(90 days)
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No
The document describes a mechanical spinal implant system and its components. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies mentioned are mechanical fatigue and static testing, not algorithmic performance.
Yes
The device is described as an "Osteonics® Spinal System" intended for "fixation of the T4-S2 spine" with specific indications for use in patients with conditions like scoliosis, vertebral fracture, spondylolisthesis, and degenerative disc disease, facilitating fusions and providing stability, which are all therapeutic actions.
No
The device is described as an Osteonics® Spinal System Variable Offset Connector Assembly, intended for use in spinal fixation and fusion surgeries. Its purpose is to physically connect and stabilize spinal components, not to diagnose medical conditions or analyze data for diagnostic purposes.
No
The device description clearly describes physical components made of stainless steel or titanium alloy, intended for surgical implantation. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description and Intended Use: The description clearly states that this device is part of a spinal system intended for fixation of the spine and is used within the body during surgical procedures. It is a mechanical implant used to stabilize the spine.
- Lack of IVD Characteristics: There is no mention of examining specimens, diagnostic testing, or any other activity typically associated with IVDs.
Therefore, the Osteonics® Spinal System Variable Offset Connector Assembly is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The subject components of the Osteonics® Spinal System Variable Offset 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 Ti6A14V ELI Alloy. Stainless steel components are intended for use only with other stainless steel components; Ti6AV ELI alloy components are intended for use only with other Ti6Al4V ELI alloy components.
The Osteonics® Spinal System, including the subject additional components, is intended for fixation of the T4-S2 spine. All bone screws are indicated for sacral fixation, or for limited pedicular fixation. When used as a pedicle screw system is intended only for use with autogenous bone graft in order to facilitate fusions of the LS-S1 joint in patients with grade 3 or 4 spondylolisthesis. The screws are not intended for placement in the pedicles above L3, and are intended for removal after development of a solid fusion mass.
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 (comma separated list FDA assigned to the subject device)
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Device Description
The Osteonics® Spinal System Variable Offset Connector Assembly may be used in any application where greater flexibility in bone screw placement is needed. This assembly allows a spinal rod to be joined to a bone screw when variations in the distance between these two components exists. The Variable Offset Connector is provided with a Ball Ring, which secures into the top of the bone screw. The bone screw is rotated to provide an access to the Variable Offset Connector in conjunction with the longitudinal construct. The Osteonics® Spinal System Clamping Screw is used with the Variable Offset Connector to provide a stable lock on the longitudinal rod.
The connector features a cylindrical arm at one end, a center round hole, and an open-ended split screw hole at the other end. The Ball Ring component is preassembled around the cylindrical arm. The round hole accommodates the spinal rod, and the split screw hole accepts the Clamping Screw, which secures the spinal rod into place.
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
T4-S2 spine, sacral, L5-S1 joint, lumbar and sacral spine, pedicles above L3
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)
Fatigue and static testing demonstrates the mechanical and endurance properties of these components.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
TSRH™ Spinal System, ISOLA Spinal System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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
ਦ
FEB | | 1997
510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS OSTEONICS® SPINAL SYSTEM - VARIABLE OFFSET 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 | |
| Contact Person: | Donna S. Wilson |
| Regulatory Affairs Specialist | |
| Date Summary Prepared: | February 10, 1997 |
| Device Identification | |
| Proprietary Name: | Osteonics® Spinal System - Variable Offset Connector Assembly |
| Common Name: | Spinal Fixation Appliances |
| Classification Name and Reference: | Spinal Interlaminal Fixation Orthosis |
| 21 CFR 888.3050 |
Predicate Device Identification
The Osteonics® Spinal System Variable Offset Connector Assembly components are substantially equivalent to other legally marketed spinal system offset components. These predicate components are part of the commercially available spinal systems stated below:
- TSRH™ Spinal System: Sofamor Danek .
- ISOLA Spinal System: Acromed .
Device Description
The Osteonics® Spinal System Variable Offset Connector Assembly may be used in any application where greater flexibility in bone screw placement is needed. This assembly allows a spinal rod to be joined to a bone screw when variations in the distance between these two components exists. The Variable Offset Connector is provided with a Ball Ring, which secures into the top of the bone screw. The bone screw is rotated to provide an access to the Variable Offset Connector in conjunction with the longitudinal construct. The Osteonics® Spinal System Clamping Screw is used with the Variable Offset Connector to provide a stable lock on the longitudinal rod.
1
The connector features a cylindrical arm at one end, a center round hole, and an open-ended split screw hole at the other end. The Ball Ring component is preassembled around the cylindrical arm. The round hole accommodates the spinal rod, and the split screw hole accepts the Clamping Screw, which secures the spinal rod into place.
TO
Intended Use
The subject components of the Osteonics® Spinal System Variable Offset 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 Ti6A14V ELI Alloy. Stainless steel components are intended for use only with other stainless steel components; Ti6AV ELI alloy components are intended for use only with other Ti6Al4V ELI alloy components.
The Osteonics® Spinal System, including the subject additional components, is intended for fixation of the T4-S2 spine. All bone screws are indicated for sacral fixation, or for limited pedicular fixation. When used as a pedicle screw system is intended only for use with autogenous bone graft in order to facilitate fusions of the LS-S1 joint in patients with grade 3 or 4 spondylolisthesis. The screws are not intended for placement in the pedicles above L3, and are intended for removal after development of a solid fusion mass.
Indications
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 Comnarison
The components of the Osteonics Spinal System Variable Offset 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.