MANTIS & MANTIS REDUX SPINAL SYSTEM, RADIUS SPINAL SYSTEM, TRIO & TRIO+ SPINAL FIXATION SYSTEMS, AND TRIO TRAUMA SPINAL

K133188 · Stryker Spine · NKB · Dec 17, 2013 · Orthopedic

Device Facts

• Record ID: K133188
• Device Name: MANTIS & MANTIS REDUX SPINAL SYSTEM, RADIUS SPINAL SYSTEM, TRIO & TRIO+ SPINAL FIXATION SYSTEMS, AND TRIO TRAUMA SPINAL
• Applicant: Stryker Spine
• Product Code: NKB · Orthopedic
• Decision Date: Dec 17, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

MANTIS® & MANTIS Redux Spinal Systems (K102235) The MANTIS® Spinal System and MANTIS® Redux Spinal System is intended for percutaneous, posterior, non-cervical pedicle and non-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 (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; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthrosis; and Failed Previous Fusion Radius® Spinal System (K101144) The Radius® Spinal System is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation system, the Radius® Spinal system is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: 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; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthrosis; and Failed Previous Fusion

Device Story

Stryker Spine thoraco-lumbar systems (MANTIS, Radius, TRIO, XIA) are spinal fixation implants (screws, rods, plates, hooks, connectors, washers, staples) used for spinal stabilization/immobilization. Systems are used in non-cervical spine; implanted by surgeons during spinal fusion procedures. This submission specifically clears sterile packaging for these existing systems. Implants are manufactured from Titanium, Stainless Steel, or Cobalt-Chromium-Molybdenum alloy. Sterilization is performed via gamma radiation. No design modifications were made to the implants themselves; the change is limited to sterile presentation to the end-user.

Clinical Evidence

Bench testing only. No clinical data provided. Accelerated aging studies demonstrated the effectiveness of the sterilization process and sterile barrier packaging in maintaining sterility.

Technological Characteristics

Implants made of Titanium, Stainless Steel, or Cobalt-Chromium-Molybdenum (Vitallium). Components include screws, rods, plates, hooks, connectors, washers, and staples. Sterile packaging via gamma radiation.

Indications for Use

Indicated for non-cervical spinal fixation (pedicle/non-pedicle) in skeletally mature patients as adjunct to fusion for DDD, spondylolisthesis, trauma, spinal stenosis, curvature (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, and failed fusion. XIA® and XIA® 4.5 systems also indicated for adolescent idiopathic scoliosis in pediatric patients (posterior approach only).

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

• MANTIS® & MANTIS® Spinal Systems (K061813, K073151, K092631, K102235)
• Radius® Spinal System (K062270, K07063, K082608, K101144)
• TRIO® & TRIO + Spinal Fixation Systems (K052971, K062698, K070368, K100737)
• TRIO® Trauma Spinal System (K103292)
• XIA® Spinal Systems (K982494, K013823, K031893, K043473, K052181, K060361, K060979)
• XIA® 3 Spinal System (K071373, K083393, K091291, K113666)
• XIA® 4.5 Spinal System (K050461, K060361, K060748, K060979, K092605, K121342)

Reference Devices

• DIAPASON® Spinal System
• OPUS® Spinal System

Submission Summary (Full Text)

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## K133188 - Page 1 of 10

### Special 510(k) Premarket Notification – Sterile Packaging

DEC 1 7 2013

### Bundled Submission STRYKER SPINE Thoraco-lumbar Spinal Systems -MANTIS®, MANTIS® Redux, Radius®, TRIO® & TRIO® +, TRIO® Trauma, XIA®, XIA® 3, and XIA® 4.5

### 510(k) Summary

| Submitter: | Stryker Spine<br>Building 59 / Route 17 South<br>Allendale, New Jersey 07401 | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person | Ms. Soraya King<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | |
| Date Prepared | December 13, 2013 | |
| Trade/Device Name | 1. MANTIS® & MANTIS® Redux Spinal Systems<br>2. Radius® Spinal System<br>3. TRIO® & TRIO + Spinal Fixation Systems<br>4. TRIO® TRAUMA Spinal System<br>5. XIA® Spinal Systems<br>6. XIA® 3 Spinal System<br>7. XIA® 4.5 Spinal System | |
| Common Name | Spinal Fixation Appliances | |
| Regulatory Class,<br>Regulation Number,<br>and Regulation Name | 1. MANTIS® & MANTIS® Redux Spinal Systems Class III 21 CFR 888.3050: Spinal Interlaminal Fixation Orthosis 21 CFR 888.3070: Pedicle Screw Spinal System | |
| | 2. Radius® Spinal System Class III 21 CFR 888.3050: Spinal Interlaminal Fixation Orthosis 21 CFR 888.3060: Spinal Intervertebral Body Fixation Orthosis 21 CFR 888.3070: Pedicle Screw Spinal System | |
| | 3. TRIO® & TRIO + Spinal Fixation Systems Class III | |
| | XIA® 3, and XIA® 4.5 | |
| | • CFR 888.3070: Pedicle Screw Spinal System | |
| 4. | TRIO® TRAUMA Spinal Systems Class III 21 CFR 888.3070: Pedicle Screw Spinal System | |
| 5. | XIA® Spinal Systems Class III 21 CFR 888.3050: Spinal Interlaminal Fixation Orthosis 21 CFR 888.3060: Spinal Intervertebral Body Fixation Orthosis 21 CFR 888.3070: Pedicle Screw Spinal System | |
| 6. | XIA® 3 Spinal System Class III 21 CFR 888.3050: Spinal Interlaminal Fixation Orthosis 21 CFR 888.3060: Spinal Intervertebral Body Fixation Orthosis 21 CFR 888.3070: Pedicle Screw Spinal System | |
| 7. | XIA® 4.5 Spinal System Class III 21 CFR 888.3050: Spinal Interlaminal Fixation Ortosis 21 CFR 888.3060: Spinal Intervertebral Body Fixation Orthosis 21 CFR 888.3070: Pedicle Screw Spinal System | |
| Device Product Code | | |
| 1. | MANTIS® & MANTIS® Redux Spinal Systems KWP, MNH, MNI, NKB | |
| 2. | Radius® Spinal System KWP, KWQ, MNH, MNI, NKB | |
| 3. | TRIO® and TRIO + Spinal Fixation Systems MNH, MNI, NKB | |
| 4. | TRIO® Trauma Spinal System MNH, MNI, NKB | |
| 5. | XIA® Spinal Systems | |
| | | |
| | KWP, KWQ, MNH, MNI, NKB | |
| 6. XIA® 3 Spinal System | KWP, KWQ, MNH, MNI, NKB, OSH | |
| 7. XIA® 4.5 Spinal System | KWP, KWQ, MNH, MNI, NKB, OSH | |
| Predicate Devices | 1. MANTIS® & MANTIS® Spinal Systems K061813, K073151, K092631, and K102235 2. Radius® Spinal System K062270, K07063, K082608, and K101144 3. TRIO® & TRIO + Spinal Fixation Systems K052971, K062698, K070368, and K100737 4. TRIO® Trauma Spinal System K103292 5. XIA® Spinal Systems K982494, K013823, K031893, K043473, K052181, K060361, and K060979 6. XIA® 3 Spinal System K071373, K083393, K091291, and K113666 7. XIA® 4.5 Spinal System K050461, K060361, K060748, K060979, K092605, and K121342 | |
| Description of Device<br>Modifications | The STRYKER Spine thoraco-lumbar spinal fixation systems, subject<br>of this 510(k), are non-cervical, pedicle and non-pedicle fixation<br>systems comprised of screws, rods, plates, hooks, connectors, washers<br>and staples. The components are manufactured from either Titanium<br>(Titanium Alloy and CP Titanium), Stainless Steel or Cobalt-<br>Chromium-Molybdenum Alloy (Vitallium®).<br><br>This Special 510(k) submission seeks clearance for sterile labeling of<br>the listed STRYKER Spine thoraco-lumbar spinal fixation systems.<br>All of the components of the subject devices will be sterilized by | |
| gamma radiation, a traditional sterilization method as per FDA<br>guidance document, Updated 510(k) Sterility Review Guidance K90-1;<br>Guidance for Industry and FDA. | | |
| Intended Use | MANTIS® & MANTIS Redux Spinal Systems (K102235)<br>The MANTIS® Spinal System and MANTIS® Redux Spinal System is<br>intended for percutaneous, posterior, non-cervical pedicle and non-<br>pedicle fixation of the spine to provide immobilization and<br>stabilization of spinal segments in skeletally mature patients as an<br>adjunct to fusion for the following indications:<br>Degenerative Disc Disease (defined as back pain of discogenic<br>origin with degeneration of the disc confirmed by history and<br>radiographic studies); Spondylolisthesis; Trauma (i.e. fracture or dislocation); Spinal Stenosis; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthrosis; and Failed Previous Fusion<br>Radius® Spinal System (K101144)<br>The Radius® Spinal System is intended for use in the noncervical<br>spine. When used as an anterior/anterolateral and posterior,<br>noncervical pedicle and non-pedicle fixation system, the Radius®<br>Spinal system is intended to provide additional support during fusion<br>using autograft or allograft in skeletally mature patients in the<br>treatment of the following acute and chronic instabilities or<br>deformities:<br>Degenerative Disc Disease (DDD) (defined as back pain of<br>discogenic origin with degeneration of the disc confirmed by<br>history and radiographic studies); | |

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Bundled Submission STRYKER SPINE Thoraco-lumbar Spinal Systems –

MANTIS®, MANTIS® Redux, Radius®, TRIO® & TRIO® +, TRIO® Trauma, XIA®,

XIA® 3, and XIA® 4.5

Page 2 of 10

·

And Children Children

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Bundled Submission STRYKER SPINE Thoraco-lumbar Spinal Systems –

MANTIS®, MANTIS® Redux, Radius®, TRIO® & TRIO® +, TRIO® Trauma, XIA®,

Page 3 of 10

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Bundled Submission STRYKER SPINE Thoraco-lumbar Spinal Systems –

MANTIS®, MANTIS® Redux, Radius®, TRIO® & TRIO® +, TRIO® Trauma, XIA®,

XIA® 3, and XIA® 4.5

Page 4 of 10

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:

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### Special 510(k) Premarket Notification – Sterile Packaging

Bundled Submission STRYKER SPINE Thoraco-lumbar Spinal Systems –

MANTIS®, MANTIS® Redux, Radius®, TRIO® & TRIO® +, TRIO® Trauma, XIA®,

XIA® 3. and XIA® 4.5

| XIA® 3, and XIA® 4.5 | |
|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| • Spondylolisthesis; | |
| • Trauma (i.e. fracture or dislocation); | |
| • Spinal Stenosis; | |
| • Curvature (i.e. scoliosis, kyphosis, and/or lordosis); | |
| • Tumor; | |
| • Pseudoarthorisis; | |
| • and Failed Pervious Fusion | |
| The Radius® Spinal System can also be linked to the XIA® Titanium | |
| Spinal System via the Ø5.5mm to Ø6.0mm Radius® rod-to-rod | |
| connector. | |
| TRIO® Spinal Systems | |
| ➤ Stryker Spine TRIO® Plate System (K070368) | |
| 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; | |
| • Curvature (i.e. scoliosis, kyphosis, and/or lordosis); | |
| • Tumor; | |
| • Pseudoarthorisis; | |
| • and Failed Pervious Fusion | |
| ➤ Stryker Spine TRIO® Spinal Fixation System (K070368) | |
| 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; |
| ● | Curvature (i.e. scoliosis, kyphosis, and/or lordosis); |
| ● | Tumor; |
| ● | Pseudoarthorisis; |
| ● | and Failed Pervious Fusion |
| | The TRIO® Spinal Fixation Sytem is intended to be used in<br>conjunction with the OSS Diapson Rods, Opus Spinal System Rods,<br>and the Multi-Axis Cross Connectors. |
| ➤ | Stryker Spine TRIO® + Spinal System (K070368 & K100737) |
| | The Stryker Spine TRIO® Spinal System is intended for posterior,<br>noncervical pedicle and nonpedicle fixation of the spine to provide<br>immobilization and stabilization of spinal segements in skeletally<br>mature patients as an adjunct to fusion for the following indications: |
| ● | 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; |
| ● | Curvature (i.e. scoliosis, kyphosis, and/or lordosis); |
| ● | Tumor; |
| ● | Pseudoarthorisis; |
| ● | and Failed Pervious Fusion |
| | The TRIO® + Spinal System is intended to be used in conjunction<br>with the OSS/Diapason Rods or Opus Rods, XIA® Pre-bent Rods, and |

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Special 510(k) Premarket Notification – Sterile Packaging

Bundled Submission STRYKER SPINE Thoraco-lumbar Spinal Systems –

MANTIS®, MANTIS® Redux, Radius®, TRIO® & TRIO® +, TRIO® Trauma, XIA®,

XIA® 3, and XIA® 4.5

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Page 6 of 10

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Bundled Submission STRYKER SPINE Thoraco-lumbar Spinal Systems -

MANTIS®, MANTIS® Redux, Radius®, TRIO® & TRIO® +, TRIO® Trauma, XIA®,

XIA® 3, and XIA® 4.5

the Multi-Axis Cross Connectors."

#### TRIO® TRAUMA (K103292)

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;
- Curvature (i.e. scoliosis, kyphosis, and/or lordosis); .
- Tumor; .
- Pseudoarthorisis; .
- and Failed Pervious Fusion

#### XIA® Spinal Systems (K060361)

The XIA® Spinal System and XIA® 4.5 Spinal System are intended for anterior/anterolateral and posterior, noncervical pedicle and nonpedicle fixation 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; .

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Bundled Submission STRYKER SPINE Thoraco-lumbar Spinal Systems –

MANTIS®, MANTIS® Redux. Radius®, TRIO® & TRIO® +, TRIO® Trauma, XIA®,

XIA® 3. and XIA® 4.5

| | XIA® 3, and XIA® 4.5 |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| • | Pseudoarthrosis and; |
| • | Failed previous fusion. |
| | The 6mm diameter rods from the DIAPASON® Spinal System and<br>OPUS® Spinal System are intended to be used with the other<br>components of the XIA® Titanium Spinal System. The Titanium<br>Multi-Axial Cross Connector are intended to be used with the other<br>components of the XIA® Titanium Spinal System |
| | XIA® 3 Spinal System (K113666) |
| | The XIA® 3 Spinal System is intended for use in the noncervical<br>spine. When used as an anterior/anterolateral and posterior,<br>noncervical pedicle and non-pedicle fixation system, the XIA® 3<br>Spinal System is intended to provide additional support during fusion<br>using autograft or allograft in skeletally mature patients in the<br>treatment of the following acute and chronic instabilities or<br>deformities: |
| • | 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; |
| • | Curvature (i.e. scoliosis, kyphosis, and/or lordosis); |
| • | Tumor; |
| • | Pseudoarthorisis; |
| • | and Failed Pervious Fusion |
| | The Ø5.5mm rods from the Stryker Spine Radius® Spinal System and<br>the Ø6.0mm Vitallium Rods from the XIA® Spinal System are<br>intended to be used with the other components of the XIA® 3 Spinal<br>System. |
| | When used for posterior noncervical pedicle screw fixation in pediatric |
| patients, the XIA® Spinal System implants are indicated as an adjunct<br>to fusion to treat adolescent idiopathic scoliosis. |…