MODIFICATION TO: XIA STAINLESS STEEL SYSTEM

K051973 · Stryker Spine · KWP · Aug 18, 2005 · Orthopedic

Device Facts

Record IDK051973
Device NameMODIFICATION TO: XIA STAINLESS STEEL SYSTEM
ApplicantStryker Spine
Product CodeKWP · Orthopedic
Decision DateAug 18, 2005
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 888.3050
Device ClassClass 2
AttributesTherapeutic

Intended Use

The Xia Stainless Steel System is intended for use in the noncervical spine. When used as a pcdicle screw fixation system, the Xia Stainless Steel System is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. When used as a pedicle screw fixation system, the Xia Stainless Steel System is also 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 neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis). When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the Xia Stainless Steel System is indicated for patients with degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts.

Device Story

Xia Stainless Steel System is a spinal fixation assembly comprising monoaxial/polyaxial screws, washers, hooks, blockers, rods, staples, and connectors. This line extension adds offset and rod-to-rod connectors. Device is used by surgeons in the OR to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion. Components are implanted to treat acute/chronic instabilities or deformities. System provides mechanical support to the spine, facilitating fusion; hardware is typically removed after solid fusion mass development.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Stainless steel spinal fixation system. Components include monoaxial/polyaxial screws, washers, hooks, blockers, rods, staples, and connectors. Mechanical properties verified via bench testing. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients requiring noncervical spinal stabilization/immobilization. Conditions include severe spondylolisthesis (L5-S1), degenerative spondylolisthesis with neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed fusion (pseudarthrosis), spinal stenosis, and degenerative disc disease (discogenic back pain).

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows a handwritten text that appears to be a combination of letters and numbers. The text reads 'kos1973' in a slightly stylized or cursive font. The letters 'kos' are followed by the numbers '1973', all written in black ink on a white background. ### Special 510(k) Summary of Safety and Effectiveness: Line Extension to the Xia Stainless Steel System AUG 1 8 2005 | Submission Information | | |--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Name and Address of the Sponsor<br>of the 510(k) Submission: | Stryker Spine<br>2 Pearl Court<br>Allendale, NJ 07401 | | Contact Person: | Simona Voic<br>Regulatory Affairs Project Manager | | Date of Summary Preparation: | July 20, 2005 | | Device Identification | | | Proprietary Name: | Xia Stainless Steel System | | Common Name: | Spinal Fixation Appliances | | Classification Name and Reference: | Spinal Interlaminal Fixation Orthosis,<br>21 CFR §888.3050<br>Spinal Intervertebral Body Fixation Orthosis<br>21 CFR §888.3060<br>Pedicle Screw Spinal System<br>21 CFR §888.3070 | #### Predicate Device Identification The Xia Stainless Steel System consists of Monoaxial and Polyaxial Screws, Washer, Hooks, Blocker, Rods, Staples, Connectors and Multi-Axial Cross Connectors (MACs). #### Description of Device Modification This submission is intended to address a line extension to the Xia Stainless Steel System. The line extension includes a new range of offset and rod to rod connectors. #### Intended Use: The Xia Stainless Steel System is intended for use in the noncervical spine. When used as a pcdicle screw fixation system, the Xia Stainless Steel System is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. When used as a pedicle screw fixation system, the Xia Stainless Steel System is also 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 neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis). When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the Xia Stainless Steel System is indicated for patients with degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc Page 1 of 2 {1}------------------------------------------------ confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts. ## Statement of Technological Comparison: Statement of I components share the same intended use and basic design concepts as that of the r no bate device: Xia Stainless Steel System (K012870 and K031090). Mechanical testing also demonstrated comparable mechanical properties to the predicate device. Page 2 of 2 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is written around the circle's perimeter. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 1 8 2005 Ms. Simona Voic RA Project Manager Stryker Spine 2 Pearl Court Allendale, New Jersey 07401 Re: K051973 Trade/Device Name: Xia Stainless Steel System Regulation Number: 21 CFR 888.3050, 21 CFR 888.3060, 21 CFR 888.3070 Regulation Name: Spinal interlaminal fixation orthosis, Spinal intervertebral body fixation orthosis, Pedicle screw spinal system Regulatory Class: II Product Code: KWP, KWQ, MNH, MNI Dated: July 20, 2005 Received: July 21, 2005 Dear Ms. Voic: We have reviewed your Section 510(k) premarket notification of intent to market the device w Filtere a Prove 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 use stated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner to print of the provision 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 r ou may , mers, sportions 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. {3}------------------------------------------------ Page 2-Ms. Simona Voic This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter witi anow you to begin manical equivalence of your device of your device to a legally premitset notincation. The Privating of castion 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 advice for your as 0) 276-0120. Also, please note the regulation entitled, a comati the Office of Comphalled at (210) = if = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = Mission of Icrerchee to premainer to premainter the Act from the Division of Small other general information on your responsive Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Sr Mark N. Melkerson Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): KOSA73______________________________________________________________________________________________________________________________________________ Device Name: Xia Stainless Steel System Indications For Use: The Xia Stainless Steel System is intended for use in the noncervical spine. When used as a The Xia Grainless Stock of Stainless Steel System is intended for patients: (a) having pealule serville likelion bytem, the Ala Cla) at the fifth lumbar - first sacral (L5-S1) vertebral joint, severe spondylonomene (on asing autogenous bone graft only; (c) who are having the device (b) who are roosting rasimal sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. When used as a pedicle screw fixation system, the Xia Stainless Steel System is also intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an to provide in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence the therelore, impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw viton about an antener steel System is indicated for patients with degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, tumor, pseudoarthrosis or revision of failed fusion attempts. Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 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 General, Restorative, and Neurological Devices Page 1 Page 1 of ____________________________________________________________________________________________________________________________________________________________________ 510(k) Number_K051833
Innolitics
510(k) Summary
Decision Summary
Classification Order
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