(203 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biological absorption of a physical screw, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as an absorbable, tapered, cannulated, threaded fastener used for interference fixation of soft tissue grafts or bone-tendon grafts in various reconstructive procedures (e.g., cruciate ligament reconstruction, bicep tenodesis), which directly treats or mitigates a medical condition.
No
The device is an absorbable, tapered, cannulated, threaded fastener used for interference fixation of grafts during surgical reconstruction procedures. It is a surgical implant, not a diagnostic tool.
No
The device description clearly states it is a physical, absorbable screw made of a composite material, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used for attaching grafts and repairing ligaments within the body (knee, shoulder, elbow). This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details a physical, absorbable screw made of specific materials, designed for mechanical fixation. This aligns with a surgical implant, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting markers, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Small Size DePuy Mitek Milagro® Interference Screws are indicated as follows:
| Screw Diameter x Length, mm | 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 procedures. | Knee: Medial and lateral collateral ligament repair | Shoulder: Proximal bicep tenodesis | Elbow: Distal bicep tenodesis |
|---|---|---|---|---|---|
| 5x23 | V | V | V | V | |
| 5x30 | V | ||||
| 6x23 | V | V | V | V | |
| 6x30 | V | ||||
| 7x23 | V | V | V | V | V |
| 7x30 | V | V | |||
| 8x23 | V | V | V | V | V |
| 8x30 | V | V | |||
| 9x23 | V | V | V | V | V |
| 9x30 | V | V | |||
| 9x35 | V | V | |||
| 10x23 | V | V | |||
| 10x30 | V | V | |||
| 10x35 | V | V | |||
| 11x30 | V | V | |||
| 11x35 | V | V | |||
| 12x30 | V | V | |||
| 12x35 | V | V |
Product codes
MAI, HWC
Device Description
The Small Size DePuy Mitek Milagro® 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 proposed Small Size DePuy Mitek Milagro® Interference Screws are offered in diameters of 5mm and 6mm and lengths of 23mm and 30mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee: tibia and/or femur; Shoulder: Proximal bicep; Elbow: Distal bicep
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical testing performed: Insertion Torque, Anchor Pullout (at T=0, 6 and 12 week in-vitro physiological aging), and Torque to Failure. Results demonstrated that the proposed device is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K060830, K032717, K051726, K041356, K020043
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
103831
Image /page/0/Picture/1 description: The image shows the logo for DePuy Mitek Inc., a Johnson & Johnson company. The logo features the DePuy name in bold, black letters, with a small graphic to the left. Below the name is the text "Mitek Inc. a Johnson & Johnson company" in a smaller font. To the right of the logo is the tagline "never stop moving" in a cursive font.
milagro interference screw PRODUCT: SUBMISSION DATE: 12/29/2010 SUBMISSION TYPE: TRADITIONAL
JUL 2 1 2011 5 I O(k) SUMMARY - DEPUY MITEK MILAGRO® INTERFERENCE SOREWS
SUBMITTER'S NAME AND ADDRESS
DePuy Mitek, Inc. a Johnson & Johnson company 325 Paramount Drive Raynham, MA 02767
CONTACT PERSON
Deep Pal Regulatory Affairs Specialist II TELEPHONE 508-828-3359 FACSIMILE 508-977-6911 dpal3@its.jnj.com E-MAIL DATE PREPARED 12/29/2010
NAME OF MEDICAL DEVICE
CLASSIFICATION NAME Fastener, Fixation, Nondegradable, Soft Tissue
COMMON/USUAL NAME
Bone Anchor
PROPRIETARY NAME
DePuy Mitek Milagro® Interference Screws
SUBSTANTIAL EQUIVALENCE
Small Size DePuy Mitek Milagro® Interference Screws are substantially equivalent to the following devices.
- K060830 Milagro® Interference Screws
- Milagro® Interference Screw/previously known as Biocryl Rapide Interference Screw . K032717
- . K051726, K041356, K020043 Arthrex Tenodesis Screw Family
FDA PRODUCT CODE
MAI, HWC
DEVICE CLASSIFICATION
This type of fixation screw was originally classified as a Class II medical device by the Orthopedic Review Panel, regulated as 21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener.
1
| Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Image /page/5/Picture/0 description: The image shows the DePuy Mitek Inc. logo, which is a Johnson & Johnson company. The logo is black and white and includes the words "DePuy" and "Mitek Inc." The image also includes the phrase "never stop moving-" in a smaller font. The logo is simple and professional.
MILAGRO INTERFERENCE SCREW PRODUCT: SUBMISSION DATE: DECEMBER 29™, 2010 รมหาวิราชิก TYPE: โชคติเมื่อปี
ATTACHMENT 2
INDICATIONS FOR USE
K103831 510(k) Number (if known): ____
Device Names: DePuy Mitek Milagro® Interference Screws
Indications for Use: The Small Size DePuy Mitek Milagro® Interference Screws are indicated as follows:
| Screw
Diameter x Length, mm | 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
procedures. | Knee: Medial and lateral
collateral ligament repair | Shoulder: Proximal bicep
tenodesis | Elbow:
Distal
tenodesis | bicep |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|---------------------------------------|-------------------------------|-------|
| 5x23 | | V | V | V | | V |
| 5x30 | | V | | | | |
| 6x23 | | V | V | V | | V |
| 6x30 | | V | | | | |
| 7x23 | V | V | V | V | | V |
| 7x30 | V | V | | | | |
| 8x23 | V | V | V | V | | V |
| 8x30 | V | V | | | | |
| 9x23 | V | V | V | V | | V |
| 9x30 | V | V | | | | |
| 9x35 | V | V | | | | |
| 10x23 | V | V | | | | |
| 10x30 | V | V | | | | |
| 10x35 | V | V | | | | |
| 11x30 | V | V | | | | |
| 11x35 | V | V | | | | |
| 12x30 | V | V | | | | |
| 12x35 | V | V | | | | |
| 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)
| (Division Sign-Off) | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|---|
| Division of Surgical, Orthopedic, and Restorative Devices | Page 1 of 1 |
510(k) Number