(75 days)
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as a "Posterior Spinal Fixation System" intended to "provide immobilization of spinal segments" as an "adjunct to fusion" for various spinal conditions, which directly indicates a therapeutic purpose.
No
Explanation: The provided text describes the Momentum™ Posterior Spinal Fixation System as a device intended for surgical fixation and stabilization of the spine, specifically as an "adjunct to fusion." This is a therapeutic function, not a diagnostic one. The device consists of various components like rods, screws, and connectors, used for immobilization and stabilization of spinal segments.
No
The device description explicitly states it consists of physical components like rods, screws, connectors, and fasteners, 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 (like blood, urine, tissue) to provide information about a person's health.
- Momentum System Description: The provided text describes a system of implants (rods, screws, connectors) intended to be surgically implanted into the spine to provide structural support and aid in fusion.
- Intended Use: The intended use clearly states it's for "immobilization of spinal segments... as an adjunct to fusion." This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
The Momentum Posterior Spinal Fixation System is a surgical implant/device, not an IVD.
N/A
Intended Use / Indications for Use
The Momentum™ Posterior Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracolumbar and sacroiliac spine. When used as a posterior spine system, Momentum is intended for the following indications: degenerative disc disease, spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, and/ or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudoarthrosis and failed previous fusion.
In order to achieve additional levels of fixation, the Momentum Posterior System can also be connected to the neon3® universal OCT spinal stabilization system via transition rods or connectors. Please refer to the neon3 Instructions for Use for a list of indications for use.
Product codes
NKB
Device Description
The Momentum™ Posterior Spinal Fixation System consists of longitudinal members (rods), anchors (screws), connectors (rod/rod and rod/anchor) and fasteners in a variety of sizes to accommodate differing anatomic requirements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar and sacroiliac spine
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
Mechanical testing of worst case Momentum™ System constructs included static and dynamic compression bending and static torsion according to ASTM F1717. In addition, tulip/shank pull-off testing was performed. The mechanical test results demonstrate that the Momentum™ Posterior Spinal Fixation System performance is substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
uCentum™ comprehensive posterior system (ulrich GmbH & Co. KG. – K123717), Tiger® Spine System (CoreLink LLC – K133369), flamenco™ Spinal Fixation System (ulrich GmbH & Co. KG–K102853), neon3® universal OCT spinal stabilization clearance (ulrich GmbH & Co. KG – K161032), Diplomat® Spinal System (SIGNUS Medizintechnik GmbH - K151704)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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October 2, 2019
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Ulrich Medical USA Hans Stover President & CEO 5865 East State Rd.14 Chesterfield, Missouri 63005
Re: K191932
Trade/Device Name: Momentum™ Posterior Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: September 25, 2019 Received: September 26, 2019
Dear Hans 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Ronald P. Jean, Ph.D. Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Momentum™ Posterior Spinal Fixation System
Indications for Use (Describe)
The Momentum™ Posterior Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracolumbar and sacroiliac spine. When used as a posterior spine system, Momentum is intended for the following indications: degenerative disc disease, spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, and/ or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudoarthrosis and failed previous fusion.
In order to achieve additional levels of fixation, the Momentum Posterior System can also be connected to the neon3® universal OCT spinal stabilization system via transition rods or connectors. Please refer to the neon3 Instructions for Use for a list of indications for use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
Image /page/3/Picture/2 description: The image shows the logo for Ulrich medical USA. The logo consists of the word "Ulrich" in a bold, sans-serif font, with the "U" stylized and partially contained within a black square. Below "Ulrich" is the text "medical USA" in a smaller, thinner font.
| Date: | 18 July 2019 |
|---|---|
| Sponsor: | ulrich medical USA, Inc. |
| 18221 Edison Avenue | |
| Chesterfield, MO 63005 | |
| (636) 519-0268 Office | |
| (636) 519-0271 Fax | |
| Sponsor Contact: | Hans Stover, President & CEO |
| Proposed Trade Name: | Momentum™ Posterior Spinal Fixation System |
| Common Name: | Posterior pedicle screw system |
| Device Classification: | Class II |
| Classification Name: | Thoracolumbosacral pedicle screw system |
| Regulation: | 888.3070 |
| Device Product Code: | NKB |
| Device Description: | The Momentum™ Posterior Spinal Fixation System consists of longitudinal |
| members (rods), anchors (screws), connectors (rod/rod and rod/anchor) and | |
| fasteners in a variety of sizes to accommodate differing anatomic | |
| requirements. | |
| Indications for Use: | The Momentum™ Posterior Spinal Fixation System is intended to |
| provide immobilization and stabilization of spinal segments in | |
| skeletally mature patients as an adjunct to fusion of the thoracolumbar | |
| and sacroiliac spine. When used as a posterior spine system, | |
| Momentum is intended for the following indications: degenerative disc | |
| disease, spinal stenosis, spondylolisthesis, spinal deformities (i.e., | |
| scoliosis, kyphosis, and/ or lordosis), trauma (i.e., fracture or | |
| dislocation), tumor, pseudoarthrosis and failed previous fusion. | |
| In order to achieve additional levels of fixation, the Momentum Posterior | |
| Spinal Fixation System can also be connected to the neon3® universal OCT | |
| spinal stabilization system via transition rods or connectors. Please refer to | |
| the neon Instructions for Use for a list of indications for use. | |
| Materials: | The Momentum™ System is manufactured from Ti-6Al-4V ELI titanium alloy |
| (ASTM F136) and Cobalt Chrome (ASTM F1537). | |
| Primary Predicate: | uCentum™ comprehensive posterior system (ulrich GmbH & Co. KG. – |
| K123717) | |
| Additional Predicates: | Tiger® Spine System (CoreLink LLC – K133369), flamenco™ Spinal Fixation |
| System (ulrich GmbH & Co. KG–K102853), neon3® universal OCT spinal | |
| stabilization clearance (ulrich GmbH & Co. KG – K161032), Diplomat® Spinal | |
| System (SIGNUS Medizintechnik GmbH - K151704) | |
| Performance Data: | Mechanical testing of worst case Momentum™ System constructs included static and dynamic compression bending and static torsion according to ASTM F1717. In addition, tulip/shank pull-off testing was performed. The mechanical test results demonstrate that the Momentum™ Posterior Spinal Fixation System performance is substantially equivalent to the predicate devices. |
| Technological Characteristics: | The Momentum™ Posterior Spinal Fixation System possesses similar technological characteristics as one or more of the predicate devices. These include: basic design (rod and screw configuration), material (titanium alloy, cobalt chrome) and sizes (dimensions are comparable to those offered by the predicate systems) The fundamental scientific technology of the Momentum™ Posterior Spinal Fixation System is the same as previously cleared devices. |
| Conclusion: | The Momentum™ Posterior Spinal Fixation System possesses the same intended use and similar technological characteristics as the predicate devices. The Momentum™ Posterior Spinal Fixation is substantially equivalent for its intended use. |
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