The Knotilus+ PEEK Knotless Anchor is intended to be used for soft-tissue to bone fixation in the shoulder, foot and ankle, knee, hand and wrist, elbow, and hip in skeletally mature pediatric and adult patients. It is indicated for use in the following procedures:

2.4x11.3mm, 2.9x12.5mm, and 2.9x15.5mm:

Shoulder: Rotator Cuff Repair. Bankart Repair. SLAP Lesion Repair. Biceps Tenodesis. Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift, or Capsulolabral Reconstruction Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament and Tendon Repair Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hand and /Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair Hip: Acetabular Labral Repair

2.4x8.9mm:

Hip: Acetabular Labral Repair

Device Description

The Knotilus+ PEEK Knotless Anchors (herein referred to as the subject device(s)) are bone anchors with a push-in mechanism. The subject device system is comprised of a poly-ether-etherketone (PEEK) eyelet and anchor, pre-assembled onto a disposable stainless-steel inserter, which enables insertion of the anchor into bone after creation of a pilot hole. The devices are single use, provided sterile, and are packaged in sterile barrier systems (SBS).

AI/ML Overview

The provided text is a 510(k) premarket notification clearance letter for the Stryker Endoscopy Knotilus+ PEEK Knotless Anchor. It details the device's intended use, regulatory classification, and a summary of performance testing and conclusions regarding its substantial equivalence to predicate devices. However, the document does not contain the kind of detailed information typically found in a study report for an AI/software device, such as specific acceptance criteria for performance metrics, detailed sample sizes for training or test sets, data provenance, expert qualifications, adjudication methods, or MRMC study results.

The device in question, the Knotilus+ PEEK Knotless Anchor, is a physical medical device (a bone anchor) and not an AI or software-driven device. Therefore, the questions related to AI/software performance criteria, ground truth, expert adjudication, and MRMC studies are not applicable to this submission.

Here's a breakdown of the information that can be extracted relevant to the device and its testing, and why other requested information is not present:

1. Table of acceptance criteria and the reported device performance

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Ultimate Tensile Strength (UTS)	Sufficiently strong for soft-tissue to bone fixation, comparable to or exceeding predicate devices.	"The proposed devices demonstrated higher pull-out strength as compared to the predicate devices." (Quantitative values not provided in this summary)
Insertion Performance	Successful insertion into bone after creation of a pilot hole.	"Successful insertion."
Bacterial Endotoxin	Below required limits.	"Passing results below the required limits."
Safety and Effectiveness	No new issues of safety and effectiveness identified.	"No new issues of safety and effectiveness were identified."
Substantial Equivalence	Demonstrates equivalence to predicate devices in terms of intended use, indications for use, raw materials, general anchor system design, and operational principle.	Concluded that the device is "substantially equivalent to the predicate devices, and will perform as safely and effectively within the intended use."

Study that proves the device meets the acceptance criteria:

The document states: "Non-clinical benchtop testing was performed to evaluate the performance characteristics of the Knotilus+ PEEK Knotless Anchor, including ultimate tensile strength (UTS) and insertion testing." It also mentions "Bacterial endotoxin testing was performed on the Knotilus+ PEEK Knotless Anchor".

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. These details are typically found in a full test report, which is not part of this clearance letter. Given this is a physical device, "data provenance" like country of origin for clinical data or retrospective/prospective studies is generally not applicable to bench testing, which uses manufactured device samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as this is a physical medical device, not an AI/software device requiring "ground truth" established by human experts in the context usually meant for AI. The performance testing (tensile strength, insertion, endotoxin) are objective measurements performed in a laboratory setting according to engineering and bioload testing standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for a physical medical device. Adjudication methods are relevant for subjective assessments, often in clinical trials or AI performance evaluations, not for objective benchtop engineering tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. MRMC studies are used to evaluate diagnostic imaging systems or AI software performance in clinical settings. This device is a surgical implant, and no such study type would be relevant to its clearance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For physical benchtop testing, the "ground truth" is typically the quantitative measurement obtained through calibrated testing equipment using established engineering and material science methodologies. For example, the "ground truth" for ultimate tensile strength is the physical force recorded by the testing machine at the point of failure.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This is a physical device, not an AI model requiring a training set and associated ground truth establishment.

Summary

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October 24, 2023

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of human services. To the right of the symbol is a blue square containing the acronym "FDA" in white letters. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

Stryker Endoscopy Madison Mutchler Senior Regulatory Affairs Specialist 5900 Optical Ct. San Jose, California 95138

Re: K232683

Trade/Device Name: Knotilus+ PEEK Knotless Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: August 31, 2023 Received: September 1, 2023

Dear Madison Mutchler:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).

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Sincerely,

Digitally signed by Jesse Jesse Muir -> Muir -> Muir -> 14:07:59 -04'00'

Jesse Muir, 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

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Indications for Use

Submission Number (if known)

K232683

Device Name

Knotilus+ PEEK Knotless Anchor

Indications for Use (Describe)

Indications for Use:

2.4x11.3mm, 2.9x12.5mm, and 2.9x15.5mm:

2.4x8.9mm:

Hip: 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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510(k) Summary

Submitter:

Applicant	Stryker Endoscopy5900 Optical CourtSan Jose, CA 95138
Contact Person	Madison MutchlerSenior Regulatory Affairs SpecialistPhone: (408) 754-2000Email: madison.mutchler@stryker.com
Date Prepared	August 31, 2023

Subject Device:

Name of Device	Knotilus+ PEEK Knotless Anchor
Common or Usual Name	Suture, Fastener, Fixation, Nondegradable, Soft Tissue
Classification Name	Fastener, Fixation, Nondegradable, Soft Tissue, 21 CFR 888.3040
Regulatory Class	Class II
Product Code	MBI

Predicate and Reference Devices:

Name of Device	Predicate - Arthrex PushLock Anchors, K101679
	Predicate - Arthrex Short Suture Anchors, K151092
	Reference - Stryker 3.9MM ReelX STT Suture Anchor System,K120824
	Reference - Stryker AlphaVent Suture Anchors, K231093

Device Description:

Intended Use:

2.4x11.3mm, 2.9x12.5mm, and 2.9x15.5mm:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift, Capsulolabral Reconstruction

Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament and Tendon Repair Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon

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Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hand and Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair Hip: Acetabular Labral Repair

2.4x8.9mm: Hip: Acetabular Labral Repair

Comparison of Technological Characteristics with the Predicate Device:

The Knotilus+ PEEK Knotless Anchor is equivalent to the predicate devices 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 other technological characteristics and performance attributes. Any 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.

Performance Testing:

Non-clinical benchtop testing was performed to evaluate the performance characteristics of the Knotilus+ PEEK Knotless Anchor, including ultimate tensile strength (UTS) and insertion testing. The proposed devices demonstrated higher pull-out strength as compared to the predicate devices as well as successful insertion, and no new issues of safety and effectiveness were identified.

Bacterial endotoxin testing was performed on the Knotilus+ PEEK Knotless Anchor, with passing results below the required limits.

Conclusions:

The information presented within this Traditional 510(k) demonstrates that the Knotilus+ PEEK Knotless Anchor is substantially equivalent to the predicate devices, and will perform as safely and effectively within the intended use.

Regulation Number and Section

N/A