(77 days)
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None
No
The summary describes a mechanical spinal plating system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for the treatment of various spinal conditions, including degenerative disc disease, pseudarthrosis, stenosis, scoliosis, spondylolisthesis, unsuccessful previous attempts at spinal fusion, or tumor resection, which are all therapeutic interventions.
No
The provided text describes a medical device called the Ultium Spinal Plating System, which is used for spinal fixation and attachment. Its stated "Intended Use / Indications for Use" are for the treatment of conditions like spondylolisthesis, degenerative disc disease, pseudarthrosis, stenosis, scoliosis, unsuccessful previous attempts at spinal fusion, or tumor resection, and it is a mechanical implant. There is no information suggesting it is used for diagnosing any condition.
No
The device description explicitly states that the Ultium Spinal Plating System includes physical components (plates, locking nut, bolts) made from a titanium alloy. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant system for spinal fixation. This is a therapeutic device used in vivo (within the body) to provide structural support.
- Device Description: The device components are physical implants (plates, bolts, nuts) made of titanium alloy. These are not reagents, instruments, or software used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), diagnostic testing, or providing information about a patient's health status based on in vitro analysis.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used for structural support and stabilization.
N/A
Intended Use / Indications for Use
Posterior Fixation / Attachment (Pedicle fixation): The Ultium Spinal Plating System bolts when placed in the pedicles are intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (LS-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. When used as a pedicle screw system, the bolts may be used for the indications specified previously to affix the plates to vertebral levels L3 to S1 inclusive.
Anterior Fixation / Attachment (antervertebral intervertebral bodies). The Ultium Spinal Plating System when attached anterolaterally to the vertebral bodies of levels T10 to S1, inclusive, is intended for the treatment of: degenerative disc disease (defined as back pain of discogenic orgin with degeneration of the disk confirmed by historical and radiographic studies); pseudarthrosis, stenosis. scoliosis, spondylolisthesis; unsuccessful previous attempts at spinal fusion; or tumor resection.
Product codes
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Device Description
The Ultium Soinal Plating System includes plates, a locking nut, standard bolts, and offset bolts. All components are manufactured from a titanium alloy.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
fifth lumbar - first sacral (LS-S1) vertebral joint; lumbar and sacral spine; vertebral levels L3 to S1 inclusive; vertebral bodies of levels T10 to S1
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Mechanical testing was performed according to ASTM standard test methods. All of the test results indicate that the Ultium Spinal Plating System is capable of withstanding in vivo loading without failure.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Summary of Safety and Effectiveness Smith & Nephew Richards Inc. Ultium Spinal Plating System
Substantial Equivalence Information
The Ultium Spinal Plating System is similar to the following systems:
- Simmons Plating System Smith & Nephew Orthopaedics 1 .
- Rogozinski Spinal Rod System Smith & Nephew Orthopaedics 2.
- Steffee Plating System (VSP) Acromed 3.
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- DynaLok System Danek
All of the devices listed above are similar in design to the Ultium Spinal Plating System. The safety and effectiveness of the Ultium Spinal Plating System is based on the long history of use of these devices in the market place.
Device Description
ﺘﻈﺮ
The Ultium Soinal Plating System includes plates, a locking nut, standard bolts, and offset bolts. All components are manufactured from a titanium alloy.
Indications for Use
Posterior Fixation / Attachment (Pedicle fixation): The Ultium Spinal Plating System bolts when placed in the pedicles are intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (LS-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. When used as a pedicle screw system, the bolts may be used for the indications specified previously to affix the plates to vertebral levels L3 to S1 inclusive.
Anterior Fixation / Attachment (antervertebral intervertebral bodies). The Ultium Spinal Plating System when attached anterolaterally to the vertebral bodies of levels T10 to S1, inclusive, is intended for the treatment of: degenerative disc disease (defined as back pain of discogenic orgin with degeneration of the disk confirmed by historical and radiographic studies); pseudarthrosis, stenosis. scoliosis, spondylolisthesis; unsuccessful previous attempts at spinal fusion; or tumor resection.
Mechanical Testing
Mechanical testing was performed according to ASTM standard test methods. All of the test results indicate that the Ultium Spinal Plating System is capable of withstanding in vivo loading without failure.
OCT - 2 1996