VERSALOK SCREW ASSEMBLY (PROPOSED NAME)
Device Facts
| Record ID | K961572 |
|---|---|
| Device Name | VERSALOK SCREW ASSEMBLY (PROPOSED NAME) |
| Applicant | Wrightmedicaltechnologyinc |
| Product Code | MNH · Orthopedic |
| Decision Date | Sep 17, 1996 |
| Decision | SN |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3070 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The VERSALOK™ Screw Assembly is supplied as an alternative component for use with the WRIGHTLOCK™ Posterior Spinal Fixation System to fix the spine for appropriate indications. Limited indications apply when used as a pedicle screw. A WRIGHTLOCK™ construct with screws attached to the pedicles of the lumbar and sacral spine (L3 to S1) and autogenous bone graft may be used for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the fifth lumbar - first sacral (L5-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 spine (T1 to S1) during bony fusion healing secondary to: (1) Unstable spinal fractures (such as fracture dislocations) or spinal tumors; (2) Degenerative 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, neuromuscular 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.
Device Story
Polyaxial screw assembly (screws, locking sleeves, caps) designed as component for WRIGHTLOCK™ Posterior Spinal Fixation System; provides spinal stabilization via posterior surgical approach. Features top-loading design; allows 6mm rod offset and 30-degree angulation in all planes prior to locking. Used by orthopedic/neurosurgeons in hospital setting to fix spine during bony fusion healing. Provides temporary stability for fractures, tumors, degenerative disk disease, or spinal deformities; removed after solid fusion mass development. Benefits patient by restoring spinal stability and facilitating fusion.
Clinical Evidence
Bench testing only. Fatigue endurance limit: 353N; axial push strength: 1096N; torsional grip strength: 1.95Nm. Results indicate adequate performance under physiological loading.
Technological Characteristics
Stainless steel (ASTM F 1314). Polyaxial screw assembly with locking sleeves and caps. Top-loading design. 6mm offset capacity; 30-degree angulation range. Mechanical fixation device.
Indications for Use
Indicated for patients requiring spinal fixation for severe spondylolisthesis (Grade 3-4, L5-S1) when used as pedicle screws with autogenous bone graft. Also indicated for temporary stability of thoracic, thoracolumbar, or lumbar spine (T1-S1) for unstable fractures, tumors, degenerative disk disease, or progressive spinal curvatures (scoliosis/kyphoscoliosis) when not used as pedicle screw fixation.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- WRIGHTLOCK™ Posterior Spinal Fixation System (K950074)
- MOSS® Miami System (DePuy)
Related Devices
- K253545 — Vulcan Spinal System · K2m, Inc. · Feb 10, 2026
- K051063 — POLYAXIAL HEMISPHERICAL SPINAL SCREWS · Scient'X · May 23, 2005
- K142576 — Spinal System · Eisertech, LLC · Feb 26, 2015
- K153446 — OLYMPIC Posterior Spinal Fixation System · Astura Medical · Apr 8, 2016
- K111940 — S 100 PEDICLE SCREW SYSTEM · Renovis Surgical Technologies, LLC · May 15, 2012
