(149 days)
No
The device description and intended use clearly describe a physical interference screw made of absorbable material, used with manual instruments. There is no mention of software, algorithms, or any computational processing that would involve AI or ML.
No
The device is an orthopedic surgical implant used to attach soft tissue to bone, which is a structural and supportive function, not directly therapeutic (i.e. treating a disease or disorder).
No
The device is an interference screw designed to attach soft tissues to bone in orthopedic surgical procedures; it does not diagnose medical conditions.
No
The device description clearly states it is a physical interference screw made of absorbable material, used in orthopedic surgical procedures. It 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: The intended use is to attach soft tissues to bone in orthopedic surgical procedures. This is a surgical implant, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The device is an interference screw made of absorbable material, designed for physical fixation during surgery. It does not involve any reagents, calibrators, or other components typically associated with in vitro diagnostic tests.
- Performance Studies: The performance studies described are bench-top mechanical testing focusing on fixation strength, which is relevant to the physical function of a surgical implant, not the analytical or clinical performance of a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, the Milagro Interference Screw is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
MAI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Elbow, Knee (tibia and/or femur)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Orthopedic surgical procedures
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)
Bench-top mechanical testing: Fixation strength data on bone foam model were compared with the data of the predicate device. The data demonstrated substantial equivalence of fixation performance.
Summary: The fixation strength testing demonstrated substantial equivalency of product performance. There is no change to material, packaging system and sterilization; therefore additional studies of biocompatibility, sterility and stability were unnecessary.
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.
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.
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
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
1
(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
2
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.
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.
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:
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3
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's | ||
| Name and | ||
| Address | DePuy Mitek | |
| a Johnson & Johnson company | ||
| 325 Paramount Drive | ||
| Raynham, MA 02767 | ||
| Contact Person | Yayoi Fujimaki | |
| Regulatory Affairs Senior Associate | ||
| DePuy Mitek | ||
| a Johnson & Johnson company | ||
| 325 Paramount Drive | ||
| Raynham, MA 02767, USA | Telephone: 508-828-3541 | |
| Facsimile: 508-977-6911 | ||
| e-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 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 |
4
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
| 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 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.
Additionally, the 7, 8 and 9mm x 23mm screws are indicated for: medial and
lateral collateral ligament repair, medial patellofemoral ligament reconstruction
(femur fixation) of the knee, proximal bicep tenodesis in the shoulder and distal
bicep tenodesis in the elbow. |
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| PREDICATE DEVICE | |
|---|---|
| Same | |
| technological | |
| elements | ■ Indication: The proposed indication is Medial Patellofemoral Ligament |
| Reconstruction that is a part of Patellar Realignment for which is the predicate | |
| device is indicated. The reference is used for the same intended use (soft | |
| tissue 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 is | |
| similar 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 also | |
| absorbable, and used for the same intended use (soft tissue fixation to bone). | |
| Material degradation did not raise a performance concern per bench-top | |
| fixation strength testing. | |
| Different | |
| technological | |
| elements | There is no significant different technological element. |
5
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 product |
| performance. | |
| There is no change to material, packaging system and sterilization; therefore | |
| additional studies of biocompatibility, sterility and stability were unnecessary. |
VIII. CONCLUSION
| | The proposed devices are, similarly to the predicate and reference devices, bone
implants that are intended to be used for stabilizing soft tissue to bone in such as
knee, shoulder and elbow. The proposed devices are similar to the predicate and
reference devices in technological elements. The proposed devices demonstrated
substantial equivalency of device performance (bench-top). |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial
Equivalence | 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 devices
and the predicate/reference devices, and there is no new question raised
regarding to product safety and efficacy. The proposed devices are considered
substantially equivalent to the predicate device. |