(153 days)
Not Found
No
The summary describes a physical implant and surgical instruments, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma, which directly addresses a pathological condition and restores function.
No
This device is a vertebral body replacement system, an implantable medical device used to replace damaged vertebrae. It is a therapy device, not a diagnostic one, as it does not diagnose or detect medical conditions.
No
The device description explicitly states it is comprised of physical components made of Trabecular Metal Porous Tantalum and stainless steel instruments, 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 perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Description: The provided text describes a surgical implant (Vertebral Body Replacement System) and the instruments used to implant it. These devices are used within the body during surgery to replace a damaged vertebral body.
- Intended Use: The intended use is to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. This is a surgical intervention, not a diagnostic test performed on a sample.
The device is a surgical implant and associated instrumentation, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
The Trabecular Metal Vertebral Body Replacement System is comprised of vertebral body replacement devices intended for use in thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Trabecular Metal Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Trabecular Metal Vertebral Body Replacement may be used with bone graft.
Product codes
MQP
Device Description
The existing, commercially available Trabecular Metal Vertebral Body Reconstruction System is intended for use in thoracolumbar (TI-L5) surgical cases to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Trabecular Metal Vertebral Body Reconstruction System is wholly comprised of Trabecular Metal Porous Tantalum (tantalum deposited on a vitreous carbon skeleton) and is available in a variety of configurations to accommodate the anatomical requirements of different patients.
The Trabecular Metal Vertebral Body Replacement System Instrumentation Set which is the subject of this premarket notification is intended for use in these thoracolumbar surgical cases and facilitates the implantation of the Trabecular Metal Vertebral Body Replacement implant system. The provisionals size the surgical site in order to determine the appropriate TM-400 implant size. The straight inserter and tamp facilitate implantation of the TM-400 implant via anterior or lateral lumbar approach. All instruments included in the set are made from 17-4 stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1-L5)
Indicated Patient Age Range
Not Found
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 results of testing and analyses conducted demonstrate that the worst cases of the proposed instruments adequately meet the predetermined requirements established for its mechanical performance.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
93127
510(k) Summary
| Submitter: | Zimmer Trabecular Metal Technology, Inc.
MAR - 4 2010
10 Pomeroy Road
Parsippany, New Jersey 07054 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kathleen Rutherford
Associate Director, Regulatory Affairs
Telephone: (973) 576-0139
Fax: (973) 884-8792 |
| Date: | September 15, 2009 |
| Trade Name: | Trabecular MetalTM Vertebral Body Replacement System
Instrumentation Set |
| Common Name: | Vertebral Body Replacement Device Instrumentation Set |
| Classification Name and
Reference: | Spinal Intervertebral Body Fixation Orthosis
21 CFR § 888.3060, MQP |
DEVICE DESCRIPTION
The existing, commercially available Trabecular Metal Vertebral Body Reconstruction System is intended for use in thoracolumbar (TI-L5) surgical cases to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Trabecular Metal Vertebral Body Reconstruction System is wholly comprised of Trabecular Metal Porous Tantalum (tantalum deposited on a vitreous carbon skeleton) and is available in a variety of configurations to accommodate the anatomical requirements of different patients.
The Trabecular Metal Vertebral Body Replacement System Instrumentation Set which is the subject of this premarket notification is intended for use in these thoracolumbar surgical cases and facilitates the implantation of the Trabecular Metal Vertebral Body Replacement implant system. The provisionals size the surgical site in order to determine the appropriate TM-400 implant size. The straight inserter and tamp facilitate implantation of the TM-400 implant via anterior or lateral lumbar approach. All instruments included in the set are made from 17-4 stainless steel.
Zimmer TMT. Inc. Traditional 510(k) - Trabecular Metal Vertebral Body Replacement System Instrumentation
1
INDICATIONS FOR USE
The Trabecular Metal Vertebral Body Replacement System is comprised of vertebral body replacement devices intended for use in thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Trabecular Metal Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Trabecular Metal Vertebral Body Replacement may be used with bone graft.
DEVICE TECHNOLOGICAL CHARACTERISTICS AND COMPARISON TO PREDICATE DEVICE(S)
Zimmer Trabecular Metal Technology, Inc. has submitted documentation demonstrating the substantial equivalence of the proposed instrument set to its predicate devices. The subject instrument set is similar to its predicate devices with respect to intended use/indications for use, materials, and basic principles of operation.
PERFORMANCE DATA
The results of testing and analyses conducted demonstrate that the worst cases of the proposed instruments adequately meet the predetermined requirements established for its mechanical performance.
SUBSTANTIAL EQUIVALENCE
The redesigned Trabecular Metal™ Vertebral Body Replacement System Instrument Set is substantially equivalent to the predicate instruments with respect to intended use/indications for use, technological characteristics and basic principles of operation. As demonstrated by supporting tests and descriptions, this minor redesign does not present any new issues of safety or effectiveness.
Zimmer TMT, Inc.
Traditional 510(k) - Trabecular Metal Vertebral Body Replacement System Instrumentation
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with its wings spread and head facing to the left.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
MAR - 4 2010
Zimmer Trabecular Metal Technology, Inc % Ms. Kathleen Rutherford Associate Director, Regulatory Affairs 10 Pomeroy Road Parsippany, New Jersey 07054
Re: K093127
Trade/Device Name: Trabecular Metal Vertebral Body Replacement System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: February 23, 2010 Received: February 25, 2010
Dear Ms. Rutherford:
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
3
Page 2 - Ms. Kathleen Rutherford
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 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark A. Milliken
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
510(k) Number (if known): K0913127
Device Name: Trabecular Metal™ Vertebral Body Replacement System Instrument Set
Indications for Use:
The Trabecular Metal Vertebral Body Replacement System is comprised of vertebral body replacement devices intended for use in thoracolumbar spine (TI-L5) to replace a collapsed, damaged or unstable vertebral body duc to tumor or trauma (i.e., fracture). The Trabecular Metal Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Trabecular Metal Vertebral Body Replacement may be used with bone graft.
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)
Page 1 of 1
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093127
Zimmer TMT, Inc. Traditional 510(k) - Trabecular Metal Vertebral Body Replacement System Instrumentation
Page 15