TRIO PLATE SYSTEM, TRIO SPINAL FIXATION SYSTEM, TRIO+ SPINAL SYSTEM

K070368 · Stryker Corp. · NKB · May 4, 2007 · Orthopedic

Device Facts

• Record ID: K070368
• Device Name: TRIO PLATE SYSTEM, TRIO SPINAL FIXATION SYSTEM, TRIO+ SPINAL SYSTEM
• Applicant: Stryker Corp.
• Product Code: NKB · Orthopedic
• Decision Date: May 4, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker Spine Trio® Plate System is intended for posterior, noncervical (T10-S1) pedical and nonpedical fixation of the spine 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. The Stryker Spine Trio® Spinal Fixation System is intended for posterior, noncervical pedicle and non-pedicle fixation of the spine. The Stryker Spine Trio® Spinal Fixation System is indicated for: 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. The Trio® Spinal Fixation System is intended to be used in conjunction with the OSS Diapason Rods, Opus Spinal System Rods, and the Multi-Axis Cross Connectors. The Stryker Spine Trio®+ Spinal System is intended for posterior, noncervical pedicle and non-pedicle fixation of the spine. The Stryker Spine Trio®+ Spinal System is indicated for: 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. 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

Spinal fixation systems (Trio PS, Trio, Trio+) comprising titanium alloy screws, plates, rods, and connectors. Used by surgeons in clinical settings for posterior, noncervical spinal stabilization. Devices provide mechanical support to the spine to facilitate fusion in patients with degenerative, traumatic, or structural spinal pathologies. Systems are used in conjunction with specific compatible rods and cross-connectors. Output is physical stabilization of spinal segments. No new components introduced; submission solely expands indications for use to include Class III pedicle screw system requirements.

Clinical Evidence

Bench testing only. No clinical data presented. Compliance with FDA's 'Guidance for Industry and FDA Staff: Spinal System 510(k)s' (May 3, 2004) was demonstrated via testing presented in previous predicate 510(k) submissions.

Technological Characteristics

Titanium alloy spinal fixation components (screws, plates, rods, connectors). Mechanical fixation principle. No software or electronic components. Sterilization method not specified.

Indications for Use

Indicated for patients requiring posterior, noncervical (T10-S1 for PS) pedicle and non-pedicle spinal fixation. Conditions include degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, spinal curvatures (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

• Stryker Spine Trio® Plate System (K043180)
• Stryker Spine Xia® and Xia® 4.5 Spinal Systems (K060361)
• Stryker Spine Opus™ Spinal System (K060369)
• Stryker Spine MAPS System (K032855)
• Stryker Spine Trio® Spinal Fixation System (K052971)
• Stryker Spine Trio®+ Spinal System (K062698)

Submission Summary (Full Text)

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010368

Traditional 510(k) Premarket Notification

Stryker Spine Trio® PS, Trio® Spinal Fixation System & Trio®+ Spinal System

# Stryker Spine Submitter: 2 Pearl Court Allendale, New Jersey 07401 Ms. Simona Voic Contact Person Regulatory Affairs Project Manager Phone: [phone] FAX: [phone] Email: [e-mail] April 17, 2007 Date Prepared Stryker Spine Trio® Plate System Trade Name Class III Proposed Class Pedicle Screw Spinal System Classification Name [21 CFR 888.3070(b) (1) & (b) (2)] and Number NKB, MNH, and MNI Product Code K043180 - Stryker Spine Trio® Plate System (PS) Predicate Devices K060361 - Stryker Spine Xia® and Xia ® 4.5 Spinal Systems K060369 - Stryker Spine Opus™ Spinal System The Stryker Spine Trio® Plate System is comprised of spinal Device Description screws, plates and locking components, fabricated from Titanium alloy.

### 510(k) Summary of Safety and Effectiveness Stryker Spine Trio® Plate System

MAY - 4 2007

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| | This submission adds the Class III indications per product code |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | NKB, 21 CFR 888.3070(b)(2), but no additional components. |
| | The expanded indications for use statement for the TRIO® PS |
| | has also been modeled on the suggested indications for use |
| | statement for posterior thoracolumbar systems (product codes |
| | MNI, MNH, NKB) suggested by FDA in FDA's "Guidance for |
| | Industry and FDA Staff: Spinal System 510(k)s," dated May 3, |
| | 2004. |
| Intended Use | The Stryker Spine Trio® Plate System is intended for posterior, |
| | noncervical (T10-S1) pedical and nonpedical fixation of the |
| | spine 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. |
| | |
| Summary of the | Testing in compliance with FDA's Guidance for Spinal System |
| Technological | 510(k)'s May 3, 2004 was performed for the Stryker Spine Trio® |
| Characteristics | Plate System and was presented in their respective predicate |
| | 510(k)s. This 510(k) contains no new components. It only |
| | addresses the additional Class III indications associated with |
| | product code NKB. |

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:

Stryker Spine Trio® PS, Trio® Spinal Fixation System & Trio®+ Spinal System

| 510(k) Summary of Safety and Effectiveness |
|--------------------------------------------|
| Stryker Spine Trio® Spinal Fixation System |

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| Submitter: | Stryker Spine<br>2 Pearl Court<br>Allendale, New Jersey 07401 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Ms. Simona Voic<br>Regulatory Affairs Project Manager<br>Phone: [phone]<br>FAX: [phone]<br>Email: [e-mail] |
| Date Prepared | April 17, 2007 |
| Trade Name | Trio® Spinal Fixation System |
| Proposed Class | Class III |
| Classification Name<br>and Number | Pedicle Screw Spinal System<br>21 CFR 888.3070(b) (1) & (b) (2) |
| Product Code | NKB, MNH, and MNI |
| Predicate Devices | K032855 – Stryker Spine MAPS System<br>K052971 - Stryker Spine Trio® Spinal Fixation System<br>K060361 - Stryker Spine Xia® and Xia ® 4.5 Spinal Systems |
| Device Description | The Stryker Spine Trio® Spinal Fixation System is comprised of<br>spinal screws, rods, and offset connectors, fabricated from<br>Titanium alloy. |
| | This submission adds the Class III indications per product code |
| | NKB, 21 CFR 888.3070(b)(2), but no additional components. |
| | The expanded indications for use statement for the TRIO® |
| | Spinal Fixation System has also been modeled on the suggested |
| | indications for use statement for posterior thoracolumbar |
| | systems (product codes MNI, MNH, NKB) suggested by FDA in |
| | FDA's "Guidance for Industry and FDA Staff: Spinal System |
| | 510(k)s," dated May 3, 2004. |
| Intended Use | The Stryker Spine Trio® Spinal Fixation System is intended for |
| | posterior, noncervical pedicle and non-pedicle fixation of the spine. |
| | The Stryker Spine Trio® Spinal Fixation System is indicated for: |
| | Degenerative disc disease (DDD) (defined as back pain of<br>discogenic origin with degeneration of the disc confirmed by<br>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. |
| | The Trio® Spinal Fixation System is intended to be used in |
| | conjunction with the OSS Diapason Rods, Opus Spinal System<br>Rods, and the Multi-Axis Cross Connectors. |
| | |
| Summary of the | Testing in compliance with FDA's Guidance for Spinal System |
| Technological | 510(k)'s May 3, 2004 was performed for the Stryker Spine Trio® |
| Characteristics | Spinal Fixation System and presented in K032855 and K052971. |
| | This 510(k) contains no new components. It only addresses the |
| | additional Class III indications associated with product code |
| | NKB. |
| | |

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Stryker Spine Trio® PS, Trio® Spinal Fixation System & Trio®+ Spinal System

### 510(k) Summary of Safety and Effectiveness Stryker Spine Trio®+ Spinal System

| Submitter: | Stryker Spine<br>2 Pearl Court<br>Allendale, New Jersey 07401 |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Ms. Simona Voic<br>Regulatory Affairs Project Manager<br>Phone: [phone]<br>FAX: [phone]<br>Email: [e-mail] |
| Date Prepared | April 17, 2007 |
| Trade Name | Stryker Spine Trio®+ Spinal System |
| Proposed Class | Class III |
| Classification Name<br>and Number | Pedicle Screw Spinal System<br>21 CFR 888.3070(b) (1) & (b) (2) |
| Product Code | NKB, MNH, and MNI |
| Predicate Devices | K052971 - Stryker Spine Trio® Spinal Fixation System<br>K062698 - Stryker Spine Trio®+ Spinal System<br>K060361 – Stryker Spine Xia® and Xia® 4.5 Spinal Systems |
| Device Description | The Stryker Spine Trio®+ Spinal System contains spinal screws,<br>rods, and connectors, fabricated from Titanium alloy. This<br>submission adds the Class III indications per product code NKB, |
| | 21 CFR 888.3070(b)(2), but no additional components. |
| | The expanded indications for use statement for the TRIO® + |
| | Spinal System has also been modeled on the suggested |
| | indications for use statement for posterior thoracolumbar |
| | systems (product codes MNI, MNH, NKB) suggested by FDA in |
| | FDA's "Guidance for Industry and FDA Staff: Spinal System |
| | 510(k)s," dated May 3, 2004. |
| Intended Use | The Stryker Spine Trio®+ Spinal System is intended for |
| | posterior, noncervical pedicle and non-pedicle fixation of the |
| | spine. |
| | The Stryker Spine Trio®+ Spinal System is indicated for: |
| | 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. |
| | 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. |
| Summary of the<br>Technological<br>Characteristics | Testing in compliance with FDA's Guidance for Spinal System<br>510(k)'s May 3, 2004 was performed for the Stryker Spine<br>Trio®+ Spinal System, and was presented in the respective<br>predicate 510(k)s. This 510(k) contains no new components. It<br>only addresses the additional Class III indications associated<br>with product code NKB. |

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K 0 70368

3 of 3

Traditional 510(k) Premarket Notification

Stryker Spine Trio® PS, Trio® Spinal Fixation System & Trio®+ Spinal System

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Public Health Service

Image /page/7/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing service to the nation. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stryker Spine Corporation c/o Ms. Simona Voic 2 Pearl Court Allendale, New Jersey 07401

MAY - 4 2007

Re: K070368

Trade Name: TRIO® Plate System, TRIO® Spinal Fixation System, TRIO®+ Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: III Product Code: NKB, MNH,MNI Dated: April 13, 2007 Received: April 17, 2007

Dear Ms. Voic:

We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the device are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA), they 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 devices comply 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 - Mr. Christopher Klaczyk

This letter will allow you to begin marketing your devices as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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.

Barbara Mueller

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

Enclosure

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& Trio®+ Spinal System

# Indications for Use

510(k) Number (if known): K070368

Device Name: Stryker Spine Trio® Plate System

Indications For Use:

The Stryker Spine Trio® Plate System is intended for posterior, noncervical (T10-S1) pedical and nonpedical fixation of the spine 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. ●

AND/OR Over-The-Counter Use Prescription Use X____________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Saubare Breechup

Division of General, Restorative, and Neurological Devices

Page 1 of 1

**510(k) Number** K070368

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## Indications for Use

510(k) Number (if known): K070368 Device Name: Stryker Spine Trio® Spinal Fixation System

Indications For Use:

The Stryker Spine Trio® Spinal Fixation System is intended for posterior, noncervical pedicle and non-pedicle fixation of the spine.

The Stryker Spine Trio® Spinal Fixation System is indicated for:

- . 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. .

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

Prescription Use __ × (Part 21 CFR 801 Subpart D)

AND/OR

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,

Jaubare Bouenn
Division Sign Off

Division of General, Restorati and Neurological Devices

Page 1 of 1

510(k) Number K070368

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Stryker Spine Trio® PS, Trio® Spinal Fixation System & Trio®+ Spinal System

## Indications for Use

510(k) Number (if known): K070368 Device Name: Stryker Spine Trio + Spinal System

Indications For Use:

The Stryker Spine Trio 4 Spinal System is intended for posterior, noncervical pedicle and nonpedicle fixation of the spine.

The Stryker SpineTrio®+ Spinal System is indicated for:

- 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. .

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 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

Division of General. Resto and Neurological Devices

Page 1 of 1

510(k) Number k070368