(29 days)
Not Found
No
The device description and intended use clearly define a system of physical plates and screws for surgical fixation. There is no mention of software, algorithms, or any computational components that would suggest the use of AI or ML. The performance studies described are engineering analyses of mechanical properties, not validation of algorithmic performance.
Yes.
The device is intended for use in stabilization of fresh fractures, revision procedures, joint fusion, and reconstruction of bones, which implies it is used to treat or manage a disease or condition.
No
This device is described as a "Plating System" intended for stabilizing fractures, fusions, and reconstruction of bones in the feet and toes, which are surgical and treatment procedures, not diagnostic ones.
No
The device description clearly states it includes physical components such as plates, screws, and reusable instrumentation, all made from Titanium Alloy. This indicates it is a hardware medical 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 states the device is for the stabilization of bones in the feet and toes through surgical procedures like fracture fixation, fusion, and reconstruction. This is a direct intervention on the body.
- Device Description: The device is described as plates and screws made of titanium alloy, along with surgical instrumentation. These are physical implants and tools used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze biological samples. This device is used inside the body during surgery.
N/A
Intended Use / Indications for Use
The Medline UNITE® Ancillary Foot Recon Plating System is 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 UNITE® 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 repar, and fracture fixation, appropriate for the size of the device.
The Medline UNITE® Lisfranc Screws are intended to be used for fixation such as Lisfranc arthrodesis, first metatarsophalangeal arthrodesis, midfoot and hindfoot arthrodeses or osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.
Product codes
HRS, HWC
Device Description
The Medline UNITE® Ancillary Foot Recon Plating System Plates and Screws are manufactured from Titanium Alloy (Ti-6Al-4V ELI). The System includes plates offered in various styles, sizes and options; each contoured for specific anatomy and designed for specific procedures, 2.7mm, and 4.0mm diameter locking and non-locking cortical screws to be used with the polyaxial locking holes and compression slots included in the plates, 3.5mm cross-plate screws to be used with the dual-mode compression slot(s) in select plates, and 3.7mm and 4.1mm solid Lisfranc screws. The system also includes reusable instrumentation necessary to implant the plates and screws, e.g. drill guides, tissue protectors, and drill bits. The Medline UNITE® Ancillary Plating System 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
bones of the feet and toes, first metatarsalcuneiform joint, first metatarsophalangeal joint (MTP), Midfoot / Hindfoot, Lateral Column, Medial Cuneiform, Calcaneal, LisFranc, Tarsometatarsal (TMT) Fusions, Intercuneiform, Navicular-Cuneiform (NC), Talo-Navicular (TN), Calcaneo-Cuboid (CC), Medial Column
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)
Non-Clinical Testing: An engineering analysis was performed to determine the subject Medline UNITE® Ancillary Foot Recon Plating System does not represent a new worst-case when compared to the previously cleared Medline Foot Plates and Screws (K151235) for bending and pullout strength. The results of this analysis demonstrate the subject Medline UNITE® Ancillary Foot Recon Plating System are substantially equivalent to the predicate Medline Foot Plates and Screws (K151235).
An engineering analysis was performed to determine the subject Medline UNITE® Ancillary Foot Recon Plating System does not represent a new worst-case when compared to the previously cleared Medline Foot Plates and Screws (K151235) for bending strength (plates) and axial pullout and torsional yield strength (screws). The results of this analysis demonstrate the subject Medline UNITE® Ancillary Foot Recon Plating System are substantially equivalent to the predicate Medline Foot Plates and Screws (K151235).
Performance Testing (Animal): This section does not apply. No animal testing was performed.
Performance Testing (Clinical): This section does not apply. No clinical testing was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Medline Foot Plates and Screws K151235, CHARLOTTE™ LisFranc Bone Screw & CHARLOTTE™ LisFranc Plate K081374, Medline Cannulated Screw K130319
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
January 18, 2024
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. The FDA logo is on the right, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are placed side by side.
Medline Industires, LP Jennifer Mason Regulatory Affairs Principal Three Lakes Drive Northfield, Illinois 60093
Re: K234031
Trade/Device Name: Medline UNITE Ancillary Foot Recon Plating System 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: December 19, 2023 Received: December 20, 2023
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Shumaya Ali -S
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K234031
Device Name
Medline UNITE® Ancillary Foot Recon Plating System
Indications for Use (Describe)
The Medline UNITE® Ancillary Foot Recon Plating System is 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 UNITE® 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 repar, and fracture fixation, appropriate for the size of the device.
The Medline UNITE® Lisfranc Screws are intended to be used for fixation such as Lisfranc arthrodesis, first metatarsophalangeal arthrodesis, midfoot and hindfoot arthrodeses or osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
510(k) SUMMARY [AS REQUIRED BY 21 CFR 807.92(c)] K234031
Submitter / 510(k) Sponsor
Medline Industries, LP Three Lakes Drive Northfield, IL 60093
Registration Number: 1417592
Contact Person
Contact Person: Jennifer Mason, Regulatory Affairs Principal Phone: 847-643-3652 Email: jamason(@medline.com
Summary Preparation Date January 17, 2024
Type of 510(k) Submission Special
Device Name / Classification
Trade Name: Medline UNITE® Ancillary Foot Recon Plating System Common Name: Plate, Fixation, Bone Screw, Fixation, Bone Classification Name: Single/multiple component metallic bone fixation appliances and accessories (primary) Smooth or threaded metallic bone fixation fastener Product Code: HRS (primary), HWC Classification Panel: Orthopedics Regulatory Class: Class II Regulation Number: 21 CFR 888.3030 and 21 CFR 888.3040
Primary Predicate Device Medline Foot Plates and Screws K151235
Predicate Device CHARLOTTE™ LisFranc Bone Screw & CHARLOTTE™ LisFranc Plate K081374
5
Predicate Device Information
Medline Cannulated Screw K130319
Device Description
The Medline UNITE® Ancillary Foot Recon Plating System Plates and Screws are manufactured from Titanium Alloy (Ti-6Al-4V ELI). The System includes plates offered in various styles, sizes and options; each contoured for specific anatomy and designed for specific procedures, 2.7mm, and 4.0mm diameter locking and non-locking cortical screws to be used with the polyaxial locking holes and compression slots included in the plates, 3.5mm crossplate screws to be used with the dual-mode compression slot(s) in select plates, and 3.7mm and 4.1mm solid Lisfranc screws. The system also includes reusable instrumentation necessary to implant the plates and screws, e.g. drill guides, tissue protectors, and drill bits. The Medline UNITE® Ancillary Plating System Plates and Screws are within the currently marketed sizes and indications of the identified predicate devices.
Indications for Use
The Medline UNITE® Ancillary Foot Recon Plating System is intended for use in stabilization and fixation 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 ●
- 1*(Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions .
- Intercuneiform Fusions ●
- Navicular-Cuneiform (NC) Fusion ●
6
- Talo-Navicular (TN) Fusion ●
- Calcaneo-Cuboid (CC) Fusion ●
- Medial Column Fusions (NC and 1st TMT) ●
The Medline UNITE® 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 fixation, appropriate for the size of the device.
The Medline UNITE® Lisfranc Screws are intended to be used for fixation such as Lisfranc arthrodesis, first metatarsophalangeal arthrodesis, midfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.
Summary of Technological Characteristics
The proposed Medline UNITE® Ancillary Foot Recon Plating System and the predicate device(s) have a similar intended use.
The design features of the Medline UNITE® Ancillary Foot Recon Plates and Screws are compared to the predicate device(s) in the tables below.
| Device
| Characteristic | Proposed Device | Predicate Device | Comparison Analysis |
|---|---|---|---|
| Product Name | Medline UNITE® Ancillary | ||
| Foot Recon Plating System | Medline Foot Plates and | ||
| Screws | N/A | ||
| 510(k) Reference | N/A | K151235 | N/A |
| Product Owner | Medline Industries, LP | Medline Industries, LP | Same |
| Product Code | HRS | HRS | Same |
| Regulation Number | 21 CFR 888.3030 | 21 CFR 888.3030 | Same |
| Materials - Plates | Titanium Alloy | Titanium Alloy | Same |
| Design | |||
| Configurations | Left and Right, Universal | Left and Right | Similar |
| Design Features - | |||
| Plates | Polyaxial Locking up to 15° | ||
| Compression Slots | Polyaxial Locking up to 15° | ||
| Compression Slots | Same |
TABLE 1: Comparison of Plates
7
| Device
| Characteristic | Proposed Device | Predicate Device | Comparison Analysis |
|---|---|---|---|
| Product Name | Medline UNITE® Ancillary | ||
| Foot Recon Plating System | Medline Foot Plates and | ||
| Screws | N/A | ||
| 510(k) Reference | N/A | K151235 | N/A |
| Product Owner | Medline Industries, LP | Medline Industries, LP | Same |
| Product Code | HWC | HWC | Same |
| Regulation Number | 21 CFR 888.3040 | 21 CFR 888.3040 | Same |
| Materials | Titanium Alloy | Titanium Alloy | Same |
| Design Features | Locking and Non Locking | Locking and Non Locking | Same |
| Diameters | 2.7mm, 3.5mm, 4.0mm | 2.7mm, 3.5mm | Similar |
| Lengths | 2.7mm: 10-60mm | ||
| 3.5mm: 10-60mm | |||
| 4.0mm: 14-60mm | 2.7mm: 10-30mm | ||
| 3.5mm: 10-60mm | Similar |
TABLE 2: Comparison of Plating Screws
TABLE 3: Comparison of LisFranc Screws
| Device
Characteristic | Proposed Device | Predicate Device | Predicate Device | Comparison
Analysis |
|--------------------------|----------------------------------------------------------|--------------------------------------|-------------------------------------------------------|------------------------|
| Product Name | Medline UNITE®
Ancillary Foot Recon
Plating System | CHARLOTTE LisFranc
Bone Screw | Medline Cannulated
Screws | N/A |
| 510(k)
Reference | N/A | K081374 | K130319 | N/A |
| Product Owner | Medline Industries, LP | Wright Medical
Technology, Inc | Medline Industries, LP | Different |
| Product Code | HWC | HWC | HWC | Same |
| Regulation
Number | 21 CFR 888.3040 | 21 CFR 888.3040 | 21 CFR 888.3040 | Same |
| Materials | Titanium Alloy | Stainless Steel | Titanium Alloy | Different |
| Design
Features | Torx drive mechanism,
Self-Tapping | Hex drive mechanism,
Self-tapping | Torx drive mechanism,
Self-Tapping | Similar |
| Diameters | 3.7mm, 4.1mm | 3.7mm, 4.5mm | 2.0mm, 2.5mm, 3.0mm,
3.5mm, 4.0mm, 6.5mm,
7.5mm | Similar |
8
| Lengths | 3.7mm: 20-100mm
4.1mm: 20-100mm | 3.7mm: 20-50mm
4.5mm: 30-50mm | 2.0mm: 10-24mm
2.5mm: 10-40mm
3.0mm: 10-40mm
3.5mm: 12-50mm
4.0mm: 14-50mm
6.5mm: 40-130mm
7.5mm: 40-130mm | Similar |
| --------- | ------------------------------------ | ---------------------------------- | ------------------------------------------------------------------------------------------------------------------------------ | --------- |
|---|
Summary of Non-Clinical Testing
The subject Medline UNITE® Ancillary Foot Recon Plating System does not represent a new worst-case when compared to the previously cleared Medline Foot Plates and Screws (K151235).
An engineering analysis was performed to determine the subject Medline UNITE® Ancillary Foot Recon Plating System does not represent a new worst-case when compared to the previously cleared Medline Foot Plates and Screws (K151235) for bending and pullout strength. The results of this analysis demonstrate the subject Medline UNITE® Ancillary Foot Recon Plating System are substantially equivalent to the predicate Medline Foot Plates and Screws (K151235).
An engineering analysis was performed to determine the subject Medline UNITE® Ancillary Foot Recon Plating System does not represent a new worst-case when compared to the previously cleared Medline Foot Plates and Screws (K151235) for bending strength (plates) and axial pullout and torsional yield strength (screws). The results of this analysis demonstrate the subject Medline UNITE® Ancillary Foot Recon Plating System are substantially equivalent to the predicate Medline Foot Plates and Screws (K151235).
Performance Testing (Animal)
This section does not apply. No animal testing was performed.
Performance Testing (Clinical) This section does not apply. No clinical testing was performed.
Other Testing
Summary of Clinical Testing Not applicable.
Conclusion
9
In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, LP. concludes that the Medline UNITE® Ancillary Foor Recon Plating System is as safe and as effective for their intended use as the predicate device Medline Foot Plates and Screws.