(59 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is described as a "spinal fixation system" intended for "immobilization and stabilization of spinal segments as an adjunct to fusion" and used for conditions like "fracture or dislocation," "spinal stenosis," and "curvatures." These uses are primarily for structural support and immobilization rather than providing therapy that directly treats or heals a disease or condition.
No
The TriALTIS™ System is described as a spinal fixation system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion. Its purpose is to treat conditions like degenerative disc disease, spondylolisthesis, and spinal deformities, not to diagnose them.
No
The device description explicitly states it consists of physical components like bone anchors (screws), longitudinal components (rods), and interconnection mechanisms, all made of Titanium alloy. This indicates it is a hardware-based medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The TriALTIS™ System is a surgical implant designed to provide mechanical support and stabilization to the spine. It is used in vivo (within the body) during surgical procedures.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic testing, or any function related to providing diagnostic information based on in vitro analysis.
The device is clearly described as a spinal fixation system used as an adjunct to fusion, which is a surgical treatment.
N/A
Intended Use / Indications for Use
The TriALTIS™ System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The TriALTIS™ Spine System is intended for pedicle fixation of the thoracic, lumbar, and sacral spine (T1-S2) and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudarthrosis; and failed previous fusion in skeletally mature patients.
When used for posterior pedicle screw fixation of the thoracic, lumbar, and sacral spine (T1-S2) in pediatric patients, the TriALTIS™ Spine System is indicated as an adjunct to fusion to treat spinal deformities (i.e, scoliosis, or lordosis) including adolescent idiopathic scoliosis, and congenital scoliosis. Additionally, the TriALTIS™ System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The TriALTIS™ Spine System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
When the TriALTIS™ Spine System fenestrated screws are used in conjunction with CONFIDENCE™ High Viscosity Spinal Cement, the TriALTIS™ Spine System is intended to stabilize 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. The TriALTIS™ fenestrated screws augmented with the CONFIDENCE™ High Viscosity Spinal Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised.
Product codes
NKB, PML
Device Description
The TriALTIS™ Spine System is a posterior spinal fixation system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic lumbar and sacral spine (T1-S2). The system is components to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The system consists of bone anchors (such as screws) for connection by longitudinal components (such as rods) via an interconnection mechanism (e.g., set screws and connectors) to link the longitudinal components for addity. The subject TriALTIS™ Spine System implant components are comprised of Titanium alloy conforming to ASTM F136.
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
skeletally mature patients, pediatric 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)
The TriALTIS™ System was evaluated against the predicate system, EXPEDIUM connectors on a component level using ASTM F1798 "Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants", specifically axial and torsional grip testing. Clinical testing is not applicable. Evaluation of the subject device performance data as compared to the predicate systems has found that the subject devices of the TriALTIS™ Spine System are substantially equivalent to predicate systems identified above.
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
§ 888.3070 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.
0
September 9, 2024
Image /page/0/Picture/1 description: The image shows 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.
Medos International SARL % Denielle Smith Regulatory Affairs Specialist DePuy Synthes Spine 325 Paramount Dr Raynham, Massachusetts 02767
Re: K242042
Trade/Device Name: TriALTIS™ Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, PML Dated: July 11, 2024 Received: July 12, 2024
Dear Denielle Smith:
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.
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"
1
(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 OS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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, Eileen Digitally signed by Eileen Cadel -S
Date: Cadel -2024.09.09 S 13:10:26 -04'00' for
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) K242042
Device Name TriALTIS™ Spine System
Indications for Use (Describe)
The TriALTIS™ System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The TriALTIS™ Spine System is intended for pedicle fixation of the thoracic, lumbar, and sacral spine (T1-S2) and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudarthrosis; and failed previous fusion in skeletally mature patients.
When used for posterior pedicle screw fixation of the thoracic, lumbar, and sacral spine (T1-S2) in pediatric patients, the TriALTIS™ Spine System is indicated as an adjunct to fusion to treat spinal deformities (i.e, scoliosis, or lordosis) including adolescent idiopathic scoliosis, and congenital scoliosis. Additionally, the TriALTIS™ System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The TriALTIS™ Spine System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
When the TriALTIS™ Spine System fenestrated screws are used in conjunction with CONFIDENCE™ High Viscosity Spinal Cement, the TriALTIS™ Spine System is intended to stabilize 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. The TriALTIS™ fenestrated screws augmented with the CONFIDENCE™ High Viscosity Spinal Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised.
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) #: K242042 | 510(k) Summary | K242042 - Page 1 of 2 | ||
|---|---|---|---|---|
| Prepared on: 2024-07-12 | ||||
| Contact Details | 21 CFR 807.92(a)(1) | |||
| Applicant Name | Medos International SARL | |||
| Applicant Address | Chemin-Blanc 38 L eocle H-N 2400 Switzerland | |||
| Applicant Contact Telephone | 978-538-8842 | |||
| Applicant Contact | Ms. Denielle Smith | |||
| Applicant Contact Email | dsmith76@its.jnj.com | |||
| Correspondent Name | DePuy Synthes Spine | |||
| Correspondent Address | 325 Paramount Dr Raynham MA 02767 United States | |||
| Correspondent Contact Telephone | 978-538-8842 | |||
| Correspondent Contact | Ms. Denielle Smith | |||
| Correspondent Contact Email | dsmith76@its.jnj.com | |||
| Device Name | 21 CFR 807.92(a)(2) | |||
| Device Trade Name | TriALTIS™ Spine System | |||
| Common Name | Thoracolumbosacral pedicle screw system | |||
| Classification Name | Thoracolumbosacral Pedicle Screw System | |||
| Regulation Number | 888.3070 | |||
| Product Code(s) | NKB, PML | |||
| Legally Marketed Predicate Devices | ||||
| 21 CFR 807.92(a)(3) | ||||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | ||
| K231479 | TriALTIS Spine System | NKB | ||
| K2336 84 | TriALTIS Spine System | NKB | ||
| Device Description Summary | ||||
| 21 CFR 807.92(a)(4) | ||||
| The TriALTIST™ Spine System is a posterior spinal fixation system intended to provide immobilization and stabilization of spinal segments |
The TriALTIS™ Spine System is a posterior system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic lumbar and sacral spine (T1-S2). The system is components to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The system consists of bone anchors (such as screws) for connection by longitudinal components (such as rods) via an interconnection mechanism (e.g., set screws and connectors) to link the longitudinal components for addity. The subject TriALTIS™ Spine System implant components are comprised of Titanium alloy conforming to ASTM F136.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
5
The TriALTIS™ Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The TriALTIS™ Spine System is intended for pedicle fixation of the thoracic, lumbar, and sacral spine (T1-S2) and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudarthrosis; and failed previous fusion in skeletally mature patients.
When used for posterior pedicle screw fixation of the thoracic, lumbar, and sacral spine (T1-S2) in pediatric patients, the TriALTIS" Spine System is indicated as an adjunct to fusion to treat spinal deformities (i.e, scollosis) including adolescent idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the TriALTIS™ Spine System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or failed previous fusion. The TriALTIS™ Spine System is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
When the TriALTIS™ Spine System fenestrated screws are used in conjunction with CONFIDENCE™ High Viscosty Spinal Cement, the TriALTIS™ Spine System is intended to stabilize 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. The TriALTIS™ fenestrated screws augmented with the CONFIDENCE™ High Viscosity Spinal Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised.
Indications for Use Comparison
Indications for use of the subject device are identical and substantially equivalent to the predicate, cleared in K233684.
Technological Comparison
Evaluation of the subject device intended use, technological characteristics, and performance data demonstrates substantial equivalence with the predicate devices.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The TriALTIS™ System was evaluated against the predicate system, EXPEDIUM connectors on a component level using ASTM F1798 "Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants", specifically axial and torsional grip testing.
Clinical testing is not applicable.
Evaluation of the subject device performance data as compared to the predicate systems has found that the subject devices of the TriALTIS™ Spine System are substantially equivalent to predicate systems identified above.