· 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

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

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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for DePuy Mitek MILAGRO Interference Screws. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through clinical trials and detailed acceptance criteria for an AI/software as a medical device (SaMD).

Therefore, the document does not contain the information requested regarding acceptance criteria and studies for an AI/SaMD. Specifically:

No acceptance criteria table or device performance is reported in the context of an AI/SaMD. The document mentions "performance testing for insertion force" and "assessment of fixation strength" for the physical interference screws, which are not relevant to AI/SaMD performance.
No sample size information for a test set for AI/SaMD is present.
No data provenance for AI/SaMD is mentioned.
No information regarding experts for ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, or types of ground truth is available.
No information about training set size or ground truth establishment for a training set for AI/SaMD is provided.

The document primarily focuses on:

Device Identification: MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw.
Regulatory Information: Class II medical device, product codes MAI, MBI, regulated under 21 CFR 888.3030.
Substantial Equivalence: Listing predicate devices (K103831, K143660, K123362, K161001). The primary reason for this 510(k) is a modification to the labeling to add additional foot and ankle indications, asserting that the "anchor design, materials, principal of operation, and intended use of the subject devices are identical to that of the predicate devices."
Indications for Use: Detailed list of applications in knee, shoulder, elbow, foot, and ankle for various screw types and sizes.
Non-clinical Testing: Briefly states "Verification activities were performed... included an assessment of fixation strength... as well as performance testing for insertion force," concluding that these tests demonstrated suitability for the additional indications.

In summary, the provided text does not describe an AI/software medical device or the specific types of studies (like MRMC or standalone performance evaluations) that would involve acceptance criteria for AI algorithms. It pertains to a physical orthopedic implant and its substantial equivalence to previously cleared devices.

Summary

{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

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

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.

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

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.

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.

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.

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.

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 Medicinea Johnson & Johnson company325 Paramount DriveRaynham, MA 02767 On behalf of: Medos International SARLChemin-Blanc 38, Le Locle NeuchatelCH 2400, Switzerland
Contact Person	Ashley AromandoManager, Regulatory Affairs
	Telephone: 508-977-3907Email: aaromand@its.jnj.com
	DePuy Synthes Mitek Sports Medicinea Johnson & Johnson company325 Paramount DriveRaynham, MA 02767
Name of Medical Device	Proprietary Name:MILAGRO Interference Screw,MILAGRO ADVANCE Interference ScrewClassification Name:Fastener, Fixation, Biodegradable, Soft Tissue; Fastener, Fixation, Nondegradable,Soft TissueProduct Code:MAI, MBICommon 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 substantiallyequivalent to predicate:
• K123362 MILAGRO ADVANCE Interference Screws
The MILAGRO ADVANCE PEEK Screws are substantially equivalent topredicate:
• K161001 MILAGRO ADVANCE PEEK Interference Screws
DeviceClassification	The MILGRO and MILAGRO ADVANCE Interference Screws are classified as:Single/multiple component metallic bone fixation appliances and accessoriesclassified as Class II, product code MAI, regulated under 21 CFR 888.3030.Smooth or threaded metallic bone fixation fastener classified as Class II, productcode MBI, regulated under 21 CFR 888.3040.
Device Panel	Orthopedic Devices
DeviceDescription	The subject devices of this Special 510(k) are the MILAGRO Interference Screwsand the Milagro ADVANCE Interference Screws. These interference screws arecannulated, threaded, tapered fasteners for use in interference fixation of soft tissuegrafts and/or bone-tendon-bone grafts.The MILAGRO Interference Screws and MILAGRO ADVANCE InterferenceScrews are offered in varying sizing configurations. The devices are offered inabsorbable Biocryl Rapide material which is a biocomposite material of 70%PLGA copolymer (85% PLLA/15% PGA) and 30% β-TCP or PEEK (Polyetherether ketone) material.The devices are provided sterile via Ethylene Oxide (EO) sterilization and are forsingle use only.
TechnologicalCharacteristics	The anchor design, materials, principal of operation, and intended use of thesubject devices are identical to that of the predicate devices. This submission ismade in support of a modification to the labeling of the subject devices to addadditional foot and ankle indications.
Indications forUse	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.

{12}------------------------------------------------

lohnson

●

Knee:	Attachment of a soft tissue (ST) graft to the tibia and/or femur duringcruciate 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-clinicalTesting	Verification activities were performed on the proposed device. Verificationincluded an assessment of fixation strength for proposed indications at T=0 andover the healing period, as well as performance testing for insertion force.
Safety andPerformance	Results of performance testing have demonstrated that the proposed devices aresuitable for the additional indications for use.

{13}------------------------------------------------

ohnson

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.

Regulation Number and Section

§ 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.