(119 days)
Not Found
No
The description focuses on the mechanical design and materials of a spinal fusion device and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for intervertebral body fusion to treat degenerative disc disease, which is a medical condition, making it a therapeutic device.
No
This device is an intervertebral body fusion device used for treatment of degenerative disc disease, not for diagnosis.
No
The device description clearly states it is an "Interbody Fusion Device (IBD) implants" made from "medical grade titanium alloy" and includes "integrated screws." This indicates a physical, implantable hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Endoskeleton® TCS System is an implantable medical device designed for surgical use in the cervical spine to facilitate bone fusion. It is a physical device implanted into the body, not a device used to analyze samples outside the body.
The description clearly indicates it's a surgical implant for treating degenerative disc disease through fusion, which is a therapeutic intervention, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Endoskeleton® TCS System is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as neck pain with degeneration of the disc confirmed by history and radiographic studies) at one disc level from C2 to T1. Patients should have received 6 weeks of non-operative treatment pror to treatment with the device is indicated to be used with autograft bone. The device is a stand-alone system when used with Endoskeleton® TCS integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared in the cervical spine.
Product codes (comma separated list FDA assigned to the subject device)
OVE, ODP
Device Description
The Endoskeleton® TCS Interbody Fusion Device (IBD) implants are available in a variety of sizes with a variety of lordotic angles, to accommodate patient anatomy. Endoskeleton® TCS IBD implants are intended for treatment in Cervical Interbody Fusion used in single placement treatment placed across the disc space, and are designed with a large hollow region in the center to house bone graft material. The superior and inferior surfaces are acid etched to improve fixation to the adjacent bone.
The device is a stand-alone system when used with Endoskeleton® TCS integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared in the cervical spine.
All implantable components are manufactured from medical grade titanium alloy (Ti-6AI-4V-ELI).
The primary modification being made in this submission is that the hex size on the screws is being changed from T6 to T8 and as a result the heights now range from 13 – 21.35mm. As a result, there was a small change to the overall length of the screws and a change to the instruments associated with the hex update.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, one disc level from 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)
An engineering rationale was provided in lieu of performance testing because these modifications do not impact the overall function of the device and the screw thread length is identical to the predicate. The change in height is due to a small increase in the height of the screw, which does not impact testing.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol consisting of three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 9, 2015
Titan Spine, LLC. % Ms. Christine Scifert Managing Partner Memphis Regulatory Consulting, LLC 3416 Roxee Run Cove, Bartlett, Tennessee 38133
Re: K151596
Trade/Device Name: Endoskeleton® TCS Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE, ODP Dated: September 3, 2015 Received: September 8, 2015
Dear Ms. Scifert:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Endoskeleton(R) TCS Interbody Fusion Device
Indications for Use (Describe)
The Endoskeleton® TCS System is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as neck pain with degeneration of the disc confirmed by history and radiographic studies) at one disc level from C2 to T1. Patients should have received 6 weeks of non-operative treatment pror to treatment with the device is indicated to be used with autograft bone. The device is a stand-alone system when used with Endoskeleton® TCS integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared in the cervical spine.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
K151596 Page 1 of 1
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510(k) Summary
Endoskeleton® System October 6, 2015
| Company: | Titan Spine, LLC
6140 West Executive Drive, Suite A
Mequon, WI 53092, USA |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Establishment
Registration: | 3006340236 |
| Primary Contact: | Christine Scifert
Phone: 901-831-8053 |
| Company Contact: | Jane Rodd
Phone: 866-822-7800
Fax: 262-242-7802 |
| Trade Name: | Endoskeleton® TCS Interbody Fusion Device |
| Common Name: | Intervertebral Body Fusion Device with Integrated Fusion Cervical
Intervertebral Fusion Device with Bone Graft, Cervical |
| Classification: | Class II |
| Regulation Number: | 21 CFR 888.3080 (Intervertebral body fusion device) |
| Panel: | 87- Orthopedic |
| Product Code: | OVE ODP |
| Primary Predicate: | Titan Spine Endoskeleton® TCS (K142940 S.E. January 28, 2015) |
Device Description:
The Endoskeleton® TCS Interbody Fusion Device (IBD) implants are available in a variety of sizes with a variety of lordotic angles, to accommodate patient anatomy. Endoskeleton® TCS IBD implants are intended for treatment in Cervical Interbody Fusion used in single placement treatment placed across the disc space, and are designed with a large hollow region in the center to house bone graft material. The superior and inferior surfaces are acid etched to improve fixation to the adjacent bone.
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The device is a stand-alone system when used with Endoskeleton® TCS integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared in the cervical spine.
All implantable components are manufactured from medical grade titanium alloy (Ti-6AI-4V-ELI).
The primary modification being made in this submission is that the hex size on the screws is being changed from T6 to T8 and as a result the heights now range from 13 – 21.35mm. As a result, there was a small change to the overall length of the screws and a change to the instruments associated with the hex update.
Indications for Use:
The Endoskeleton® TCS System is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one disc level from C2 to T1. Patients should have received 6 weeks of non-operative treatment prior to treatment with the device is indicated to be used with autograft bone. The device is a stand-alone system when used with Endoskeleton® TCS integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared in the cervical spine.
Substantial Equivalence:
The subject Endoskeleton® TCS IBD is substantially equivalent to Titan Spine's previously cleared Endoskeleton® TCS IBD (K142940 S.E. January 28, 2015).
The primary modification being made in this submission is that the hex size on the screws is being changed from T6 to T8 and as a result the heights now range from 13 - 21.35mm. As a result, there was a small change to the overall length of the screws and a change to the instruments associated with the hex update. The Indications for Use, materials, and geometry of the IBD devices and the locking collar are identical to the predicate devices. An engineering rationale was provided in lieu of performance testing because these modifications do not impact the overall function of the device and the screw thread length is identical to the predicate. The change in height is due to a small increase in the height of the screw, which does not impact testing. Thus, it can be concluded that the subject does not raise new questions about safety and effectiveness.