SFX SNAP-FIT CROSS CONNECTOR
Device Facts
| Record ID | K062196 |
|---|---|
| Device Name | SFX SNAP-FIT CROSS CONNECTOR |
| Applicant | Depuy Spine, Inc. |
| Product Code | MNH · Orthopedic |
| Decision Date | Sep 11, 2006 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3070 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The SFX Snap-Fit Cross Connectors are designed to transversely connect two rods used in spinal instrumentation constructs. The SFX Snap-Fit Cross Connector devices are intended for use with components of the commercially available EXPEDIUM™ 5.5mm Spine System. The uses of the legally marketed EXPEDIUM™ 5.5mm Spine System are as follows: The EXPEDIUM™ Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
Device Story
SFX Snap-Fit Cross Connector is a spinal instrumentation component designed to transversely connect two spinal rods. By linking rods, the device minimizes torsional forces on the construct, reducing micromotion and preventing construct shifting post-placement. It is compatible with various DePuy Spine systems (EXPEDIUM, VIPER, VSP, ISOLA, MOSS MIAMI, MONARCH, TIMX) using 5.5mm or 6.35mm rods. The device is implanted by a surgeon during spinal fusion procedures to provide immobilization and stabilization of spinal segments. It is intended for use in the thoracic, lumbar, and sacral spine. The connector provides mechanical stability to the spinal construct, potentially improving fusion outcomes and patient recovery.
Clinical Evidence
No clinical data provided. Substantial equivalence is based on bench testing and design characteristics.
Technological Characteristics
Manufactured from ASTM F-136 implant grade titanium alloy. Mechanical transverse connector designed for 5.5mm and 6.35mm spinal rods. Non-active, mechanical implant.
Indications for Use
Indicated for skeletally mature patients requiring noncervical spinal stabilization/fixation as an adjunct to fusion. Conditions include degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, spinal deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, and failed previous fusion.
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
- MOSS MIAMI Spinal System Transverse Connector (K955348)
Reference Devices
- EXPEDIUM 5.5mm Spine System
- VIPER System
- VSP 6.35mm Spine System
- ISOLA 6.35mm Spine System
- MOSS MIAMI 5.5mm and 6.35mm Spine Systems
- MONARCH 5.5mm and 6.35mm Spine System
- TIMX 6.35mm Spine System
Related Devices
- K021879 — CROSSOVER CROSS CONNECTOR (ISOLA SPINAL SYSTEM) · Depuyacromed · Jun 26, 2002
- K070300 — EXPEDIUM SFX CROSS CONNECTOR SYSTEM · Depuy Spine, Inc. · Apr 10, 2007
- K021880 — CROSSOVER CROSS CONNECTOR (MOSS MIAMI SPINE SYSTEM) · Depuyacromed · Jun 26, 2002
- K070460 — ALLEZ SPINE CROSS CONNECTORS · Allez Spine, LLC · Jun 11, 2007
- K013296 — MOSS MIAMI SPINAL SYSTEMS · Depuyacromed · Oct 9, 2001
Submission Summary (Full Text)
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K062196
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| SUBMITTER: | DePuy Spine<br>325 Paramount Drive<br>Raynham, MA 02780 | SEP 11 2006 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| CONTACT PERSON: | Mary Gray | |
| DATE PREPARED: | July 31, 2006 | |
| CLASSIFICATION NAME: | Appliance, Fixation, Spinal Interlaminal<br>Orthosis, Spinal Pedicle Fixation | |
| PROPRIETARY NAME: | SFX Snap-Fit Cross Connector | |
| PREDICATE DEVICES: | MOSS MIAMI Spinal System Transverse Connector<br>(K955348). | |
| DEVICE DESCRIPTION: | The SFX Connector is designed to transversely connect<br>two rods used in spinal instrumentation constructs. The<br>connector minimizes the torsional forces on the construct,<br>thus reducing the micromotion and the probability of the<br>construct shifting after placement. It is designed to<br>accommodate the 5.5mm spinal rods of the EXPEDIUM<br>Spine System. | |
| INTENDED USE: | The SFX Snap-Fit Cross Connectors are designed to<br>transversely connect two rods used in spinal<br>instrumentation constructs. The SFX Snap-Fit Cross<br>Connector devices are intended for use with components of<br>the commercially available EXPEDIUM™ 5.5mm Spine<br>System. | |
| | The uses of the legally marketed EXPEDIUM™ 5.5mm<br>Spine System are as follows: | |
| | The EXPEDIUM™ Spine System is intended for<br>noncervical pedicle fixation and nonpedicle fixation for the<br>following indications: degenerative disc disease (defined as<br>back pain of discogenic origin with degeneration of the disc<br>confirmed by history and radiographic studies);<br>spondylolisthesis; trauma (i.e., fracture or dislocation);<br>spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or<br>lordosis); tumor; pseudoarthrosis; and failed previous fusion<br>in skeletally mature patients. | |
| MATERIALS: | Manufactured from ASTM F-136 implant grade titanium<br>alloy. | |
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# PERFORMANCE DATA:
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| SUBMITTER: | DePuy Spine<br>325 Paramount Drive<br>Raynham, MA 02780 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Mary Gray |
| DATE PREPARED: | July 31, 2006 |
| CLASSIFICATION NAME: | Appliance, Fixation, Spinal Interlaminal<br>Orthosis, Spinal Pedicle Fixation |
| PROPRIETARY NAME: | SFX Snap-Fit Cross Connector |
| PREDICATE DEVICES: | MOSS MIAMI Spinal System Transverse Connector<br>(K955348). |
| DEVICE DESCRIPTION: | The SFX Connector is designed to transversely connect<br>two rods used in spinal instrumentation constructs. The<br>connector minimizes the torsional forces on the construct,<br>thus reducing the micromotion and the probability of the<br>construct shifting after placement. It is designed to<br>accommodate the 5.5mm spinal rods of the VIPER System. |
| INTENDED USE: | The SFX Snap-Fit Cross Connectors are designed to<br>transversely connect two rods used in spinal<br>instrumentation constructs. The SFX Snap-Fit Cross<br>Connector devices are intended for use with components of<br>the commercially available VIPER™ System. |
| | The uses of the legally marketed VIPER™ System are as<br>follows: |
| | The VIPER Spine System is intended for noncervical<br>pedicle fixation and nonpedicle fixation for the following<br>indications: degenerative disc disease (defined as back<br>pain of discogenic origin with degeneration of the disc<br>confirmed by history and radiographic studies);<br>spondylolisthesis; trauma (i.e., fracture or dislocation);<br>spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or<br>lordosis); tumor; pseudoarthrosis; and failed previous fusion<br>in skeletally mature patients. |
| | When used in a percutaneous, posterior approach with MIS<br>instrumentation, the VIPER System is intended for<br>noncervical pedicle fixation and nonpedicle fixation for the<br>following indications: degenerative disc disease (defined as<br>back pain of discogenic origin with degeneration of the disc |
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confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
# MATERIALS:
Manufactured from ASTM F-136 implant grade titanium alloy.
PERFORMANCE DATA:
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| SUBMITTER: | DePuy Spine<br>325 Paramount Drive<br>Raynham, MA 02780 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Mary Gray |
| DATE PREPARED: | July 31, 2006 |
| CLASSIFICATION NAME: | Appliance, Fixation, Spinal Interlaminal<br>Orthosis, Spinal Pedicle Fixation |
| PROPRIETARY NAME: | SFX Snap-Fit Cross Connector |
| PREDICATE DEVICES: | MOSS MIAMI Spinal System Transverse Connector<br>(K955348). |
| DEVICE DESCRIPTION: | The SFX Connector is designed to transversely connect<br>two rods used in spinal instrumentation constructs. The<br>connector minimizes the torsional forces on the construct,<br>thus reducing the micromotion and the probability of the<br>construct shifting after placement. It is designed to<br>accommodate the 6.35mm spinal rods of the VSP Spine<br>System. |
| INTENDED USE: | The SFX Snap-Fit Cross Connectors are designed to<br>transversely connect two rods used in spinal<br>instrumentation constructs. The SFX Snap-Fit Cross<br>Connector devices are intended for use with components of<br>the commercially available VSP® 6.35mm Spine System.<br><br>The uses of the legally marketed VSP® Spine System are<br>as follows:<br><br>The VSP System is indicated for degenerative<br>spondylolisthesis, in skeletally mature patients, with<br>objective evidence of neurologic impairment, fracture,<br>dislocation, scoliosis, kyphosis, spinal tumor, and failed<br>previous fusion (pseudoarthrosis). Levels of fixation are for<br>the thoracic, lumbar and sacral spine.<br><br>The VSP® Spine System is also indicated for pedicle screw<br>fixation for severe spondylolisthesis (Grade 3 and 4) at L5-<br>S1, in skeletally mature patients, when autogeous bone<br>graft is used, when affixed to the posterior lumbosacral<br>spin, and intended to be removed after solid fusion is<br>attained. Levels of fixation are from L3-S1. |
| MATERIALS: | Manufactured from ASTM F-136 implant grade titanium<br>alloy. |
| PERFORMANCE<br>DATA: | Performance data were submitted to characterize the SFX<br>Snap-Fit Cross Connector. |
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| SUBMITTER: | DePuy Spine<br>325 Paramount Drive<br>Raynham, MA 02780 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Mary Gray |
| DATE PREPARED: | July 31, 2006 |
| CLASSIFICATION NAME: | Appliance, Fixation, Spinal Interlaminal<br>Orthosis, Spinal Pedicle Fixation |
| PROPRIETARY NAME: | SFX Snap-Fit Cross Connector |
| PREDICATE DEVICES: | MOSS MIAMI Spinal System Transverse Connector<br>(K955348). |
| DEVICE DESCRIPTION: | The SFX Connector is designed to transversely connect<br>two rods used in spinal instrumentation constructs. The<br>connector minimizes the torsional forces on the construct,<br>thus reducing the micromotion and the probability of the<br>construct shifting after placement. It is designed to<br>accommodate the 6.35mm spinal rods of the ISOLA Spine<br>System. |
| INTENDED USE: | The SFX Snap-Fit Cross Connectors are designed to<br>transversely connect two rods used in spinal<br>instrumentation constructs. The SFX Snap-Fit Cross<br>Connector devices are intended for use with components of<br>the commercially available ISOLA® 6.35mm Spine System.<br>The uses of the legally marketed ISOLA 6.35mm Spine<br>System are as follows:<br>The ISOLA Spine Systems is a pedicle screw system<br>intended to provide immobilization and stabilization of<br>spinal segments in skeletally mature patients as an adjunct<br>to fusion in the treatment of the following acute and chronic<br>instabilities or deformities of the thoracic, lumbar, and<br>sacral spine: degenerative spondylolisthesis with objective<br>evidence of neurological impairment, fracture, dislocation,<br>scoliosis, kyphosis, spinal tumor, and failed previous fusion<br>(pseudarthrosis).<br>The ISOLA Spine Systems is also indicated for pedicle<br>screw fixation for the treatment of severe spondylolisthesis<br>(Grades 3 and 4) of the L5-S1 vertebra in skeletally mature<br>patients receiving fusion by autogenous bone graft having |
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implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The ISOLA Spine Systems is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).
The ISOLA Spinal System when used with pedicle screws is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.
Manufactured from ASTM F-136 implant grade titanium MATERIALS: alloy.
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| SUBMITTER: | DePuy Spine<br>325 Paramount Drive<br>Raynham, MA 02780 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Mary Gray |
| DATE PREPARED: | July 31, 2006 |
| CLASSIFICATION NAME: | Appliance, Fixation, Spinal Interlaminal<br>Orthosis, Spinal Pedicle Fixation |
| PROPRIETARY NAME: | SFX Snap-Fit Cross Connector |
| PREDICATE DEVICES: | MOSS MIAMI<br>Spinal<br>System<br>Transverse<br>Connector<br>(K955348). |
| DEVICE DESCRIPTION: | The SFX Connector is designed to transversely connect<br>two rods used in spinal instrumentation constructs. The<br>connector minimizes the torsional forces on the construct,<br>thus reducing the micromotion and the probability of the<br>construct shifting after placement. It is designed to<br>accommodate the 5.5mm and 6.35mm spinal rods of the<br>MOSS MIAMI Spine System. |
| INTENDED USE: | The SFX Snap-Fit Cross Connectors are designed to<br>transversely connect two rods used in spinal<br>instrumentation constructs. The SFX Snap-Fit Cross<br>Connector devices are intended for use with components of<br>the commercially available MOSS® MIAMI 5.5mm and<br>6.35mm Spine Systems. |
| | The uses of the legally marketed MOSS MIAMI 5.5mm and<br>6.35mm Spine Systems are as follows: |
| | When used as a posterior, noncervical hook, and/or<br>sacral/iliac screw fixation system, or as an anterior,<br>thoracic/lumbar screw fixation system, the MOSS MIAMI<br>Spinal System is intended to treat scoliosis, kyphosis and<br>lordosis, fracture, loss of stability due to tumor, spinal<br>stenosis, spondylolisthesis, a previously failed fusion<br>surgery or degenerative disc disease (i.e., discogenic back<br>pain with degeneration of the disc confirmed by patient<br>history and radiographic studies). |
| | When used as a pedicle screw fixation system of the<br>noncervical spine in skeletally mature patients, the MOSS<br>MIAMI Spinal System is indicated for degenerative<br>spondylolisthesis with objective evidence of neurologic |
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impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
The MOSS MIAMI Spine Systems is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S1) and for whom the device system is intended to be removed after solid fusion is attained.
MATERIALS:
Manufactured from ASTM F-136 implant grade titanium alloy.
PERFORMANCE DATA:
{10}------------------------------------------------
| SUBMITTER: | DePuy Spine<br>325 Paramount Drive<br>Raynham, MA 02780 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Mary Gray |
| DATE PREPARED: | July 31, 2006 |
| CLASSIFICATION NAME: | Appliance, Fixation, Spinal Interlaminal<br>Orthosis, Spinal Pedicle Fixation |
| PROPRIETARY NAME: | SFX Snap-Fit Cross Connector |
| PREDICATE DEVICES: | MOSS MIAMI Spinal System Transverse Connector<br>(K955348). |
| DEVICE DESCRIPTION: | The SFX Connector is designed to transversely connect<br>two rods used in spinal instrumentation constructs. The<br>connector minimizes the torsional forces on the construct,<br>thus reducing the micromotion and the probability of the<br>construct shifting after placement. It is designed to<br>accommodate the 5.5mm and 6.35mm spinal rods of the<br>MONARCH Spine System. |
| INTENDED USE: | The SFX Snap-Fit Cross Connectors are designed to<br>transversely connect two rods used in spinal<br>instrumentation constructs. The SFX Snap-Fit Cross<br>Connector devices are intended for use with components of<br>the commercially available MONARCH® 5.5mm and<br>6.35mm Spine System.<br>The uses of the legally marketed MONARCH 5.5mm and<br>6.35mm Spine System are as follows:<br>The MONARCH Spine Systems is a pedicle screw system<br>intended to provide immobilization and stabilization of<br>spinal segments in skeletally mature patients as an adjunct<br>to fusion in the treatment of the following acute and chronic<br>instabilities or deformities of the thoracic, lumbar, and<br>sacral spine: degenerative spondylolisthesis with objective<br>evidence of neurological impairment, fracture, dislocation,<br>scoliosis, kyphosis, spinal tumor, and failed previous fusion<br>(pseudarthrosis).<br>The MONARCH Spine Systems is also indicated for pedicle<br>screw fixation for the treatment of severe spondylolisthesis |
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patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The MONARCH Spine Systems is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).
The MONARCH Spine System when used with pedicle screws is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.
## MATERIALS:
Manufactured from ASTM F-136 implant grade titanium alloy.
# PERFORMANCE DATA:
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:
## IX. 510(k) Summary
1
| SUBMITTER: | DePuy Spine<br>325 Paramount Drive<br>Raynham, MA 02780 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Mary Gray |
| DATE PREPARED: | July 31, 2006 |
| CLASSIFICATION NAME: | Appliance, Fixation, Spinal Interlaminal<br>Orthosis, Spinal Pedicle Fixation |
| PROPRIETARY NAME: | SFX Snap-Fit Cross Connector |
| PREDICATE DEVICES: | MOSS MIAMI Spinal System Transverse Connector<br>(K955348). |
| DEVICE DESCRIPTION: | The SFX Connector is designed to transversely connect<br>two rods used in spinal instrumentation constructs. The<br>connector minimizes the torsional forces on the construct,<br>thus reducing the micromotion and the probability of the<br>construct shifting after placement. It is designed to<br>accommodate the 6.35mm spinal rods of the TIMX Spine<br>System. |
| INTENDED USE: | The SFX Snap-Fit Cross Connectors are designed to<br>transversely connect two rods used in spinal<br>instrumentation constructs. The SFX Snap-Fit Cross<br>Connector devices are intended for use with components of<br>the commercially available TIMX® 6.35mm Spine System.<br>The uses of the legally marketed TIMX Spine System are<br>as follows:<br>The TIMX Spine Systems is a pedicle screw system<br>intended to provide immobilization and stabilization of<br>spinal segments in skeletally mature patients as an adjunct<br>to fusion in the treatment of the following acute and chronic<br>instabilities or deformities of the thoracic, lumbar, and<br>sacral spine: degenerative spondylolisthesis with objective<br>evidence of neurological impairment, fracture, dislocation,<br>scoliosis, kyphosis, spinal tumor, and failed previous fusion<br>(pseudarthrosis).<br>The TIMX Spine Systems is also indicated for pedicle screw<br>fixation for the treatment of severe spondylolisthesis<br>(Grades 3 and 4) of the L5-S1 vertebra in skeletally mature<br>patients receiving fusion by autogenous bone graft having<br>implants attached to the lumbar and sacral spine (L3 to |
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sacrum) with removal of the implants after the attainment of a solid fusion.
The TIMX Spine Systems is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).
# MATERIALS:
Manufactured from ASTM F-136 implant grade titanium alloy.
PERFORMANCE DATA:
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Image /page/14/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.
i
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
# SEP 1 1 2006
DePuy Spine % Mr. Mary Gray Senior RA Associate 325 Paramount Drive Raynham, Massachusetts 02767
Re: K062196
Trade/Device Name: SFX Snap-Fit Cross Connector Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal Fixation Regulatory Class: Class II Product Code: MNH, MNI, KWP Dated: July 31, 2006 Received: August 1, 2006
Dear Ms. Gray:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Mary Gray
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276- 0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Prichum
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# SFX™ Snap-Fit Cross Connector
### Indications for Use III.
510(k) Number (if known): _
SFX Snap-Fit Cross Connector Device Name:
Indications For Use:
The SFX Snap-Fit Cross Connectors are designed to transversely connect two rods used in spinal instrumentation constructs. The SFX Snap-Fit Cross Connector devices are intended for use with components of the commercially available VIPER™ System.
The uses of the legally marketed VIPER™ are as follows:
The VIPER Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used in a percutaneous, posterior approach with MIS instrumentation, the VIPER System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
OR Over-The-Counter Use: × Prescription Use: (Per 21 CFR 801.109)
(Please do not write below this line - continue on another page if needed)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | <div> <span style="text-decoration: overline;">Barbara Bienvenu</span> </div> |
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(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K062196
DePuy Spine, Inc. Special 510K
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#### Indications for Use lll.
510(k) Number (if known): __
SFX Snap-Fit Cross Connector Device Name:
Indications For Use:
The SFX Snap-Fit Cross Connectors are designed to transversely connect two rods used in spinal instrumentation constructs. The SFX Snap-Fit Cross Connector devices are intended for use with components of the commercially available VSP® 6.35mm Spine System.
The uses of the legally marketed VSP® Spine System are as follows:
The VSP System is indicated for degenerative spondylolisthesis, in skeletally mature patients, with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.
The VSP® Spine System is also indicated for pedicle screw fixation for severe spondylolisthesis (Grade 3 and 4) at L5-S1, in skeletally mature patients, when autogeous bone graft is used, when affixed to the posterior lumbosacral spin, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.
X Prescription Use: (Per 21 CFR 801.109)
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Burchud for MXM
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number K062196
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### 111. Indications for Use
510(k) Number (if known):
SFX Snap-Fit Cross Connector Device Name:
Indications For Use:
The SFX Snap-Fit Cross Connectors are designed to transversely connect two rods used in spinal instrumentation constructs. The SFX Snap-Fit Cross Connector devices are intended for use with components of the commercially available ISOLA® 6.35mm Spine System.
The uses of the legally marketed ISOLA 6.35mm Spine System are as follows:
The ISOLA Spine Systems is a pedicle screw system 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The ISOLA Spine Systems is also indicated for pedicle screw fixation for the treatment of severe spondvlolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The ISOLA Spine Systems is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).
The ISOLA Spinal System when used with pedicle screws is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.
Prescription Use: _ OR Over-The-Counter Use: _ × (Per 21 CFR 801.109)
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (DE)
(Division Sign-Off)
Division of and Neurol
DePuy Spine, Inc. Special 510K
510(k) Number_
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### Indications for Use III.
510(k) Number (if known): __
SFX Snap-Fit Cross Connector Device Name:
Indications For Use:
The SFX Snap-Fit Cross Connectors are designed to transversely connect two rods used in spinal instrumentation constructs. The SFX Snap-Fit Cross Connector devices are intended for use with components of the commercially available MOSS® MIAMI 5.5mm and 6.35mm Spine Systems.
The uses of the legally marketed MOSS MIAM1 5.5mm and 6.35mm Spine Systems are as follows:
When used as a posterior, noncervical hook, and/or sacral/iliac screw fixation system, or as an anterior, thoracic/lumbar screw fixation system, the MOSS MIAMI Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e., discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).
When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the MOSS MIAMI Spinal System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
The MOSS MIAMI Spine Systems is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S1) and for whom the device system is intended to be removed after solid fusion is attained.
X_ Prescription Use: (Per 21 CFR 801.109)
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Oarbaie bucurD
Division of General. Restorative. and Neurological Devices
510(k) Number_
Page 8
DePuy Spine, Inc. Special 510K
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### 111. Indications for Use
510(k) Number (if known):
Device Name: SFX Snap-Fit Cross Connector
# Indications For Use:
The SFX Snap-Fit Cross Connectors are designed to transversely connect two rods used in spinal instrumentation constructs. The SFX Snap-Fit Cross Connector devices are intended for use with components of the commercially available MONARCH® 5.5mm and 6.35mm Spine Systems.
The uses of the legally marketed MONARCH 5.5mm and 6.35mm Spine Systems are as follows:
The MONARCH Spine Systems is a pedicle screw system 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The MONARCH Spine Systems is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The MONARCH Spine Systems is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).
The MONARCH Spine System when used with pedicle screws is indicated for degenerative disc disease {defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.
X Prescriptio…
