DVX SPINE SYSTEM

K090424 · Bk Meditech, Co., Ltd. · MNH · May 14, 2009 · Orthopedic

Device Facts

• Record ID: K090424
• Device Name: DVX SPINE SYSTEM
• Applicant: Bk Meditech, Co., Ltd.
• Product Code: MNH · Orthopedic
• Decision Date: May 14, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DVX 5.5 Spine System is intended for posterior, noncervical, pedicle fixation in order 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, including degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the DVX Spine System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 and below), with removal of the implants after the attainment of solid fusion.

Device Story

DVX 5.5 Spinal System is a posterior spinal fusion system consisting of multi-axial pedicle screws, locking caps, solid rods, and cross-links. Used by surgeons in clinical settings to provide fixed stabilization between cephalad and caudad vertebrae. System is implanted via symmetric, bilateral arrangement of screws and rods to immobilize spinal segments during fusion. Benefits include stabilization of acute/chronic spinal instabilities. Device is a smaller version of the predicate system.

Clinical Evidence

Bench testing only. Mechanical testing performed according to ASTM 1717-04 to confirm that the smaller system meets basic performance requirements for spinal fusion systems.

Technological Characteristics

Posterior spinal fusion system; components include multi-axial pedicle screws, locking caps, solid rods, and cross-links. Symmetric, bilateral configuration. Mechanical performance validated per ASTM 1717-04. Materials, sterilization, and packaging are identical to the predicate DVX Spine System.

Indications for Use

Indicated for skeletally mature patients requiring posterior, noncervical, pedicle fixation for immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion. Conditions include degenerative spondylolisthesis with neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and pseudarthrosis. Also indicated for severe spondylolisthesis (Grades 3-4) at L5-S1 when using autogenous bone graft with implants attached to L3 or below.

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

• DVX Spine System (K080876)

Submission Summary (Full Text)

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K090424

## 510(k) Summary

## Submitted on behalf of:

BK MEDITECH Co., Ltd. 215-5 Yodang-Li, Yanggam-Myun, Hwasung-Si, Kyunggi-Do, Republic of Korea

MAY 14 2009

by:

Elaine Duncan, M.S.M.E., RAC President, Paladin Medical, Inc. PO Box 560 Stillwater, MN 55082 715-549-6035 715-549-5380

Telephone: Fax:

CONTACT PERSON: DATE PREPARED:

Elaine Duncan February 16, 2009

TRADE NAME: COMMON NAME: CLASSIFICATION NAME: REGULATION and CLASS PANEL and PRO CODE:

DVX 5.5 Spinal System Spinal System, Fusion Posterior Spinal Fusion System with solid rod and pedicle screws 21 CFR § 888.3070, Class 2 Orthopedic; MNH

SUBSTANTIALLY EQUIVALENT TO: The DVX 5.5 Spine System is substantially equivalent to the original DVX Spine System cleared under K080876. Because of the difference in size for the 5.5 System, ASTM 1717-04 was repeated. There are no other substantial differences between the subject devices and the predicate devices and thus no differences which could affect safety or efficacy.

DESCRIPTION of the DEVICE: The DVX 5.5 Spine System DVX5.5 Spine System (like the predicate The DVX Spine System) consists of four or more pedicle screws and two solid rods in a symmetric. bilateral arrangement. The pedicle screws are placed axially in the pedicles with two screws in the cephalad position and two screws in the caudad position. The rods are secured in the heads of the pedicle screws so that fixed stabilization is provided between the cephalad and caudad vertebrae. Cross-links can be used if additional stabilization is necessary. The DVX5.5 Spine System ( See Figure 1) is made of components for fixation of the spine: multi-axial pedicle screws, locking cap, rod and cross-link . The materials, sterilization and packaging are the same as those in DVX Spine System, the predicate.

INDICATIONS FOR USE: The DVX 5.5 Spine System has the same indication for use and same intended use as the predicate DVX Spine System, cleared by this sponsor (BK Meditech Co., Ltd.) The indication is:

The DVX 5.5 Spine System is intended for posterior, noncervical, pedicle fixation in order 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 of the thoracic, lumbar, and sacral spine, including degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the DVX Spine System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 and below), with removal of the implants after the attainment of solid fusion.

BASIS for SUBSTANTIAL EQUIVALENCE: DVX 5.5 Spine System is a small version of the predicate DVX Spine System previously cleared under K080876. Testing to ASTM 1717-04 confirms the smaller system also meets basic performance requirements for spinal fusion systems.

510K Submission: BKMEDITECH Co., Ltd

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized depiction of an eagle or bird-like figure, with its wings spread and head turned to the side.

Public Health Service

MAY 14 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

BK Meditech Company, Ltd. % Paladin Medical Ms. Elaine Duncan, M.S.M.E., RAC President P.O. Box 560 Stillwater, Minnesota 55082

Re: K090424

Trade/Device Name: DVX 5.5 Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNH Dated: February 17, 2009 Received: February 19, 2009

Dear Ms. Duncan:

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.

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); medical device reporting (reporting of medical device-rclated adverse events) (21 CFR 803); 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- Ms. Elaine Duncan, M.S.M.E. RAC

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Barbara Buem

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

K090424 510(k) Number (if known):

Device Name:

Indications For Use:

The DVX 5.5 Spine System is intended for posterior, noncervical, pedicle fixation in order 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, including degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the DVX Spine System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 and below), with removal of the implants after the attainment of solid fusion.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

for (Division Sign-Off) Hfis

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090424

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