Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical properties and sterile packaging of a suture anchor, with no mention of AI or ML technology.

Therapeutic

Yes

Explanation: The device is a suture anchor intended for fixation of soft tissue to bone, which is a therapeutic intervention aimed at repairing damaged or injured body parts.

Diagnostic

No

This device is a surgical implant (suture anchor) used for fixation of soft tissue to bone, not for diagnosis. Its description and intended use focus on repair procedures.

SaMD (Software as a Medical Device)

No

The device description clearly describes a physical, implantable medical device made of PEEK and UHMWPE, including a screw-in design, sutures, and an inserter. There is no mention of software as the primary or sole component.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes a surgical implant for fixing soft tissue to bone in various anatomical locations. This is a therapeutic and structural function, not a diagnostic one.
Device Description: The description details a physical implant (suture anchor) made of PEEK and suture material, designed for surgical insertion. This is consistent with a medical device used in surgery, not a diagnostic test.
Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis or monitoring of a disease or condition.
Performance Studies: The performance studies focus on mechanical properties (tensile strength, insertion testing, pull-out strength) and sterility, which are relevant to the safety and effectiveness of a surgical implant, not a diagnostic test.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (inside the body) as a structural support during surgical repair.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The AlphaVent PEEK Suture Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip 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 and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis and Quadriceps Tendon Repair. Secondary or adjunct 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 Ligament Reconstruction, Lateral Epicondylitis Repair.

Hip: Capsular Repair, Acetabular Labral Repair.

Product codes

MBI

Device Description

The AlphaVent PEEK Suture Anchor (herein referred to as the proposed device(s)) are bone anchors with a screw-in design. Each anchor is vented and is provided pre-loaded with one or more working sutures with or without needles. The working sutures run through the cannulated anchor body and are attached to the distal end of the anchor by an integrated suture loop, referred to as a "soft eyelet." The anchor with working sutures is provided pre-assembled on an inserter, which enables insertion of the anchor into bone after creation of a pilot hole. The anchors are offered in a poly-ether-ether-keytone (PEEK) material with the integrated suture eyelet offered in non-absorbable USP braided ultra-high molecular weight polyethylene (UHMWPE) high strength suture. The devices are provided sterile and are packaged in sterile barrier systems (SBS) that include one anchor pre-loaded with suture on an inserter.

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 performed to evaluate the performance characteristics of the Stryker AlphaVent PEEK Suture Anchor, including ultimate tensile strength (UTS) and insertion testing. The proposed devices demonstrated similar or increased pull-out strength to the predicate devices, and no new issues of safety and effectiveness were identified. The shelf life of the device is 2 years. Additionally, bacterial endotoxin testing was performed and results of testing met the acceptance criteria.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K191226

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 4, 2021

Stryker Endoscopy Christie Samsa Principal Regulatory Affairs Specialist 5900 Optical Ct. San Jose, California 95138

Re: K211502

Trade/Device Name: Alpha Vent 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: May 13, 2021 Received: May 14, 2021

Dear Christie Samsa:

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

1

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) 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 (OS) 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 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).

Sincerely,

for

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

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Indications for Use

510(k) Number (if known) K211502

Device Name AlphaVent PEEK Suture Anchors

Indications for Use (Describe)

The AlphaVent PEEK Suture Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:

Shoulder: Rotator Cuff Repair, Bankart Repair, Siceps 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 Repair and Bunionectomy.

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis and Quadriceps Tendon Repair. Secondary or adjunct 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 Ligament 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)

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Image /page/3/Picture/0 description: The image shows the Stryker logo in black, with the text "K211502" above it. The logo is a stylized version of the company name, with bold, sans-serif letters. The text "K211502" is in a smaller font size and is centered above the logo. The logo and text are set against a white background.

510(k) Summary

Submitter:

| Applicant | Stryker Endoscopy
5900 Optical Court
San Jose, CA 95138 |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Christie Samsa
Principal Regulatory Affairs Specialist
Phone: (978) 500-1303
Facsimile: (408) 754-2598
Email: christie.samsa@stryker.com |
| Date Prepared | May 13, 2021 |

Subject Device:

Name of Device	AlphaVent PEEK Suture 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 Device:

Name of Device	Arthrex Swivelock Anchors, K191226
----------------	------------------------------------

Note: The predicate device has not been subject to a design-related recall.

Device Description:

The AlphaVent PEEK Suture Anchor (herein referred to as the proposed device(s)) are bone anchors with a screw-in design. Each anchor is vented and is provided pre-loaded with one or more working sutures with or without needles. The working sutures run through the cannulated anchor body and are attached to the distal end of the anchor by an integrated suture loop, referred to as a "soft eyelet." The anchor with working sutures is provided pre-assembled on an inserter, which enables insertion of the anchor into bone after creation of a pilot hole. The anchors are offered in a poly-ether-ether-keytone (PEEK) material with the integrated suture eyelet offered in non-absorbable USP braided ultra-high molecular weight polyethylene (UHMWPE) high strength suture. The devices are provided sterile and are packaged in sterile barrier systems (SBS) that include one anchor pre-loaded with suture on an inserter.

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Indications for Use:

The AlphaVent PEEK Suture Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip 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 and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis and Quadriceps Tendon Repair. Secondary or adjunct 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 Ligament Reconstruction, Lateral Epicondylitis Repair.

Hip: Capsular Repair, Acetabular Labral Repair.

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| | Subject Device
(This Submission) | Predicate Device
(K191226) |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Feature | AlphaVent PEEK Suture Anchor | Arthrex SwiveLock
Suture Anchor |
| Intended Use | Fixation of soft tissue to bone | Same as subject device |
| Indications for
Use | The AlphaVent PEEK Suture Anchors are intended
for fixation of suture (soft tissue) to bone in the
shoulder, foot/ankle, knee, hand/wrist, elbow, and
hip 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 and Ankle: Lateral Stabilization, Medial
Stabilization, Achilles Tendon Repair, Hallux
Valgus Reconstruction, Midfoot Reconstruction,
Metatarsal Ligament Repair/Tendon Repair and
Bunionectomy.

Knee: Anterior Cruciate Ligament Repair, Medial
Collateral Ligament Repair, Lateral Collateral
Ligament Repair, Patellar Tendon Repair, Posterior
Oblique Ligament Repair, Illiotibial Band Tenodesis
and Quadriceps Tendon Repair. Secondary or
adjunct 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 Ligament
Reconstruction, Lateral Epicondylitis Repair.

Comparison of Technological Characteristics with the Predicate Device:

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Performance Testing:

Non-clinical benchtop testing was performed to evaluate the performance characteristics of the Stryker AlphaVent PEEK Suture Anchor, including ultimate tensile strength (UTS) and insertion testing. The proposed devices demonstrated similar or increased pull-out strength to the predicate devices, and no new issues of safety and effectiveness were identified. The shelf life of the device is 2 years. Additionally, bacterial endotoxin testing was performed and results of testing met the acceptance criteria.

Conclusions:

The AlphaVent PEEK Suture Anchor is substantially equivalent in design, intended use, principles of operation, technological characteristics and safety features to the predicate device. There are no new issues of safety and/or effectiveness introduced by the AlphaVent PEEK Suture Anchor when used as instructed.