(63 days)
No
The document describes a mechanical pedicle screw and its intended use, with no mention of software, algorithms, or any technology related to AI or ML.
Yes.
The device, a pedicle screw, is intended for use in solid fusion and internal fixation applications as part of a spinal system, specifically for grade 3 or 4 spondylolisthesis at L5-S1. These uses suggest a therapeutic purpose, as it aims to treat a medical condition by providing support and stability for bone fusion.
No
Explanation: The device is a pedicle screw, which is an implant used for internal fixation in spinal surgery, not for diagnosing medical conditions.
No
The device description clearly describes a physical implant (pedicle screw) made of material components, 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 for spinal fixation (pedicle screw) used in the treatment of spondylolisthesis. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components and design of a screw intended for implantation. This aligns with a surgical device, not a device used to examine specimens from the human body.
- Anatomical Site: The device is intended for use at L5-S1, which is a specific location within the human body, not a sample taken from the body.
- Performance Studies: The performance studies mentioned are static and fatigue testing, which are relevant to the mechanical properties and durability of a surgical implant, not the diagnostic accuracy of a test.
IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device is a physical implant used in surgery.
N/A
Intended Use / Indications for Use
The AcroMed Pedicle Screw is designed to be utilized with the ISOLA Spine System (K944737). The ISOLA Spinal System, when used with pedicle screws, is intended for use in grade 3 or 4 spondylolisthesis at L5-S1 utilizing autologous bone graft and intended to be removed after solid fusion is attained. The ISOLA Spinal System, when not used with pedicle screws, is intended hook, wire, and/or sacral/iliac screw fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture and previous failed surgery. As a whole, the ISOLA Spinal System is intended for T1-sacral fixation. Screw fixation is from L3-S1. The component that is the subject of this premarket notification, the 4.75 mm diameter pedicle screw, is a line extension version of AcroMed Pedicle Screws previously cleared under K951657 for the ISOLA system. It is intended for use in pediatric and other applications where anatomic considerations limit the size of the implants that can be used for internal fixation applications.
Product codes
Not Found
Device Description
The AcroMed Pedicle Screw is composed of two sections: a long cancellous section with an integral fixed lower nut, and a machine threaded section topped with an hexagonal drive head. The integral nut serves two purposes: it creates a stronger bolt connection between the screw and rod and it eliminates the "claw hammer" effect associated with other screw designs. The AcroMed Pedicle Screw is supplied with an adjustable tapered nut and an optional lock nut, which enables a pedicle screw and a slotted connector to be adjoined utilizing a locking nut system. The junction point of the adjustable integral nut and machine thread portion of the pedicle screw is also rounded to reduce potential stress concentration. The screw is available in cancellous thread lengths from 25-50 mm, in 5 mm increments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L5-S1, T1 to the ilium/sacrum, T1-sacral, L3-S1
Indicated Patient Age Range
pediatric
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)
Static and fatigue testing show the AcroMed pedicle screws (4.75 mm) to perform consistently with previously cleared components.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
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
K963639 ા બે રે
NOV 14 1996
ISOLA SYSTEM AcroMed Pedicle Screw (4.75 mm) 510(k) SUMMARY
AcroMed Corporation COMPANY: 3303 Carnegie Avenue Cleveland, OH 44115
AcroMed Pedicle Screw TRADENAME:
CLASSIFICATION: Spondylolisthesis Spinal Fixation Device Unclassified, preamendment device system
The AcroMed Pedicle Screw is composed of two sections: a long DESCRIPTION: cancellous section with an integral fixed lower nut, and a machine threaded section topped with an hexagonal drive head. The integral it creates a stronger bolt connection nut serves two purposes: between the screw and rod and it eliminates the "claw hammer" effect associated with other screw designs.
The AcroMed Pedicle Screw is supplied with an adjustable tapered nut and an optional lock nut, which enables a pedicle screw and a slotted connector to be adjoined utilizing a locking nut system. The junction point of the adjustable integral nut and machine thread portion of the pedicle screw is also rounded to reduce potential stress concentration.
The screw is available in cancellous thread lengths from 25-50 mm, in 5 mm increments.
The AcroMed Pedicle Screw is manufactured from implant grade MATERIAL: stainless steel conforming to ASTM F1314 specifications.
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INDICATIONS:
The AcroMed Pedicle Screw is designed to be utilized with the ISOLA Spine System (K944737). The ISOLA Spinal System, when used with pedicle screws, is intended for use in grade 3 or 4 spondylolisthesis at L5-S1 utilizing autologous bone graft and intended to be removed after solid fusion is attained.
The ISOLA Spinal System, when not used with pedicle screws, is intended hook, wire, and/or sacral/iliac screw fixation from T1 to the non-pedicle screw indications are ilium/sacrum. The spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture and previous failed surgery.
As a whole, the ISOLA Spinal System is intended for T1-sacral fixation. Screw fixation is from L3-S1.
The component that is the subject of this premarket notification, the 4.75 mm diameter pedicle screw, is a line extension version of AcroMed Pedicle Screws previously cleared under K951657 for the It is intended for use in pediatric and other ISOLA system. applications where anatomic considerations limit the size of the implants that can be used for internal fixation applications.
PERFORMANCE DATA:
Static and fatigue testing show the AcroMed pedicle screws (4.75 mm) to perform consistently with previously cleared components.
SUBSTANTIAL EQUIVALENCE:
The AcroMed 4.75 mm diameter pedicle screw is equivalent to other AcroMed pedicle screws as cleared under K951116.
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