(269 days)
Not Found
No
The summary describes a physical implant (interbody fusion cage) and its mechanical testing, with no mention of software, algorithms, or AI/ML terms.
Yes.
The device is indicated for intervertebral body fusion of the lumbar spine for the treatment of degenerative disc disease, which is a medical condition. Therefore, it is a therapeutic device designed to treat a medical condition.
No
The device is an intervertebral body fusion device used for treatment, not for diagnosing conditions.
No
The device description clearly states it is a "Titanium Cage Family" comprised of physical implants, which are hardware, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for surgical implantation to facilitate intervertebral body fusion in the lumbar spine. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details a physical implant (titanium cage) designed to be placed within the body. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body in vitro (outside the body).
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting markers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on mechanical testing (compression, subsidence) which are relevant to the structural integrity and function of an implant, not the diagnostic accuracy of a test.
In summary, the tezo™ device is a surgical implant used for spinal fusion, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
tezo™ is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and with autograft to facilitate fusion.
Product codes
MAX
Device Description
The tezo™ Titanium Cage Family is comprised of three principal interbody fusion cages. The tezo-P and tezo-T devices have a basic rectangular shape while the tezo-A device has a basic kidney shape. All implants have a hollow center for placement of autograft. The tezo implants are available in an assortment of height, length, width and anteroposterior angulation combinations to accommodate a variety of anatomic requirements
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine, from L2 to 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)
Mechanical testing of the worst case tezo™ device included static and dynamic compression according to ASTM F2077 and subsidence according to ASTM F2267.
The mechanical test results demonstrate that tezo™ is substantially equivalent to the predicate devices and therefore that tezo™ is as safe and as effective as the predicate devices.
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
510(k) Summary
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Image /page/0/Picture/2 description: The image shows the logo for Ulrich medical USA. The word "Ulrich" is in a bold, sans-serif font, with the "U" extending into a black square on the left. Below "Ulrich" is the text "medical USA" in a smaller, sans-serif font.
JUN 2 1 2012
| Date: | 21 September 2012
JUN 21 2013 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | ulrich GmbH & Co. KG
Buchbrunnenweg 12
89081 Ulm
Germany
Phone: +49 (0) 731-9654-1304
Fax: +49 (0) 731-9654-2802 |
| Contact Person: | Hans Stover
ulrich medical USA, Inc.
612 Trade Center Blvd.
Chesterfield, MO 63005
(636) 519-0268 Office
(636) 519-0271 Fax |
| Proposed Trade Name: | tezo™ Titanium Cage Family |
| Device Classification | Class II |
| Classification Name: | Intervertebral body fusion device |
| Regulation: | 888.3080 |
| Device Product Code: | MAX |
| Device Description: | The tezo™ Titanium Cage Family is comprised of three principal
interbody fusion cages. The tezo-P and tezo-T devices have a basic
rectangular shape while the tezo-A device has a basic kidney shape.
All implants have a hollow center for placement of autograft. The
tezo implants are available in an assortment of height, length, width
and anteroposterior angulation combinations to accommodate a
variety of anatomic requirements |
| Intended Use: | tezo™ is indicated for intervertebral body fusion of the lumbar spine,
from L2 to S1, in skeletally mature patients who have had six months
of non-operative treatment. The device is intended for use at either
one level or two contiguous levels for the treatment of degenerative
disc disease (DDD) with up to Grade I spondylolisthesis or
retrolisthesis. DDD is defined as back pain of discogenic origin with
degeneration of the disc confirmed by history and radiographic
studies. The device is intended for use with supplemental fixation
and with autograft to facilitate fusion. |
| Materials: | tezo™ devices are manufactured from Ti-6Al-4V titanium alloy which
conforms to ASTM F136. |
.
:
.
1
Predicate Devices:
pezo™ PEEK Cage Family - K103814 Fuse Cage - K100945 and K121288
Technological Characteristics: tezo™ possesses the same technological characteristics as one or more of the predicate devices. These include:
- intended use (as described above) .
- . basic design (hollow structure for the containment of autograft),
- . material (titanium),
- manufacturing (additive) .
- sizes (dimensions are comparable to those offered by the ● predicate systems) and
The fundamental scientific technology of tezo™ is the same as previously cleared devices.
Performance Data:
Mechanical testing of the worst case tezo™ device included static and dynamic compression according to ASTM F2077 and subsidence according to ASTM F2267.
The mechanical test results demonstrate that tezo™ is substantially equivalent to the predicate devices and therefore that tezo™ is as safe and as effective as the predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized wing segments.
Public Health Service
June 21, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WOliti-Cloup Silver Spring, MD 20993-002
ulrich GmbH & Co. KG % ulrich medical USA. Incorporated Mr. Hans Stover President and CEO 612 Trade Center Boulevard Chesterfield. Missouri 63005
Re: K122957
Trade/Device Name: tezo TM Titanium Cage Family Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 11, 2013 Received: June 12. 2013
Dear Mr. Stover:
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 10 devices that have been reclassified in accordance with the provisions of the Federal Food, Drug. and Cosmetic Act (Act) that do not require annroval 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, FDA mav 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 - Mr. Hans Stover
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/CentersOfTices/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.lda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRF'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.
Anton E. Dmitriev
- For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number:___K122957 Device Name: tezo™ Titanium Cage Family
Indications for Use:
tezo™ is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and with autograft to facilitate fusion.
Prescription Use _ X
AND/OR
Over-the-Counter Use_ ________________________________________________________________________________________________________________________________________________________
(21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedic Devices
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