(87 days)
No
The device description and intended use clearly describe a system of physical implants (plates and screws) and surgical instruments for orthopedic procedures. There is no mention of software, algorithms, or any computational components that would suggest the use of AI or ML. The performance studies are mechanical tests of the physical components.
Yes
The device is intended for the stabilization of fractures, revision procedures, joint fusion, and reconstruction of bones, all of which are considered therapeutic interventions designed to treat medical conditions or injuries.
No
The device is described as foot plates and screws used for stabilization and reconstruction of bones, which are therapeutic interventions, not diagnostic.
No
The device description clearly states that the device is comprised of physical components made from Titanium Alloy, including plates, screws, and reusable instrumentation. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the stabilization of bones in the feet and toes during surgical procedures (fractures, fusions, reconstructions, osteotomies). This is a direct surgical intervention on the patient's body.
- Device Description: The device description details physical implants (plates and screws) made of Titanium Alloy, along with surgical instrumentation. These are all components used in vivo (within the living body).
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. There is no mention of this device interacting with or analyzing any biological specimens.
The device described is a surgical implant system used for orthopedic procedures on the foot and ankle.
N/A
Intended Use / Indications for Use
The Medline Foot Plates and Screws are intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of bones of the feet and toes. Specific examples include:
- · Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion)
- · Arthrodesis of the first metatarsophalangeal joint (MTP) including:
- Primary MTP Fusion due to hallux ridgidus and/or hallux valgus
- Revision MTP Fusion
- · Revision of failed first MTP Arthroplasty implant
Flatfoot Osteotomies:
- · Lateral Column Lengthening (Evans Osteotomy)
- · Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)
- · Medial Displacement Calcaneal Osteotomy (MDCO)
Midfoot / Hindfoot Fusions:
- · LisFranc Arthrodesis and/or Stabilization
- · 1st(Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions
- · Intercuneiform Fusions
- · Navicular-Cuneiform (NC) Fusion
- · Talo-Navicular (TN) Fusion
- · Calcaneo-Cuboid (CC) Fusion
- · Medial Column Fusions (NC and 1st TMT)
The Medline Locking and Non-Locking Cortical Screws are indicated for use with the Medline Foot 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 Foot 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 2.7mm and 3.5mm diameter locking and non-locking cortical screws to be used with the polyaxial locking holes and compression slots included in the plates. The non-locking cortical screws can also be used for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture fixation, appropriate for the size of the device. The system also includes reusable instrumentation necessary to implant the plates and screws, e.g. drill guides, tissue protectors, and drill bits. The Medline Foot Plates and Screws are within the currently marketed sizes and indications of the identified predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
feet and toes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
| Test Type | Testing Standards | Performance Results |
|---|---|---|
| Static 4-Point Bending Testing (Plates) | ASTM F382 | Equivalent to Predicate |
| Static Pullout Testing (Screws) | ASTM F543 | Equivalent to Predicate |
| Static Torque Testing (Screws) | ASTM F543 | Equivalent to Predicate |
Static 4-Point Bend Testing
Static 4-point bend testing was conducted per ASTM F382-99 (2008). The purpose of this test was to ensure that the average load to failure of the proposed Medline Foot Plates was equivalent to the average load to failure bending stiffness of the predicate Wright Medical ORTHOLOC™ Plates.
Static Axial Pullout Testing
Static axial pullout testing was conducted per ASTM F543-13. The purpose of this test was to ensure that the axial pullout strength of the proposed Medline Locking Screws and Non-Locking Cortical Screws were equivalent to the pullout strength of the predicate Wright Medical ORTHOLOC™ Locking and Bone Screws.
Static Torque Testing
Static torque testing was conducted per ASTM F543-13. The purpose of this test was to ensure that the torsional strength of the proposed Medline Locking Screws and Non-Locking Cortical Screws were equivalent to the torsional strength of the predicate Wright Medical ORTHOLOC™ Locking and Bone Screws.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked one behind the other. The faces are rendered in a simple, abstract style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 6, 2015
Medline Industries, Incorporated Ms. Jennifer Mason Senior Regulatory Affairs Specialist 1 Medline Place Mundelein, Illinois 60060
Re: K151235
Trade/Device Name: Medline Foot 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: May 8, 2015 Received: May 11, 2015
Dear Ms. 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. 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/ResourcesforYou/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,
Mark N. Melkerson -S
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) K151235
Device Name
Medline Foot Plates and Screws
Indications for Use (Describe)
The Medline Foot Plates and Screws are intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of bones of the feet and toes. Specific examples include:
- · Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion)
- · Arthrodesis of the first metatarsophalangeal joint (MTP) including:
- Primary MTP Fusion due to hallux ridgidus and/or hallux valgus
- Revision MTP Fusion
- · Revision of failed first MTP Arthroplasty implant
Flatfoot Osteotomies:
- · Lateral Column Lengthening (Evans Osteotomy)
- · Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)
- · Medial Displacement Calcaneal Osteotomy (MDCO)
Midfoot / Hindfoot Fusions:
- · LisFranc Arthrodesis and/or Stabilization
- · 1st(Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions
- · Intercuneiform Fusions
- · Navicular-Cuneiform (NC) Fusion
- · Talo-Navicular (TN) Fusion
- · Calcaneo-Cuboid (CC) Fusion
- · Medial Column Fusions (NC and 1st TMT)
The Medline Locking and Non-Locking Cortical Screws are indicated for use with the Medline Foot 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)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
K151235 Page 1 of 3
Image /page/3/Picture/1 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, stacked vertically, with a white starburst-like symbol to the right of the text. The background is a solid dark blue color. The logo is simple and clean, with a focus on the company name and a memorable symbol.
ledline Industries, Inc. One Medline Place Mundelein, IL 60060
SECTION 5 510(k) SUMMARY [AS REQUIRED BY 21CFR807.92(c)]
Submitter / 510(k) Sponsor
Medline Industries, Inc. 1 Medline Place Mundelein, IL 60060
Registration Number: 1417592
Contact Person
Jennifer Mason Senior Regulatory Affairs Specialist Phone: 847-643-3652 Email: jamason@medline.com
Summary Preparation Date July 31, 2015
Type of 510(k) Submission Traditional
Device Name / Classification
Name of Device: Medline Foot Plates and Screws Proprietary Name: Medline Foot Plates and Screws Common Name: Plate, Fixation, Bone Classification Number: 21 CFR 888.3030 - Class II Classification Name: Single/multiple component metallic bone fixation appliances and accessories Product Code: HRS: Plate, Fixation, Bone HWC: Screw, Fixation Bone Classification Panel: Orthopedics
Predicate Device
WRIGHT MEDICAL ORTHOLOC™ 3Di System K121651 (Primary) – ORTHOLOC™ 3Di Midfoot/Flatfoot System (Wright Midfoot/Flatfoot System)
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Image /page/4/Picture/1 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, set against a dark blue square. To the right of the word is a white star-like symbol with four points. The logo is positioned on the left side of the image.
ledline Industries. Inc One Medline Place Mundelein, IL 60060
Device Description
The Medline Foot 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 2.7mm and 3.5mm diameter locking and non-locking cortical screws to be used with the polyaxial locking holes and compression slots included in the plates. The non-locking cortical screws can also be used for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture fixation, appropriate for the size of the device. The system also includes reusable instrumentation necessary to implant the plates and screws, e.g. drill guides, tissue protectors, and drill bits. The Medline Foot Plates and Screws are within the currently marketed sizes and indications of the identified predicate devices.
Indications for Use
The Medline Foot Plates and Screws are intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of bones of the feet and toes. Specific examples include:
- · Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion)
- · Arthrodesis of the first metatarsophalangeal joint (MTP) including:
- Primary MTP Fusion due to hallux ridgidus and/or hallux valgus
- Revision MTP Fusion
- · Revision of failed first MTP Arthroplasty implant
Flatfoot Osteotomies:
- · Lateral Column Lengthening (Evans Osteotomy)
- · Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)
- · Medial Displacement Calcaneal Osteotomy (MDCO)
Midfoot / Hindfoot Fusions:
- LisFranc Arthrodesis and/or Stabilization
- · 1st(Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions
- · Intercuneiform Fusions
- Navicular-Cuneiform (NC) Fusion
- Talo-Navicular (TN) Fusion
- Calcaneo-Cuboid (CC) Fusion
- · Medial Column Fusions (NC and 1st TMT)
The Medline Locking and Non-Locking Cortical Screws are indicated for use with the Medline Foot 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 device,
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Image /page/5/Picture/1 description: The image is the logo for Medline. The logo is a blue square with the word "MEDLINE" in white, sans-serif font. A white, stylized starburst is behind the word "MEDLINE". To the right of the blue square is a gray rectangle.
edline Industries. Inc ne Medline Place Mundelein II 60060
Summary of Technological Characteristics
The proposed device is substantially equivalent to the predicate devices. The Wright Medical ORTHOLOC™ 3Di System K121651, ORTHOLOC 3Di Hallux System K120359, ORTHOLOC™ 3Di Ankle Plating System and the Ortholoc Bone Screws K120802 were selected as the predicates based on the same intended use and same materials.
Summary of Non-Clinical Testing
| Test Type | Testing Standards | Performance Results |
|---|---|---|
| Static 4-Point Bending Testing | ||
| (Plates) | ASTM F382 | Equivalent to Predicate |
| Static Pullout Testing (Screws) | ASTM F543 | Equivalent to Predicate |
| Static Torque Testing (Screws) | ASTM F543 | Equivalent to Predicate |
Summary of Performance Testing
Static 4-Point Bend Testing
Static 4-point bend testing was conducted per ASTM F382-99 (2008). The purpose of this test was to ensure that the average load to failure of the proposed Medline Foot Plates was equivalent to the average load to failure bending stiffness of the predicate Wright Medical ORTHOLOC™ Plates.
Static Axial Pullout Testing
Static axial pullout testing was conducted per ASTM F543-13. The purpose of this test was to ensure that the axial pullout strength of the proposed Medline Locking Screws and Non-Locking Cortical Screws were equivalent to the pullout strength of the predicate Wright Medical ORTHOLOC™ Locking and Bone Screws.
Static Torque Testing
Static torque testing was conducted per ASTM F543-13. The purpose of this test was to ensure that the torsional strength of the proposed Medline Locking Screws and Non-Locking Cortical Screws were equivalent to the torsional strength of the predicate Wright Medical ORTHOLOC™ Locking and Bone Screws.
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 Foot Plates and Screws are safe, effective and substantially equivalent to the predicate, Wright Medical ORTHOLOC 3Di System (K 121651) as described herein.