← Product Code [HTY](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY) · K203698

# CoLink Sfx Implant System (K203698)

_In2bones USA, LLC · HTY · May 4, 2021 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K203698

## Device Facts

- **Applicant:** In2bones USA, LLC
- **Product Code:** [HTY](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY.md)
- **Decision Date:** May 4, 2021
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3040
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic

## Intended Use

The In2Bones USA CoLink® Sfx Implant System is a system of implantable K-wires and caps indicated for temporary fixation and stabilization of bone fractures and reconstructions. In addition, the K-wires can be used as guide pins for insertion of other implants. The caps are indicated for use in the protection of protruding ends of wires.

## Device Story

CoLink® Sfx Implant System consists of stainless steel K-wires and polyethylene tip protectors (caps). K-wires provide temporary fixation/stabilization for extremity bone fractures and reconstructions or serve as guide pins for other implants. Caps are non-implantable accessories used to cover protruding wire ends. System is used in clinical settings by orthopedic surgeons. Device provides mechanical stabilization of bone segments; caps prevent soft tissue irritation from wire ends. Benefits include temporary bone alignment and protection during healing. No mechanical loading on caps; wires are part of the broader CoLink® Plating System.

## Clinical Evidence

No clinical data. Bench testing only. Validations performed for sterilization (ISO 11137-2), biocompatibility (ISO 10993-1), packaging/shelf life (ISO 111607-1), and pyrogenicity (ANSI-AAMI ST72). Bacterial endotoxin testing (LAL) performed on each lot.

## Technological Characteristics

K-wires: Stainless steel (ASTM F138). Caps: Polyethylene. System provided sterile. No mechanical loading on caps. Biocompatibility per ISO 10993-1; sterilization per ISO 11137-2; packaging/shelf life per ISO 111607-1; pyrogenicity per ANSI-AAMI ST72.

## Regulatory Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

## Predicate Devices

- In2Bones Kirschner Wire ([K153204](/device/K153204.md))
- New Deal K Wire and K-Fix® ([K022599](/device/K022599.md) & [K022597](/device/K022597.md))
- Wright Medical WMT Implantable K-wires ([K132895](/device/K132895.md))

## Reference Devices

- CoLink® Plating System ([K163293](/device/K163293.md))

## Submission Summary (Full Text)

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In2Bones USA, LLC Ms. Christine Scifert VP, QA & RA 6000 Poplar Ave, Suite 115 Memphis, Tennessee 381 19

Re: K203698

Trade/Device Name: CoLink® Sfx Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: April 6, 2021 Received: April 7, 2021

Dear Ms. 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 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

May 4, 2021

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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 (OS) 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/cdrl-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.

for

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal 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) K203698

Device Name CoLink® Sfx Implant System

#### Indications for Use (Describe)

The In2Bones USA CoLink® Sfx Implant System is a system of implantable K-wires and caps indicated for temporary fixation and stabilization of bone fractures and reconstructions. In addition, the K-wires can be used as guide pins for insertion of other implants. The caps are indicated for use in the protection of protruding ends of wires.

| Type of Use (Select one or both, as applicable)                                  |                                                                                 |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span>      Prescription Use (Part 21 CFR 801 Subpart D)    </span> </div> | <div> <span>      Over-The-Counter Use (21 CFR 801 Subpart C)    </span> </div> |

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# 510(k) Summary

CoLink® Sfx Implant System April 2, 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® Sfx Implant System                                                           |
| Common Name:       | Pin, Fixation, Smooth                                                                |
| Classification:    | II                                                                                   |
| Regulation Number: | 888.3040 – Smooth or threaded metallic bone fixation fastener                        |
| Panel:             | 87-Orthopedic                                                                        |
| Product Code(s):   | HTY                                                                                  |

Device Description: The CoLink® Sfx Implant system is a system of implantable k-wires with tip protectors (caps) used to provide temporary fixation and stabilization of fractured bones of the extremities. The k-wire is made from stainless steel (ASTM F138) and the tip protectors are made from polyethylene. The tip protectors are not implantable and are for protection for protruding ends of wires. These subject devices are part of the overarching CoLink® Plating System.

The In2Bones USA CoLink® Sfx Implant System is a system of implantable K-Indications for Use: wires and caps indicated for temporary fixation and stabilization of bone fractures and reconstructions. In addition, the K-wires can be used as guide pins for insertion of other implants. The caps are indicated for use in the protection of protruding ends of wires.

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

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Primary Predicate

- K153204 – In2Bones Kirschner Wire
# Additional Predicates

- K022599 & K022597 New Deal K Wire and K-Fix® ●
- K132895 - Wright Medical WMT Implantable K-wires

Reference Device

- o K163293 - CoLink® Plating System
Similar to the primary predicate device (K153204), the subject CoLink® Sfx Implant System is made of Stainless and provided sterile. The CoLink® Sfx Implant System has similar indications to the New Deal K Wire and K-Fix® (K022599 & K022597) and Wright Medical WMT Implantable K-wires (K132895). This submission is adding k-wires and protective caps to the CoLink® family. The subject k-wires and caps have been demonstrated to be substantially equivalent to the previously cleared devices identified above as the products are similar in indications, materials and geometry.

Performance Testing: No additional mechanical testing was required for the CoLink® Sfx Implant System as the subject wires are not considered a worst case based on engineering analysis comparing the subject implants to legally marketed predicates. The protector caps do not require mechanical testing as they will not see any mechanical loading. Validations and risk assessments were conducted for the CoLink® Sfx Implant System for sterilization (ISO 11137-2), biocompatibility (ISO 10993-1), packaging and shelf life (ISO 111607-1) and pyrogenicity (ANSI-AAMI ST72). Bacterial endotoxin testing (LAL) is performed on each lot.

# 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.

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K203698](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K203698)

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