(192 days)
No
The device description and summary of performance studies focus solely on mechanical components and testing, with no mention of AI/ML or related concepts.
Yes
The device is described as "immobilization and stabilization of spinal segments as an adjunct to fusion" and is intended for various medical conditions like "degenerative disc disease," "spinal stenosis," "spondylolisthesis," and "fracture," which are all therapeutic interventions for health issues.
No.
The tangoRS™ is a surgical implant designed for spinal immobilization and stabilization during fusion, not for diagnosing medical conditions.
No
The device description explicitly states that the tangoRS™ consists of physical components like rods, polyaxial pedicle screws, and crosslinks, which are hardware.
Based on the provided information, the tangoRS™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the tangoRS™ is for the "immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and sacral spine." This describes a surgical implant used in vivo (within the body) to treat structural issues.
- Device Description: The device is described as consisting of "rods, polyaxial pedicle screws and crosslinks with locking set screws." These are physical components designed to be implanted into the spine.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The tangoRS™ does not perform any such tests. It is a structural implant.
Therefore, the tangoRS™ is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The tangoRS is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and sacral spine (T1-S2). When used as a posterior spine thoracic/lumbar system, the tangoRS is intended for the following indications: degenerative disc disease (as defined by back pain of discogenic with degeneration of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., degenerative scoliosis, kyphosis, and/or lordosis).
The tangoRS™ is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and sacral spine (T1-S2). When used as a posterior spine thoracic/lumbar system, the tangoRS is intended for the following indications: degenerative disc disease (as defined by back pain of discogenic with degeneration of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., degenerative scoliosis, kyphosis, and/or lordosis), fracture, spinal tumor, pseudarthrosis and failed previous fusion.
Product codes
MNI, MNH, NKB
Device Description
The tangoRS™ consists of rods, polyaxial pedicle screws and crosslinks with locking set screws. The components are available in various sizes to accommodate differing patient anatomy. Rods are available in one diameter and a variety of lengths. Polyaxial screws are available in a variety of diameter-length combinations. Crosslinks are offered in four lengths. The purpose of this submission is to add components (a screw size and crosslink options) and two indications for use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar and sacral spine (T1-S2)
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)
Mechanical testing of the worst case tangoRS™ constructs included static and dynamic compression bending, and static torsion according to ASTM F1717. The mechanical test results demonstrate that tangoRS™ performs as well as or better than the predicate devices and therefore that the device is as safe and as effective as the predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K102853, K031655, K041460, K041119, K062196, K052385
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
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
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K120891
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.
Image /page/0/Picture/1 description: The image shows the logo for Ulrich medical USA. The word "Ulrich" is written in a bold, sans-serif font, with the "U" extending from a black square on the left. Below "Ulrich" is the text "medical USA" in a smaller font.
OCT
1 2012
510(k) Summary
| Date: | 21 March 2012 |
|---|---|
| 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: | tangoRS™ multifunctional posterior system |
| Device Classifications: | Class II & Class III |
| Classification & Common Name: | Pedicle screw spinal system |
| Regulation: | 888.3070 |
| Device Product Code: | MNI, MNH, NKB |
| Device Description: | The tangoRS™ consists of rods, polyaxial pedicle screws and |
| crosslinks with locking set screws. The components are available in | |
| various sizes to accommodate differing patient anatomy. Rods are | |
| available in one diameter and a variety of lengths. Polyaxial screws | |
| are available in a variety of diameter-length combinations. Crosslinks | |
| are offered in four lengths. | |
| The purpose of this submission is to add components (a screw size | |
| and crosslink options) and two indications for use. | |
| Intended Use: | The tangoRS is intended to provide immobilization and stabilization |
| of spinal segments as an adjunct to fusion of the thoracic, lumbar | |
| and sacral spine (T1-S2). When used as a posterior spine | |
| thoracic/lumbar system, the tangoRS is intended for the following | |
| indications: degenerative disc disease (as defined by back pain of | |
| discogenic with degeneration of the disc confirmed by patient history | |
| and radiographic studies), spinal stenosis, spondylolisthesis, spinal | |
| deformities (i.e., degenerative scoliosis, kyphosis, and/or lordosis). |
1
K120891
page 2 of 2
Materials:
The tangoRS™ components are manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. flamenco™ {K102853} CD HORIZON® (K031655/K041460) Expedium (K041119/K062196) tangoRS™ (K052385)
Technological Characteristics:
Predicate Devices:
tangoRS™ possesses the same technological characteristics as one or more of the predicate devices. These include:
- intended use (as described above) .
- basic design (rod-based having screw anchors), .
- . material (titanium alloy),
- sizes (dimensions are comparable to those offered by the . predicate systems) and
The fundamental scientific technology of tangoRS™ is the same as previously cleared devices.
Performance Data:
Mechanical testing of the worst case tangoRS™ constructs included static and dynamic compression bending, and static torsion according to ASTM F1717.
The mechanical test results demonstrate that tangoRS™ performs as well as or better than the predicate devices and therefore that the device is as safe and as effective as the predicates.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT
1 2012
Ulrich GmbH & Company KG % Ulrich Medical USA Mr. Hans Stover President & CEO 612 Trade Center Boulevard Chesterfield, Missouri 63005
Re: K120891
Trade/Device Name: tangoRS™ multifunctional posterior system Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: August 22, 2012 Received: August 23, 2012
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 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 - 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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Millikan
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
510(k) Number: K120891
Device Name: tangoRS™ multifunctional posterior system
Indications for Use:
The tangoRS™ is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and sacral spine (T1-S2). When used as a posterior spine thoracic/lumbar system, the tangoRS is intended for the following indications: degenerative disc disease (as defined by back pain of discogenic with degeneration of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., degenerative scoliosis, kyphosis, and/or lordosis), fracture, spinal tumor, pseudarthrosis and failed previous 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)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120891