(92 days)
Not Found
No
The summary describes a purely mechanical, absorbable interference screw and makes no mention of AI or ML capabilities.
No
This device is an interference screw used for attaching grafts during ligament reconstruction, repair, and tenodesis procedures, rather than delivering therapy.
No
Explanation: The MILAGRO ADVANCE Interference Screw is a surgical implant designed for attachment of grafts during ligament reconstruction and repair procedures, not for identifying or diagnosing diseases or conditions.
No
The device description clearly states it is a physical, absorbable screw made of polymer and TCP, intended for surgical implantation. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- MILAGRO ADVANCE Interference Screw Function: The description clearly states that the MILAGRO ADVANCE Interference Screw is a surgical implant used for mechanical fixation of grafts during orthopedic procedures. It is a physical device inserted into the body to provide structural support.
- Lack of Diagnostic Activity: There is no mention of this device analyzing biological samples or providing diagnostic information. Its function is purely structural and mechanical.
The information provided about the device's intended use, description, and performance studies all point to it being a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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 9 mm x 23 mm screws will be indicated for: medial and lateral collateral ligament repair of the knee, proximal bicep tenodesis in the shoulder and distal bicep tenodesis in the elbow.
Product codes
HWC, MAI
Device Description
The MILAGRO ADVANCE Interference Screw is an absorbable, tapered, cannulated, threaded fastener for use in interference fixation of soft tissue grafts or bone-tendon grafts. The Interference Screw is made from a composite made of absorbable Poly (lactide-co-glycolide) polymer and Tricalcium Phosphate (TCP). The MILAGRO ADVANCE Interference Screw is provided sterile and is for single patient use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tibia and/or femur, knee, shoulder, elbow
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Non-clinical Testing
Screw fixation strength testing (at time zero and in vitro testing throughout healing. period) was performed to confirm that the proposed screws perform similarly to the predicate screws or meet the acceptance criteria. Screw torque testing was performed to confirm that there is no issue for screw insertion into the bone. Results of the testing have demonstrated that the proposed screws are suitable for the intended use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K123362 (page 1 of 2)
SECTION 2 - 510(k) SUMMARY
MILAGRO ADVANCE Interference Screw
| 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, Inc.
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767, USA
Telephone: 508-828-3541
Facsimile: 508-977-6911
e-mail: yfujimal@its.jnj.com |
| Name of
Medical Device | MILAGRO ADVANCE Interference Screw
Proprietary Name:
Classification Name: Smooth or threaded metallic bone fixation fastener
Common Name: fastener, fixation, biodegradable, soft tissue |
| Substantial
Equivalence
Facility | The MILAGRO ADVANCE Interference Screw is substantially equivalent to:
K060830: MILAGRO Interference Screw
K032717: Biocryl Rapide Interference Screw |
| Device
Classification | HWC - Smooth or threaded metallic bone fixation fastener, classified as Class II,
regulated under 21 CFR 888.3040
MAI - Single/multiple component metallic bone fixation appliances and accessories,
classified as Class II, regulated under 21 CFR 888.3030. |
1
K123362 (Page 2 of 2)
·
| Device
Description | The MILAGRO ADVANCE Interference Screw is an absorbable, tapered, cannulated,
threaded fastener for use in interference fixation of soft tissue grafts or bone-tendon
grafts. The Interference Screw is made from a composite made of absorbable Poly
(lactide-co-glycolide) polymer and Tricalcium Phosphate (TCP).
The MILAGRO ADVANCE Interference Screw is provided sterile and is for single
patient use only. |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | 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 9 mm x 23 mm screws will be indicated for: medial and
lateral collateral ligament repair of the knee, proximal bicep tenodesis in the shoulder
and distal bicep tenodesis in the elbow. |
| Safety and
Performance | Non-clinical Testing
Screw fixation strength testing (at time zero and in vitro testing throughout healing.
period) was performed to confirm that the proposed screws perform similarly to the
predicate screws or meet the acceptance criteria. Screw torque testing was performed
to confirm that there is no issue for screw insertion into the bone. Results of the testing
have demonstrated that the proposed screws are suitable for the intended use.
Based on the indications for use, technological characteristics, and comparison to the
predicate devices, the proposed MILAGRO ADVANCE Interference Screw has been
shown to be substantially equivalent to the predicate device under the Federal Food,
Drug and Cosmetic Act. |
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Image /page/2/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
DePuy Mitek, a Johnson and Johnson Company % Yayoi Fujimaki Regulatory Affairs Senior Associate 325 Paramount Drive Raynham, Massachusetts 02767
Letter dated: February 1, 2013
Re: K123362
Trade/Device Name: MILAGRO ADVANCE Interference Screw . Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MAI Dated: January 8, 2013 Received: January 11, 2013 ·
Dear Yayoi 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 (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
3
Page 2 – Yayoi Fujimaki
forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K123362
Device Name: MILAGRO ADVANCE Interference Screw
Indications for Use:
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 9 mm x 23 mm screws will be indicated for: medial and lateral ligament repair of the knee, proximal bicep tenodesis in the shoulder and distal bicep tenodesis in the elbow.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use_
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedic Devices 2013.02.01 14:22:01 -05'00'
Page 1 of 1
Premarket Notification: Traditional MILAGRO ADVANC Interference Screw