CoLink NeoFuse Plating System

K213069 · In2bones USA, LLC · HRS · Dec 13, 2021 · Orthopedic

Device Facts

• Record ID: K213069
• Device Name: CoLink NeoFuse Plating System
• Applicant: In2bones USA, LLC
• Product Code: HRS · Orthopedic
• Decision Date: Dec 13, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CoLink® NeoFuse Plating System is indicated for anterior fixation of ankle arthrodesis and fractures, including the distal tibia and talus. The addition of a compression screw through the tibiotalar joint (example CoLag 6.7mm screw) is required.

Device Story

System consists of sterile titanium alloy fusion plates and screws; used for anterior fixation of ankle arthrodesis and fractures (distal tibia and talus). Requires supplemental medial-lateral compression screw through tibiotalar joint. Used in clinical/surgical settings by orthopedic surgeons. Provides mechanical stabilization of bone segments to facilitate fusion/healing. Benefits patient by maintaining alignment and stability during bone recovery.

Clinical Evidence

Bench testing only. Mechanical testing performed per modified ASTM F382. Biocompatibility validated per ISO 10993-1. Sterilization validated per ISO 11137-2. Packaging validated per ISO 11607-1. Endotoxin testing performed per ANSI/AAMI ST72.

Technological Characteristics

Material: Titanium Alloy (ASTM F136). Components: Fusion plates (anterior/anterolateral, 3-5 hole) and screws (3.5mm/4.5mm locking, non-locking, or VAL). Sterilization: Gamma. Packaging: ISO 11607-1 compliant. Mechanical testing: Modified ASTM F382.

Indications for Use

Indicated for anterior fixation of ankle arthrodesis and fractures, including distal tibia and talus, in patients requiring ankle fusion. Requires concurrent use of a compression screw through the tibiotalar joint.

Regulatory Classification

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.

Predicate Devices

• In2Bones SAS NeoFuse Ankle Fusion Plating System (K173121)
• In2Bones CoLink® Plating System (K163293)
• Wright Ortholoc® 3Di Ankle Fusion Plating System (K121425)
• In2Bones CoLink® Afx Plating System (K181113)

Reference Devices

• In2Bones Fracture and Correction System (K170518)
• In2Bones CoLink / Fracture and Correction System Packaging (K193543)

Submission Summary (Full Text)

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December 13, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

In2Bones USA, LLC Christine Scifert VP of Quality and Regulatory 6000 Poplar Ave, Suite 115 Memphis, Tennessee 38119

Re: K213069

Trade/Device Name: CoLink® NeoFuse 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: September 21, 2021 Received: September 23, 2021

Dear Christine Scifert:

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

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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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Shumaya Ali, MPH 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) K213069

Device Name CoLink® NeoFuse Plating System

Indications for Use (Describe)

The CoLink® NeoFuse Plating System is indicated for anterior fixation of ankle arthrodesis and fractures, including the distal tibia and talus.

The addition of a compression screw through the tibiotalar joint (example CoLag 6.7mm screw) is required.

| Type of Use (Select one or both, as applicable) | <p>☑ Residential Use (Part 21 CFR 601 Subpart E) </p> <p>☐ Compassionate Use (21 CFR 601 Subpart E)</p> |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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### 510(k) Summary

# CoLink® NeoFuse Plating System December 8, 2021

| Company: | In2Bones USA, LLC<br>6000 Poplar Ave, Suite 115<br>Memphis, TN 38119<br>901-260-7931 |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Christine Scifert |
| Trade Name: | CoLink® NeoFuse Plating System |
| Common Name: | Plate, Fixation, Bone<br>Screw, Fixation, Bone |
| Classification: | II |
| Regulation Number: | 888.3030 - Single/multiple component metallic bone fixation appliances<br>and accessories (Primary)<br>888.3040 - Smooth or threaded metallic bone fixation fastener |
| Panel: | 87-Orthopedic |
| Product Code(s): | HRS, HWC |

Device Description: The In2Bones CoLink® NeoFuse Plating System includes sterile fusion plates and screws for anterior fixation of ankle arthrodesis and fractures, including the distal tibia and talus. The addition of a medial-lateral compression screw through the tibiotalar joint is required. These subject devices are part of the overarching CoLink® Plating System and will be commonly referred to as the CoLink NeoFuse Plating System.

### Indications for Use:

The CoLink® NeoFuse Plating System is indicated for anterior fixation of ankle arthrodesis and fractures, including the distal tibia and talus.

The addition of a compression screw through the tibiotalar joint (example CoLag 6.7mm screw) is required for ankle fusion procedure.

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Substantial Equivalence: The subject components were demonstrated to be substantially equivalent to the following systems previously cleared by the FDA:

Primary Predicate

- . K173121 – In2Bones SAS NeoFuse Ankle Fusion Plating System
Additional Predicates

- K163293 In2Bones CoLink® Plating System ●
- K121425 Wright Ortholoc® 3Di Ankle Fusion Plating System ●
- . K181113 – In2Bones CoLink® Afx Plating System

Reference Devices

- . K170518 - In2Bones Fracture and Correction System
- K193543 In2Bones CoLink / Fracture and Correction System Packaging ●

A comparison of the technological similarities and differences between the subject and predicate devices is shown below:

| Device | CoLink® NeoFuse Plating System<br>(Subject Device) | CoLink® Plating System<br>(K163293) | In2Bones SAS NeoFuse Ankle<br>Fusion Plating System<br>(K173121) |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Fixation Plates and Screws | Fixation Plates and Screws | Fixation Plates and Screws |
| Indications for<br>Use | The CoLink® NeoFuse Plating<br>System is a fusion plate indicated<br>for anterior fixation of ankle<br>arthrodesis and fractures,<br>including the distal tibia and<br>talus.<br>The addition of a compression<br>screw through the tibiotalar joint<br>(example CoLag 6.7mm screw) is<br>required for ankle fusion<br>procedure. | The In2Bones USA LLC, CoLink®<br>Plating System is indicated for<br>stabilization and fixation of<br>fractures, revision procedures,<br>joint fusion, osteotomies and<br>reconstruction of the small<br>bones in the hand, wrist, foot<br>and ankle in both pediatric and<br>adult patients. | The In2Bones NeoFuse Ankle<br>Fusion plating system is<br>indicated for anterior fixation of<br>ankle arthrodesis and fractures,<br>including the distal tibia, talus<br>and calcaneus.<br>The addition of a compression<br>screw through the tibiotalar<br>joint (example IBS 6.5mm<br>screw) is required. |
| Product Code | HRS, HWC | HRS, HWC | HRS, HWC |
| Material | Titanium Alloy (ASTM F136) | Titanium Alloy (ASTM F136) | Titanium Alloy (ASTM F136) |
| Geometry and<br>Dimensions | Available in 2 styles, 2 sizes each:<br>Anterior and Anterolateral, 3<br>Hole and 5 Hole. | Plate type: MTP, Lapidus, Y-<br>Plate, Universal Plate, H-Plate;<br>2-hole through 8-hole plates | Plate: Available in 1 size only<br>Screws: |
| | Screws:<br>3.5mm locking, non-locking or<br>VAL screw or 4.5mm locking,<br>non-locking or VAL screw | Screws:<br>3.0 and 3.5 locking and non-<br>locking screws | 3.5mm locking screw with<br>washer, 4.5mm locking screw<br>with washer or 4.5mm cortical<br>screw |
| | Plate Length:3.10in- 4.28in<br>Plate Thickness: .098in -.123in | Plate Length: 0.9in - 2.3in<br>Plate Thickness: 0.050-.064in | Plate Length: 3.7in<br>Plate Thickness: .138in |

The subject CoLink® NeoFuse Plating System is made of Titanium Alloy and has been demonstrated to be substantially equivalent to the previously cleared devices identified above as the products are similar in indications, materials and geometry.

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Performance Testing: Testing was conducted per a modified ASTM F382 set up for the plates for the CoLink® NeoFuse Plating System and the plates were found to be substantially equivalent. No additional mechanical testing was required for the screws. The CoLink® NeoFuse Plating System were validated per ISO 10993-1 for biocompatibility, ISO 11137-2 for gamma sterilization and ISO 11607-1 for packaging. Endotoxin testing was completed per ANSI/AAMI ST72.

### Conclusion

Based on the test results and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predicate devices.