(115 days)
No
The device description and performance studies focus on the mechanical properties and equivalence to predicate devices, with no mention of AI or ML.
Yes
The device, Medline Unite® Mini Plates and Screws, is used for stabilization of fractures and reconstruction of small bones, which are direct actions to treat a medical condition.
No
The device is a system of plates and screws used for the stabilization and fixation of fractures and for bone reconstruction, osteotomy, arthrodesis, and joint fusion. These are interventional and therapeutic procedures, not diagnostic ones.
No
The device description clearly states that the system includes physical components such as plates, screws, and reusable instrumentation (drill guides, tissue protectors, drill bits), which are hardware.
Based on the provided information, the Medline Unite® Mini Plates and Screws are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for the stabilization of fractures, joint fusion, and reconstruction of small bones within the body. This is an in vivo (within a living organism) application.
- Device Description: The description details plates and screws made of Titanium Alloy, designed for surgical implantation. This aligns with a surgical implant, not a device used to examine specimens outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) in vitro.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Medline Unite® Mini Plates and Screws are surgical implants used to physically stabilize and reconstruct bone structures within the body.
N/A
Intended Use / Indications for Use
The Medline Unite® Mini Plates and Screws are in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system can be used in both adult and pediatric patients.
Examples include:
- · Metatarsal or metacarpal fractures and osteotomies
- · Cuboid fractures
- Navicular fractures
- Talar neck fractures
- Jones and avulsion fractures of the 5th metatarsal
- · Lesser metatarsal shortening osteotomies (i.e. Weil Osteotomies)
- ·Phalanges fractures and osteotomies
The Medline Unite® Mini Locking and Non-Locking Screws are indicated for use with the Medline Unite® Plates of the same base material. The Non-Locking Cortical Screws are also indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
Product codes
HRS, HWC
Device Description
The Medline Unite® Mini Plates and Screws are manufactured from Titanium Alloy. The System includes plates offered in various styles, sizes and options; each contoured for specific anatomy and designed for specific procedures, and 2.0mm, 2.4mm and 2.7mm diameter locking and non-locking screws to be used with the polyaxial locking holes and compression slots included in the plates as well as 4.0mm cannulated screws to be used with the hook plate. The system also includes reusable instrumentation necessary to implant the plates and screws, e.g. drill guides, tissue protectors, and drill bits.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones of the hand, feet, wrist, ankles, fingers and toes.
Indicated Patient Age Range
adult and pediatric patients.
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:
Plates:
- Single Cycle 4-Point Bend Testing per ASTM F382-17. Purpose: to ensure that the bending stiffness of the proposed Medline Unite® Mini Plates was equivalent to the bending stiffness of the predicate Wright Medical Plates. Results: Medline Unite® Mini Plates and the predicate Wright Medical ORTHOLOC® 2.0/2.4 plates are substantially equivalent in 4-point static bend testing.
Screws:
- Static Axial Pullout Testing per ASTM F543-17. Purpose: to ensure that the axial pullout strength of the proposed Medline Unite® Mini Locking Screws and Non-Locking Cortical Screws were equivalent to the pullout strength of the predicate Wright Medical ORTHOLOC®2.4/2.4 Locking and Non-Locking Screws. Results: Medline Locking and Non-locking Screws and the predicate Wright Medical ORTHOLOC® 2.0/2.4 Locking and Non-locking Screws are equivalent in axial pullout.
- Static Torsion Testing per ASTM F543-17. Purpose: to ensure that the torsional strength of the proposed Medline Locking and Non-Locking Screws was equivalent to the torsional strength of the predicate Wright Medical ORTHOLOC® Locking and Non-Locking Screws. Results: Medline Locking and Non-locking Screws and the predicate Wright Medical ORTHOLOC® 2.0/2.4 Locking and Non-locking Screws are equivalent in torsional strength.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services, which features a stylized human figure. To the right is the logo for the U.S. Food & Drug Administration (FDA). The FDA logo includes the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" written below in a smaller font.
Medline Industries, Inc. Jennifer Mason Senior Regulatory Affairs Specialist Three Lakes Drive Northfield. Illinois 60093
November 1, 2018
Re: K181820
Trade/Device Name: Medline Unite Mini Plates and Screws Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: July 6, 2018 Received: July 9, 2018
Dear Jennifer Mason:
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. 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 located 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.
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 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
| Jesse | Digitally signed by
Jesse Muir -S |
|---------|--------------------------------------|
| Muir -S | Date: 2018.11.01
11:26:20 -04'00' |
For:
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K181820
Device Name Medline Unite® Mini Plates and Screws
Indications for Use (Describe)
The Medline Unite® Mini Plates and Screws are in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system can be used in both adult and pediatric patients.
Examples include:
- · Metatarsal or metacarpal fractures and osteotomies
- · Cuboid fractures
- Navicular fractures
- Talar neck fractures
- Jones and avulsion fractures of the 5th metatarsal
- · Lesser metatarsal shortening osteotomies (i.e. Weil Osteotomies)
- ·Phalanges fractures and osteotomies
The Medline Unite® Mini Locking and Non-Locking Screws are indicated for use with the Medline Unite® Plates of the same base material. The Non-Locking Cortical Screws are also indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
Type of Use (Select one or both, as applicable)
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K181820 Page 1 of 4
Submitter / 510(k) Sponsor
Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093
Registration Number: 1417592
Contact Person
Jennifer Mason Senior Regulatory Affairs Specialist Phone: 847-643-3652 Email: jamason@medline.com
Summary Preparation Date September 25, 2018
Type of 510(k) Submission
Traditional
Device Name / Classification
Name of Device: Medline Unite® Mini Plates and Screws Proprietary Name: Medline Unite® Mini Plates and Screws Common Name: Plate, Fixation, Bone Classification Name: Single/multiple component metallic bone fixation appliances and accessories Product Code: HRS: Plate, Fixation, Bone HWC: Screw, Fixation Bone Classification Panel: Orthopedics Regulatory Class: II Regulation #: 21 CFR 888.3030
Primary Predicate Device
ORTHOLOC® 2.0/2.4 Plate & ORTHOLOC® 2.0/2.4 Screw K090692
Predicate Devices Medline Foot Plates and Screws K151235
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K181820 Page 2 of 4
Medline Cannulated Screw K130319
Reference Device
Monster Screw System K151418
Device Description
The Medline Unite® Mini Plates and Screws are manufactured from Titanium Alloy. The System includes plates offered in various styles, sizes and options; each contoured for specific anatomy and designed for specific procedures, and 2.0mm, 2.4mm and 2.7mm diameter locking and non-locking screws to be used with the polyaxial locking holes and compression slots included in the plates as well as 4.0mm cannulated screws to be used with the hook plate. The system also includes reusable instrumentation necessary to implant the plates and screws, e.g. drill guides, tissue protectors, and drill bits.
Indications for Use
The Medline Unite® Mini Plates and Screws are intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system can be used in both adult and pediatric patients. Examples include:
- · Metatarsal or metacarpal fractures and osteotomies
- · Cuboid fractures
- Navicular fractures
- Talar neck fractures
- · Jones and avulsion fractures of the 5th metatarsal
- · Lesser metatarsal shortening osteotomies (i.e. Weil Osteotomies)
- · Phalanges fractures and osteotomies
The Medline Unite® Mini Locking and Non-Locking Screws are indicated for use with the Medline Unite® Mini Plates of the same base material. The Non-Locking Cortical Screws are also indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture fixation, appropriate for the size of the device.
Summary of Technological Characteristics
The proposed device is substantially equivalent to the predicate, the Wright Medical ORTHOLOC®
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K181820 Page 3 of 4
Both devices have the same intended use, same materials (titanium alloy), similar design features and both systems are provided non-sterile.
Both the Medline Unite® Mini Plates and the predicate plates feature locking and compression slots and polyaxial locking up to 15 degrees. Both systems feature locking and non-locking screws made from the same material, titanium alloy.
Summary of Non-Clinical Testing
Testing was conducted to demonstrate substantial equivalence of the Medline Unite® Mini Plates and Screws to the predicate, Wright Medical ORTHOLOC® 2.0/2.4 Plates and Screws.
Plates
The following tests were performed in accordance with ASTM F382-17 to demonstrate substantial equivalence between the proposed Medline Unite® Mini Plates and the predicate Wright Medical ORTHOLOC® 2.0/2.4 Plates.
Single Cycle 4-Point Bend Testing
Single cycle 4-point bend testing was conducted per ASTM F382. The purpose of this test was to ensure that the bending stiffness of the proposed Medline Unite® Mini Plates was equivalent to the bending stiffness of the predicate Wright Medical Plates. The results from single cycle 4-point bend test demonstrate that the Medline Unite® Mini Plates and the predicate Wright Medical ORTHOLOC® 2.0/2.4 plates are substantially equivalent in 4-point static bend testing.
Screws
The following tests were performed in accordance with ASTM F543-17 to demonstrate substantial equivalence between the proposed Medline Unite® Mini Screws and the predicate Wright Medical ORTHOLOC®2.0/2.4 Screws.
Static Axial Pullout Testing
Static axial pullout testing was conducted per ASTM F543-17. The purpose of this test was to ensure that the axial pullout strength of the proposed Medline Unite® Mini Locking Screws and Non-Locking Cortical Screws were equivalent to the pullout strength of the predicate Wright Medical ORTHOLOC®2.4/2.4 Locking and Non-Locking Screws. The results from the axial pullout test demonstrate that the Medline Locking and Non-locking Screws and the predicate Wright Medical ORTHOLOC® 2.0/2.4 Locking and Non-locking Screws are equivalent in axial pullout.
Static Torsion Testing
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K181820 Page 4 of 4
Static torsion testing was conducted per ASTM F543-17. The purpose of this test was to ensure that the torsional strength of the proposed Medline Locking and Non-Locking Screws was equivalent to the torsional strength of the predicate Wright Medical ORTHOLOC® Locking and Non-Locking Screws. The results from the static torsional testing show that the Medline Locking and Non-locking Screws and the predicate Wright Medical ORTHOLOC® 2.0/2.4 Locking and Non-locking Screws are equivalent in torsional strength.
Summary of Clinical Testing
Not applicable.
Conclusion
In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, Inc. concludes that the Medline Unite® Mini Plates and Screws are substantially equivalent to the predicate device, the ORTHOLOC® 2.0/2.4 Plate System K090692.