(147 days)
K950074-SE
K950074-SE 08/11/95
No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as a "Fixation System" intended to "fix the spine" and "provide temporary stability...during bony fusion healing" for conditions such as severe spondylolisthesis, unstable spinal fractures, spinal tumors, degenerative disk diseases, and spinal curvatures. These uses directly involve treating or mitigating a disease or injury, which aligns with the definition of a therapeutic device.
No
The device is a screw assembly designed for spinal fixation and stability, not for diagnosis.
No
The device description clearly states it is a "polyaxial screw assembly consisting of screws, locking sleeves, and caps," which are physical hardware components used in spinal fixation. There is no mention of software as the primary or sole component.
Based on the provided information, the VERSALOK™ Screw Assembly is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a device designed for surgical implantation to fix and stabilize the spine during bony fusion healing. This is a therapeutic and structural function within the body, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a mechanical assembly of screws, locking sleeves, and caps used in spinal surgery. This aligns with a surgical implant, not a diagnostic tool.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
Therefore, the VERSALOK™ Screw Assembly is a surgical implant used for spinal fixation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The VERSALOK™ Screw Assembly is supplied as an alternative component for use with the WRIGHTLOCK™ Postedor Spinal Fixation System to fix the spine for appropriate indications apply when used as a pedicle screw.
A WRIGHTLOCK™ construct with screws attached to the pedicies of the lumbar and sacral spine (L3 to S1) and autogenous bone graft may be used for the treatment of severe spondylolisthesis (Grade 3) at the fith lumbar - first sacral (LS-S1) vertebral joint. The device is intended to be implanted using a posterior surgical approach and removed after development of a solid fusion mass.
When not used as a pedicle screw fixation system, various combinations of the system are also indicated to provide temporary stability of the thoracic, thoracolumbar. or lumbar spino (T1 to S1) during bony fusion healing secondary to: (1) Unstable spinal fractures (such as fracture diskcations) or spinal tumors; (2) Degeneralive disk diseases of the spine (defined as back pain of diskogenic origin with degeneration of the disk confirmed by radiographic studies); (3) Spinal curvatures (such as idiopathic scoliosis/kyphoscoliosis with associated paralysis or spasticity, and secondary to spinal fractures) which are: progressive, despite other forms of treatment; detrimental to cardiopulmonary function; interfering with spinal mechanics or causing severe back pain; or cosmetically unacceptable, progressive, and painful.
Product codes
Not Found
Device Description
The VERSALOK™ Screw Assembly is a polyaxial screw assembly consisting of screws, locking sleeves, and caps. The system is designed to accommodate the rods of the commercially available WRIGHTLOCK™ Posterior Spinal Fixation System (K950074-SE 08/11/95). The system features a low profile as well as a top loading design. It allows for up to 8mm offset from the rod and up to 30 degrees of angulation in all planes prior to final locking. The VERSALOK™ Screw Assembly is available in a range of sizes to fit varying anatomical requirements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar and sacral spine (L3 to S1), fith lumbar - first sacral (LS-S1) vertebral joint, thoracic, thoracolumbar. or lumbar spino (T1 to S1)
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)
The VERSALOK™ Screw Assembly tested with the following mean results: faligue endurance limit of 353N, axial push strength of 1086N, and torsional grip strength of 1.95Nm. Based on these results, the VERSALOK™ Screw Assembly should perform adequately when subjected to normal physiological loading.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
WRIGHTLOCK™ Posterior Spinal Fixation System (Wright Medical Technology, Inc.), MOSS® Miami System (DePuy)
Reference Device(s)
K950074-SE 08/11/95
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.
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Image /page/0/Picture/2 description: The image shows a stylized letter "W" in black against a white background. The "W" is formed by two inverted triangles that are connected at their apexes. The right side of the "W" has a break in the triangle, creating a gap. There is a small circle with a dot in the center below the "W".
Contact Person: Judy English Date Prepared: September 8, 1996
17 1003
510(k) Summary
Trade Name:
Common Name:
Predicate Devices:
VERSALOK™ Screw Assembly. Product line addition to WRIGHTLOCK™ Posterior Spinal Fixation System Soondstolisthesis Spinal Fixation Device System WRIGHTLOCK™ Posterior Spinal Fixation System (Wright Medical Technology, Inc.) MOSS® Miami System (DePuy)
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR §807.92.
Description/intended Use The VERSALOK™ Screw Assembly is a polyaxial screw assembly consisting of screws, locking sleeves, and caps. The system is designed to accommodate the rods of the commercially available WRIGHTLOCK™ Posterior Spinal Fixation System (K950074-SE 08/11/95). The system features a low profile as well as a top loading design. It allows for up to 8mm offset from the rod and up to 30 degrees of angulation in all planes prior to final locking. The VERSALOK™ Screw Assembly is available in a range of sizes to fit varying anatomical requirements.
The VERSALOK™ Screw Assembly is supplied as an alternative component for use with the WRIGHTLOCK™ Postedor Spinal Fixation System to fix the spine for appropriate indications apply when used as a pedicle screw.
A WRIGHTLOCK™ construct with screws attached to the pedicies of the lumbar and sacral spine (L3 to S1) and autogenous bone graft may be used for the treatment of severe spondylolisthesis (Grade 3) at the fith lumbar - first sacral (LS-S1) vertebral joint. The device is intended to be implanted using a posterior surgical approach and removed after development of a solid fusion mass.
When not used as a pedicle screw fixation system, various combinations of the system are also indicated to provide temporary stability of the thoracic, thoracolumbar. or lumbar spino (T1 to S1) during bony fusion healing secondary to: (1) Unstable spinal fractures (such as fracture diskcations) or spinal tumors; (2) Degeneralive disk diseases of the spine (defined as back pain of diskogenic origin with degeneration of the disk confirmed by radiographic studies); (3) Spinal curvatures (such as idiopathic scoliosis/kyphoscoliosis with associated paralysis or spasticity, and secondary to spinal fractures) which are: progressive, despite other forms of treatment; detrimental to cardiopulmonary function; interfering with spinal mechanics or causing severe back pain; or cosmetically unacceptable, progressive, and painful.
Material. Components in the VERSALOK™ Screw Assembly are manufactured from stainless steel conforming to ASTM F 1314.
Summary of Technological Differences The VERSALOK™ Screw Assembly is a product line addition to the WRIGHTLOCK™ Posterior Spinal Fixation System and there are few differences between the devices. Both devices have the same intended use and are manufactured from the same material. They are different in that the VERSALOK™ Screw Assembly is a polyaxial screw option to the system that previously included only a monoaxial screw. In addition, the design of the VERSALOK™ Screw Assembly differs from the screw assembly of the MOSS® Miami System in minor design features and locking mechanism: however, the differences only address surgeon preferences and do not impact the function or negatively impact the safety of the device.
Testing Summary The VERSALOK™ Screw Assembly tested with the following mean results: faligue endurance limit of 353N, axial push strength of 1086N, and torsional grip strength of 1.95Nm. Based on these results, the VERSALOK™ Screw Assembly should perform adequately when subjected to normal physiological loading.
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