 conducted to evaluate the performance characteristics of the modified Stryker Omega PEEK Knotless Anchor System. Ultimate tensile strength (UTS) and insertion testing were performed to assess the proposed eyelet modification, and cyclic displacement testing was performed to demonstrate that the displacement of the modified Omega anchors is within a clinically acceptable range for meniscal root repair. The modified Omega anchors demonstrated equivalent pull-out strength to the Predicate A devices and equivalent displacement to the Predicate B devices, and no new issues of safety and effectiveness were identified.
Biocompatibility testing was performed on the final finished devices per ISO 10993-1:2018 to confirm that the modified Omega system met all required biocompatibility testing endpoints. Testing for materialmediated pyrogenicity and bacterial endotoxins was also performed, with passing results below the required limits.
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
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
November 13, 2020
Image /page/0/Picture/1 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 and Human Services logo on the left and the FDA logo on the right. The FDA logo includes a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Stryker Katie Farraro Staff Regulatory Affairs Specialist 5900 Optical Ct. San Jose, California 95138
Re: K202355
Trade/Device Name: Stryker Omega 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: August 18, 2020 Received: August 19, 2020
Dear Katie Farraro:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Food and Drug Administration
Expiration Date: 06/30/2020
510(k) Number (if known) K202355
Device Name Stryker Omega PEEK Knotless Anchor System
Indications for Use (Describe)
The Stryker Omega PEEK Knotless Anchor System is intended 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 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, Meniscal Root Repair
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction
Elbow: Biceps Tendon Reattachment, Temis Elbow Repair, Unar or Radial Collateral Reconstruction, Lateral Epicondylitis Repair
Hip: Capular 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) |
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3
510(k) Summary
I. SUBMITTER
Stryker Endoscopy 5900 Optical Ct. San Jose, CA 95138
| Contact Person: | Katie Farraro, PhD, RAC |
|---|---|
| Staff Regulatory Affairs Specialist | |
| Phone: 408-754-2285 |
Date Prepared: August 18, 2020
II. DEVICE
| Name of Device: | Stryker Omega PEEK Knotless Anchor System |
|---|---|
| Common 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 DEVICE
Predicate A (Primary Predicate): Stryker All-PEEK Knotless Anchor System Company Name: Stryker 510(k) Number: K181083
Predicate B: Arthrex SwiveLock C Anchors Company Name: Arthrex 510(k) Number: K173845
IV. OBJECTIVE
The purpose of this Traditional 510(k) submission is to obtain Food and Drug Administration (FDA) authorization to market a modified Omega PEEK Knotless Anchor System. Specifically, this submission proposes two unrelated modifications to Stryker's legally marketed Omega system: 1) a modification to the anchor system's eyelet, and 2) an expansion in the indications for use to include meniscal root repair.
V. DEVICE DESCRIPTION
The Stryker Omega PEEK Knotless Anchor System consists of poly-ether-ether-ketone ("PEEK") cannulated screws with a separate PEEK 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
4
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 eyelets.
VI. INTENDED USE
The Stryker Omega 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, Acromioclavicular 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 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, Meniscal Root 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
VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
The modified Omega PEEK Knotless Anchor System is identical to Predicate A (original Omega system) in terms of intended use, geometric design, operational principle, sterilization method, packaging, and shelf life. It is identical to Predicate B (SwiveLock C Anchors) in terms of intended use, indications for use, general design features, and operational principle. It is equivalent to both predicate devices in terms of materials intended for implantation and performance attributes. The minor differences between the modified Omega system and predicate devices 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.
VIII. PERFORMANCE DATA
Non-clinical benchtop testing was conducted to evaluate the performance characteristics of the modified Stryker Omega PEEK Knotless Anchor System. Ultimate tensile strength (UTS) and insertion testing were performed to assess the proposed eyelet modification, and cyclic displacement testing was performed to demonstrate that the displacement of the modified Omega anchors is within a clinically
5
acceptable range for meniscal root repair. The modified Omega anchors demonstrated equivalent pull-out strength to the Predicate A devices and equivalent displacement to the Predicate B devices, and no new issues of safety and effectiveness were identified.
Biocompatibility testing was performed on the final finished devices per ISO 10993-1:2018 to confirm that the modified Omega system met all required biocompatibility testing endpoints. Testing for materialmediated pyrogenicity and bacterial endotoxins was also performed, with passing results below the required limits.
IX. CONCLUSIONS
The information presented within this Traditional premarket submission demonstrates that the modified Stryker Omega PEEK Knotless Anchor System is substantially equivalent to the predicate devices and will perform as safely and effectively within the intended use.