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 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, heights and lordosis angles. 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the SpineSmith IN:C2 Spinal Fixation System, a medical device. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily through mechanical testing, rather than reporting on a clinical study or AI-driven performance. Therefore, many of the requested elements are not present in the provided text.

Here is an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test)	Reported Device Performance	Comments
ASTM F2077-03: Test Methods for Intervertebral Body Fusion Devices	Met (implied)	The non-clinical mechanical test results "demonstrate that any minor differences do not impact device performance as compared to the predicates."
ASTM F2267-04: Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression	Met (implied)	Same as above.
Draft Document Submitted to ASTM F-04.25.02.02: Static Pushout Test Method for Intervertebral Body Fusion Devices	Met (implied)	Same as above.
ASTM F1877-05: Standard Practice for Characterization of Particles	Met (implied)	Same as above.

2. Sample size used for the test set and the data provenance

Not applicable. The submission relies on mechanical (non-clinical) testing, not clinical data or a test set in the context of an AI model.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a medical device clearance based on mechanical testing and substantial equivalence, not a study involving expert consensus for ground truth on patient data.

4. Adjudication method for the test set

Not applicable. No clinical test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This submission concerns a physical medical device (spinal fixation system) and does not involve AI or human readers evaluating images.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This submission does not involve an algorithm or AI.

7. The type of ground truth used

For the mechanical testing, the "ground truth" or acceptance criteria are the standards set by the relevant ASTM test methods (e.g., specific load resistance, deformation limits). The device's performance compared to these predefined engineering standards establishes its suitability.

8. The sample size for the training set

Not applicable. There is no AI model, and therefore no training set.

9. How the ground truth for the training set was established

Not applicable. There is no AI model, and therefore no training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The SpineSmith IN:C2 Spinal Fixation System demonstrated its compliance with acceptance criteria through a series of non-clinical mechanical tests. These tests were conducted according to established ASTM (American Society for Testing and Materials) standards relevant to intervertebral body fusion devices. The specific standards cited are:

ASTM F2077-03: 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
Draft Document Submitted to ASTM F-04.25.02.02: Static Pushout Test Method for Intervertebral Body Fusion Devices
ASTM F1877-05: Standard Practice for Characterization of Particles

The conclusion drawn from these tests was that "any minor differences [between the subject device and predicate devices] do not impact device performance as compared to the predicates." This indicates that the SpineSmith IN:C2 system performed comparably to, and met the safety and performance expectations set by, its predicate devices when subjected to these standardized mechanical stresses. The FDA's 510(k) clearance is based on this demonstration of substantial equivalence through mechanical testing, rather than clinical efficacy studies. The "acceptance criteria" were therefore the performance benchmarks inherent in these ASTM standards and the performance of the legally marketed predicate devices.

Summary

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SpineSmith IN:C2 Spinal Fixation Svstem

5 2012 510(k) Summary of Safety and Effectiveness DEC

EC 5 2012

SUBMITTED BY

SpineSmith Partners, LLP 93 Red River Austin, TX 78701

3006404071

ESTABLISHMENT REGISTRATION NUMBER

CONTACT PERSON

Clifton (Chris) Naivar Director - Quality and Regulatory Affairs Phone: 512-637-2068 Fax: 512-637-2096 Email: cnaivar@spinesmithusa.com

SUBMISSION PREPARED BY Clifton (Chris) Naivar Director - Quality and Regulatory Affairs Phone: 512-637-2068

DATE PREPARED September 30, 2012

OVE - intervertebral fusion device with integrated CLASSIFICATION fixation, cervical

REGULATION NUMBER 21 CFR 888.3080

Intervertebral Body Fusion Device COMMON NAME

SpineSmith IN:C2 Spinal Fixation System PROPRIETARY NAME

IDENTIFICATION OF PREDICATE DEVICES:

The SpineSmith IN:C2 System was determined to be substantially equivalent to the previously cleared Cimplicity System (K080971) as well as the Coalition Spacer (K083389) and the InterPlate C-Ti (K092070).

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.

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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 autoqenous 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 F2077-03, 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.
Draft Document Submitted to ASTM F-04.25.02.02. Static Pushout Test . Method for Intervertebral Body Fusion Devices.
ASTM F1877-05 Standard Practice for Characterization of Particles .

CONCLUSIONS:

The subject and predicate device share the same intended use, primary implant design and material of manufacture. The non-clinical mechanical test results demonstrate that any minor differences do not impact device performance as compared to the predicates and demonstrate that the IN:C2 System is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines extending from its base, enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 5, 2012

Spine Smith Partners, L.P. % Clifton Naivar Director, Quality and Regulatory Affairs 93 Red River Austin, Texas 78701

Re: K122630

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: November 2, 2012 Received: November 5, 2012

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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Page 2 - Mr. Clifton Naivar

forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Mark N. Méikerson 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): K122630

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 hemiated 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.

Prescription Use X (Part 21 CFR 801 Subpart D) 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)

Caroline Rhim -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: 122630

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
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.(b)
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.