(72 days)
No
The summary describes a passive implantable device (spinal spacer) and does not mention any computational or analytical capabilities that would suggest the use of AI or ML.
Yes
The device is described for vertebral body replacement, intervertebral fusion, treatment of tumors, fractures, and degenerative disc disease, all of which are considered therapeutic interventions.
No
This device is a surgical implant (vertebral body replacement and intervertebral fusion device), not a diagnostic tool. Its purpose is to treat conditions of the spine, not to identify or diagnose them.
No
The device description explicitly states the device is a "spacer constructed of medical grade Polyetheretherketone (PEEK) with tantalum radiographic markers," indicating it is a physical implant, not software.
Based on the provided text, the C-Thru™ Anterior Spinal System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for vertebral body replacement and intervertebral fusion. This is a therapeutic device used in vivo (within the body) to treat a physical condition.
- Device Description: The device is described as a spacer constructed of PEEK with tantalum markers. This is a physical implant, not a reagent, instrument, or system intended for the examination of specimens derived from the human body.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information based on laboratory tests
- Using reagents or analytical instruments
In summary, the C-Thru™ Anterior Spinal System is a medical device intended for surgical implantation and structural support within the spine, which falls under the category of therapeutic devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The C-Thru™ Anterior Spinal System is indicated for vertebral body replacement and intervertebral fusion. When used as a vertebral body replacement device, the C-Thru™ Spacers are indicated for use in the thoracolumbar spine (i.e., TI to L.5) for partial replacement of a diseased vertebral body resected or excised for the treatment of turnors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The C-Thru™ Spacers are also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The C-ThruTM Spacers are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
When used as a cervical intervertebral fusion device, the C-Thru™ Anterior Spinal System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. The C-Thru™ Spacers are intended for use with supplemental fixation and autogenous bone graft to facilitate the fusion.
Product codes
ODP, MQP
Device Description
The C-Thru™ Anterior Spinal System consists of a spacer constructed of medical grade Polyetheretherketone (PEEK) with tantalum radiographic markers for spinal applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic studies
Anatomical Site
thoracolumbar spine (i.e., T1 to L5), cervical spine (C2 to T1)
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)
Based upon the mechanical testing, C-Thru™ Anterior Spinal System is substantially equivalent for its intended use to other spacers currently on the market.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K040928, K082406, K081730, K063393
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for Biomet Spine. The word "BIOMET" is in a bold, sans-serif font, with the letters connected. Below the word "BIOMET" is the word "SPINE" in a smaller, sans-serif font. The logo is black and white.
510(k) Summary
| Preparation Date: | July 31, 2009 | |
|---|---|---|
| Applicant/Sponsor: | Biomet Spine | |
| 100 Interpace Parkway | ||
| Parsippany, NJ 07054 | OCT 1 5 2009 | |
| Contact Person: | Vivian Kelly | |
| Phone: 973-299-9300 | ||
| Fax: 973-257-0232 | ||
| Trade name: | C-Thru™ Anterior Spinal System | |
| Common Name: | Cervical and non-cervical spinal spacer | |
| Classification Name: | Intervertebral fusion device, 21 CFR §888.3080 | |
| Spinal Intervertebral Body Fixation Orthosis, 21 CFR § 888.3060 | ||
| Device Panel/Product Code: | Orthopedic ODP & MQP |
Device Description:
The C-Thru™ Anterior Spinal System consists of a spacer constructed of medical grade Polyetheretherketone (PEEK) with tantalum radiographic markers for spinal applications.
Indications for Use:
The C-Thru™ Anterior Spinal System is indicated for vertebral body replacement and intervertebral fusion. When used as a vertebral body replacement device, the C-Thru™ Spacers are indicated for use in the thoracolumbar spine (i.e., TI to L.5) for partial replacement of a diseased vertebral body resected or excised for the treatment of turnors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The C-Thru™ Spacers are also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The C-ThruTM Spacers are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
When used as a cervical intervertebral fusion device, the C-Thru™ Anterior Spinal System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. The C-Thru™ Spacers are intended for use with supplemental fixation and autogenous bone graft to facilitate the fusion.
Summary of Technologies:
The technological characteristics (material, design and sizing) of the C-Thru™ Spacer is the same as, or similar to, the predicate devices.
Substantial Equivalence:
The C-Thru™ Anterior Spinal System is substantially equivalent to its predicate devices with respect to intended use and indications, technological characteristics, and principles of operation and do not present any new issues of safety or effectiveness. An example of a predicate intervertebral body fusion device distributed for the similar indications includes the Expandable PEEK Implant (K040928 and K082406), and Novel® Spinal Spacer System (K081730), while the Small Stature Spacer System (K063393) has similar design features. Based upon the mechanical testing, C-Thru™ Anterior Spinal System is substantially equivalent for its intended use to other spacers currently on the market.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Biomet Spine % Ms. Vivian Kelly 100 Interpace Parkway Parsippany, New Jersey 07054
OCT 1 5 2009
Re: K092336
Trade/Device Name: C-Thru™ Anterior Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: ODP, MQP Dated: July 31, 2009 Received: August 4, 2009
Dear Ms. Kelly:
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 f general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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 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.
2
Page 2 - Ms. Vivian Kelly
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 (240) 276-3150 or at its Internet address
http://www.fda.gov/McdicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Mark A. Mellman
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name: C-Thru™ Anterior Spinal System
Indications for Use:
The C-Thru™ Anterior Spinal System is indicated for vertebral body replacement and intervertebral fusion. When used as a vertebral body replacement device, the C.Thru™ Spacers are indicated for use in the thoracolumbar spine (i.e., T1 to L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The C-Thru™ Spacers are also indicated to reartial vertebral body replacement for the treatment of fractures of the thoracic and luced to purch The C-Thru™ Spacers are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged proiod,
When used as a cervical intervertebral fusion device, the C-Thru Anterior Spinal System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radia graphic studies. These patients should have had six months of non-operative treatment. The C-Thru Spacers are intended for use with supplemental fixation and autogenous bone graft to facilitate the fusion.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_ K092336
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