(136 days)
Not Found
Not Found
No
The device description focuses on mechanical components for spinal fixation and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
Yes
The device is described as a "pedicle screw system" and is intended for fixing to the lumbar and sacral spine in patients with severe spondylolisthesis and other spinal deformities, which indicates a therapeutic purpose.
No
The device is a surgical implant designed for spinal fixation and fusion, not for diagnosing medical conditions.
No
The device description clearly outlines a physical implantable system made of 316L stainless steel or Titanium alloy, including clamps, screws, rods, and nuts. This is a hardware medical device, 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the Synthes Universal Modular Spinal System is a system of implants (screws, rods, clamps) intended for surgical fixation of the spine.
- Intended Use: The intended use describes the surgical conditions and procedures for which the device is used, all of which involve direct implantation into the body.
There is no mention of the device being used to analyze biological samples or provide diagnostic information based on such analysis. It is a surgical implant used for structural support and stabilization.
N/A
Intended Use / Indications for Use
When used as a pedicle screw system, the Synthes Universal Modular Spinal System is intended for patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (LS-S1) vertebral joint (levels of screw fixation L3-S2); who are receiving fusions using autogenous bone graft only; who are having the device fixed or attached to the lumbar and sacral spine; and who are having the device removed after the development of a solid fusion.
When used as a nonpedicle screw system, it is also intended for scoliotic, or kyphotic deformities (such as scoliosis, Schueremann's disease); degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies; and fractures of the posterior thoracolumbar spine (levels T8-S2)
The overall levels of fixation are T8-S2.
Product codes
Not Found
Device Description
The Synthes Universal Modular Spinal System includes a clamp with posterior nut and Schanz screws for use with the Synthes (USA) Universal Spinal Hook, Rod and Pedicle/Sacral Screw Fixation System. The clamp with posterior nut consists of a clamp body (jaw), a swing clamp bushing (collet), a serrated washer, a nut, and a set (hex) screw. The Schanz screw is placed in the sacral and lumbar spine up to and including L3 sacral for fixation over the L5-S1 joint. The clamp body is slid onto an unthreaded rod. The clamp assembly (nut, serrated washer, jaw and swing clamp bushing) with unthreaded rod is slid over the top, smooth part of the Schanz screw. The clamp is secured onto the unthreaded rod by the use of the set screw, and is locked against rotation by tightening the nut on top of the clamp assembly. The cephalad end of the rods attaches to the spine with a hook, collar and nut from the Universal Spinal Hook, Rod and Pedicle/Sacral Screw Fixation System. The system is manufactured from 316L stainless steel or Titanium alloy.
Synthes Universal Modular Spinal System is provided non-sterile; moist heat sterilization is recommended.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiographic studies
Anatomical Site
fifth lumbar-first sacral (LS-S1) vertebral joint (levels of screw fixation L3-S2); lumbar and sacral spine; posterior thoracolumbar spine (levels T8-S2)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Synthes Universal Spinal Hook, Rod, and Pedicle/Sacral Screw Fixation System, Titanium TSRH Spinal System (Screws), Synthes Modular Spinal Fixation System and Locking Hook Spinal Rod System.
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
Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, sans-serif font. To the left of the word is a circular logo with a stylized figure inside. A small circle with a tail is located to the upper right of the "S" in "SYNTHES", likely representing a trademark symbol. The text and logo are all in black against a white background.
1296335
Attachment B: Summary of Safety and Effectiveness Information [510(k) Summary]
Synthes (USA) 1690 Russell Road Paoli, PA 19301
(610) 647-9700 Contact: Angela Silvestri December 1996
Synthes Universal Modular Spinal System, as compared to the Synthes Universal Spinal Hook, Rod and Pedicle/Sacral Screw Fixation System.
When used as a pedicle screw system, the Synthes Universal Modular Spinal System is intended for patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (LS-S1) vertebral joint (levels of screw fixation L3-S2); who are receiving fusions using autogenous bone graft only; who are having the device fixed or attached to the lumbar and sacral spine; and who are having the device removed after the development of a solid fusion.
When used as a nonpedicle screw system, it is also intended for scoliotic, or kyphotic deformities (such as scoliosis, Schueremann's disease); degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies; and fractures of the posterior thoracolumbar spine (levels T8-S2)
The overall levels of fixation are T8-S2.
The Synthes Universal Modular Spinal System includes a clamp with posterior nut and Schanz screws for use with the Synthes (USA) Universal Spinal Hook, Rod and Pedicle/Sacral Screw Fixation System. The clamp with posterior nut consists of a clamp body (jaw), a swing clamp bushing (collet), a serrated washer, a nut, and a set (hex) screw. The Schanz screw is placed in the sacral and lumbar spine up to and including L3 sacral for fixation over the L5-S1 joint. The clamp body is slid onto an unthreaded rod. The clamp assembly (nut, serrated washer, jaw and swing clamp bushing) with unthreaded rod is slid over the top, smooth part of the Schanz screw. The clamp is secured onto the unthreaded rod by the use of the set screw, and is locked against rotation by tightening the nut on top of the clamp assembly. The cephalad end of the rods attaches to the spine with a hook, collar and nut from the Universal Spinal Hook, Rod and Pedicle/Sacral Screw Fixation System. The system is manufactured from 316L stainless steel or Titanium alloy.
Synthes Universal Modular Spinal System is provided non-sterile; moist heat sterilization is recommended.
Based on the above, Synthes Universal Modular Spinal System is substantially equivalent to Synthes Universal Spinal Hook, Rod, and Pedicle/Sacral Screw Fixation System, Titanium TSRH Spinal System (Screws), and Synthes Modular Spinal Fixation System and Locking Hook Spinal Rod System.