Aevumed FASE Suture Anchor

K253040 · Aevumed, Inc. · MBI · Oct 21, 2025 · Orthopedic

Device Facts

• Record ID: K253040
• Device Name: Aevumed FASE Suture Anchor
• Applicant: Aevumed, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Oct 21, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aevumed FASE™ Suture Anchors are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clabicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/ Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all Digits, Digital Tendon Transfers Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction Hip: Capsular repair, Acetabular Labral Repair

Device Story

Aevumed FASE Suture Anchor is a PEEK-based bone fixation fastener; preloaded on disposable inserter assembly. Used by surgeons for soft tissue-to-bone fixation in orthopedic procedures (shoulder, foot, ankle, knee, hand, wrist, elbow, hip). Device provides mechanical anchor for sutures; facilitates tissue repair/reconstruction. Benefits include secure fixation of tendons/ligaments to bone. Single-use, sterile device.

Clinical Evidence

Bench testing only. Mechanical pullout strength testing performed comparing subject device to predicate. Results demonstrated significantly higher pullout strength for the subject device. Sterilization, packaging, pyrogenicity, and biocompatibility are identical to the predicate.

Technological Characteristics

Material: PEEK. Form factor: Suture anchor with HS Fiber™ suture, 4.75mm and 5.5mm diameters. Operational principle: Mechanical bone fixation fastener. Sterilization: Sterile, single-use.

Indications for Use

Indicated for suture or tissue fixation in foot, ankle, knee, hand, wrist, elbow, shoulder, and hip in patients age 18 and older. Contraindicated for use across growth plates in skeletally immature patients.

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

• Aevumed PHANTOM™ Suture Anchors (K242895)

Reference Devices

• Aevumed PHANTOM™ Suture Anchor (K180464)
• Aevumed PHANTOM™ -LP Suture Anchor (K222363)

Submission Summary (Full Text)

{0}

FDA U.S. FOOD & DRUG ADMINISTRATION

October 21, 2025

Aevumed, Inc.
Saif Khalil
CEO
109 Great Valley Parkway
Malvern, Pennsylvania 19355

Re: K253040
Trade/Device Name: Aevumed FASE 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: August 28, 2025
Received: September 22, 2025

Dear Saif Khalil:

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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

{1}

K253040 - Saif Khalil
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-

{2}

K253040 - Saif Khalil
Page 3

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

CHRISTOPHER FERREIRA -S

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

{3}

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known)

K253040

Device Name

Aevumed FASE Suture Anchor

Indications for Use (Describe)

The Aevumed FASE™ Suture Anchors are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:

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

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/ Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all Digits, Digital Tendon Transfers

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

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)

## 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
[e-mail]

"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."

{4}

Aevumed Inc.
K253040
Page 1 of 3

# 5. Premarket Notification 510(k) Summary (Special)

MANUFACTURER / SPONSOR:
Aevumed Inc.
109 Great Valley Parkway
Malvern, PA 19355

CONTACT:
Saif Khalil, Ph.D.
Chief Operating Officer
Phone: [phone]
email: [e-mail]

DATE PREPARED:
August 28th, 2025

TRADE NAME:
Aevumed FASE™ Suture Anchor

COMMON NAME:
Suture Anchor

DEVICE
Smooth or threaded metallic bone fixation fasteners, classified as
CLASSIFICATION:
Class II, product code MBI Regulation 21 CFR 888.3040

PRIMARY PREDICATE DEVICE:
Aevumed PHANTOM™ Suture Anchors, 510(k) number K242895

REFERENCE DEVICES:
Aevumed PHANTOM™ Suture Anchor, 510(k) number K180464
Aevumed PHANTOM™ -LP Suture Anchor, 510(k) number K222363

DEVICE DESCRIPTION:
The Aevumed FASE™ Sutures Anchor with HS Fiber™ suture is a suture anchor manufactured from polyetheretherketone (PEEK) material and are preloaded on a disposable inserter assembly intended for fixation of soft tissue to bone. The Aevumed FASE™

{5}

Aevumed Inc. K253040
Page 2 of 3

Suture Anchors are available in diameter sizes: 4.75mm and 5.5mm. They are offered sterile and are for single use only.

## TECHNOLOGICAL CHARACTERISTICS:

The proposed FASE™ Suture Anchors with HS Fiber™ suture is similar to the predicate PHANTOM™ Anchor (K242895) in that they share the same intended use, geometric design, material, operational principle, sterilization method, packaging, and shelf life. The subject device anchors are larger diameter than the predicate and have modified thread design. The minor differences between the modified FASE™ Suture Anchors and predicate PHANTOM™ Anchor (K242895) do not raise new questions of safety and effectiveness.

## INDICATIONS FOR USE:

The Aevumed FASE™ Suture Anchors are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:

- Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clabicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction
- Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
- Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all Digits, Digital Tendon Transfers
- Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
- Hip: Capsular repair, Acetabular Labral Repair

## INTENDED POPULATION:

Patients age 18 and older. Contraindication: Not for use across growth plates in patients who are not skeletally mature. The Aevumed FASE™ Suture Anchor is prescribed by the physician.

{6}

Aevumed Inc.
K253040
Page 3 of 3

## NON-CLINICAL TESTS:
The substantial equivalence is bases on non-clinical data. Both the Aevumed FASE™ Suture Anchor and predicate PHANTOM™ Anchor (K242895) were mechanically tested for maximum pullout strength. The Aevumed FASE™ Suture Anchor demonstrated significantly higher pullout strength in comparison to the predicate PHANTOM™ Anchor (K242895).

The sterilization, packaging, pyrogenicity/endotoxin monitoring, biocompatibility of the Aevumed FASE™ Suture Anchor are identical to the predicate device Aevumed PHANTOM™ Suture Anchor (K242895).

## SAFETY&
## PERFORMANCE:
The Aevumed FASE™ Suture Anchor is substantially equivalent to the predicate device. The data support the safety of the device and demonstrate that the Aevumed FASE™ Suture Anchor device should perform as intended in the specified use conditions and performs comparably to the predicate device that is currently marketed for the same intended use. Any differences between the Aevumed FASE™ Suture Anchor and the predicate device are considered minor and do not raise questions concerning safety and efficacy.