The MILAGRO ADVANCE Interference Screw is intended for attachment of soft tissue grafts or bone-tendon-bone grafts to the tibia and/or femur during cruciate ligament reconstruction procedures.

Additionally, the 7, 8 and 9mm x 23mm screws are indicated for: medial and lateral ligament repart, medial patellofemoral ligament reconstruction (femur fixation) of the knee, proximal bicep tenodesis in the shoulder and distal bicep tenodesis in the elbow.

Device Description

The proposed devices are interference screws used for attachment of soft tissue to bone in Orthopedic surgeries. The proposed devices are cannulated, threaded interference screws, made of absorbable Biocryl® Rapide™ (composite of β-TCP and PLGA copolymer). The devices are provided as sterile (EtO), and are for single patient use only.

There is no accessory accompanied with the devices. Manual Orthopedic instruments such as tap and driver are used for screw insertion. Instruments are classified as LXH: Orthopedic Manual Surgical Instruments, Class I Exempt device, regulated per 21 CFR 888.4540. No new instrumentation is developed for the purpose of this submission.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding the Milagro / Milagro Advance Interference Screw. It focuses on establishing substantial equivalence to a predicate device rather than presenting a novel device requiring extensive clinical trials with specific acceptance criteria related to accuracy or performance metrics.

Therefore, the requested information components related to acceptance criteria, ground truth, expert adjudication, and comparative effectiveness studies typical for AI/CAD devices are not applicable in this context. The device is a bone fixation appliance, not an AI or diagnostic device.

Here's a breakdown of the available information based on your request, highlighting why certain sections are not applicable:

Table of acceptance criteria and reported device performance:
- Acceptance Criteria: Not explicitly defined in terms of numerical performance thresholds as this is a medical implant seeking substantial equivalence, not a diagnostic or AI device with performance metrics like sensitivity/specificity. The implicit "acceptance criterion" is demonstrating substantial equivalence to the predicate device in terms of safety and effectiveness for the stated indications for use.
- Reported Device Performance:
  | Performance Metric | Reported Performance |
  | :----------------- | :------------------- |
  | Fixation Strength | Demonstrated substantial equivalence to the predicate device. |
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in the provided document. The study was "bench-top mechanical testing," implying lab-based material or device samples, not patient data.
- Data Provenance: Not applicable. This was a physical bench-top test, not a study involving human data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. The ground truth for mechanical testing is typically established by engineering standards and measurement accuracy, not expert consensus as in diagnostic imaging.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a human-readable diagnostic test; it's mechanical performance assessment.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a medical implant, not an AI or diagnostic tool that would involve human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a medical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the mechanical testing would be defined by engineering standards and measured physical properties (e.g., force required for failure, displacement under load) obtained through controlled laboratory experiments. It's not clinical data like pathology or outcomes.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
How the ground truth for the training set was established:
- Not applicable. As above, this is not an AI device.

Summary of the Study:

The study conducted was bench-top mechanical testing to assess the fixation strength of the Milagro / Milagro Advance Interference Screw. The primary goal was to demonstrate that its fixation performance was substantially equivalent to that of the predicate device (Bioraptor Knotless Anchor and BioTenodesis Interference Screw). The document explicitly states: "The data demonstrated substantial equivalence of fixation performance." There were no changes to the material, packaging system, or sterilization, further supporting the substantial equivalence claim.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 21, 2015

DePuy Mitek, a Johnson and Johnson Company Ms. Yayoi Fujimaki Regulatory Affairs Senior Associate 325 Paramount Drive Raynham, Massachusetts 02767

Re: K143660

Trade/Device Name: Milagro / 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 Dated: April 20, 2015 Received: April 22, 2015

Dear Ms. Fujimaki:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing

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(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins -S

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K143660

Device Name

Milagro / Milagro Advance Interference Screw

Indications for Use (Describe)

Milagro Interference Screw (5x12, 6x12, 7x15, 8x15)

The MILAGRO BR Interference Screws are 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)

Milagro Advance Interference Screw (7x23, 8x23, 9x23)

The MILAGRO ADVANCE Interference Screw is intended for attachment of soft tissue grafts or bone-tendon-bone grafts to the tibia and/or femur during cruciate ligament reconstruction procedures.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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

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Image /page/3/Picture/1 description: The image displays the logo for DePuy Synthes Mitek Sports Medicine, a company of Johnson & Johnson. The DePuy Synthes logo features a stylized, golden-colored geometric design to the left of the company name, which is written in a dark blue sans-serif font. Below the company name, "MITEK SPORTS MEDICINE" is written in a smaller, dark blue sans-serif font. Underneath that, the text "COMPANIES OF" is written in a small, gray sans-serif font, followed by the Johnson & Johnson logo in red script.

510(k) SUMMARY Milagro / Milagro Advance Interference Screw

I. SUBMITTER

Date Prepared	December 18, 2014
Submitter'sName andAddress	DePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767
Contact Person	Yayoi FujimakiRegulatory Affairs Senior AssociateDePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767, USA	Telephone: 508-828-3541Facsimile: 508-977-6911e-mail: yfujima1@its.jnj.com

II. DEVICE

Name of Device	Milagro Interference Screw (K122869, K120589) Milagro Advance Interference Screw (K123362)
Common Name	fastener, fixation, biodegradable, soft tissue
Classification Name	Single/multiple component metallic bone fixation appliances and accessories
Regulatory Class	Class II
Product Code	MAI (21CFR888.3030)

III. PREDICATE DEVICE

Predicate Device	• Bioraptor Knotless Anchor (K121018, K093428; Smith & Nephew)
Reference Device	• BioTenodesis Interference Screw (K051726, K041356, K020043; Arthrex)

IV. DEVICE DESCRIPTION

Device	Description
	The proposed devices are interference screws used for attachment of soft tissueto bone in Orthopedic surgeries. The proposed devices are cannulated, threadedinterference screws, made of absorbable Biocryl® Rapide™ (composite of β-TCPand PLGA copolymer). The devices are provided as sterile (EtO), and are for

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Image /page/4/Picture/1 description: The image shows the logo for DePuy Synthes MITEK Sports Medicine, which is a company of Johnson & Johnson. The logo features a geometric design to the left of the text "DePuy Synthes" in a bold, dark blue font. Below that is the text "MITEK SPORTS MEDICINE" in a smaller, dark blue font. Underneath that is the text "companies of Johnson-Johnson" in a smaller, red font.

single patient use only.
There is no accessory accompanied with the devices. Manual Orthopedic
instruments such as tap and driver are used for screw insertion. Instruments are
classified as LXH: Orthopedic Manual Surgical Instruments, Class I Exempt
device, regulated per 21 CFR 888.4540. No new instrumentation is developed
for the purpose of this submission.

V. INDICATIONS FOR USE

MilagroInterferenceScrew(5x12, 6x12,7x15, 8x15)	The MILAGRO BR Interference Screws are designed to attach soft tissues tobone in Orthopedic surgical procedures for following indications:Shoulder: Proximal Biceps Tenodesis, Acromio-Clavicular RepairElbow: Distal Biceps Tenodesis, Ulnar Collateral Ligament repairKnee: Collateral Ligament Repair, Medial Patellofemoral LigamentReconstruction (patella fixation)
MilagroAdvanceInterferenceScrew(7x23, 8x23,9x23)	The MILAGRO ADVANCE Interference Screw is intended for attachment ofsoft tissue grafts or bone-tendon-bone grafts to the tibia and/or femur duringcruciate ligament reconstruction procedures.Additionally, the 7, 8 and 9mm x 23mm screws are indicated for: medial andlateral collateral ligament repair, medial patellofemoral ligament reconstruction(femur fixation) of the knee, proximal bicep tenodesis in the shoulder and distalbicep tenodesis in the elbow.

MilagroInterferenceScrew(5x12, 6x12,7x15, 8x15)

The MILAGRO BR Interference Screws are designed to attach soft tissues tobone in Orthopedic surgical procedures for following indications:Shoulder: Proximal Biceps Tenodesis, Acromio-Clavicular RepairElbow: Distal Biceps Tenodesis, Ulnar Collateral Ligament repairKnee: Collateral Ligament Repair, Medial Patellofemoral LigamentReconstruction (patella fixation)

MilagroAdvanceInterferenceScrew(7x23, 8x23,9x23)

The MILAGRO ADVANCE Interference Screw is intended for attachment ofsoft tissue grafts or bone-tendon-bone grafts to the tibia and/or femur duringcruciate ligament reconstruction procedures.Additionally, the 7, 8 and 9mm x 23mm screws are indicated for: medial andlateral collateral ligament repair, medial patellofemoral ligament reconstruction(femur fixation) of the knee, proximal bicep tenodesis in the shoulder and distalbicep tenodesis in the elbow.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

	PREDICATE DEVICE
Sametechnologicalelements	■ Indication: The proposed indication is Medial Patellofemoral LigamentReconstruction that is a part of Patellar Realignment for which is the predicatedevice is indicated. The reference is used for the same intended use (softtissue fixation to bone) and used by similar orthopedic procedures.■ Implant design: The proposed and predicate devices are cannulated,threaded/ribbed bone implants used for soft tissue fixation to bone. This issimilar to the predicate and reference.■ Implant size: Within the size range of the predicate and reference.■ Material: The proposed devices are absorbable. The reference is alsoabsorbable, and used for the same intended use (soft tissue fixation to bone).Material degradation did not raise a performance concern per bench-topfixation strength testing.
Differenttechnologicalelements	There is no significant different technological element.

PREDICATE DEVICE

Sametechnologicalelements

■ Indication: The proposed indication is Medial Patellofemoral LigamentReconstruction that is a part of Patellar Realignment for which is the predicatedevice is indicated. The reference is used for the same intended use (softtissue fixation to bone) and used by similar orthopedic procedures.■ Implant design: The proposed and predicate devices are cannulated,threaded/ribbed bone implants used for soft tissue fixation to bone. This issimilar to the predicate and reference.■ Implant size: Within the size range of the predicate and reference.■ Material: The proposed devices are absorbable. The reference is alsoabsorbable, and used for the same intended use (soft tissue fixation to bone).Material degradation did not raise a performance concern per bench-topfixation strength testing.

Differenttechnologicalelements

There is no significant different technological element.

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VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Bench-top	Fixation strength data on bone foam model were compared with the data of the
mechanical	predicate device. The data demonstrated substantial equivalence of fixation
testing	performance.
Summary	The fixation strength testing demonstrated substantial equivalency of productperformance.There is no change to material, packaging system and sterilization; thereforeadditional studies of biocompatibility, sterility and stability were unnecessary.

VIII. CONCLUSION

	The proposed devices are, similarly to the predicate and reference devices, boneimplants that are intended to be used for stabilizing soft tissue to bone in such asknee, shoulder and elbow. The proposed devices are similar to the predicate andreference devices in technological elements. The proposed devices demonstratedsubstantial equivalency of device performance (bench-top).
SubstantialEquivalence	Regarding to the proposed devices, there has been no change to material, design,sterilization and manufacturing; therefore there is no change to material safety,stability and sterility to the proposed devices.
	In conclusion, there is no significant difference between the proposed devicesand the predicate/reference devices, and there is no new question raisedregarding to product safety and efficacy. The proposed devices are consideredsubstantially equivalent to the predicate device.

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.