Who is the manufacturer of Alpha Vent PEEK Suture Anchor?

Stryker Endoscopy filed the 510(k) submission for Alpha Vent PEEK Suture Anchor (K211502).

What is the FDA product code for Alpha Vent PEEK Suture Anchor?

MBI. It is classified under 21 CFR 888.3040 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for Alpha Vent PEEK Suture Anchor?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Alpha Vent PEEK Suture Anchor?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Alpha Vent PEEK Suture Anchor

Q: What are the predicate devices for Alpha Vent PEEK Suture Anchor?

Arthrex Swivelock Anchors (K191226).

K211502 · Stryker Endoscopy · MBI · Aug 4, 2021 · Orthopedic

Device Facts

Record ID	K211502
Device Name	Alpha Vent PEEK Suture Anchor
Applicant	Stryker Endoscopy
Product Code	MBI · Orthopedic
Decision Date	Aug 4, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3040
Device Class	Class 2
Attributes	Therapeutic

Intended 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, 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.

Device Story

Bone anchor system for soft tissue-to-bone fixation; screw-in PEEK anchor design; pre-loaded with UHMWPE suture; includes inserter for pilot hole placement; used by surgeons in clinical settings; provides mechanical fixation via interference fit; benefits patient by securing soft tissue during orthopedic repairs; sterile, single-use.

Clinical Evidence

Bench testing only. Evaluated ultimate tensile strength (UTS) and insertion performance. Results demonstrated pull-out strength similar or superior to predicate. Bacterial endotoxin testing met acceptance criteria.

Technological Characteristics

Materials: PEEK anchor, UHMWPE suture. Design: Cannulated, screw-in anchor with integrated soft eyelet. Sizes: 4.75mm, 5.5mm, 6.5mm. Sterilization: Ethylene Oxide (EO), SAL 10^-6. Biocompatibility: ISO 10993-1 compliant.

Indications for Use

Indicated for soft tissue-to-bone fixation in shoulder, foot/ankle, knee, hand/wrist, elbow, and hip orthopedic procedures.

Regulatory Classification

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.

Predicate Devices

Arthrex Swivelock Anchors (K191226)

Related Devices

K151660 — MultiFIX S Knotless Fixation System · ArthroCare Corporation · Jul 16, 2015
K260004 — Aevumed PROTEKT Suture Anchor · Aevumed, Inc. · Jan 28, 2026
K160996 — Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm · Dunamis, LLC · Jul 6, 2016
K180464 — AEVUMED PHANTOM Suture Anchors · Aevumed, Inc. · May 31, 2018
K153313 — SpeedLock Knotless Fixation System · ArthroCare Corporation · Dec 11, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) | |-------------------------------------------------| |-------------------------------------------------| | <div> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </div> | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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. {4}------------------------------------------------ ### 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. {5}------------------------------------------------ | | 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. Hip: Capsular Repair, Acetabular Labral Repair. | Same as subject device | | Operational Principle | Fixation of suture to bone achieved by interference fit with screw-in anchor, suture fixated by eyelet | Fixation of suture to bone achieved by interference fit with sutures and screw- in anchor | | Key Patient- Contacting Materials | Material: Poly-ether-ether ketone (PEEK), UHMWPE | Same as subject device | | Anchor System Design | Screw in anchor with eyelet Inserter Sutures for fixation | Similar to subject device | | Eyelet Design | Integrated Closed eyelet | Separate Closed eyelet | | Feature | Subject Device (This Submission) | Predicate Device (K191226) | | | AlphaVent PEEK Suture Anchor | Arthrex SwiveLock Suture Anchor | | Anchor Diameter | 4.75mm 5.5mm 6.5mm | 3.5mm - 9mm | | Sterilization Method, SAL | Ethylene Oxide (EO), SAL: 10-6 | Similar to subject device | | Packaging | Double Barrier Blister or Pouch Single Use Only | Similar to subject device | | Biocompatibility | Device conforms to ISO 10993-1 for patient contact nature and duration | Similar to subject device | # Comparison of Technological Characteristics with the Predicate Device: {6}------------------------------------------------ ### 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.