(105 days)
P950019, P960025, K083714, P950002-S3
None
No
The summary describes a physical interbody fusion device and its mechanical testing, with no mention of software, algorithms, or AI/ML terms.
Yes
The device is used to treat Degenerative Disc Disease (DDD) and is implanted to provide support and promote fusion, which aligns with the definition of a therapeutic device designed to cure, mitigate, treat, or prevent a disease.
No
The device is an interbody fusion device, specifically an implant used for spinal fusion in patients with Degenerative Disc Disease, not a tool for diagnosis.
No
The device description explicitly states it is comprised of implantable components manufactured from titanium alloy, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly describes a surgical implant (an interbody fusion device) used to treat Degenerative Disc Disease in the spine. It is implanted directly into the body and is not used to analyze specimens taken from the body.
The information provided describes a Class II or Class III medical device used in a surgical procedure, not an IVD.
N/A
Intended Use / Indications for Use
The Endoskeleton TO® Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). It is indicated to be used with autograft bone.
Product codes
MAX
Device Description
The Endoskeleton TO is comprised of a variety of implant sizes to accommodate various patient's anatomy and pathology, and associated instrumentation. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2-S1
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)
Static and dynamic axial compression, static and dynamic compression shear, and static torsion were completed following ASTM F2077-03. Subsidence was tested following ASTM F2267-04. Expulsion testing was conducted following a recognized protocol to allow comparison evaluation of intervertebral body fusion device assemblies, and characterize their resistance to expulsion. The above pre-clinical testing performed on the Endoskeleton TO Interbody Fusion Device indicated that the Endoskeleton TO Interbody Fusion Device is substantially equivalent to the predicate devices and is adequate for the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
P950019, P960025, K083714, P950002-S3
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.
0
510(k) SUMMARY Titan Spine's Endoskeleton TO
NOV-5 2010
| Date: | May 28, 2010 | |
|---|---|---|
| Contact: | Kevin Gemas | |
| President | ||
| 866-822-7800 | Titan Spine, LLC | |
| Mequon Research Center | ||
| 6140 Executive Dr., Suite A | ||
| Mequon, WI 53092 | ||
| Trade Name: | Endoskeleton TO® Interbody Fusion Device | |
| Product Class: | Class II | |
| Classification: | 21 CFR §888.3080 Orthosis, intervertebral body fusion device | |
| Product Codes: | MAX | |
| Panel Code: | 87 |
Name of Device and Name/Address of Sponsor Endoskeleton TO
Titan Spine, LLC Mequon Research Center 6140 W. Executive Drive, Suite A Mequon, WI 53092
Common or Usual Name
Intervertebral body fusion device
Predicate Devices
The Endoskeleton TO was shown to be substantially equivalent to legally marketed predicate devices. The predicate devices include the Ray Threaded Fusion Cage (P950019), the Lumbar I/F Cage (P960025), the Endoskeleton TT Interbody Fusion Device (K083714) and the BAK Proximity (P950002-S3).
Intended Use / Indications for Use
The Endoskeleton TO® Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). It is indicated to be used with autograft bone.
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Technological Characteristics
The Endoskeleton TO is comprised of a variety of implant sizes to accommodate various patient's anatomy and pathology, and associated instrumentation. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI).
Performance Data
Static and dynamic axial compression, static and dynamic compression shear, and static torsion were completed following ASTM F2077-03. Subsidence was tested following ASTM F2267-04. Expulsion testing was conducted following a recognized protocol to allow comparison evaluation of intervertebral body fusion device assemblies, and characterize their resistance to expulsion. The above pre-clinical testing performed on the Endoskeleton TO Interbody Fusion Device indicated that the Endoskeleton TO Interbody Fusion Device is substantially equivalent to the predicate devices and is adequate for the intended use.
Summary:
The Endoskeleton TO Interbody Fusion Device and predicate devices have the same intended use, to provide mechanical stability in the lumbar disc space to facilitate biologic fusion. The indications for use of the Endoskeleton TO Interbody Fusion Device contain no new language that is not already included in at least one of the predicate devices. Moreover, the device is very similar in its size to the predicate devices. The materials used are also the same as in some predicate devices. There are no significant differences in technological characteristics compared to the predicates, and the minor differences that do exist do not raise any new types of safety or efficacy issues. Furthermore, bench testing demonstrates that these differences do not adversely impact device performance, as discussed below.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized emblem resembling an abstract eagle or bird-like figure, composed of three curved lines that suggest wings or feathers.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Titan Spine, LLC % Silver Pine Consulting, LLC Rich Jansen, Pharm.D. 13540 Guild Avenue Apple Valley, Minnesota 55124
NOV - 5 2010
Re: K102067
Trade/Device Name: Endoskeleton® TO Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: July 22, 2010 Received: August 11, 2010
Dear Dr. Jansen:
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, Or te 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 revistration, 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 davine 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 not hot hact
3
Page 2 - Rich Jansen, Pharm.D.
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 (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.html 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 A. Millan
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
$$\mathtt{510}(\mathtt{k})$$
$$\mathtt{Number (if
$$\mathtt{k}\mathtt{noown}$$
):
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NOV - 5 2010
Device Name: Endoskeleton TO
Indications for Use:
The Endoskeleton TO® Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). It is indicated to be used with autograft bone.
Prescription Use (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic. and Restorative Devices
K102067 510(k) Number_