(91 days)
Not Found
No
The summary describes a physical implant and surgical instrumentation, with no mention of software, algorithms, or AI/ML terms.
Yes
The device is indicated for treating Degenerative Disc Disease (DDD) and is used with autograft bone in patients, signifying its therapeutic purpose.
No
The document describes the Endoskeleton® TAS Interbody Fusion Device as an implant used for treating Degenerative Disc Disease, not for diagnosing it. It is used after diagnosis has already been confirmed.
No
The device description explicitly states it is comprised of "a variety of implant sizes" and "associated instrumentation," indicating it is a physical implant and surgical tools, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant used for spinal fusion in patients with Degenerative Disc Disease. This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The description mentions implants and instrumentation for surgical use.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition based on such analysis.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used for treatment.
N/A
Intended Use / Indications for Use
The Endoskeleton® TAS 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 may be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be use with autograft bone.
Product codes
OVD
Device Description
The Endoskeleton TAS is comprised of a variety of implant sizes to accommodate various patients' anatomy and pathology, and includes associated instrumentation. All implantable
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2-S1 (discogenic back pain)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
K111626
Page 1 of 2
SEP - 9 2011
510(k) SUMMARY Titan Spine's Endoskeleton TAS
| Date: | May 28, 2010 | ||
|---|---|---|---|
| Contact: | Kevin Gemas | Titan Spine, LLC | |
| President | Mequon Research Center | ||
| 866-822-7800 | 6140 Executive Dr., Suite A | ||
| Mequon, WI 53092 | |||
| Trade Name: | Endoskeleton® TAS | ||
| Product Class: | Class II | ||
| Classification: | 21 CFR §888.3080 Orthosis, intervertebral body fusion device | ||
| Product Codes: | OVD | ||
| Panel Code: | 87 |
Name of Device and Name/Address of Sponsor
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 TAS was shown to be substantially equivalent to legally marketed predicate devices. The predicate devices are the Endoskeleton TA Interbody Fusion Device (K080615) and the Stalif TT (K073109) and the BAK Lumbar device (P950002).
Intended Use / Indications for Use
The Endoskeleton® TAS 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 may be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be use with autograft bone.
Technological Characteristics
The Endoskeleton TAS is comprised of a variety of implant sizes to accommodate various patients' anatomy and pathology, and includes associated instrumentation. All implantable
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized symbol that resembles a human figure with three flowing lines extending from it.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP - 9 2011
Titan Spine, LLC % Silver Pine Consulting, LLC Richard Jansen, Pharm.D. 13540 Guild Avenue Apple Valley, Minnesota 55124
Re: K111626
Trade/Device Name: Endoskeleton® TAS Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: August 24, 2011 Received: August 25, 2011
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, 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 vou: 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, I-DA 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
2
Page 2 -Richard 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 (2) 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.
If you desire specific advice for your device on our labeling requiration (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/ReportalProblem/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 yours,
Mark A. Millhurn
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 Statement
510(k) Number (if known):_ Device Name: Endoskeleton TAS
Indications for Use:
The Endoskeleton® TAS 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 is a standalone system intended to be used with the bone screws provided and requires no additional supplementary fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be use 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 Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_ KI11626