(122 days)
Not Found
No
The document describes a standard pedicle screw and rod system with the addition of bone cement. There is no mention of AI, ML, image processing for analysis, or any data-driven algorithms for diagnosis, treatment planning, or device operation. The performance studies focus on the usability and removal of the bone cement.
Yes
The device is intended to immobilize spinal segments and restore the integrity of the spinal column for conditions such as degenerative disc disease, spinal stenosis, trauma, and tumors, which are all therapeutic indications.
No
The device is a spinal fixation system, intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion or to restore integrity of the spinal column for a limited time. It is a treatment device, not one that identifies or characterizes a disease or condition.
No
The device description clearly states it is a "standard pedicle screw and rod system" and includes components like bone cement, which are physical hardware components, not software.
Based on the provided text, 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, or tissue) to provide information about a person's health.
- Device Description: The Momentum® Posterior Spinal Fixation System is a surgical implant (pedicle screw and rod system) used to stabilize the spine. It is a physical device implanted into the body.
- Intended Use: The intended use describes the device's function in providing immobilization and stabilization of spinal segments, often as an adjunct to fusion. This is a surgical intervention, not a diagnostic test performed on a sample.
- No Mention of Samples: The text does not mention the device being used to test or analyze any samples from the human body.
Therefore, the Momentum® Posterior Spinal Fixation System is a surgical implant, not an In Vitro Diagnostic device.
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 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.
When used in conjunction with G21 V-Steady Bone Cement, the Momentum Posterior Spinal Fixation System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. Momentum Posterior Spinal Fixation System Screws augmented with G21 V-Steady Bone Cement are limited for use at spinal levels where the structural integrity of the spine is not severely compromised. Iliac screws are not intended to be used with bone cement.
In order to achieve additional levels of fixation the Momentum Posterior System can also be connected to the neon38 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.
The Momentum® MIS Posterior 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 MS 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.
When used in conjunction with G21 V-Steady Bone Cement, the Momentum MIS Posterior Spinal Fixation System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. Momentum MIS Posterior System Screws augmented with G21 V-Steady Bone Cement are limited for use at spinal levels where the structural integrity of the spine is not severely compromised. Iliac screws are not intended to be used with bone cement.
Product codes (comma separated list FDA assigned to the subject device)
PML, NKB
Device Description
The Momentum® Posterior Spinal Fixation System, and Momentum® MIS Posterior Spinal Fixation System are standard pedicle screw and rod systems designed for fixation in the thoracolumbar and sacroiliac spine. There have been no major changes to the device since K191932, and K223274, respectively. The subject devices are identical to the previously cleared versions with the addition of the option to use bone cement (G21 V-Steady) with the fenestrated screws.
G21 V-Steady Bone Cement consists of a liquid and powder component. The powder component is constituted of PMMA beads shaped particles containing the initiator benzoy1 peroxide required for starting to initiate the cement curing. The radiopacifier agent, zirconium dioxide, is necessary for the cement visibility under radiographs but it does not take part of the curing process (radical polymerization). The liquid component comprises the monomer, methylmemethylmethacrylate (MMA); dimethyl-para-toluidine (DMPT) as polymerization accelerator and hydroquinone (HQ) as stabilizer to prevent polymerization of the liquid during storage. V-STEADY bone cement has an immediate development of viscosity and thus it is a high viscosity cement that maintains its properties throughout the useful working time.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar and sacroiliac spine, thoracic and lumbar 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bone cement usability testing and screw removal testing was conducted to validate the use of the Momentum® Posterior Spinal Fixation System used with bone cement.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K200596, K191932, K222256, K223274
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
0
October 20, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Ulrich Medical USA % Michael Coladonato Manager, Regulatory Affairs MCRA LLC 803 7th Street NW Washington, District of Columbia 20001
Re: K231809
Trade/Device Name: Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (Pmma) Bone Cement Regulatory Class: Class II Product Code: PML, NKB Dated: September 18, 2023 Received: September 19, 2023
Dear Michael Coladonato:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
2
Sincerely,
Colin O'neill -STD
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K231809
Device Name
Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement
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 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.
When used in conjunction with G21 V-Steady Bone Cement, the Momentum Posterior Spinal Fixation System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. Momentum Posterior Spinal Fixation System Screws augmented with G21 V-Steady Bone Cement are limited for use at spinal levels where the structural integrity of the spine is not severely compromised. Iliac screws are not intended to be used with bone cement.
In order to achieve additional levels of fixation the Momentum Posterior System can also be connected to the neon38 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) | ||
|---|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. |
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Indications for Use
510(k) Number (if known) K231809
Device Name
The Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement
Indications for Use (Describe)
The Momentum® MIS Posterior 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 MS 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.
When used in conjunction with G21 V-Steady Bone Cement, the Momentum MIS Posterior System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. Momentum MIS Posterior System Screws augmented with G21 V-Steady Bone Cement are limited for use at spinal levels where the structural integrity of the spine is not severely compromised. Iliac screws are not intended to be used with bone cement.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
510(k) Summary
| Device Trade Name: | Momentum® Posterior Spinal Fixation System with G21 V-
STEADY Bone Cement
Momentum® MIS Posterior Spinal Fixation System with G21
V-STEADY Bone Cement |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | ulrich medical USA, Inc.
ulrich medical USA, Inc.
3700 E Plano Parkway,
STE 200
Plano, TX 75074
Office: 469.238.0800 |
| Contact: | Mr. Michael Coladonato
Manager, Regulatory Affairs
MCRA, LLC
803 7th Street NW, Third Floor
Washington, DC 20001
Phone: (202) 552-5800
Email: mcoladonato@mcra.com |
| Prepared by: | MCRA, LLC
803 7th Street, NW, 3rd Floor
Washington, DC 20001
Office: 202.552.5800 |
| Date Prepared: | October 18, 2023 |
| Classifications: | 21 CFR §888.3027, Polymethylmethacrylate (PMMA) Bone
Cement |
| Class: | II |
| Product Codes: | PML, NKB |
| Primary Predicates: | G21 Cement, VADER® Pedicle System, icotec ag, K200596 |
| Additional Predicates: | Additional Predicate: Momentum® Posterior Spinal Fixation
System (K191932) |
| | Additional Predicate: Momentum® MIS Posterior Spinal
Fixation System (K223274) |
| | Additional Predicate: BonOs® Inject Bone Cement; NEO
Pedicle Screw SystemTM, Neo Medical SA, K222256 |
6
Indications For Use:
The Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement:
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.
When used in conjunction with G21 V-Steady Bone Cement, the Momentum Posterior Spinal Fixation System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. Momentum Posterior Spinal Fixation System Screws augmented with G21 V-Steady Bone Cement are limited for use at spinal levels where the structural integrity of the spine is not severely compromised. Iliac screws are not intended to be used with bone cement.
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 neon3 Instructions for Use for a list of indications for use.
The Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement:
The Momentum® MIS 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 MIS 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.
When used in conjunction with G21 V-Steady Bone Cement, the Momentum MIS Posterior Spinal Fixation System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. Momentum MIS Posterior Spinal Fixation System Screws augmented with G21 V-Steady Bone Cement are limited for use at spinal levels where the structural integrity of the spine is not severely compromised. Iliac screws are not intended to be used with bone cement.
7
Device Description:
The Momentum® Posterior Spinal Fixation System, and Momentum® MIS Posterior Spinal Fixation System are standard pedicle screw and rod systems designed for fixation in the thoracolumbar and sacroiliac spine. There have been no major changes to the device since K191932, and K223274, respectively. The subject devices are identical to the previously cleared versions with the addition of the option to use bone cement (G21 V-Steady) with the fenestrated screws.
G21 V-Steady Bone Cement consists of a liquid and powder component. The powder component is constituted of PMMA beads shaped particles containing the initiator benzoy1 peroxide required for starting to initiate the cement curing. The radiopacifier agent, zirconium dioxide, is necessary for the cement visibility under radiographs but it does not take part of the curing process (radical polymerization). The liquid component comprises the monomer, methylmemethylmethacrylate (MMA); dimethyl-para-toluidine (DMPT) as polymerization accelerator and hydroquinone (HQ) as stabilizer to prevent polymerization of the liquid during storage. V-STEADY bone cement has an immediate development of viscosity and thus it is a high viscosity cement that maintains its properties throughout the useful working time.
Predicate Device:
ulrich medical USA, Inc. submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement is substantially equivalent in indications, design principles, and performance to the following predicate devices, which have been determined by FDA to be substantially equivalent to the predicate devices:
- Primary Predicate: G21 Cement, VADER® Pedicle System, icotec ag, K200596 ●
- Additional Predicate: Momentum® Posterior Spinal Fixation System, ulrich Medical . USA, K191932
- Additional Predicate: BonOs® Inject Bone Cement; NEO Pedicle Screw System™, . Neo Medical SA, K222256
ulrich medical USA, Inc. submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement is substantially equivalent in indications, design principles, and performance to the following predicate devices, which have been determined by FDA to be substantially equivalent to the predicate devices:
- Primary Predicate: G21 Cement, VADER® Pedicle System, icotec ag, K200596 ●
- Additional Predicate: Momentum® MIS Posterior Spinal Fixation System, ulrich . Medical USA, K223274
- . Additional Predicate: BonOs® Inject Bone Cement; NEO Pedicle Screw System™, Neo Medical SA, K222256
8
Performance Testing Summary:
Bone cement usability testing and screw removal testing was conducted to validate the use of the Momentum® Posterior Spinal Fixation System used with bone cement.
Substantial Equivalence:
The subject device was demonstrated to be substantially equivalent to the predicates cited above with respect to indications, design materials, function, manufacturing, and performance. The non-clinical tests performed by the company included bone cement usability testing and screw removal testing conducted to validate the use of the Momentum® Posterior Spinal Fixation System with bone cement.
Conclusion:
The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of similar materials. The subject and predicate devices are packaged in similar materials and are sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above. The Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement and the Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement are substantially equivalent to the cited predicate devices.