(151 days)
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Not Found
No
The device description and performance studies focus on mechanical components and surgical outcomes, with no mention of AI or ML.
Yes
The device is described as a "Posterior pedicle screw fixation" and "Posterior hook and/or sacral/iliac screw fixation" system intended for the treatment of various spinal conditions like severe spondylolisthesis, degenerative disc disease, scoliosis, fracture, and tumor resection, all of which fall under therapeutic applications.
No
Explanation: The provided text describes a spinal rod system composed of rods, hooks, and screws intended for the treatment of various spinal conditions by spinal fusion, not for diagnosing them.
No
The device description explicitly states that the system consists of "two stainless steel rods attached to the spinal column through the use of hooks and/or screws," and describes various hardware components like rods, hooks, screws, and cross-bars. This indicates a physical medical device, not a software-only one.
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, or tissue) to provide information about a person's health.
- Device Description: The provided text describes a spinal implant system consisting of rods, screws, and hooks made of stainless steel. These are surgically implanted devices used to stabilize the spine.
- Intended Use: The intended use clearly states the device is for posterior pedicle screw fixation and posterior hook and/or sacral/iliac screw fixation to treat various spinal conditions. This involves surgical implantation and mechanical support of the spine.
- Lack of IVD Characteristics: There is no mention of testing bodily samples, analyzing biological markers, or providing diagnostic information based on laboratory analysis.
The device described is a surgical implant used for spinal fixation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Posterior pedicle screw fixation: The Rogozinka Spinal Rod System Direct ("U"-shaped head) and Offset ("T"-shaped head) screws when placed in the pertebral levels 1.3 to SL are intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (LS-S 1) vetebral joint; (b) who are receiving fissions using autogenous bone graft only; and (c) who are having the device fixed or attached to the lumbar and sacral spine. Other and Officet Screws are intended only for sacral/linac attachment as specified below.
Posterior hook and/or sacrabiliae screw fization: The Rogozinski Rod System is intended for the treatment of degeneralive disc disease (defined as spinal instability and one of the following: decreased disc height, ridging of vertebral end plates, scaring or thickening of ligamentous tissues and or change in the process, solicis; spendyblishes; fracture; unsucessful previous attempts at spinal fusion; or tumor resection. The Rogozinski Thoracolumbar Spinal Rod system is limited to non-cervical use.
Product codes
Not Found
Device Description
The Rogainski Thoracolumbar Spinal Rod System onsists of two stainless steel rods attached to the spiral column through the use andor screws. Universal cross-hars may be used to rods to provide a more rigid construct, as well as screws to rods and hooks to rods. Scews at provided in a variety of lengths and in-angle, neutsal, dover-angle and pedicle hooks are provided in several sizes to accomodate varing patient morphology. Screws used with this system feature a "T" shaped head for offect attachment to the rod using a coupler, crossbar, and set screw or a "T". shaped head for direct attachment to the rod use screw. Up-angle, down-angle, neutral and pedice hooks may be attached editer directly to the rod or offset from the rod attached with to the rod with crossbar mechanism.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine, lumbar and sacral spine, non-cervical
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)
Martjetto et.a.l. presented the results of the literature relating to degeneralive spondylolisthess. Accepted for inclusion in this meta-analysis were 25 papers published between 1970 and 1973 representing with degeneralive spondylolistesis with radicular leg pain or neurogenc claudication involving the lumbar spine from 11-51. Degenerative spondylolisthess is characterized by degenerative articles is association with disc degeneration. Remodeling of the face is the cephalad on the caude lumbar vertebra. This meta-analysis stratified pages into the following groups: (i) Nonoperativelnatural history - 3 papers todal, (ii) Posterior decompression procedures without fusion - 1 I papers with 216 palients total, (ii) Posterior decompression without instrumentation - 6 pages with 84 patients total, (iv) Posterior decompression with "control" device, i.e. legally marketed Jass II devices - 4 papers with 138 patients total, (v) Posterior decompression with fision with pedicalar instrumentation - 5 papers with (v) Anterior spinal fusion - 3 pages with 72 patients total. Mardietto stated that the recognized advantages of pelicular instrumentation over control devices as an adjunct to posterolateral spinal first-schieve threcolums spinal control from a posterior and maintenance of physiologic spinal alignners in all planes, (ii) no space-scupying metallic devices within the degencrative lund (iv) the ability to achieve fixation across segments with deficient or abserty spinal elements, potentially minimizing the spiral sequiring instrumentation and fusion. Mardietto concluded that the results of the support the clinical in the surgical management of degeneralive lumbar spondylolishesis, spinal fusion significantly improves patient salisfaction, and adjunctive spinal instrumentation entral FDA Class II devices and pedicular instrumentation are comparable with regards to rates of fision, patient satisfactions. The results of an open, northinded, historical cohort study presented by Yuan et al." support Madjetto findings. This historical cohort study collected data on patients who has pedicle screw devices as well as those who had received legally marked spinal fusion devices or no instrumentation at all. A total of 2,634 patients with degenerative spondylolisthesis were included in this cohot study with 2,177 (81.1%) in the pedicle screw group, 456 (1.9%) in the non-instrumented group, and 51 (1.9%) in the non-pedicle screw instrumentation group. The safety of pedicle screw devices for the treatment of degenerative spondytoing the nature and frequency of intraoperative and postoperative events. Intractive events related to pedices occurred infrequently. The rate of implant breakage was externely low (0.2%) The remaining intracter were were felt to be related to surgical technique rather than the implant. Pedice serents were comprised mainly of screw fracture and screw looseniant control group for degeneralive spondylolisthesis was non-instrumented fixations, no such rate compansons for these events could be made. However, many of these events were without consequence. For postoperative events that could have occurred in both trainent groups, the nature of these events were comparable. Additionally, the time adjusted rates of events were not statistically different between the two teather was higher in the pedicle scever group than in the non-instrumented group (17.6% versus 15.0%) primarily due to device removals. The rates of referations, which can ocur in both teatment groups were simlar. In terms of effectiveness, the pedicient group had a statistically higher rate of fusion the non-instrumented control group (simple: 89.1% versus 70.4%). Additionally, the ime to fision tended to be faster for the pedice sorew goup patients. Maintenance of spiral alignment and ober levels, although not statistically different, fixation gov. Yuan concluded that the benefits of pedicle sorew fixation for the treatment of degenerative spondylolisthesis were demonstrates compared to conventional non-instrumented control surgical treatments with pedicle screw palients achieving better over. Garfin" in a summation of the works of Martjetko et al. and Yuan et al. states that data derved from a scientifically valid study show that perient of to a significant number of people. The literature review as well as the color story show the finion rate markedly improves when is added and that pedicle screw systems are at least as the currently macked, commercially available Class II users of increasing the fusion rate. Gafin further states that albough the complication rates are higher in those has have instrumented fusion, pedice screw devices have no higher complication rates and no nore significati complivations than the currently available Class I instrumentation. Therefore, in properly chosen patches, matched to the appropriate device and procedure, the results in obtaining a fuccessful outcome may be better using pedices, than with other system that are currently available and approved for use in the United States of a randomized study of 124 patients undergoing lumbar or lumbosaral fusion for degenerative conditions of the spine. Patients were randomly assigned to one of the following three treatment groups: (1) posteroiseral fision using autogenous bone graft, (I) autogenous posterolated with the Luque II screwinter fixation system (Sofamor) and (III) autogenous posterolateral fusions supplemented with the TSRH screwrod fixation system (Solamor)Danek). Of the 124 patients entered into the study, 56 presented with degeneralive or istimic spondylolishes: 21 in Group II. The fision rate for degeneralive spondylolisthers for Groups I, II, and III were 65%, 50%, and 86%, respectively. The fusion rate for istumic spondylolistis for Groups I, II, and III were 80%, 89%, and 100%, respectively. Overall fision rates for Groups I, II and III were 65%, 77%, and 95%, respectively. Zdeblick also assessed each patient chically and assigned asch a rating of either "excellent", "good". The overall good or excellent clinical results were 71% in Group II, and 95% in Group III. Zdeblick concluded that pedically higher rate of fusion in degeneralive lumbar disease than did fusion without instrumentation and that the clinical results mimic the radiographic results in all three Groups.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Harington "Lag" Screw, ISOLA® Spinal System, CD Spiral System, GDLH™ Posterior Spiral System, TSRFM Spiral System, Posterior Spinal System, Unit Rod System, MOSS™ Modular Segmental System, Modulock™ Posterior Spinal Fixation System, Wilse System of Internal Fixation
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
Rogozinski Thoracolumbar Spinal Rod System Smith & Nephew Spine a division of Smith & Nephew Richards Inc. 1450 Brooks Road Memphis, TN 38116
MAR 1 1996
1. Description
The Rogainski Thoracolumbar Spinal Rod System onsists of two stainless steel rods attached to the spiral column through the use andor screws. Universal cross-hars may be used to rods to provide a more rigid construct, as well as screws to rods and hooks to rods. Scews at provided in a variety of lengths and in-angle, neutsal, dover-angle and pedicle hooks are provided in several sizes to accomodate varing patient morphology. Screws used with this system feature a "T" shaped head for offect attachment to the rod using a coupler, crossbar, and set screw or a "T". shaped head for direct attachment to the rod use screw. Up-angle, down-angle, neutral and pedice hooks may be attached editer directly to the rod or offset from the rod attached with to the rod with crossbar mechanism.
Identification of the Predicate Device(s) 2.
The Rogozinski Thoracolumbar Solnal Rod System are substantially equivalent to the Harington "Lag" Screw manufactured by Zimer, Inc. the ISOLA® Spinal System by Acromed, Inc., the CD Spiral System by SolamorDanel, the GDLH™ Posterior Spiral System by SofamorDanel, the TSRFM Spiral System by Sofamor Danet of Posterior Spinal System by Sofanor Danel, the Unit Rod System by Sofamor Danel, the MOSS™ Modular Segmental System by DepuyMotest™, the Modulock™ Posterior Spinal Fixation System by Zimmer, Inc., and the Wilse System of Internal Fixation by Advanced Spine Fixation Systems, Inc.
3. Intended Use(s)
Posterior pedicle screw fixation: The Rogozinka Spinal Rod System Direct ("U"-shaped head) and Offset ("T"-shaped head) screws when placed in the pertebral levels 1.3 to SL are intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (LS-S 1) vetebral joint; (b) who are receiving fissions using autogenous bone graft only; and (c) who are having the device fixed or attached to the lumbar and sacral spine. Other and Officet Screws are intended only for sacral/linac attachment as specified below.
Posterior hook and/or sacrabiliae screw fization: The Rogozinski Rod System is intended for the treatment of degeneralive disc disease (defined as spinal instability and one of the following: decreased disc height, ridging of vertebral end plates, scaring or thickening of ligamentous tissues and or change in the process, solicis; spendyblishes; fracture; unsucessful previous attempts at spinal fusion; or tumor resection. The Rogozinski Thoracolumbar Spinal Rod system is limited to non-cervical use.
4. Information Bearing on Safety and Effectiveness
Martjetto et.a.l. presented the results of the literature relating to degeneralive spondylolisthess. Accepted for inclusion in this meta-analysis were 25 papers published between 1970 and 1973 representing with degeneralive spondylolistesis with radicular leg pain or neurogenc claudication involving the lumbar spine from 11-51. Degenerative spondylolisthess is characterized by degenerative articles is association with disc degeneration. Remodeling of the face is the cephalad on the caude lumbar vertebra. This meta-analysis stratified pages into the following groups: (i) Nonoperativelnatural history - 3 papers todal, (ii) Posterior decompression procedures without fusion - 1 I papers with 216 palients total, (ii) Posterior decompression without instrumentation - 6 pages with 84 patients total, (iv) Posterior decompression with "control" device, i.e. legally marketed Jass II devices - 4 papers with 138 patients total, (v) Posterior decompression with fision with pedicalar instrumentation - 5 papers with (v) Anterior spinal fusion - 3 pages with 72 patients total. Mardietto stated that the recognized advantages of pelicular instrumentation over control devices as an adjunct to posterolateral spinal first-schieve threcolums spinal control from a posterior and maintenance of physiologic spinal alignners in all planes, (ii) no space-scupying metallic devices within the degencrative lund (iv) the ability to achieve fixation across segments with deficient or abserty spinal elements, potentially minimizing the spiral sequiring instrumentation and fusion. Mardietto concluded that the results of the support the clinical in the surgical management of degeneralive lumbar spondylolishesis, spinal fusion significantly improves patient salisfaction, and adjunctive spinal instrumentation entral FDA Class II devices and pedicular instrumentation are comparable with regards to rates of fision, patient satisfactions. The results of an open, northinded, historical cohort study presented by Yuan et al." support Madjetto findings. This historical cohort study collected data on patients who has pedicle screw devices as well as those who had received legally marked spinal fusion devices or no instrumentation at all. A total of 2,634 patients with degenerative spondylolisthesis were included in this cohot study with 2,177 (81.1%) in the pedicle screw group, 456 (1.9%) in the non-instrumented group, and 51 (1.9%) in the non-pedicle screw instrumentation group. The safety of pedicle screw devices for the treatment of degenerative spondytoing the nature and frequency of intraoperative and postoperative events. Intractive events related to pedices occurred infrequently. The rate of implant breakage was externely low (0.2%) The remaining intracter were were felt to be related to surgical technique rather than the implant. Pedice serents were comprised mainly of screw fracture and screw looseniant control group for degeneralive spondylolisthesis was non-instrumented fixations, no such rate compansons for these events could be made. However, many of these events were without consequence. For postoperative events that could have occurred in both trainent groups, the nature of these events were comparable. Additionally, the time adjusted rates of events were not statistically different between the two teather was higher in the pedicle scever group than in the non-instrumented group (17.6% versus 15.0%) primarily due to device removals. The rates of referations, which can ocur in both teatment groups were simlar. In terms of effectiveness, the pedicient group had a statistically higher rate of fusion the non-instrumented control group (simple: 89.1% versus 70.4%). Additionally, the ime to fision tended to be faster for the pedice sorew goup patients. Maintenance of spiral alignment and ober levels, although not statistically different, fixation gov. Yuan concluded that the benefits of pedicle sorew fixation for the treatment of degenerative spondylolisthesis were demonstrates compared to conventional non-instrumented control surgical treatments with pedicle screw palients achieving better over. Garfin" in a summation of the works of Martjetko et al. and Yuan et al. states that data derved from a scientifically valid study show that perient of to a significant number of people. The literature review as well as the color story show the finion rate markedly improves when is added and that pedicle screw systems are at least as the currently macked, commercially available Class II users of increasing the fusion rate. Gafin further states that albough the complication rates are higher in those has have instrumented fusion, pedice screw devices have no higher complication rates and no nore significati complivations than the currently available Class I instrumentation. Therefore, in properly chosen patches, matched to the appropriate device and procedure, the results in obtaining a fuccessful outcome may be better using pedices, than with other system that are
1
currently available and approved for use in the United States of a randomized study of 124 patients undergoing lumbar or lumbosaral fusion for degenerative conditions of the spine. Patients were randomly assigned to one of the following three treatment groups: (1) posteroiseral fision using autogenous bone graft, (I) autogenous posterolated with the Luque II screwinter fixation system (Sofamor) and (III) autogenous posterolateral fusions supplemented with the TSRH screwrod fixation system (Solamor)Danek). Of the 124 patients entered into the study, 56 presented with degeneralive or istimic spondylolishes: 21 in Group II. The fision rate for degeneralive spondylolisthers for Groups I, II, and III were 65%, 50%, and 86%, respectively. The fusion rate for istumic spondylolistis for Groups I, II, and III were 80%, 89%, and 100%, respectively. Overall fision rates for Groups I, II and III were 65%, 77%, and 95%, respectively. Zdeblick also assessed each patient chically and assigned asch a rating of either "excellent", "good". The overall good or excellent clinical results were 71% in Group II, and 95% in Group III. Zdeblick concluded that pedically higher rate of fusion in degeneralive lumbar disease than did fusion without instrumentation and that the clinical results mimic the radiographic results in all three Groups,
ี Madjetko SM, Comolly P., Shott S: Degenerative Lumbar Spondylolisthesis: A Meta-Analysis of Literature 1970-1993. Spine 19(208):2265-22655, 1994. " Yuar HA, Garfin SR, Dickman CA, Martical Cohor Study of Pedice Scew Fixation in Thoracic, Lumbar, and Saral Spinel Fisions, Spine 19(20S):2279S-2296S, 1994.
Garfin SR: Summation. Spine 19(20S):2300S-2305S, 1994.
17 Zdeblick TA: A Prospective, Randomized Study of Lumbar Fusion. Spine 18(8):983-991, 1993.