CoLink View Plating System

K172300 · In2bones USA, LLC · HRS · Nov 27, 2017 · Orthopedic

Device Facts

• Record ID: K172300
• Device Name: CoLink View Plating System
• Applicant: In2bones USA, LLC
• Product Code: HRS · Orthopedic
• Decision Date: Nov 27, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The In2Bones USA LLC, CoLink™ Plating System is indication and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediativ and adult patients.

Device Story

CoLink™ View Plating System consists of bone plates and screws used for orthopedic fixation and reconstruction of small bones in extremities. System expands existing line (K163293) by introducing plates featuring PEEK or titanium alloy inserts. Device used by surgeons in clinical/OR settings to stabilize bone segments during fracture repair or reconstructive procedures. Surgeon selects appropriate plate/screw configuration based on patient anatomy and clinical need. Output is mechanical stabilization of bone; benefits include support for bone healing and structural alignment.

Clinical Evidence

Bench testing only. Mechanical four-point bend testing performed per ASTM F382-14. Material mediated pyrogen testing and bacterial endotoxin testing conducted to establish non-pyrogenicity.

Technological Characteristics

Materials: ASTM F 136 Titanium 6Aluminum 4Vanadium Alloy (Ti6Al4V) and ASTM F 2026 Poly Ether Ether Ketone (PEEK). Components: Plates, screws, and surgical instruments. Mechanical testing: ASTM F382-14 four-point bend testing.

Indications for Use

Indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies, and reconstruction of small bones in hand, wrist, foot, and ankle in pediatric and adult patients.

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 CoLink™ Plating System (K163293)
• Wright Medical Mini MaxLock Extreme® Plating System (K120157)

Submission Summary (Full Text)

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November 27, 2017

In2Bones USA, LLC % Christine Scifert Exec VP MRC-X, LLC 6060 Poplar Ave, Suite 380 Memphis, Tennessee 38119

Re: K172300

Trade/Device Name: CoLink™ View 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: October 19, 2017 Received: October 20, 2017

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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K172300

Device Name CoLink™ Plating System

#### Indications for Use (Describe)

The In2Bones USA LLC, CoLink™ Plating System is indication and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediativ and adult patients.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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# 510(k) Summary

CoLink™ Plating System November 22, 2017

| Company: | In2Bones USA, LLC<br>6060 Poplar Ave, Suite 380<br>Memphis, TN 38119<br>901-260-7931 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Christine Scifert |
| Company Contact: | Rebecca Wahl |
| Trade Name: | CoLinkTM View 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<br>888.3040 - Smooth or threaded metallic bone fixation fastener |
| Panel: | 87-Orthopedic |
| Product Code(s): | HRS, HWC |

The In2Bones CoLink™ View Plating System is a system of plates and screws and Device Description: surgical instruments used to treat fracture and reconstruction of the extremities. The current plate offering cleared under K163293 are made of ASTM F 136 Titanium 6Aluminum 4Vanadium Alloy (Ti6Al4V) material. The scope of this submission is to add plates that include inserts made of ASTM F 2026 Poly Ether Ether Ketone (PEEK) or ASTM F 136 Titanium 4Vanadium Alloy (Ti6A14V) materials.

The In2Bones USA LLC, CoLink™ Plating System is indicated for stabilization Indications for Use: and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.

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

- K163293 In2Bones CoLink™ Plating System .
Additional Predicates

- K120157 Wright Medical Mini MaxLock Extreme® Plating System ●
The subject CoLink™ Plating System made of Titanium Alloy and PEEK have demonstrated to be substantially equivalent to the previously cleared devices cleared under K163293 and K120157 as the products are similar in indications, materials and geometry.

Performance Testing: Mechanical testing four-point bend testing was performed per ASTM F382-14 on the subject CoLink™ View Plates and the results show the subject plates to be substantially equivalent to the predicate plates. Material Mediated Pyrogen Testing and bacterial endotoxin testing were conducted to establish non-pyrogenicity.

## 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.