(99 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and design of a spinal fixation system, with no mention of AI or ML capabilities.
Yes
The device is a spinal fixation system intended to stabilize the spine and promote bony fusion, addressing cervical disc disease which is a medical condition.
No
The device is a spinal fixation system, indicated for anterior cervical interbody fusion procedures. It is a stand-alone implant used to stabilize the spine, not to diagnose a condition.
No
The device description clearly states that the IN:C2 Spinal Fixation System consists of physical components like a PEEK block, titanium marker, cover plate assembly, and bone screws, which are implanted into the patient. This indicates it is a hardware medical device, not software-only.
Based on the provided information, the IN:C2 Spinal Fixation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- IN:C2 Function: The IN:C2 Spinal Fixation System is a surgical implant designed to stabilize the spine during fusion procedures. It is a physical device implanted into the body, not used to analyze biological samples.
- Intended Use: The intended use clearly describes a surgical procedure for treating cervical disc disease by providing structural support and promoting bone fusion.
- Device Description: The description details the physical components of the implant (PEEK block, titanium marker, cover plate, screws).
- Performance Studies: The performance studies focus on the mechanical properties and structural integrity of the implant, not on the analysis of biological samples.
Therefore, the IN:C2 Spinal Fixation System falls under the category of a surgical implant or medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OVE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical disc (C2-C3 disc to the C7-T1 disc)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
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.
1
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 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.
2
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
3
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
4
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