CAPLESS PEDICLE SCREW SYSTEM

K052847 · X-Spine Systems, Inc. · MNI · Dec 12, 2005 · Orthopedic

Device Facts

• Record ID: K052847
• Device Name: CAPLESS PEDICLE SCREW SYSTEM
• Applicant: X-Spine Systems, Inc.
• Product Code: MNI · Orthopedic
• Decision Date: Dec 12, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Capless Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3and 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 Capless Pedicle Screw System is 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).

Device Story

Capless Pedicle Screw System provides spinal immobilization and stabilization as an adjunct to fusion; used in thoracic, lumbar, and sacral spine. System components include pedicle screws (self-tapping), yokes, screw caps, rods (5.5 mm diameter), and optional cross bar assemblies. Implants attached to spine by surgeon during fusion procedure; intended for removal after solid fusion attainment. Titanium alloy construction. Device provides mechanical support to spinal segments; aids in stabilization of deformities or instabilities. Benefits patient by facilitating fusion and correcting spinal alignment.

Clinical Evidence

No clinical data.

Technological Characteristics

Titanium alloy (ASTM F136). Components: pedicle screws (5.5-7.5 mm diameter), yokes, screw caps, 5.5 mm diameter rods, and cross bar assemblies. Mechanical fixation system. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients requiring spinal fusion for severe spondylolisthesis (Grade 3-4) at L5-S1, or acute/chronic instabilities/deformities of the thoracic, lumbar, and sacral spine including degenerative spondylolisthesis with neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and pseudarthrosis.

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.

Submission Summary (Full Text)

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510(k) Premarket Notification

Capless™ Pedicle Screw System

# 510(k) Summary

# ADMINISTRATIVE INFORMATION

| Manufacturer Name: | X-spine Systems, Inc.<br>7026 Corporate Way #212<br>Centerville, OH 45459-4288 |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Telephone [phone]<br>FAX [phone] |
| Official Contact: | David Kirschman, MD |
| Representative/Consultant: | Floyd G. Larson<br>PaxMed International, LLC<br>11234 El Camino Real, Suite 200<br>San Diego, CA 92130<br>Telephone [phone]<br>FAX [phone] |
| DEVICE NAME | |
| Classification Names: | Orthosis, Spondylolisthesis Spinal Fixation<br>Orthosis, Pedicle Spinal Fixation |
| Trade/Proprietary Name: | Capless™ Pedicle Screw System |
| Common Name: | Pedicle Screw Spinal System |

ESTABLISHMENT REGISTRATION NUMBER

X-spinc Systems, Inc. has submitted an Establishment Registration to FDA. The Establishment Registration number is 3005031160. The owner/operator number for X-spine Systems, Inc. is 9063903.

# DEVICE CLASSIFICATION

FDA has classified pedicle screw spinal systems as Class II devices (21 CFR 888.3070). The product code for Orthosis, Spondylolisthesis Spinal Fixation is (MNH). The product code for Orthosis, Spinal Pedicle Fixation is (MNI). These device classifications are reviewed by the Orthopedic Devices Branch.

# INTENDED USE

The Capless Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3and 4) of the L5-S1 vertebra in skeletally mature patients

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## 510(k) Premarket Notification

Capless™ Pedicle Screw System

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 Capless Pedicle Screw System is 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).

## DEVICE DESCRIPTION

#### Capless Rod

Capless rods are 5.5 mm diameter solid cylinders with spherically rounded ends. provided in 40 mm, 60 mm, 100 mm, 120 mm, 140 mm, 160 mm, 160 mm, 200 mm, and 300 mm lengths.

## Capless Pedicle Screw Assembly

Each Capless pedicle screw assembly consists of a pedicle screw, yoke, and screw cap. Self-tapping pedicle screw assemblies are provided in diameters of 5.5 mm, 6.5 mm. and 7.5 mm. The 5.5 mm diameter screw assemblics are provided in lengths of 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, and 55 mm. The 6.5 mm diameter screw assemblies arc provided in lengths of 40 mm, 45 mm, 50 mm, and 55 mm. The 7.5 mm diameter screw assemblies are provided in lengths of 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, and 55 ınm.

#### Capless Cross Bar Assembly

The Capless cross bar assembly is an optional component and can be used for additional stabilization. Cross bar assemblies are available in lengths from 25 mm to 81 mm.

#### Material composition

The rods, pedicle screws and transverse links of the Capless Pedicle Screw System are made of titanium alloy conforming to ASTM F136.

# EQUIVALENCE TO MARKETED PRODUCT

X-spine Systems, Inc. has submitted information to demonstrate that, for the purposes of FDA`s regulation of medical devices, the Capless Pedicle Screw System is substantially equivalent in indications and design principles to predicate devices, that have been determined by FDA to be substantially equivalent to pre-amendment devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 2 2005

X-spine Systems, Inc. c/o Mr. Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130

Re: K052847

Trade/Device Name: Capless Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: II Product Code: MNI, MNH Dated: October 5, 2005 Received: October 7, 2005

Dear Mr. Larson:

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 for associoin 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 I ou may, dicrolere, mains 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 or any I 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

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# Page 2 - Mr. Floyd G. Larson

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the qualisms control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product faction of to begin marketing your device as described in your Section 510(k) r ms letter will and the FDA finding of substantial equivalence of your device to a legally prematics notificated with 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 if you desire specific aaroliance at [phone]. Also, please note the regulation entitled, connact the Office or Computer of the the the the Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general micronational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Cor Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Capless Pedicle Screw System

# Indications for Use

510(k) Number (if known): Kosza )

Device Name: Capless™ Pedicle Screw System

Indications for Use:

The Capless Pedicle Screw System is indicated for the treatment of severe Fice Capiess I odiolo Borolog 4) of the L5-S1 vertebra in skeletally mature patients spondyionstions (Grausgenous 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.

In addition, the Capless Pedicle Screw System is intended to provide immobilization and In addition, the Captobs I valents in skeletally mature patients as an adjunct to fusion in the stabilization of spilar sognients in steer on othronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of numour and subrar opinor degeture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

Prescription Use > (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Ceneral, Restorative, and Neurological Devices

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510(k) Number K052847