(30 days)
Not Found
No
The document describes a physical medical device (interference screws) and its intended uses and materials. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML.
Yes.
The device is indicated for various surgical procedures such as ligament reconstruction, tendon repair, and stabilization, all of which are therapeutic interventions.
No
Explanation: This device is described as an interference screw used for attaching soft tissue and bone-tendon-bone grafts during orthopedic surgical procedures, such as ligament reconstruction and tendon repair. Its function is to provide fixation, which is a therapeutic or surgical action, not a diagnostic one.
No
The device description clearly states that the device is a physical, cannulated, threaded, tapered fastener made of absorbable Biocryl Rapide or PEEK material, intended for surgical implantation. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as an implantable screw used for attaching grafts and repairing ligaments and tendons during surgical procedures. This is a therapeutic and structural function within the body.
- Device Description: The device is described as a "cannulated, threaded, tapered fastener" made of materials like Biocryl Rapide or PEEK, designed for "interference fixation of soft tissue grafts and/or bone-tendon-bone grafts." This further reinforces its role as a surgical implant.
- Lack of IVD Characteristics: An In Vitro Diagnostic device is used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The description of the MILAGRO Interference Screw does not involve any such testing of specimens.
The device is a surgical implant used directly within the patient's body for structural support and fixation. This falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
MILAGRO ADVANCE PEEK Interference Screws (7x23mm, 8x23mm, 9x23mm):
The DePuy Mitek MILAGRO ADVANCE PEEK Interference Screw is indicated as follows:
· Knee: Attachment of a bone-tendon-bone (BTB) graft to the tibia and/or femur during cruciate ligament reconstruction procedures.
- · Knee: Attachment of a soft tissue (ST) graft to the tibia and/or femur during cruciate ligament reconstruction
- · Knee: Medial and lateral collateral ligament repair
- · Knee: Medial patellofemoral ligament reconstruction (femur fixation)
- · Shoulder: Proximal Biceps Tenodesis
- · Elbow: Distal Biceps Tenodesis
· Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Reconstruction, Flexor Hallucis Longus for Achilles Tendon Reconstruction. Tendon Transfer in the Foot and Ankle
MILAGRO ADVANCE PEEK Interference Screws (7x30mm, 8x30mm):
The DePuy Mitek MILAGRO ADVANCE PEEK Interference Screw is indicated as follows:
· Knee: Attachment of a bone-tendon-bone (BTB) graft to the tibia and/or femur during cruciate ligament reconstruction procedures.
· Knee: Attachment of a soft tissue (ST) graft to the tibia and/or femur during cruciate ligament reconstruction
· Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Recorstruction, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfer in the Foot and Ankle
MILAGRO ADVANCE BR Interference Screws (7x23mm, 8x23mm, 9x23mm):
The DePuy Mitek MILAGRO ADVANCE BR Interference Screw is indicated as follows:
· Knee: Attachment of a bone-tendon-bone (BTB) graft to the tibia and/or femur during cruciate ligament reconstruction procedures.
- · Knee: Attachment of a soft tissue (ST) graft to the tibia and/or femur during cruciate ligament reconstruction
- · Knee: Medial and lateral ligament repair, medial patellofemoral ligament reconstruction (femur fixation)
- Shoulder: Proximal Biceps Tenodesis
- · Elbow: Distal Biceps Tenodesis
· Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Reconstruction, Flexor Hallucis Longus for Achilles Tendon Reconstruction. Tendon Transfer in the Foot and Ankle
MILAGRO ADVANCE BR Interference Screws (8x30mm, 7x30mm):
The DePuy Mitek MILAGRO ADVANCE BR Interference Screw is indicated as follows:
· Knee: Attachment of a bone-tendon-bone (BTB) graft to the tibia and/or femur during cruciate ligament reconstruction procedures.
· Knee: Attachment of a soft tissue (ST) graft to the tibia and/or femur during cruciate ligament reconstruction
· Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Recor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfer in the Foot and Ankle
MILAGRO BR Interference Screws (7x15mm, 6x12mm, 5x12mm):
The DePuy Mitek MILAGRO BR Interference Screws designed to attach soft tissues to bone in orthopedic surgical procedures for the following indications:
· Shoulder: Proximal Biceps Tenodesis, Acromio-Clavicular Repair
· Elbow: Distal Biceps Tenodesis, Ulnar Collateral Ligament Repair
· Knee: Collateral Ligament Repair, Medial Patellofemoral Ligament Reconstruction (patella fixation)
· Foot and Ankle: Lateral Stabilization. Medial Stabilization. Mid-Foot Reconstruction. Tendon Transfer in the Foot and Ankle
MILAGRO BR Interference Screws (5x23mm, 6x23mm, 6x30mm, 6x30mm):
The DePuy Mitek MILAGRO Interference Screw is indicated as follows:
- · Knee: (ST) graft to the tibia and/or femur during cruciate ligament reconstruction procedures
- · Knee: Medial and lateral collateral ligament repair*
- · Shoulder: Proximal bicep tenodesis *
- Elbow: Distal bicep tenodesis*
· Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Recor Hallucis Longus for Achilles Tendon Reconstruction. Tendon Transfer in the Foot and Ankle
- These indications do not apply to 5x30mm Screws and 6x30mm Screws
Product codes (comma separated list FDA assigned to the subject device)
MAI, MBI
Device Description
The subject devices of this Special 510(k) are the MILAGRO Interference Screws and the Milagro ADVANCE Interference Screws. These interference screws are cannulated, threaded, tapered fasteners for use in interference fixation of soft tissue grafts and/or bone-tendon-bone grafts.
The MILAGRO Interference Screws and MILAGRO ADVANCE Interference Screws are offered in varying sizing configurations. The devices are offered in absorbable Biocryl Rapide material which is a biocomposite material of 70% PLGA copolymer (85% PLLA/15% PGA) and 30% β-TCP or PEEK (Polyether ether ketone) material.
The devices are provided sterile via Ethylene Oxide (EO) sterilization and are for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee, Shoulder, Elbow, Foot and Ankle
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)
Verification activities were performed on the proposed device. Verification included an assessment of fixation strength for proposed indications at T=0 and over the healing period, as well as performance testing for insertion force.
Results of performance testing have demonstrated that the proposed devices are suitable for the additional indications for use.
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.
K103831, K143660, K123362, K161001
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
March 15, 2024
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. The logos are simple and professional in appearance.
DePuy Mitek Ashley Aromando Manager, Regulatory Affairs 325 Paramount Drive Raynham, Massachusetts 02767
Re: K240441
Trade/Device Name: MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw 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 13, 2024 Received: February 14, 2024
Dear Ashley Aromando:
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.
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).
1
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 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-reportingcombination-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.
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-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,
Sara S. Thompson -S
For
Jesse Muir, 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
2
Enclosure
3
510(k) Number (if known) K240441
Device Name
MILAGRO ADVANCE PEEK Interference Screw
Indications for Use (Describe) MILAGRO ADVANCE PEEK Interference Screws (7x23mm, 8x23mm, 9x23mm):
The DePuy Mitek MILAGRO ADVANCE PEEK Interference Screw is indicated as follows:
· Knee: Attachment of a bone-tendon-bone (BTB) graft to the tibia and/or femur during cruciate ligament reconstruction procedures.
- · Knee: Attachment of a soft tissue (ST) graft to the tibia and/or femur during cruciate ligament reconstruction
- · Knee: Medial and lateral collateral ligament repair
- · Knee: Medial patellofemoral ligament reconstruction (femur fixation)
- · Shoulder: Proximal Biceps Tenodesis
- · Elbow: Distal Biceps Tenodesis
· Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Reconstruction, Flexor Hallucis Longus for Achilles Tendon Reconstruction. Tendon Transfer in the Foot and Ankle
| Type of Use ( Select one or both, as applicable ) |
|---|
| ---------------------------------------------------------- |
X 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
4
510(k) Number (if known) K240441
Device Name MILAGRO ADVANCE PEEK Interference Screw
Indications for Use (Describe) MILAGRO ADVANCE PEEK Interference Screws (7x30mm, 8x30mm):
The DePuy Mitek MILAGRO ADVANCE PEEK Interference Screw is indicated as follows:
· Knee: Attachment of a bone-tendon-bone (BTB) graft to the tibia and/or femur during cruciate ligament reconstruction procedures.
· Knee: Attachment of a soft tissue (ST) graft to the tibia and/or femur during cruciate ligament reconstruction
· Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Recorstruction, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfer in the Foot and Ankle
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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
5
510(k) Number (if known) K240441
Device Name MILAGRO ADVANCE BR Interference Screw
Indications for Use (Describe) MILAGRO ADVANCE BR Interference Screws (7x23mm, 8x23mm, 9x23mm):
The DePuy Mitek MILAGRO ADVANCE BR Interference Screw is indicated as follows:
· Knee: Attachment of a bone-tendon-bone (BTB) graft to the tibia and/or femur during cruciate ligament reconstruction procedures.
- · Knee: Attachment of a soft tissue (ST) graft to the tibia and/or femur during cruciate ligament reconstruction
- · Knee: Medial and lateral ligament repair, medial patellofemoral ligament reconstruction (femur fixation)
- Shoulder: Proximal Biceps Tenodesis
- · Elbow: Distal Biceps Tenodesis
· Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Reconstruction, Flexor Hallucis Longus for Achilles Tendon Reconstruction. Tendon Transfer in the Foot and Ankle
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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
6
510(k) Number (if known) K240441
Device Name MILAGRO ADVANCE BR Interference Screw
Indications for Use (Describe) MILAGRO ADVANCE BR Interference Screws (8x30mm, 7x30mm):
The DePuy Mitek MILAGRO ADVANCE BR Interference Screw is indicated as follows:
· Knee: Attachment of a bone-tendon-bone (BTB) graft to the tibia and/or femur during cruciate ligament reconstruction procedures.
· Knee: Attachment of a soft tissue (ST) graft to the tibia and/or femur during cruciate ligament reconstruction
· Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Recor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfer in the Foot and Ankle
Type of Use (Select one or both, as applicable)X 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
7
510(k) Number (if known) K240441
Device Name MILAGRO BR Interference Screw
Indications for Use (Describe) MILAGRO BR Interference Screws (7x15mm, 6x12mm, 5x12mm):
The DePuy Mitek MILAGRO BR Interference Screws designed to attach soft tissues to bone in orthopedic surgical procedures for the following indications:
· Shoulder: Proximal Biceps Tenodesis, Acromio-Clavicular Repair
· Elbow: Distal Biceps Tenodesis, Ulnar Collateral Ligament Repair
· Knee: Collateral Ligament Repair, Medial Patellofemoral Ligament Reconstruction (patella fixation)
· Foot and Ankle: Lateral Stabilization. Medial Stabilization. Mid-Foot Reconstruction. Tendon Transfer in the Foot and Ankle
| Type of Use (Select one or both, as applicable) | |
|---|---|
X 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
8
510(k) Number (if known) K240441
Device Name MILAGRO BR Interference Screw
Indications for Use (Describe) MILAGRO BR Interference Screws (5x23mm, 6x23mm, 6x30mm, 6x30mm):
The DePuy Mitek MILAGRO Interference Screw is indicated as follows:
- · Knee: (ST) graft to the tibia and/or femur during cruciate ligament reconstruction procedures
- · Knee: Medial and lateral collateral ligament repair*
- · Shoulder: Proximal bicep tenodesis *
- Elbow: Distal bicep tenodesis*
· Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Recor Hallucis Longus for Achilles Tendon Reconstruction. Tendon Transfer in the Foot and Ankle
- These indications do not apply to 5x30mm Screws and 6x30mm Screws
Type of Use (Select one or both, as applicable)
X 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
9
Image /page/9/Picture/0 description: The image shows the words "Johnson&Johnson MedTech" in red font. The words are stacked on top of each other, with "Johnson&Johnson" on the top line and "MedTech" on the bottom line. The font is bold and sans-serif. The background is white.
510(k) Summary
MILAGRO Interference Screw, MILAGRO ADVANCE Interference Screws
Date Prepared: 02/13/2024
| Submitter's Name and Address | DePuy Synthes Mitek Sports Medicine
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767 On behalf of: Medos International SARL
Chemin-Blanc 38, Le Locle Neuchatel
CH 2400, Switzerland |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Ashley Aromando
Manager, Regulatory Affairs |
| | Telephone: 508-977-3907
Email: aaromand@its.jnj.com |
| | DePuy Synthes Mitek Sports Medicine
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767 |
| Name of Medical Device | Proprietary Name:
MILAGRO Interference Screw,
MILAGRO ADVANCE Interference Screw
Classification Name:
Fastener, Fixation, Biodegradable, Soft Tissue; Fastener, Fixation, Nondegradable,
Soft Tissue
Product Code:
MAI, MBI
Common Name:
Screw, Fixation, Bone |
| Substantial Equivalence | The MILAGRO Interference Screws (23mm, 30mm lengths) are substantially equivalent to predicate:
K103831 MILAGRO Interference Screws The MILAGRO Interference Screws (12mm, 15mm lengths) and MILAGRO ADVANCE BR Interference Screws (23mm lengths) are substantially equivalent to predicate: |
10
Johnson&Johnson MedTech
| • K143660 MILAGRO, MILAGRO ADVANCE Interference Screws | |
|---|---|
| The MILAGRO ADVANCE BR Screws (30mm lengths) are substantially | |
| equivalent to predicate: | |
| • K123362 MILAGRO ADVANCE Interference Screws | |
| The MILAGRO ADVANCE PEEK Screws are substantially equivalent to | |
| predicate: | |
| • K161001 MILAGRO ADVANCE PEEK Interference Screws | |
| Device | |
| Classification | The MILGRO and MILAGRO ADVANCE Interference Screws are classified as: |
Single/multiple component metallic bone fixation appliances and accessories
classified as Class II, product code MAI, regulated under 21 CFR 888.3030.
Smooth or threaded metallic bone fixation fastener classified as Class II, product
code MBI, regulated under 21 CFR 888.3040. |
| Device Panel | Orthopedic Devices |
| Device
Description | The subject devices of this Special 510(k) are the MILAGRO Interference Screws
and the Milagro ADVANCE Interference Screws. These interference screws are
cannulated, threaded, tapered fasteners for use in interference fixation of soft tissue
grafts and/or bone-tendon-bone grafts.
The MILAGRO Interference Screws and MILAGRO ADVANCE Interference
Screws are offered in varying sizing configurations. The devices are offered in
absorbable Biocryl Rapide material which is a biocomposite material of 70%
PLGA copolymer (85% PLLA/15% PGA) and 30% β-TCP or PEEK (Polyether
ether ketone) material.
The devices are provided sterile via Ethylene Oxide (EO) sterilization and are for
single use only. |
| Technological
Characteristics | The anchor design, materials, principal of operation, and intended use of the
subject devices are identical to that of the predicate devices. This submission is
made in support of a modification to the labeling of the subject devices to add
additional foot and ankle indications. |
| Indications for
Use | MILAGRO BR Interference Screws (5x23mm, 5x30mm, 6x23mm, 6x30mm):
The DePuy Mitek MILAGRO Interference Screw is indicated as follows: |
11
lohnson
- Knee: (ST) graft to the tibia and/or femur during cruciate ligament ● reconstruction procedures
- Knee: Medial and lateral collateral ligament repair* ●
- Shoulder: Proximal bicep tenodesis*
- . Elbow: Distal bicep tenodesis*
- Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon . Repair, Mid-Foot Reconstruction, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfer in the Foot and Ankle
- These indications do not apply to 5x30mm Screws and 6x30mm Screws
MILAGRO BR Interference Screws (7x15mm, 6x12mm, 5x12mm):
The DePuy Mitek MILAGRO BR Interference Screws designed to attach soft tissues to bone in orthopedic surgical procedures for the following indications:
- Shoulder: Proximal Biceps Tenodesis, Acromio-Clavicular Repair ●
- Elbow: Distal Biceps Tenodesis, Ulnar Collateral Ligament Repair
- . Knee: Collateral Ligament Repair, Medial Patellofemoral Ligament Reconstruction (patella fixation)
- . Foot and Ankle: Lateral Stabilization, Medial Stabilization, Mid-Foot Reconstruction, Tendon Transfer in the Foot and Ankle
MILAGRO ADVANCE BR Interference Screws (7x23mm, 8x23mm, 9x23mm):
The DePuy Mitek MILAGRO ADVANCE BR Interference Screw is indicated as follows:
- Knee: Attachment of a bone-tendon-bone (BTB) graft to the tibia and/or femur ● during cruciate ligament reconstruction procedures.
- Knee: Attachment of a soft tissue (ST) graft to the tibia and/or femur during cruciate ligament reconstruction
- Knee: Medial and lateral collateral ligament repair, medial patellofemoral ● ligament reconstruction (femur fixation)
- . Shoulder: Proximal Biceps Tenodesis
- Elbow: Distal Biceps Tenodesis
- Foot and Ankle: Lateral Stabilization. Medial Stabilization. Achilles Tendon . Repair, Mid-Foot Reconstruction, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfer in the Foot and Ankle
MILAGRO ADVANCE BR Interference Screws (8x30mm, 7x30mm):
The DePuy Mitek MILAGRO ADVANCE BR Interference Screw is indicated as follows:
- . Knee: Attachment of a bone-tendon-bone (BTB) graft to the tibia and/or femur during cruciate ligament reconstruction procedures.
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●
| Knee: | Attachment of a soft tissue (ST) graft to the tibia and/or femur during
cruciate ligament reconstruction |
| ------- | ------------------------------------------------------------------------------------------------------------- |
|---|
- Foot and Ankle: Lateral Stabilization. Medial Stabilization. Achilles Tendon ● Repair, Mid-Foot Reconstruction, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfer in the Foot and Ankle
MILAGRO ADVANCE PEEK Interference Screws (7x23mm, 8x23mm, 9x23mm):
The DePuy Mitek MILAGRO ADVANCE PEEK Interference Screw is indicated as follows:
- . Knee: Attachment of a bone-tendon-bone (BTB) graft to the tibia and/or femur during cruciate ligament reconstruction procedures.
- Knee: Attachment of a soft tissue (ST) graft to the tibia and/or femur during ● cruciate ligament reconstruction
- Knee: Medial and lateral collateral ligament repair ●
- Knee: Medial patellofemoral ligament reconstruction (femur fixation) ●
- Shoulder: Proximal Biceps Tenodesis
- Elbow: Distal Biceps Tenodesis ●
- . Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Reconstruction, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfer in the Foot and Ankle
MILAGRO ADVANCE PEEK Interference Screws (7x30mm. 8x30mm):
The DePuy Mitek MILAGRO ADVANCE PEEK Interference Screw is indicated as follows:
- Knee: Attachment of a bone-tendon-bone (BTB) graft to the tibia and/or femur during cruciate ligament reconstruction procedures.
- . Knee: Attachment of a soft tissue (ST) graft to the tibia and/or femur during cruciate ligament reconstruction
- . Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Reconstruction, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfer in the Foot and Ankle
| Non-clinical
Testing | Verification activities were performed on the proposed device. Verification
included an assessment of fixation strength for proposed indications at T=0 and
over the healing period, as well as performance testing for insertion force. |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety and
Performance | Results of performance testing have demonstrated that the proposed devices are
suitable for the additional indications for use. |
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Based on similarities in the intended use, technological characteristics, and performance in comparison to the predicate devices, the modified MILAGRO and MILAGRO ADVANCE Interference Screws have shown to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act.