CrossCLIP Implant System

K142727 · Orthodiscovery Group, LLC(D.B.A. Crossroads Extremity Systems · JDR · Oct 24, 2014 · Orthopedic

Device Facts

• Record ID: K142727
• Device Name: CrossCLIP Implant System
• Applicant: Orthodiscovery Group, LLC(D.B.A. Crossroads Extremity Systems
• Product Code: JDR · Orthopedic
• Decision Date: Oct 24, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CrossCLIP™ Implant System is indicated for hand and foot bone fragment osteotomy fixation and joint arthrodesis.

Device Story

CrossCLIP™ Implant System is a nitinol bone staple used for hand and foot osteotomy fixation and joint arthrodesis. Device utilizes superelastic properties of nitinol to generate compression between staple legs. Implants feature internal and external barbs to resist pullout. Unlike predicate devices where the inserter attaches under the staple bridge—preventing full seating until a secondary step—the CrossCLIP inserter engages the staple leg, allowing the implant to be fully seated on the bone surface prior to release. System includes implant inserter, drill/reamer guide, drill/reamer, and provisional fixation pin. Used by surgeons in clinical settings. Benefits include improved seating mechanism and secure fixation via shape memory compression.

Clinical Evidence

Bench testing only. Performance verified against predicate device (K070031) and ASTM F2063-12 standards. Design verification activities met all acceptance criteria.

Technological Characteristics

Material: Nickel-titanium alloy (Nitinol) per ASTM F2063-12. Principle: Superelastic shape memory compression. Form factor: One-piece staple with internal/external barbs. Components: Implant, inserter, drill/reamer guide, drill/reamer, provisional fixation pin. Sterilization: Sterile packaged instruments.

Indications for Use

Indicated for patients requiring hand and foot bone fragment osteotomy fixation and joint arthrodesis.

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

• MemoMetal Memory Staples (MemoClip - EasyClip - For Fusion) (K070031)
• FuseForce Implant System (K124045)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human face in profile, with three overlapping profiles suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the face, indicating the department's name and national affiliation.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 24, 2014

OthoDiscovery Group, LLC (D.B.A. CrossRoads Extremity Systems) Mr. Vernon Hartdegen Sr. Vice President of Operations 458 Distribution Parkway Collierville, Tennessee 38017

Re: K142727 Trade/Device Name: CrossCLIP™ Implant 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: September 25, 2014 Received: September 30, 2014

Dear Mr. Vernon Hartdegen:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{1}------------------------------------------------

Page 2 - Mr. Vernon Hartdegen

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# Lori A. Wiggins -S

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

Enclosure

{2}------------------------------------------------

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES. Food and Drug Administration

# Indications for Use

510(k) Number (if known)

K142727

Device Name

CrossCLIPTM Implant System

Indications for Use (Describe)

The CrossCLIP™ Implant System is indicated for hand and foot bone fragment osteotomy fixation and joint arthrodesis.

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)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017 See PRA Statement below.

## 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)

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}------------------------------------------------

| Date of Submission | September 25, 2014 |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact/Address of<br>Manufacturing Facility | Vernon R Hartdegen<br>Sr. Vice President of Operations<br>OrthoDiscovery Group, LLC<br>458 Distribution Parkway<br>Collierville, TN 38017<br>Phone: [phone]<br>Fax: N/A<br>[e-mail] |
| Proprietary Name | CrossCLIP™ Implant System |
| Device Classification Name | Staple, Fixation, Bone |
| Product Code | JDR |
| Classification Reference | 21 CFR 888.3030 |
| Classification | Class II |
| Appropriate Classification Panel | 87 - Orthopedic |
| Predicate Devices | K070031 - MemoMetal Memory Staples (MemoClip - EasyClip -<br>For Fusion); MemoMetal Technologies<br>K124045 – FuseForce Implant System; Solana Surgical, LLC |
| Reason For Submission | New Device |

## 5 – 510(k) Summary CrossCLIP™ Implant System

## Substantial Equivalence:

The new device has the following similarities to the previously cleared predicate devices:

- Same Operating Principle o
- Same Technology o
- Same Intended Use o

Design verification analysis was performed on the CrossCLIP™ Implant System as a result of the risk analysis and product requirements. Results of the design verification activities met the required acceptance criteria. In summary, the device described in this submission is substantially equivalent to the predicate device. The subject device is similar in material, operating principle and intended use to both identified predicates. The subject device primarily differs from the predicates in the manner of the attachment of the implant to the insertion

{4}------------------------------------------------

device/delivery instrument. The predicate devices both rely on insertion/delivery instrumentation and techniques that requires the delivery instrument to attach underneath the bridge of the staple. This prevents the staple from fully seating on the surface of the bone. Due to this, once the staple is released from its inserter and the legs are allowed to converge, the staple must then undergo a final seating with an ancillary instrument. The subject device implant is not held underneath the staple bridge rather the inserter engages the staple leg thereby allowing the implant to be fully seated on the bone prior to being released from the inserter/delivery instrument. Both the subject and predicate devices have barbs on the internal surface of the staple legs to resist pullout. In addition, certain sizes of the subject implant include a barb-like feature on the outside of the staple leg to resist pullout. Neither of these differences adversely affect the safety of the device as demonstrated by the verification analysis. The subject and predicate devices both utilize the same mechanism of action, i.e. the superelastic material property of nitinol, to generate compression between the staple legs. The minor differences between the subject and predicate devices are insignificant in the safety and efficacy of the devices. In summary, the subject device described in this submission is substantially equivalent to the predicate devices.

#### Indications for Use:

The CrossCLIP™ Implant System is indicated for hand and foot bone fragment osteotomy fixation and joint arthrodesis.

#### Device Description:

The CrossCLIP™ Implant System is manufactured from nickel titanium alloy (ASTM F2063-12 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants). The implants are one-piece devices designed to be implanted into the bones of the hand or foot for fragment osteotomy fixation and joint arthrodesis. The staple legs have barb-type features on the inside and outside of the legs to resist pullout. The implants are available in a range of sizes similar to the predicate devices.

The instruments needed for implantation consist of an implant inserter, drill/reamer guide, drill/reamer and provisional fixation pin. The implant inserter is considered a Class II instrument. All other instruments are Class I.

The design features of the CrossCLIP™ Implant System are summarized below:

- Implant Grade Nitinol (ASTM F2063-12) o
- O Various sizes to accommodate patient anatomy
- o One piece construction
- Barbs to resist pull-out O
- O Single use, sterile packaged instruments

{5}------------------------------------------------

### Performance Testing:

The CrossCLIP™ implants have been verified against the predicate device (K070031 – MemoMetal Memory Staples MemoClip – For Fusion; MemoMetal Technologies) and ASTM F2063-12 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants. The completed analysis has shown that the performance of the subject device is substantially equivalent to the predicate devices.