(80 days)
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No
The document describes a mechanical spinal implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a component of a spinal system intended to treat various spinal conditions such as scoliosis, fractures, spondylolisthesis, and degenerative disc disease, which are therapeutic indications. It helps provide resistance to physiological forces in the spine.
No
Explanation: The provided text describes the Osteonics® Spinal System components which are used for spinal stabilization and fusion procedures, explicitly mentioning their use for treating conditions like scoliosis, vertebral fracture, spondylolisthesis, and degenerative disc disease. There is no mention of the device being used to identify, detect, or monitor a medical condition or disease. Instead, it describes a therapeutic function providing "additional resistance to physiological forces."
No
The device description clearly states it is a "Spinal System Top Loading Transverse Connector Assembly" and describes physical components made of stainless steel or Ti6Al4V alloy, intended for surgical implantation. This is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used to stabilize the spine during fusion procedures. It is a mechanical device for internal fixation.
- Device Description: The description details the physical components of a spinal implant assembly.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The subject components of the Osteonics® Spinal System Top Loading Transverse Connector Assembly are single-use devices which are sold non-sterile, and are intended for use only with other components of the commercially available Osteonics® Spinal System. The components of the Osteonics® Spinal System, including the additional components described herein. are available in either ASTM F-138 Stainless Steel (Type 316 LVM) or ASTM F-136 Ti6Al4V Alloy. Stainless steel components are intended for use only with other stainless steel components; Ti6Al4V alloy components are intended for use only with other Ti6Al4V alloy components.
The specific indications of the Osteonics® Spinal System, including the subject additional components, are stated below:
For non-pedicular use:
- . Long and short curve scoliosis.
- Vertebral fracture or dislocation.
- . Spondylolisthesis,
- . Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
For pedicular use:
- . When used as a pedicle screw system, the system is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 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. Pedicle screws are not intended for placement in pedicles above L3.
Product codes
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Device Description
The Osteonics® Spinal System Top Loading Transverse Connector Assembly allows a spinal construct on one side of the spine to be joined to another construct on the other side of the spine. This joining provides additional resistance to physiological forces such as unequal lateral loads, rotation, and isolated torsional movements. Construction of this assembly requires two Osteonics® Spinal System Top Loading Transverse Connectors, each with a Top Loading Connector Set Screw, and a Transverse Connector Bar. Each top loading transverse connector joins one end of the transverse connector bar to one of the longjtudinal construct. The top loading connector set screw is used to secure the transverse assembly.
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
Spine, Lumbar and sacral spine
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Osteonics® Spinal System, TSRH™ Spinal System, GDLH™ Posterior Spinal System, ISOLA Spinal System
Reference Device(s)
Not Found
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
JAN 17 1997
964304 510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS OSTEONICS® SPINAL SYSTEM -TOP LOADING TRANSVERSE CONNECTOR ASSEMBLY
Submission Information
Name and Address of the Sponsor of the 510(k) Submission:
Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677 201-825-4900
Regulatory Affairs Specialist
TO
Contact Person:
Date Summarv Prepared:
Device Identification Proprietary Name:
January 9, 1997
Donna S. Wilson
Osteonics® Spinal System -Top Loading Transverse Connector Assembly
Common Name:
Classification Name and Reference:
Spinal Interlaminal Fixation Orthosis
Spinal Fixation Appliances
21 CFR 888 3050
Predicate Device Identification
The Osteonics® Spinal System Top Loading Transverse Connector Assembly components are substantially equivalent to other legally marketed spinal system crosslinking (transversing) assembly components. These predicate components are part of the commercially available spinal systems stated below:
- Osteonics® Spinal System: Osteonics Corp. .
- . TSRH™ Spinal System: Sofamor Danek
- GDLH™ Posterior Spinal System: Sofamor Danek
- ISOLA Spinal System: Acromed .
Device Description
The Osteonics® Spinal System Top Loading Transverse Connector Assembly allows a spinal construct on one side of the spine to be joined to another construct on the other side of the spine. This joining provides additional resistance to physiological forces such as unequal lateral loads, rotation, and isolated torsional movements. Construction of this assembly requires two Osteonics® Spinal System Top Loading Transverse Connectors, each with a Top Loading Connector Set Screw, and a Transverse Connector Bar. Each top loading transverse connector
1
joins one end of the transverse connector bar to one of the longjtudinal construct. The top loading connector set screw is used to secure the transverse assembly.
TO
Intended Use
The subject components of the Osteonics® Spinal System Top Loading Transverse Connector Assembly are single-use devices which are sold non-sterile, and are intended for use only with other components of the commercially available Osteonics® Spinal System. The components of the Osteonics® Spinal System, including the additional components described herein. are available in either ASTM F-138 Stainless Steel (Type 316 LVM) or ASTM F-136 Ti6Al4V Alloy. Stainless steel components are intended for use only with other stainless steel components; Ti6Al4V alloy components are intended for use only with other Ti6Al4V alloy components.
The specific indications of the Osteonics® Spinal System, including the subject additional components, are stated below:
For non-pedicular use:
- . Long and short curve scoliosis.
- � Vertebral fracture or dislocation.
- . Spondylolisthesis,
- . Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
For pedicular use:
- . When used as a pedicle screw system, the system is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 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. Pedicle screws are not intended for placement in pedicles above L3.
Statement of Technological Comparison
The components of the Osteonics® Spinal System Top Loading Transverse Connector Assembly share the same materials, intended uses and basic design concepts as that of the predicate devices. Fatigue and static testing demonstrates the mechanical and endurance properties of these components.