(87 days)
No. This device is a bio-composite knotless anchor used for soft-tissue to bone fixation and is comprised of physical materials (PEEK, PLLA, β-TCP) with no indication of computational or AI capabilities.
No.
The device is an anchor used for soft-tissue to bone fixation during surgical repair, which is a structural support device rather than a therapeutic device that treats or cures a disease.
No
Explanation: The device is a surgical anchor used for soft-tissue to bone fixation, not for diagnosing medical conditions.
No
This device is a physical, implantable medical device (hard-body, push-in, knotless bone anchors) and not a software-only device. The description clearly details its material composition (PEEK, PLLA, β-TCP) and physical function for soft-tissue to bone fixation.
No
This device is a surgical anchor used for soft-tissue to bone fixation, which is an in vivo procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Knotilus+ Biocomposite 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
Product codes (comma separated list FDA assigned to the subject device)
MAI, MBI
Device Description
The Knotilus+ Biocomposite Knotless Anchors are hard-body, push-in, knotless bone anchors. The subject device is comprised of a poly-ether-ether-ketone (PEEK) eyelet and poly-L-lactide ("PLLA") and beta-tricalcium phosphate ("β-TCP") anchor body, 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, foot and ankle, knee, hand and wrist, elbow, and hip
Indicated Patient Age Range
Skeletally mature pediatric and adult patients
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)
Non-clinical benchtop testing was performed to evaluate the performance characteristics of the Knotilus+ Biocomposite Knotless Anchor, including ultimate tensile strength (UTS), UTS after Cyclic Loading, UTS after Degradation, 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+ Biocomposite Knotless Anchor, with passing results below the required limits.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Knotilus+ PEEK Knotless Anchor, K232863, Arthrex PushLock Anchors, K101679, Arthrex Short Suture Anchors, K151092, K201786
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Stryker AlphaVent Suture Anchors, K231093, Stryker NanoTack Suture Anchor System, K173074
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
FDA 510(k) Clearance Letter - Knotilus+ Biocomposite Knotless Anchor
Page 1
May 23, 2025
Stryker Endoscopy
Madison Mutchler
Staff Regulatory Affairs Specialist
5900 Optical Court
San Jose, California 95138
Re: K250544
Trade/Device Name: Knotilus+ Biocomposite Knotless Anchor
Regulation Number: 21 CFR 888.3030
Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories
Regulatory Class: Class II
Product Code: MAI, MBI
Dated: February 24, 2025
Received: February 25, 2025
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.
Page 2
K250544 - Madison Mutchler Page 2
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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K250544 - Madison Mutchler Page 3
assistance/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,
Thomas Mcnamara -S
For: Christopher Ferreira, M.S.
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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K250544
Device Name
Knotilus+ Biocomposite Knotless Anchor
Indications for Use (Describe)
Indications for Use:
The Knotilus+ Biocomposite 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
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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Page 5
Stryker Endoscopy
Knotilus+ Biocomposite Knotless Anchor
510(k) Summary
Submitter:
| Applicant | Stryker Endoscopy
5900 Optical Court
San Jose, CA 95138 |
|---|---|
| Contact Person | Madison Mutchler
Staff Regulatory Affairs Specialist
Phone: (408) 754-2000
Email: madison.mutchler@stryker.com |
| Date Prepared | February 24th, 2025 |
Subject Device:
| Name of Device | Knotilus+ Biocomposite Knotless Anchor |
|---|---|
| Common or Usual Name | Fastener, Fixation, Biodegradable, Soft Tissue |
| Classification Name | Single/Multiple Component Metallic Bone Fixation Appliances and Accessories (21 C.F.R. §888.3030) |
| Smooth or Threaded Metallic Bone Fixation Fastener (21 C.F.R §888.3040) | |
| Regulatory Class | Class II |
| Product Code | MAI, MBI |
Predicate and Reference Devices:
| Name of Device | Primary Predicate - Knotilus+ PEEK Knotless Anchor, K232863 (MBI)
Secondary Predicate - Arthrex PushLock Anchors, K101679 (MAI)
Secondary Predicate - Arthrex Short Suture Anchors, K151092 (MBI)/K201786 (MAI)
Reference - Stryker AlphaVent Suture Anchors, K231093 (MAI, MBI)
Reference - Stryker NanoTack Suture Anchor System, K173074 (MBI) |
|---|---|
Device Description:
The Knotilus+ Biocomposite Knotless Anchors are hard-body, push-in, knotless bone anchors. The subject device is comprised of a poly-ether-ether-ketone (PEEK) eyelet and poly-L-lactide ("PLLA") and beta-tricalcium phosphate ("β-TCP") anchor body, 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).
Indications for Use:
The Knotilus+ Biocomposite 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:
Page 6
Stryker Endoscopy
Knotilus+ Biocomposite Knotless Anchor
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 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+ Biocomposite Knotless Anchor is a device modification to introduce a line extension of the Knotilus+ PEEK Knotless Anchor in a biocomposite material. The proposed device is identical in intended use, indications for use, general anchor system design features, and operational principle. It is equivalent in terms of technological characteristics and performance attributes. Any differences between the proposed and predicate device are related to the biocomposite material and 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.
Further, the Knotilus+ Biocomposite Knotless Anchor is equivalent to the Arthex 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 Arthrex 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.
Performance Testing:
Non-clinical benchtop testing was performed to evaluate the performance characteristics of the Knotilus+ Biocomposite Knotless Anchor, including ultimate tensile strength (UTS), UTS after Cyclic Loading, UTS after Degradation, 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+ Biocomposite Knotless Anchor, with passing results below the required limits.
Conclusions:
Page 7
Stryker Endoscopy
Knotilus+ Biocomposite Knotless Anchor
The information presented within this Traditional 510(k) demonstrates that the Knotilus+ Biocomposite Knotless Anchor is substantially equivalent to the predicate devices, and will perform as safely and effectively within the intended use.