IN:C2 SPINAL FIXATION SYSTME

K141537 · Spine Smith Holdings, LLC · OVE · Nov 25, 2014 · Orthopedic

Device Facts

• Record ID: K141537
• Device Name: IN:C2 SPINAL FIXATION SYSTME
• Applicant: Spine Smith Holdings, LLC
• Product Code: OVE · Orthopedic
• Decision Date: Nov 25, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IN:C2 Spinal Fixation System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. IN:C2 is a stand-alone device intended to be used with an anterior cover plate and a minimum two provided bone screws angled both cephalad and caudal with a minimum of one screw into each vertebral body. The implants are to be used with autogenous bone graft and implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral cage.

Device Story

IN:C2 Spinal Fixation System is a stand-alone intervertebral body fusion device used to stabilize the cervical spine during fusion. The device consists of a U-shaped PEEK cage with titanium markers and an anterior cover plate assembly with two titanium bone screws. It is implanted via an open, anterior approach by a surgeon. The device acts as a spacer to maintain disc height while autogenous bone graft promotes fusion; the cover plate and screws provide supplemental fixation to the vertebral bodies. The system is designed for patients with cervical disc disease who have failed conservative treatment. The current iteration modifies the PEEK-to-plate interface by replacing a snap feature with a titanium insert to improve mechanical stability.

Clinical Evidence

Bench testing only. Testing included ASTM F2077-11 (intervertebral body fusion device testing), ASTM F2267-04 (load-induced subsidence), ASTM F1877-05 (particle characterization), and pull-off force testing for the interface between the PEEK component and the titanium anterior plate.

Technological Characteristics

Materials: PEEK and titanium. Form factor: U-shaped cage with anterior cover plate and two bone screws. Fixation: Stand-alone, screws angled cephalad and caudal. Standards: ASTM F2077-11, ASTM F2267-04, ASTM F1877-05. No software or electronic components.

Indications for Use

Indicated for anterior cervical interbody fusion in skeletally mature patients with cervical disc disease (intractable radiculopathy/myelopathy, herniated disc, or osteophyte formation) at one level from C2-C3 to C7-T1. Requires at least six weeks of prior non-operative treatment.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• IN:C2 Spinal Fixation System (K122630)
• Cimplicity System (K073320)

Submission Summary (Full Text)

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November 25, 2014

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

SpineSmith Partners, LLP Mr. Clifton Naivar Director, Quality and Regulatory Affairs 93 Red River Austin, Texas 78701

Re: K141537

Trade/Device Name: IN: C2 Spinal Fixation System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: October 2, 2014 Received: October 3, 2014

Dear Mr. Naivar:

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

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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.

# 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): K141537

#### Device Name: IN:C2 Spinal Fixation System

Indications for Use:

The IN:C2 Spinal Fixation System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. IN:C2 is a stand-alone device intended to be used with an anterior cover plate and a minimum two provided bone screws angled both cephalad and caudal with a minimum of one screw into each vertebral body. The implants are to be used with autogenous bone graft and implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral cage.

_x____________________________________________________________________________________________________________________________________________________________________________ Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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#### SpineSmith IN:C2 Spinal Fixation System

#### 510(k) Summary

| SUBMITTED BY | SpineSmith Partners, LLP<br>93 Red River<br>Austin, TX 78701 |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| ESTABLISHMENT<br>REGISTRATION NUMBER | 3006404071 |
| CONTACT PERSON | Clifton (Chris) Naivar<br>Director - Quality and Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| SUBMISSION PREPARED BY | Clifton (Chris) Naivar<br>Director - Quality and Regulatory Affairs<br>Phone: [phone] |
| DATE PREPARED | September 17, 2014 |
| CLASSIFICATION | OVE - intervertebral fusion device with integrated<br>fixation, cervical |
| COMMON NAME | Intervertebral Body Fusion Device |
| PROPRIETARY NAME | IN:C2 Spinal Fixation System |

### IDENTIFICATION OF PREDICATE DEVICES:

The SpineSmith IN:C2 System, K122630, was determined to be substantially equivalent to the previously cleared Cimplicity System previous K073320, SpineSmith; Cleared 02/07/2008. K122630 is the primary predicate for this 510(k). The original design consisted of a titanium anterior plate which mates via a snap feature to a PEEK cage. The snap interface of the PEEK component is being replaced with a titanium insert. There are no additional changes in size, geometry, manufacturing methods, overall materials used or indications for use.

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#### DEVICE DESCRIPTION:

SpineSmith Partners LLP developed the IN:C2 Spinal Fixation System to be used during spinal fusion. IN:C2 serves to stabilize the spine while bony fusion develops.

The IN:C2 System consists of a 'U' shaped PEEK block in multiple footprint configurations and heights. The PEEK implants contain a titanium marker intended to verify position radiologically. The IN:C2 is a stand-alone system, intended for use with its cover plate assembly and two titanium bone screws provided. The IN:C2 implant is intended to be implanted via an open anterior approach.

The anterior cover plate assembly attaches to the anterior most portion of the device, and includes housing features for placement of two bone screws angled cephalad and caudal. The cover plate assembly and integrated screws are supplemental fixation.

#### INDICATIONS:

The IN:C2 Spinal Fixation System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. IN:C2 is a stand-alone device intended to be used with an anterior cover plate and a minimum two provided bone screws angled both cephalad and caudal with a minimum of one screw into each vertebral body. The implants are to be used with autogenous bone graft and implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral cage.

# MECHANICAL TESTING:

The following non-clinical tests were conducted:

- ASTM F2077-11, Test Methods for Intervertebral Body Fusion Devices. ●
- . ASTM F2267-04. Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression.
- ASTM F1877-05 Standard Practice for Characterization of Particles .
- . Pull-off force testing was performed to determine the strength of the PEEK component and titanium anterior plate interface

# CONCLUSIONS:

The subject and predicate device share the same intended use. There are no additional changes in size, geometry, manufacturing methods, overall materials used or indications for use. The non-clinical mechanical test results demonstrate that any minor differences, modification of the snap interface, do not impact device performance as compared to the predicates and demonstrate that the IN:C2 System is substantially equivalent to the predicate device.