TRIO TRAUMA SPINAL SYSTEM

K103292 · Stryker Corporation · NKB · Mar 4, 2011 · Orthopedic

Device Facts

• Record ID: K103292
• Device Name: TRIO TRAUMA SPINAL SYSTEM
• Applicant: Stryker Corporation
• Product Code: NKB · Orthopedic
• Decision Date: Mar 4, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker Spine Trio Trauma Spinal System is intended for percutaneous, posterior, non-cervical pedicle fixation of the spine to provide immobilization and stabilization of spinal segment in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture and dislocation); curvature (i.e. scoliosis, kyphosis, and or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Device Story

System consists of cannulated pedicle screws, 6.0 mm diameter rods (straight/pre-bent), and offset connectors. Used for percutaneous, posterior, non-cervical spinal fixation; provides immobilization and stabilization as adjunct to fusion. Operated by surgeons in clinical/OR settings. Components implanted to stabilize spinal segments; benefits patient by facilitating fusion and correcting spinal alignment/instability.

Clinical Evidence

Bench testing only. No clinical data provided. Mechanical performance validated via static compression bending, dynamic compression bending, static torsion (ASTM F1717), and static axial gripping capacity (ASTM F1798).

Technological Characteristics

Materials: Titanium alloy (Ti6Al4V). Components: Cannulated pedicle screws, 6.0 mm diameter rods, offset connectors. Standards: ASTM F1717 (compression/torsion), ASTM F1798 (axial gripping). Mechanical fixation system; non-powered.

Indications for Use

Indicated for skeletally mature patients requiring percutaneous, posterior, non-cervical pedicle fixation as an adjunct to fusion for DDD, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, curvature (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, and failed previous fusion.

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

• Synthes Spine USS Fracture System (K010658)
• Stryker Spine Mantis Systems (K102235)
• Stryker Spine Trio+ Spinal System (K100737, K052971)
• Stryker Spine Xia 4.5 Spinal System (K050461, K052761)

Submission Summary (Full Text)

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## k103292

Stryker Spine Trio Trauma Spinal System

Traditional 510(k) Premarket Notification

## STRYKER SPINE 510(k) Summary: Trio® Trauma Spinal System

MAR - 4 20il

Submitter: Stryker Spine 2 Pearl Court Allendale, New Jersey 07401

Contact Person

Mr. Curtis Truesdale Regulatory Affairs Project Manager Phone: [phone] FAX: [phone] Email: curtis.truesdale(@stryker.com

Date Prepared March 4, 2011

Trade Name

Proposed Class Class III

Classification 1) Pedicle Screw Spinal System, 21 CFR §888.3070 Name and Number

Product Code NKB, MNH, MNI

Predicate Devices Synthes Spine USS Fracture System: 510(k) K010658 Stryker Spine Mantis Systems: 510(k) K102235 Stryker Spine Trio+ Spinal System: K100737, K052971 Stryker Spine Xia 4.5 Spinal System: 510(k) K050461, K052761

Stryker Spine Trio® Trauma Spinal System

Device Description The Trio Trauma Spinal system consists of cannulated pedicle screws in a variety of diameters and lengths, 6.0 mm diameter rods that are offered straight and pre-bent (rad rods) in a variety of lengths and an offset connector. The offset connector is supplied in one size, which accommodates the 6.0 mm diameter rods. The system components are manufactured from Titanium alloy (Ti6Al4V)

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Traditional 510(k) Premarket Notification

Intended Use The Stryker Spine Trio Trauma Spinal System is intended for percutaneous, posterior, non-cervical pedicle fixation of the spine to provide immobilization and stabilization of spinal segment in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture and dislocation); curvature (i.e. scoliosis, kyphosis, and or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Summary of the Documentation has been provided to demonstrate that the Stryker Technological Spine Trio Trauma Spinal System is substantially equivalent to the Characteristics predicate devices in terms of material, design, mechanical performance and indications for use. Static Compression Bending Testing, Dynamic Compression Bending Testing and Static Torsion Testing per ASTM F1717 were conducted on the Trio Trauma System components. In addition, Static Axial Gripping Capacity testing per ASTM F1798 was also performed. The results obtained from these tests were compared to those of a predicate system to demonstrate substantial equivalence, as recommended by the "Guidance for Industry & FDA Staff Spinal System 510(k)s May 3, 2004."

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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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles a bird or a person with outstretched arms.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Stryker Spine % Mr. Curtis Truesdale Regulatory Affairs Project Manager 2 Pearl Court Allendale, New Jersey 07401

MAR - 4 2011

Re: K103292

Trade/Device Name: Stryker Spine TRIO TRAUMA Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI Dated: March 01, 2011 Received: March 02, 2011

Dear Mr. Truesdale:

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 note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Mr. Curtis Truesdale

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-related 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Aliz B. Rater
for

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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Special 510(k) Premarket Notification

## Indications for Use

510(k) Number (if known): K | 03292

Device Name: Stryker Spine TRIO TRAUMA Spinal System

Indications for Use:

The Stryker Spine TRIO TRAUMA Spinal System is intended for percutaneous, posterior, non-cervical pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications:

- Degenerative disc disease (DDD) (defined as back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies);
- Spondylolisthesis; �
- Trauma (i.e., fracture or dislocation); ●
- Spinal Stenosis; ●
- Curvatures (i.e., scoliosis, kyphosis, and/or lordosis); .
- Tumor; .
- Pseudoarthrosis; and .
- Failed previous fusion.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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signature

(Division Sign-Off) Division of Surgical. Orthopedic, and Restorative Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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