Medline UNITE® REFLEX® Nitinol Staple System

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August 9, 2023 Medline Industries, LP Jennifer Mason Regulatory Affairs Principal Three Lakes Drive Northfield, Illinois 60093 Re: K231885 Trade/Device Name: Medline UNITE REFLEX Nitinol Staple System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: JDR Dated: June 26, 2023 Received: June 27, 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 (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. {1}------------------------------------------------ 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 devices or postmarketing safety reporting (21 CFR 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 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 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. # Limin Sun -S Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K231885 Device Name Medline UNITE® REFLEX® Nitinol Staple System Indications for Use (Describe) The Medline UNITE® REFLEX® Nitinol Staples are intended to provide fixation for fractures of the bones of the hand and foot such as: First metatarsalcuneiform arthrodesis, First metatarsophalangeal arthrodesis, Talo-Navicular Fusion, LisFranc arthrodesis, Akin osteotomy, Scarf and Chevron osteotomies. Staples are intended for single use only. Type of Use (Select one or both, as applicable) | <span style="font-size:100%;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | |-------------------------------------------------------------------------------------| | <span style="font-size:100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ K231885 Page 1 of 6 Image /page/3/Picture/1 description: The image shows the logo for Medline. The logo consists of the word "MEDLINE" in a bold, sans-serif font, with the letters stacked vertically. A white star-like shape is behind the text. The background of the logo is a solid blue color. ledline Industries, LP Three Lakes Drive Northfield, IL 60093 # K231885 510(k) SUMMARY [AS REQUIRED BY 21CFR807.92(c)] # Submitter / 510(k) Sponsor Medline Industries, LP Three Lakes Drive Northfield, IL 60093 Registration Number: 1417592 # Contact Person Contact Person: Jennifer Mason, Principal Regulatory Affairs Phone: 847-643-3652 Email: jamason(@medline.com Summary Preparation Date August 8, 2023 Type of 510(k) Submission Traditional ### Device Name / Classification Trade Name: Medline UNITE® REFLEX® Nitinol Staples Common Name: Staple, Fixation, Bone Classification Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Product Code: JDR Classification Panel: Orthopedics Regulatory Class: Class II Regulation Number: 21 CFR 888.3030 #### Predicate Device Medline UNITE® REFLEX® Nitinol Staple System K210482 ### Device Description The Medline UNITE® REFLEX® Nitinol Staples are manufactured from nickel titanium alloy (Nitimol). The staples utilize chemical etching and passivation to form a protective oxidation layer on the outer surface. The system includes staples offered in a range of sizes from 8mm x 20mm x 20mm. The {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the Medline logo. The logo is set against a blue square background. The word "MEDLINE" is written in white, block letters on the left side of the square. A white, stylized starburst shape is positioned to the right of the word, with its points extending beyond the text. Aedline Industries, LP Three Lakes Drive Northfield. IL 60093 Medline UNITE® REFLEX® Nitinol Staples are offered in different bridge lengths and include 2-leg and 4-leg staples. The system also includes reusable instrumentation necessary to implant the staples, e.g. drill guides, drills, locating pins, staple inserter, and tamp. #### Indications for Use The Medline UNITE® REFLEX® Nitinol Staples are intended to provide fixation for fractures, fusions or osteotomies of the bones of the hand and foot such as: First metatarsalcuneiform arthrodesis, First metatarsophalangeal arthrodesis. Talo-Navicular fusion. LisFranc arthrodesis. Akin osteotomy, Scarf and Chevron osteotomies. Staples are intended for single use only. #### Summary of Technological Characteristics The proposed device is substantially equivalent to the predicate device, the Medline UNITE® REFLEX® Nitinol Staple System. A discussion of similarities and differences is listed below. | Device Characteristic | Proposed Device | Predicate Device | Comparison<br>Analysis | |-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------| | Product Name | Medline UNITE® REFLEX®<br>Nitinol Staple System | Medline UNITE® REFLEX®<br>Nitinol Staple System | Same | | 510(k) Reference | TBD | K210482 | N/A | | Product Owner | Medline Industries, LP | Medline Industries, LP | Same | | Product Code | JDR | JDR | Same | | Indications for Use | The Medline UNITE®<br>REFLEX® Nitinol Staples are<br>intended to provide fixation<br>for fractures, fusions or<br>osteotomies of the bones of<br>the hand and foot such as First<br>metatarsalcuneiform<br>arthrodesis, First<br>metatarasophalangeal<br>arthrodesis, Talo-Navicular<br>fusion, LisFranc arthrodesis,<br>Akin osteotomy, Scarf and<br>Chevron osteotomies. Staples<br>are intended for single use<br>only. | The Medline UNITE®<br>REFLEX® Nitinol Staples are<br>intended to provide fixation<br>for fractures, fusions or<br>osteotomies of the bones of<br>the hand and foot such as<br>LisFranc arthrodesis, Akin<br>osteotomy, Scarf and Chevron<br>osteotomies. Staples are<br>intended for single use only. | Similar | | Regulation Number | 21 CFR 888.3030 | 21 CFR 888.3030 | Same | | Design Features | Straight top configurations | Straight top configurations | Same | # TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, set against a blue square background. To the right of the word, there is a white symbol that resembles a stylized compass or a medical cross. The overall design is clean and professional, reflecting the company's focus on medical supplies and healthcare solutions. Medline Industries, LP Three Lakes Drive Northfield, IL 60093 | Leg Lengths | 8mm<br>10mm<br>12mm<br>14mm<br>15mm<br>16mm<br>18mm<br>20mm<br>25mm | 8mm<br>10mm<br>12mm<br>15mm<br>20mm<br>25mm<br>27mm | Different | |-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | Legs | 2-leg and 4-leg | 2-leg | Different | | Bridge Lengths | 8mm<br>10mm<br>12mm<br>15mm<br>18mm<br>20mm<br>23mm<br>25mm<br>26mm<br>30mm | 8mm<br>10mm<br>12mm<br>15mm<br>18mm<br>20mm<br>25mm | Different | | Materials | Nickel Titanium Alloy | Nickel Titanium Alloy | Same | | Surface Finish | Chemical etch and passivation | Chemical etch and passivation | Same | | Manufacturing Process | Wire EDM and tumbling | Wire EDM and tumbling | Same | | Instrumentation | Drill Bit 2.0mm, 3.0mm<br>Drill Guide 8mm, 10mm,<br>12mm, 15mm, 18mm, 20mm,<br>23mm, 25mm<br>Targeting Guide 26mm, 30mm<br>Inserter MINI, MAX/ULTRA<br>Sleeve 90 degree, 1.1mm,<br>1.4mm<br>Pin 2.0mm, 3.0mm | Drill Bit 2.0mm<br>Drill Guide 8mm, 10mm,<br>12mm, 15mm, 18mm, 20mm,<br>25mm<br>Drill Guide 26mm<br>Inserter MINI, MAX, ULTRA<br>Pin 2.0mm, 3.0mm | Different | | Prescription vs. OTC | Prescription Use | Prescription Use | Same | | Sterile vs. Non-Sterile | Non-sterile | Non-sterile | Same | - . Intended Use - same. Both the subject device and the predicate device are intended to provide fixation for fractures, fusions or osteotomies of the bones of the hand and foot. - Indications for Use similar. The indications for use for the new proposed Medline UNITE® . REFLEX® Nitinol Staple System are identical to the original indications for use cleared in {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, bold, sans-serif font, stacked on top of a white abstract star shape. The background is a solid dark blue color. The logo is simple and modern, and the colors are clean and professional. Medline Industries, LP Three Lakes Drive Northfield. IL 60093 K210482. This new 510(k) for the staples includes additional specific indications including: First metatarsalcuneiform arthrodesis, First metatarsophalangeal arthrodesis, Talo-Navicular fusion. These additional more specific indications are fractures, fusions, and osteotomies in the same anatomical locations. Therefore, these indications fall under the original indications for use and do not result in a new intended use. - Design features same. Both the new predicate and the subject staples are offered in straight top ● configurations. - Leg Lengths different. The predicate and subject devices are both offered in identical leg lengths ● of 8mm. 10mm. 12mm. 15mm. 20mm and 25mm. The subject device is also available in 14mm and 16mm leg lengths that are within the cleared range of lengths of the predicate device. - Staple legs different. The predicate staple is available in a 2-leg design. The subject Medline ● UNITE® REFLEX® Nitinol Staple System will also be offered in a 2-leg design, as well as, a 4leg design. - Bridge Lengths different. The predicate and subject 2-leg staples are both offered in identical ● lengths of 8mm, 10mm, 12, 15mm, 20mm and 25mm. The subject 2-leg staple is also available in 23mm which is within the cleared range of lengths of the predicate device. The subject 4-leg staples will be offered in slightly longer lengths of 26mm as well. The difference in bridge lengths does not affect safety or effectiveness of the devices. - . Materials - same. Both the subject device and the predicate device are made from nickel titanium alloy (Nitinol) and meets the material specifications outlined in ASTM F2063. - Surface Finish same. The subject device and the predicate device have the same surface finish. . - . Manufacturing Process - same. Both the subject device and the predicate device are manufactured using the exact same process. - Instrumentation different. Although both the subject device and the predicate device includes ● instrumentation necessary for implantation of the staples, some additional instruments and sizes are included in the subject device. The new instruments include drill guides and targeting guides, inserters, sleeves and pins. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for Medline. The logo is set against a blue square background. The word "MEDLINE" is written in white, bold, sans-serif font. A white star-like symbol is placed behind the text, with its points extending beyond the letters. Medline Industries, LP Three Lakes Drive Northfield. IL 60093 - Sterility same. The predicate and subject Medline UNITE® REFLEX® Nitinol Staple System ● will be provided non-sterile and are intended to be steam sterilized at the healthcare facility prior to use. ### Summary of Non-Clinical Testing The subject Medline UNITE® REFLEX® Nitimol Staples do not represent a new worst-case when compared to the previously cleared Medline UNITE® REFLEX® Nitinol Staples (K210482). An engineering analysis was performed to determine the subject Medline UNITE® REFLEX® Nitinol Staples do not represent a new worst-case when compared to the previously cleared Medline UNITE® REFLEX® Nitinol Staples (K210482) for bending and pullout performance. The results of this analysis demonstrate the subject Medline UNITE® REFLEX® Nitinol Staples are substantially equivalent to the predicate Medline UNITE® REFLEX® Nitinol Staples (K210482). To determine the worst-case staple for corrosion susceptibility representing the subject Medline UNITE® REFLEX® Nitinol Staple, an additional engineering analysis was conducted. The results of this analysis and subsequent testing demonstrate the subject Medline UNITE® REFLEX® Nitinol Staples are substantially equivalent to the predicted Medline UNITE® REFLEX® Nitinol Staples (K210482). ### Performance Testing (Bench) The following testing was performed to demonstrate substantial equivalence between the proposed Medline UNITE® REFLEX® Nitinol Staples and the predicate Medline UNITE® REFLEX® Nitinol Staples (K210482). Engineering analysis was performed to compare the subject staple's bending strength/stiffness and pullout performance per ASTM F564 to the predicate staples (K210482). Corrosion susceptibility testing was conducted per ASTM F2129 and the FDA guidance document Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol. Testing was conducted to ensure that the proposed Medline UNITE® REFLEX® Nitinol Staples meet the predefined acceptance criteria. All samples achieved electrostatic breakdown potential in excess of the minimum acceptance criteria, demonstrating acceptable corrosion susceptibility. #### Performance Testing (Animal) This section does not apply. No animal testing was performed. #### Performance Testing (Clinical) {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, set against a blue square background. A white, stylized starburst or cross shape is positioned behind the text, with its center aligned with the middle of the word. A small gray square is in the upper right corner of the blue square. Medline Industries, LP Three Lakes Drive Northfield, IL 60093 This section does not apply. No clinical testing was performed. # Conclusion Medline Industries, LP concludes that the subject Medline UNITE® REFLEX® Nitinol Staple System is as safe and as effective for their intended use as the predicate device the Medline UNITE® REFLEX® Nitinol Staple System (K210482).