(317 days)
The Aevumed PHANTOM™ 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
The Aevumed PHANTOM™ 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 PHANTOM™ Suture Anchors are available in diameter sizes: 3.5mm and 4.5mm. They are offered sterile and are for single use only.
The document provided is an FDA 510(k) clearance letter for the Aevumed PHANTOM Suture Anchors. This type of device (a bone fixation fastener) is a physical implant and not an AI/ML-driven diagnostic or assistive technology. Therefore, the questions related to AI/ML device performance (such as acceptance criteria for AI performance, sample size for test sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment for training and test sets, and training set size) are not applicable to this submission.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Aevumed RAPID Suture Anchors, K223878) based on non-clinical performance and material characteristics, rather than diagnostic accuracy or AI effectiveness.
Here's an analysis based on the information provided, tailored to a medical device clearance:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (General for Suture Anchors) | Reported Device Performance (Aevumed PHANTOM Suture Anchor) |
|---|---|
| Mechanical Performance: | Maximum Pullout Strength: Demonstrated significantly higher pullout strength compared to the predicate RAPID™ Anchor (K223878). |
| - Adequate pullout strength | |
| - Cyclic tensile strength | Tested. No specific values provided, but implied to be acceptable and comparable or superior to predicate. |
| - Static tensile strength | Tested. No specific values provided, but implied to be acceptable and comparable or superior to predicate. |
| Material: | Manufactured from Polyetheretherketone (PEEK). Identical to predicate. |
| - Biocompatibility | Deemed identical to the predicate device (Aevumed RAPID™ Suture Anchor, K223878). |
| Sterilization: | Identical to the predicate device. |
| Packaging: | Identical to the predicate device. |
| Pyrogenicity/Endotoxin Monitoring: | Identical to the predicate device. |
| Shelf Life: | Identical to the predicate device. |
| Intended Use/Indications: | Identical to predicate for suture or tissue fixation in various anatomical locations (shoulder, foot/ankle, knee, hand/wrist, elbow, hip) |
| Operational Principle: | Identical to predicate. |
| Geometric Design: | Similar to predicate. Minor differences do not raise new questions of safety and effectiveness. Available in 3.5mm and 4.5mm diameters. |
Study Proving Device Meets Acceptance Criteria:
The study conducted was a non-clinical mechanical testing study. This involved direct comparative testing of the Aevumed PHANTOM™ Suture Anchor against its primary predicate device, the Aevumed RAPID™ Suture Anchor (K223878).
- Tests performed: Insertion testing, cyclic tensile testing, and static tensile testing.
- Key finding: The Aevumed PHANTOM™ Suture Anchor demonstrated "significantly higher pullout strength" in comparison to the predicate RAPID™ Anchor.
- Conclusion drawn: The data supports the relative safety of the device and demonstrates that it performs as intended and comparably (or superiorly in key mechanical aspects) to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact number of devices (suture anchors) used in the non-clinical mechanical tests. These tests typically involve a statistically significant number of samples to ensure repeatability and reliability of the results.
- Data Provenance: The data is generated from laboratory-based non-clinical mechanical testing. This means the "data provenance" isn't in terms of patient population (e.g., country of origin, retrospective/prospective) but rather controlled experimental conditions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not Applicable. For a physical medical device like a suture anchor, "ground truth" for non-clinical mechanical testing is established by engineering standards and validated testing methodologies, not by expert interpretation of patient data or images. The "ground truth" would be the measured physical properties (e.g., pullout strength).
4. Adjudication Method for the Test Set:
- Not Applicable. As mentioned above, this device does not involve human interpretation of data for its primary evaluation for 510(k) clearance. Mechanical tests have quantitative outputs, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No. An MRMC effectiveness study is relevant for diagnostic imaging or AI-assisted diagnostic devices where human readers interpret cases. This is not applicable to a physical implantable device like a suture anchor.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- Not Applicable. This is not an algorithm-based device.
7. The Type of Ground Truth Used:
- The "ground truth" for demonstrating substantial equivalence for this device is based on objective engineering and mechanical performance data (e.g., measured pullout strength, tensile strength, and material properties) obtained from non-clinical laboratory testing, alongside adherence to established standards for biocompatibility and sterilization.
8. The Sample Size for the Training Set:
- Not Applicable. This device is not an AI/ML model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. There is no training set for this type of device.
FDA 510(k) Clearance Letter - Aevumed PHANTOM Suture Anchors
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
August 6, 2025
Aevumed, Inc.
Saif Khalil
CEO
109 Great Valley Parkway
Malvern, Pennsylvania 19355
Re: K242895
Trade/Device Name: Aevumed PHANTOM Suture Anchors
Regulation Number: 21 CFR 888.3040
Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener
Regulatory Class: Class II
Product Code: MBI
Dated: July 7, 2025
Received: July 7, 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.
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K242895 - Saif Khalil
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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 (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-
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K242895 - Saif Khalil
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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,
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
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)
K242895
Device Name
Aevumed PHANTOM™ Suture Anchors
Indications for Use (Describe)
The Aevumed PHANTOM™ 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
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."
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Aevumed Inc.
K242895
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September 2024
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5. Premarket Notification 510(k) Summary
MANUFACTURER / SPONSOR:
Aevumed Inc.
109 Great Valley Parkway
Malvern, PA 19355
CONTACT:
Saif Khalil, Ph.D.
Chief Operating Officer
Phone: (610) 601-6614
email: skhalil@aevumed.com
DATE PREPARED: September 4th, 2024
TRADE NAME: Aevumed PHANTOM™ Suture Anchor
COMMON NAME: Suture Anchor
DEVICE CLASSIFICATION: Smooth or threaded metallic bone fixation fasteners, classified as Class II, product code MBI Regulation 21 CFR 888.3040
PRIMARY PREDICATE DEVICE: Aevumed RAPID™ Suture Anchors, 510(k) number K223878
REFERENCE PREDICATE DEVICE: Aevumed PHANTOM™ Suture Anchor, 510(k) number K180464
DEVICE DESCRIPTION: The Aevumed PHANTOM™ 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 PHANTOM™ Suture Anchors are available in diameter sizes:
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3.5mm and 4.5mm. They are offered sterile and are for single use only.
TECHNOLOGICAL CHARACTERISTICS: The proposed PHANTOM™ Suture Anchors with HS Fiber™ suture is similar to the predicate RAPID™ Anchor (K223878) in that they share the same intended use, geometric design, material, operational principle, sterilization method, packaging, and shelf life. The minor differences between the modified PHANTOM™ Suture Anchors and predicate RAPID™ Anchor (K223878) do not raise new questions of safety and effectiveness.
INDICATIONS FOR USE: The Aevumed PHANTOM™ 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 PHANTOM™ Suture Anchor is prescribed by the physician.
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NON-CLINICAL TESTS: The substantial equivalence is bases on non-clinical data (insertion testing, cyclic tensile testing and static tensile testing). Both the Aevumed PHANTOM™ Suture Anchor and predicate RAPID™ Anchor (K223878) were mechanically tested for maximum pullout strength. The Aevumed PHANTOM™ Suture Anchor demonstrated significantly higher pullout strength in comparison to the predicate RAPID™ Anchor (K223878).
The sterilization, packaging, pyrogenicity/endotoxin monitoring, biocompatibility of the Aevumed PHANTOM™ Suture Anchor are identical to the predicate device Aevumed RAPID™ Suture Anchor (K223878).
CONCLUSION: The Aevumed PHANTOM™ Suture Anchor is substantially equivalent to the predicate device. The data support the relative safety of the device and demonstrate that the Aevumed PHANTOM™ 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 PHANTOM™ Suture Anchor and the predicate device are considered minor and do not raise questions concerning safety and efficacy.
§ 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.