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.

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.

AI/ML Overview

This is a 510(k) premarket notification for a medical device, the Medline UNITE® Ancillary Foot Recon Plating System. These notifications typically establish substantial equivalence to a predicate device rather than presenting new clinical study data with acceptance criteria for device performance in the way a novel AI or diagnostic device might.

Therefore, this document does not contain the detailed information you've requested about acceptance criteria, study methodologies, ground truth establishment, or human reader performance for an AI/diagnostic device.

However, I can extract the information provided regarding the comparison to predicate devices, which serves a similar purpose in a 510(k) submission:

1. A table of acceptance criteria and the reported device performance

For a 510(k) submission of this type, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices, particularly regarding material, design, and mechanical performance. The performance is reported relative to the predicate device.

Device Characteristic	Acceptance Criterion (Implied by Predicate Equivalence)	Reported Device Performance (Medline UNITE® Ancillary Foot Recon Plating System)
Plates
Materials	Titanium Alloy (Same as predicate)	Titanium Alloy (Same)
Design Configurations	Left and Right (Similar to predicate)	Left and Right, Universal (Similar)
Design Features - Plates	Polyaxial Locking up to 15°, Compression Slots (Same as predicate)	Polyaxial Locking up to 15°, Compression Slots (Same)
Bending Strength	Not worse than predicate (K151235)	Engineering analysis determined not a new worst-case, substantially equivalent.
Pullout Strength	Not worse than predicate (K151235)	Engineering analysis determined not a new worst-case, substantially equivalent.
Plating Screws
Materials	Titanium Alloy (Same as predicate)	Titanium Alloy (Same)
Design Features	Locking and Non Locking (Same as predicate)	Locking and Non Locking (Same)
Diameters	2.7mm, 3.5mm (Predicate K151235)	2.7mm, 3.5mm, 4.0mm (Similar; 4.0mm is new but evaluated)
Lengths	2.7mm: 10-30mm, 3.5mm: 10-60mm (Predicate K151235)	2.7mm: 10-60mm, 3.5mm: 10-60mm, 4.0mm: 14-60mm (Similar; extended lengths and new diameter evaluated)
Axial Pullout Strength	Not worse than predicate (K151235)	Engineering analysis determined not a new worst-case, substantially equivalent.
Torsional Yield Strength	Not worse than predicate (K151235)	Engineering analysis determined not a new worst-case, substantially equivalent.
LisFranc Screws
Materials	Stainless Steel (Predicate K081374), Titanium Alloy (Predicate K130319)	Titanium Alloy (Different from K081374, Same as K130319)
Design Features	Hex drive, Self-tapping (Predicate K081374), Torx drive, Self-tapping (Predicate K130319)	Torx drive mechanism, Self-Tapping (Similar to K130319)
Diameters	3.7mm, 4.5mm (Predicate K081374), Various (Predicate K130319: 2.0mm-7.5mm)	3.7mm, 4.1mm (Similar)
Lengths	3.7mm: 20-50mm, 4.5mm: 30-50mm (Predicate K081374), Various (Predicate K130319)	3.7mm: 20-100mm, 4.1mm: 20-100mm (Similar; extended lengths evaluated)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not applicable. This submission relies on engineering analyses and comparison to existing predicate device data, not on a new clinical test set with human subjects or a defined image cohort.
Data Provenance: Not applicable. The "data" used is the existing performance data and designs of the predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth was established by human experts for a test set in this context. The determination of substantial equivalence is based on engineering principles and regulatory assessment, typically by engineers and regulatory specialists.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no test set requiring expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/diagnostic device; it is an orthopedic plating system. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for this submission revolves around established mechanical and material properties and regulatory requirements for predicate devices.

8. The sample size for the training set

Not applicable. There is no training set for this type of device submission.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this type of device submission.

Summary of Non-Clinical Testing:

The document states that an engineering analysis was performed to determine that the Medline UNITE® Ancillary Foot Recon Plating System does not represent a new worst-case compared to the predicate Medline Foot Plates and Screws (K151235) for:

Bending strength (for plates)
Pullout strength (for plates)
Axial pullout strength (for screws)
Torsional yield strength (for screws)

The conclusion was that the new system is substantially equivalent to the predicate device based on these analyses. No animal or clinical testing was performed for this submission.

Summary

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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).

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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

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Indications for Use

510(k) Number (if known) K234031

Device Name

Medline UNITE® Ancillary Foot Recon Plating System

Indications for Use (Describe)

· 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)

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.

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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

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Predicate Device Information

Medline Cannulated Screw K130319

Device Description

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 ●

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Talo-Navicular (TN) Fusion ●
Calcaneo-Cuboid (CC) Fusion ●
Medial Column Fusions (NC and 1st TMT) ●

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.

DeviceCharacteristic	Proposed Device	Predicate Device	Comparison Analysis
Product Name	Medline UNITE® AncillaryFoot Recon Plating System	Medline Foot Plates andScrews	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
DesignConfigurations	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

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DeviceCharacteristic	Proposed Device	Predicate Device	Comparison Analysis
Product Name	Medline UNITE® AncillaryFoot Recon Plating System	Medline Foot Plates andScrews	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: 10-60mm3.5mm: 10-60mm4.0mm: 14-60mm	2.7mm: 10-30mm3.5mm: 10-60mm	Similar

TABLE 2: Comparison of Plating Screws

TABLE 3: Comparison of LisFranc Screws

DeviceCharacteristic	Proposed Device	Predicate Device	Predicate Device	ComparisonAnalysis
Product Name	Medline UNITE®Ancillary Foot ReconPlating System	CHARLOTTE LisFrancBone Screw	Medline CannulatedScrews	N/A
510(k)Reference	N/A	K081374	K130319	N/A
Product Owner	Medline Industries, LP	Wright MedicalTechnology, Inc	Medline Industries, LP	Different
Product Code	HWC	HWC	HWC	Same
RegulationNumber	21 CFR 888.3040	21 CFR 888.3040	21 CFR 888.3040	Same
Materials	Titanium Alloy	Stainless Steel	Titanium Alloy	Different
DesignFeatures	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

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Lengths	3.7mm: 20-100mm4.1mm: 20-100mm	3.7mm: 20-50mm4.5mm: 30-50mm	2.0mm: 10-24mm2.5mm: 10-40mm3.0mm: 10-40mm3.5mm: 12-50mm4.0mm: 14-50mm6.5mm: 40-130mm7.5mm: 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

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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.

Regulation Number and Section

§ 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.