TRIO + SPINAL SYSTEM

K062698 · Stryker Spine · MNI · Oct 11, 2006 · Orthopedic

Device Facts

• Record ID: K062698
• Device Name: TRIO + SPINAL SYSTEM
• Applicant: Stryker Spine
• Product Code: MNI · Orthopedic
• Decision Date: Oct 11, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TRIO® and TRIO®+ Spinal Systems are pedicle screw systems 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, dislocations, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis). The TRIO® and TRIO®+ Spinal Systems are 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 TRIO® and TRIO®+ Spinal Systems are sacral/iliac screw fixation systems 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 review of failed fusion attempts. The TRIO® Spinal System is intended to be used in conjunction with the OSS Diapason Rods, Opus Spinal System Rods, and the Multi-Axis Cross Connectors. The TRIO®+ Spinal System is intended to be used in conjunction with the OSS Diapason Rods. Opus Spinal System Rods, Xia Pre-bent Rods, and the Multi-Axis Cross Connectors.

Device Story

Thoraco-lumbar posterior spinal fixation system; components include titanium alloy bone screws, rods, and connectors. Used for immobilization/stabilization of spinal segments as adjunct to fusion. System components available in various lengths to accommodate patient anatomy. TRIO®+ is a line extension of the TRIO® system, adding compatibility with Xia® Pre-bent Rods. Used by surgeons in clinical settings to treat spinal instabilities or deformities. Mechanical performance verified via bench testing to ensure equivalence to predicate systems.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Titanium alloy bone screws, rods, and connectors. Pedicle screw spinal system. Mechanical properties verified via bench testing. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as adjunct to fusion for thoracic, lumbar, and sacral spine conditions: degenerative spondylolisthesis with neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudarthrosis, degenerative disc disease, spinal stenosis, and lordosis. Includes L5-S1 pedicle screw fixation for severe spondylolisthesis (Grades 3-4).

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)
• Stryker Spine TRIO® Spinal System (K052971)
• Stryker Spine Xia® Spinal System (K013823)
• Stryker Spine Xia® Spinal System (K043473)
• Stryker Spine Xia® Stainless Steel System (K012870)
• Stryker Spine Xia® 4.5 Spinal System (K050461)
• Stryker Spine Osteonics Spinal System (K951725)

Submission Summary (Full Text)

{0}------------------------------------------------

K062698 pg 1/2

Special 510(k) Premarket Notification

# SPECIAL 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

OCT 1 2006

## Line Extension to the TRIO® Spinal System

## Submission Information

:

| Name and Address of the Sponsor of the 510(k) Submission: | Stryker Spine<br>2 Pearl Court<br>Allendale, NJ 07401 |
|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: | September 8, 2006 |
| Device Identification | |
| Proprietary Name: | TRIO ^® + Spinal System |
| Common Name: | Spinal Fixation Appliances |
| Classification Name and Reference: | Pedicle Screw Spinal System<br>21 CFR §888.3070 |
| Device Product Code: | 87 MNH: Spondylolisthesis Spinal Fixation<br>System<br>87 MNI: Orthosis, Spinal, Pedicle Fixation |
| Predicate Device Information: | K032855 – Stryker Spine MAPS System<br>(renamed Stryker Spine Trio ^® System)<br>K052971 - Stryker Spine TRIO ^® Spinal<br>System<br>K013823, K043473 - Stryker Spine Xia ^®<br>Spinal System<br>K012870 - Stryker Spine Xia ^® Stainless<br>Steel System<br>K050461 - Stryker Spine Xia ^® 4.5 Spinal<br>System<br>K951725 - Stryker Spine Osteonics Spinal<br>System |

{1}------------------------------------------------

#### Predicate Device Identification

The Stryker Spine TRIO® Spinal System is a thoraco-lumbar posterior fixation system comprised of bone screws, rods, and connectors. The components are available in a variety of lengths in order to accommodate patient anatomy and are fabricated from titanium alloy.

#### Description of Device Modification

This submission is intended to introduce TRIO®+ Spinal System, as a line extension to TRIO® Spinal System. The subject system consists of Titanium alloy bone screws, rods, and connectors, offered in a variety of lengths.

#### Intended Use:

The TRIO® and TRIO®+ Spinal Systems are pedicle screw systems 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, dislocations, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

The TRIO® and TRIO®+ Spinal Systems are 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 TRIO® and TRIO®+ Spinal Systems are sacral/iliac screw fixation systems 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 review of failed fusion attempts.

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

The TRIO®+ Spinal System is intended to be used in conjunction with the OSS Diapason Rods. Opus Spinal System Rods, Xia Pre-bent Rods, and the Multi-Axis Cross Connectors.

#### Statement of Technological Comparison:

The subject components share the same intended use, material, and basic design concepts as that of the predicate device: TRIO® Spinal System [K032855 (formerly MAPS System) and K0529711. Mechanical testing also demonstrated comparable mechanical properties to the predicate devices including the Xia® Spinal System (K013823 &K043473), Xia Stainless Steel Spinal System (K012870), Xia 4.5 Spinal System (K050461) and the Osteonics Spinal System (K951725).

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 1 2006

Stryker Spine % Ms. Simona Voic 2 Pearl Court Allendale, New Jersey 07401

Re: K062698

Trade/Device Name: Stryker Spine TRIO® and TRIO® + Spinal Systems Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, and MNH Dated: September 7, 2006 Received: September 11, 2006

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, and 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) 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 vours.

Caufare fuelleno

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

Enclosure

{4}------------------------------------------------

K062698

## Indications for Use

510(k) Number (if known):

Device Name: Stryker Spine TRIO® and TRIO®+ Spinal Systems

Indications for Use:

The TRIO® and TRIO®+ Spinal Systems are pedicle screw systems 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, dislocations, scoliosis, spinal tumor and failed previous fusion (pseudarthrosis).

The TRIO® and TRIO®+ Spinal Systems are 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 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 TRIO® and TRIO®+ Spinal Systems are sacral/iliac screw fixation systems 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 review of failed fusion attempts.

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

The TRIO®+ Spinal System is intended to be used in conjunction with the OSS Diapason Rods, Opus Spinal System Rods, Xia® Pre-bent Rods, and the Multi-Axis Cross Connectors.

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of

Barbara buchlud

(Division Sign Jff) Division of General, Restorative, and Neurological Device

**510(k) Number** K062698