STRYKER SPINE TRIO SPINAL FIXATION SYSTEM

K052971 · Stryker Spine · MNI · Nov 16, 2005 · Orthopedic

Device Facts

• Record ID: K052971
• Device Name: STRYKER SPINE TRIO SPINAL FIXATION SYSTEM
• Applicant: Stryker Spine
• Product Code: MNI · Orthopedic
• Decision Date: Nov 16, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker Spine TRIO® Spinal Fixation System 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 neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis). The Stryker Spine TRIO® Spinal Fixation System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) at 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 development of a solid fusion mass. The Stryker Spine TRIO® Spinal Fixation System is also a sacral/iliac screw fixation system indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, kyphosis and/or lordosis), tumor, pseudoarthrosis and revision of failed fusion attempts. The Stryker Spine TRIO® Spinal Fixation System is also intended to be used in conjunction with the OSS/Diapason Rods, Opus Spinal System Rods and the Multi-Axis Cross Connectors.

Device Story

Stryker Spine TRIO® Spinal Fixation System (formerly MAPS System) is a spinal fixation implant set; includes screws, rods, and new offset connectors. Used by surgeons in clinical settings to provide spinal stabilization/immobilization as an adjunct to fusion. Implants are attached to thoracic, lumbar, or sacral spine segments to treat deformities or instabilities. System components are non-sterile and fabricated from titanium alloy. Device provides mechanical support to the spine to facilitate fusion; implants may be removed after solid fusion mass development. No software or electronic components involved.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Spinal fixation system consisting of screws, rods, and offset connectors. Materials: Titanium alloy. Design: Pedicle screw and sacral/iliac screw fixation. Non-sterile. No software, electronics, or energy sources.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion. Treats thoracic, lumbar, and sacral spine instabilities/deformities including degenerative spondylolisthesis, fractures, dislocations, scoliosis, spinal tumors, pseudarthrosis, degenerative disc disease, and spinal stenosis. Specific indication for severe spondylolisthesis (Grades 3-4) at L5-S1 using autogenous bone graft with L3-sacrum fixation.

Regulatory Classification

Identification

(1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.

Special Controls

*Classification.* (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards; (ii) Compliance with mechanical testing standards; (iii) Compliance with biocompatibility standards; and (iv) Labeling that contains these two statements in addition to other appropriate labeling information: “Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.” “Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.” (2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls: (i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant. (iii) Device components must be demonstrated to be biocompatible. (iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments. (v) Labeling must include the following: (A) A clear description of the technological features of the device including identification of device materials and the principles of device operation; (B) Intended use and indications for use, including levels of fixation; (C) Identification of magnetic resonance (MR) compatibility status; (D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and (E) Detailed instructions of each surgical step, including device removal. (3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls: (i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate. (ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.

Predicate Devices

• Stryker Spine MAPS System (K032855)
• Osteonics Spinal System (K951725)
• Xia Spinal System (K013823)
• Xia Stainless Steel System (K012870)

Submission Summary (Full Text)

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## Kos2974

Special 510(k) Premarket Notification

## Special 510(k) Summary of Safety and Effectiveness: Line Extension to Stryker Spine TRIO® Spinal Fixation System

#### Submission Information

| Name and Address of the Sponsor<br>of the 510(k) Submission: | Stryker Spine<br>2 Pearl Court<br>Allendale, NJ 07401 | NOV 16 2005 |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Simona Voic<br>Regulatory Affairs Project Manager<br>Stryker Spine<br>2 Pearl Court, Allendale, NJ 07401<br>Tel: (201) 760 - 8145 | |
| Date of Summary Preparation: | October 21, 2005 | |
| Device Identification<br>Proprietary Name: | Stryker Spine TRIO® Spinal Fixation System | |
| Common Name: | Spinal Fixation Appliances | |
| Classification Name and Reference: | Spinal Interlaminal Fixation Orthosis,<br>21 CFR §888.3050<br>Pedicle Screw Spinal System<br>21 CFR §888.3070 | |
| Device Product Code: | 87 KWP: Appliance, Fixation, Spinal Interlaminal<br>87 MNH: Spondylolisthesis Spinal Fixation System<br>87 MNI: Orthosis, Spinal, Pedicle Fixation | |
| Predicate Device Information: | K032855 – Stryker Spine MAPS System<br>K951725 – Osteonics Spinal System<br>K013823 – Xia Spinal System<br>K012870 – Xia Stainless Steel System | |

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Kos297H

#### Predicate Device Identification

I redicate Device MAPS System is comprised of screws, rods, and connectors. The components are available in a variety of lengths in order to accommodate patient anatomy. The implants are provided non-sterile and are fabricated from titanium alloy.

#### Description of Device Modification

This submission is intended to address a line extension to Stryker Spine MAPS System and the system name change. The line extension includes the addition of a new offset connector. The name of the MAPS System is changed to TRIO® Spinal Fixation System.

#### Intended Use:

The Stryker Spine TRIO® Spinal Fixation System 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 neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Stryker Spine TRIO® Spinal Fixation System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) at the LS-S1 vertebra in skeletally mature patients recciving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the development of a solid fusion mass.

The Stryker Spine TRIO® Spinal Fixation System is also a sacral/iliac screw fixation system indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, kyphosis and/or lordosis), tumor, pseudoarthrosis and revision of failed fusion attempts.

The Stryker Spine TRIO® Spinal Fixation System is also intended to be used in conjunction with the

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K052471

343

OSS/Diapason Rods, Opus Spinal System Rods and the Multi-Axis Cross Connectors.

### Statement of Technological Comparison:

The subject connector shares the same intended use, material, and basic design concepts as that of the predicate device: Stryker Spine MAPS System (K032855). Mechanical testing also demonstrated comparable mechanical properties to the predicate device: Xia Spinal System (K013823), Xia Stainless Steel System (K012870) and Osteonics Spinal System (K951725).

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NOV 1 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Simona Voic RA Project Manager Stryker Spine 2 Pearl Court Allendale, New Jersey 07401

Re: K052971

Trade/Device Name: Stryker Spine TRIO® Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw System Regulatory Class: II Product Code: MNI, MNH, KWP Dated: October 21, 2005 Received: October 24, 2005

Dear Ms. Voic:

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 - Simona Voic

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

Sincerely yours,

So Mark N. Melkerson

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

Enclosure

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# Indications for Use

510(k) Number (if known): K052971

Device Name: Stryker Spine TRIO® Spinal Fixation System

Indications For Use:

The Stryker Spine TRIO® Spinal Fixation System 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 neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Stryker Spine TRIO® Spinal Fixation System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) at 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 development of a solid fusion mass.

The Stryker Spine TRIO® Spinal Fixation System is also a sacral/iliac screw fixation system indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, kyphosis and/or lordosis), tumor, pseudoarthrosis and revision of failed fusion attempts.

The Stryker Spine TRIO® Spinal Fixation System is also intended to be used in conjunction with the OSS/Diapason Rods, Opus Spinal System Rods and the Multi-Axis Cross Connectors.

Prescription Use X AND/OR AND/OR 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 of General, Restorative, and Neurological Devices

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**510(k) Number** K052971