(46 days)
No
The summary describes a physical interbody fusion device and a change in its surface treatment. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The device is indicated for treating degenerative disc disease, which is a medical condition, by fusing the intervertebral bodies. This direct treatment of a disease classifies it as a therapeutic device.
No
The device is described as an anterior cervical intervertebral body fusion device, which is an implant used in surgical treatment, not for diagnosing conditions.
No
The device description clearly states it is an implantable interbody fusion device made from titanium alloy, which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The Endoskeleton® TCS System is an implantable surgical device designed to be placed in the cervical spine to facilitate bone fusion. It is a physical structure used to support and stabilize the spine.
- Intended Use: The intended use is for surgical implantation in patients with degenerative disc disease to promote bone fusion. This is a therapeutic intervention, not a diagnostic test performed on a sample outside the body.
The description clearly indicates a device that is surgically implanted into the body, which is the defining characteristic of a non-IVD medical device in this context.
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 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 for the cervical spine.
Product codes
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 purpose of this submission is to change the surface treatment. 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 only modification being made in this submission is the change to a new surface treatment which was previously cleared by the FDA for the Endoskeleton® System in K141953.
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)
The predicate surface treatment was validated in the previous Endoskeleton® System (K141953). Results of that validation in addition to a design comparison of the surface treatments and devices indicated that the addition of the surface treatment presents no additional risk during implantation and all original design validations were supported. The subject Endoskeleton® TCS implant family has substantially equivalent geometry and features to predicate Endoskeleton® System devices and the geometry and features of the Endoskeleton® TCS implants are not altered by the previously cleared surface treatment, therefore it can be concluded that no additional testing is needed. Thus, it can be concluded that the subject does not raise new questions regarding safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Titan Spine Endoskeleton® TCS (K142940), Titan Spine Endoskeleton® TCS (K151596), Endoskeleton® System (K141953)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus or a staff with intertwined snakes, but in this case, it appears to be a more abstract representation of human figures or profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 14, 2015
Titan Spine, LLC % Christine Scifert Managing Partner Memphis Regulatory Consulting, LLC 3416 Roxee Run Cove Bartlett, Tennessee 38133
Re: K153122
Trade/Device Name: Endoskeleton® TCS System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE, ODP Dated: October 28, 2015 Received: October 29, 2015
Dear Christine 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 forth in
1
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 System
$\frac{d}{dx}(f(x)+g(x)) = f'(x)+g'(x)$
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 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 for 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)
Expiration Date: January 31, 2017 See PRA Statement on last page.
K153122 Page 1 of 1
Form Approved: OMB No. 0910-0120
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510(k) Summary
Endoskeleton® TCS System December 9, 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. 01/28/2015) |
| Additional Predicates: | Titan Spine Endoskeleton® TCS (K151596 S.E. 10/09/2015)
Endoskeleton® System (K141953 S.E. 10/27/2014) |
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 purpose of this submission is to change the surface treatment.
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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 only modification being made in this submission is the change to a new surface treatment which was previously cleared by the FDA for the Endoskeleton® System in K141953.
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. 01/28/2015 and K151596; S.E. 10/09/2015) and Endoskeleton® System with NanoFIX™ treatment (K141953; S.E. 10/27/2014).
The only modification being made in this submission is the change to a new surface treatment which was previously cleared by the FDA for the Endoskeleton® System in K141953. There are no changes to the device indications for use, design, dimensions, or materials. The predicate surface treatment was validated in the previous Endoskeleton® System (K141953). Results of that validation in addition to a design comparison of the surface treatments and devices indicated that the addition of the surface treatment presents no additional risk during implantation and all original design validations were supported. The subject Endoskeleton® TCS implant family has substantially equivalent geometry and features to predicate Endoskeleton® System devices and the geometry and features of the Endoskeleton® TCS implants are not altered by the previously cleared surface treatment, therefore it can be concluded that no additional testing is needed. Thus, it can be concluded that the subject does not raise new questions regarding safety and effectiveness.