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

• K Number: K133188
• Device Name: MANTIS & MANTIS REDUX SPINAL SYSTEM, RADIUS SPINAL SYSTEM, TRIO & TRIO+ SPINAL FIXATION SYSTEMS, AND TRIO TRAUMA SPINAL
• Manufacturer: STRYKER SPINE
• Date Cleared: 2013-12-17 ( 61 days)
• Product Code: NKB , KWP , KWQ , MNH , MNI , OSH
• Regulation Number: 888.3070
• Type: Special
• Panel: Orthopedic
• Reference & Predicate Devices: K061813 , K073151 , K092631 , K102235 , K062270 , K082608 , K101144 , K052971 , K062698 , K070368 , K100737 , K103292 , K982494 , K013823 , K031893 , K043473 , K052181 , K060361 , K060979 , K071373 , K083393 , K091291 , K113666 , K050461 , K060748 , K092605 , K121342
• Predicate For: K152632 , K222684

Intended Use

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.

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; 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.

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.

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; 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 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 nonpedicle fixation of the spine to provide immobilization and stabilization of spinal segements 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. The TRIO® + Spinal System is intended to be used in conjunction with the OSS/Diapason Rods or Opus Rods, XIA® Pre-bent Rods, and the Multi-Axis Cross Connectors.

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 (DD) (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.

The XIA® Spinal System and XIA® 4.5 Spinal System are intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle 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; Pseudoarthrosis and; Failed previous fusion. The 6mm diameter rods from the DIAPASON® Spinal System and OPUS® Spinal System are intended to be used with the other components of the XIA® Titanium Spinal System. The Titanium Multi-Axial Cross Connector are intended to be used with the other components of the XIA® Titanium Spinal System.

The XIA® 3 Spinal System is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle fixation system, the XIA® 3 Spinal System is intended to provide additional support during 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, Pseudoarthorisis; and Failed Pervious Fusion. The Ø5.5mm rods from the Stryker Spine Radius® Spinal System and the Ø6.0mm Vitallium Rods from the XIA® Spinal System are intended to be used with the other components of the XIA® 3 Spinal System. When used for posterior noncervical pedicle screw fixation in pediatric patients, the XIA® Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scollosis. The XIA® 3 Spinal System for pediatic use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The XIA® 4.5 Spinal System is intended for anterior/anteriolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications: Degenerative Disc Disease (DD) (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. The Stryker Spine DIAPASON® Spinal System, OPUS® Spinal System and XIA® 4.5 Spinal System can be linked to the XIA® 4.5 Spinal System via the rod-to-rod connector when used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. Except for the staples, the XIA® 4.5 Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical pedicle screw fixation in pediatric patients. The XIA® 4.5 Spinal System for pediatric use in intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Device Description

The STRYKER Spine thoraco-lumbar spinal fixation systems, subject of this 510(k), are non-cervical, pedicle and non-pedicle fixation systems comprised of screws, rods, plates, hooks, connectors, washers and staples. The components are manufactured from either Titanium (Titanium Alloy and CP Titanium), Stainless Steel or Cobalt-Chromium-Molybdenum Alloy (Vitallium®). This Special 510(k) submission seeks clearance for sterile labeling of the listed STRYKER Spine thoraco-lumbar spinal fixation systems. All of the components of the subject devices will be sterilized by gamma radiation, a traditional sterilization method as per FDA guidance document, Updated 510(k) Sterility Review Guidance K90-1; Guidance for Industry and FDA.

AI/ML Overview

This is a 510(k) Premarket Notification for sterile packaging of a range of spinal systems. The key claim is substantial equivalence to previously cleared non-sterile versions of the same devices. Therefore, the "device" in question for this submission is specifically the sterile packaging and the sterilization process, not the spinal implant itself as a medical device performing a physiological function. The "performance" being evaluated is the ability to maintain sterility and the structural integrity of the device within its packaging over its shelf life.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Sterilization Effectiveness	Demonstrated by gamma radiation, a traditional sterilization method per FDA guidance document, Updated 510(k) Sterility Review Guidance K90-1; Guidance for Industry and FDA.
Sterile Barrier Packaging System	Demonstrated effective in maintaining sterility for the recommended 5-year shelf-life.
Impact on Device Characteristics	No design modifications were incorporated to facilitate sterile packaging. The sterile-packed implant components maintain the same technological characteristics (design, technical requirements, materials of construction, indications/intended use) as the non-sterile predicate devices.
Shelf Life	Demonstrated a 5-year shelf life in sterile packaging.
Safety and Effectiveness	Concluded to be safe and effective, retaining the same intended use, indications, technological characteristics, and mode of operation as the predicate non-sterile devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily discusses the sterilization process and packaging rather than clinical performance of the implant itself. Therefore, typical "test set" in the context of clinical or diagnostic AI/software devices (e.g., patient data) is not applicable here.

• Sterilization and Packaging Validation Data: The document mentions "accelerated aging data" for validating the 5-year shelf life. It does not specify the sample size for this testing, nor the country of origin or whether it was retrospective or prospective. However, these types of tests are typically prospective laboratory studies conducted in controlled environments.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This submission is about the sterility and packaging of medical implants, not a diagnostic or clinical performance study that would require expert ground truth labeling. The "ground truth" here is the scientific validation of sterilization methods and shelf life according to recognized standards and FDA guidance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically used in clinical studies for establishing ground truth, which is not relevant to this submission on sterile packaging.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/software device and no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this submission relies on:

• Scientific Validation of Sterilization: Adherence to established scientific principles and FDA guidance for sterilization (gamma radiation), demonstrating a Sterility Assurance Level (SAL).
• Accelerated Aging Data: Laboratory testing to simulate real-time aging and demonstrate that the sterile barrier packaging system maintains sterility for the stated shelf life.
• Material and Design Specification Conformity: Confirmation that the components are manufactured from specified materials and that their design, technical requirements, and intended use are identical to the non-sterile predicate devices.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As this is not a machine learning or AI device, there is no training set and therefore no ground truth establishment for a training set.

Summary

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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 SpineBuilding 59 / Route 17 SouthAllendale, New Jersey 07401
Contact Person	Ms. Soraya KingRegulatory Affairs SpecialistPhone: 201-760-8296Fax: [phone]Email: [e-mail]
Date Prepared	December 13, 2013
Trade/Device Name	1. MANTIS® & MANTIS® Redux Spinal Systems2. Radius® Spinal System3. TRIO® & TRIO + Spinal Fixation Systems4. TRIO® TRAUMA Spinal System5. XIA® Spinal Systems6. XIA® 3 Spinal System7. XIA® 4.5 Spinal System
Common Name	Spinal Fixation Appliances
Regulatory Class,Regulation Number,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 DeviceModifications	The STRYKER Spine thoraco-lumbar spinal fixation systems, subjectof this 510(k), are non-cervical, pedicle and non-pedicle fixationsystems comprised of screws, rods, plates, hooks, connectors, washersand staples. The components are manufactured from either Titanium(Titanium Alloy and CP Titanium), Stainless Steel or Cobalt-Chromium-Molybdenum Alloy (Vitallium®).This Special 510(k) submission seeks clearance for sterile labeling ofthe listed STRYKER Spine thoraco-lumbar spinal fixation systems.All of the components of the subject devices will be sterilized by
gamma radiation, a traditional sterilization method as per FDAguidance document, Updated 510(k) Sterility Review Guidance K90-1;Guidance for Industry and FDA.
Intended Use	MANTIS® & MANTIS Redux Spinal Systems (K102235)The MANTIS® Spinal System and MANTIS® Redux Spinal System isintended for percutaneous, posterior, non-cervical pedicle and non-pedicle fixation of the spine to provide immobilization andstabilization of spinal segments in skeletally mature patients as anadjunct to fusion for the following indications:Degenerative Disc Disease (defined as back pain of discogenicorigin with degeneration of the disc confirmed by history andradiographic studies); Spondylolisthesis; Trauma (i.e. fracture or dislocation); Spinal Stenosis; Curvature (i.e. scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthrosis; and Failed Previous FusionRadius® Spinal System (K101144)The Radius® Spinal System is intended for use in the noncervicalspine. 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 fusionusing autograft or allograft in skeletally mature patients in thetreatment of the following acute and chronic instabilities ordeformities:Degenerative Disc Disease (DDD) (defined as back pain ofdiscogenic origin with degeneration of the disc confirmed byhistory 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 ofdiscogenic origin with degeneration of the disc confirmed byhistory 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 inconjunction with the OSS Diapson Rods, Opus Spinal System Rods,and the Multi-Axis Cross Connectors.
➤	Stryker Spine TRIO® + Spinal System (K070368 & K100737)
	The Stryker Spine TRIO® Spinal System is intended for posterior,noncervical pedicle and nonpedicle fixation of the spine to provideimmobilization and stabilization of spinal segements in skeletallymature patients as an adjunct to fusion for the following indications:
●	Degenerative Disc Disease (DDD) (defined as back pain ofdiscogenic origin with degeneration of the disc confirmed byhistory 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 conjunctionwith the OSS/Diapason Rods or Opus Rods, XIA® Pre-bent Rods, and

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1

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 andOPUS® Spinal System are intended to be used with the othercomponents of the XIA® Titanium Spinal System. The TitaniumMulti-Axial Cross Connector are intended to be used with the othercomponents of the XIA® Titanium Spinal System
	XIA® 3 Spinal System (K113666)
	The XIA® 3 Spinal System is intended for use in the noncervicalspine. When used as an anterior/anterolateral and posterior,noncervical pedicle and non-pedicle fixation system, the XIA® 3Spinal System is intended to provide additional support during fusionusing autograft or allograft in skeletally mature patients in thetreatment of the following acute and chronic instabilities ordeformities:
•	Degenerative Disc Disease (DDD) (defined as back pain ofdiscogenic origin with degeneration of the disc confirmed byhistory 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 andthe Ø6.0mm Vitallium Rods from the XIA® Spinal System areintended to be used with the other components of the XIA® 3 SpinalSystem.
	When used for posterior noncervical pedicle screw fixation in pediatric
patients, the XIA® Spinal System implants are indicated as an adjunctto fusion to treat adolescent idiopathic scoliosis.
The XIA® 3 Spinal System for pediatric use is intended to be usedwith autograft and/or allograft. Pediatric pedicle screw fixation islimited to a posterior approach.
XIA® 4.5 Spinal System (K121342)
The XIA® 4.5 Spinal System is intended for anterior/anteriolateral andposterior, noncervical pedicle and non-pedicle fixation for thefollowing indications:
Degenerative Disc Disease (DDD) (defined as back pain ofdiscogenic origin with degeneration of the disc confirmed byhistory 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 Stryker Spine DIAPASON® Spinal System, OPUS® SpinalSystem and XIA® 4.5 Spinal System can be linked to the XIA® 4.5Spinal System via the rod-to-rod connector when used for theaforementioned indications in skeletally mature patients as an adjunctto fusion.
Except for the staples, the XIA® 4.5 Spinal System is indicated as anadjunct to fusion to treat adolescent idiopathic scoliosis when used forposterior noncervical pedicle screw fixation in pediatric patients. TheXIA® 4.5 Spinal System for pediatric use in intended to be used withautograft and/or allograft. Pediatric pedicle screw fixation is limited toa posterior approach.

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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 9 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

Summary of theTechnologicalCharacteristics

The sterile packed implant components for the spinal fixation systemshave the same technological characteristics as the non-sterile packedpredicate devices. These characteristics include same design, technicalrequirements, materials of construction, and indications/ intended use.Design modifications were not incorporated to facilitate sterilepackaging of the implants.

Conclusion

The subject devices that are intended to be sterile packed are safe andeffective as the predicate non-sterile devices. The subject devicesretain the same intended and indications for use, technologicalcharacteristics, and mode of operation as the predicate non-steriledevices. The accelerated aging data demonstrated that the sterilizationprocess and sterile barrier packaging system are effective inmaintaining sterility for the recommended 5 year shelf-life.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/10/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it, representing medicine and health. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol. The logo is in black and white.

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

December 17, 2013

Stryker Spine Ms. Soraya King Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401

Re: K133188

Trade/Device Name: MANTIS® and MANTIS® Redux Spinal Systems, Radius® Spinal System, TRIO® Spinal Fixation System, TRIO® Plate System, TRIO® + Spinal Fixation System, TRIO® TRAUMA Spinal System, XIA® Spinal Systems, XIA® 3 Spinal System, and XIA® 4.5 Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB,OSH, MNH, MNI, KWP, KWQ Dated: November 19, 2013 Received: November 20, 2013

Dear Ms. King:

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 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

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Page 2 - Ms. Soraya King

: 2014-04-2017

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 (OS) 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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please go to .

http://www.fda.gov/MedicalDevices/Safetv/ReportalProblem/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 vours.

Ronald#99ean -5 for

• Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
  Enclosures

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Indications for Use Statement

510(k) Number (if known): K133188

Device Name: MANTIS® and MANTIS® Redux Spinal Systems

Indications for Use:

The MANTIS® Spinal System and MANIS® Redux Spinal System is intended for percutancous, 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: ●
• Pseudoarthorisis; and .
• . Failed Previous Fusion

Prescription Use × AND/OR

Over-The-Counter Use

(21 CFR 801 Subpart D)

(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)

Zane W. Wyatt -S

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Indications for Use Statement

510(k) Number (if known): _ K133188

Device Name: Radius® Spinal System

Indications for Use:

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: .
• . Pseudoarthorisis;
• . and Failed Pervious Fusion

The Radius® Spinal System can also be linked to the XIA® Titanium Spinal System via the 05.5mm to Ø6.0mm Radius® rod-to-rod connector.

Prescription Use AND/OR ×

Over-The-Counter Use _

(21 CFR 801 Subpart D)

(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)

Zane W. Wyatt -S

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Indications for Use Statement

510(k) Number (if known): K133188

Device Name: 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;
• . Curvature (i.e. scoliosis, kyphosis, and/or lordosis);
• . Tumor:
• . Pseudoarthorisis;
• . and Failed Pervious 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.

x = : Prescription Use AND/OR Over-The-Counter Use (21 CFR 801 Subpart D) (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)

Zane W. Wyatt -S

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Indications for Use Statement

510(k) Number (if known): _K133188

Device Name: TRIO® Plate System

Indications for Use:

The Stryker Spine TRIO® Plate System is intended for posterior, noncervical (T10-S1) pedicle and nonpedicle 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

Prescription Use AND/OR X

Over-The-Counter Use

(21 CFR 801 Subpart D)

(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)

Zane W. Wyatt -S

1

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Indications for Use Statement

510(k) Number (if known): K133188

Device Name: TRIO® + Spinal Fixation System

Indications for Use:

5 -2017 - 12:25 - 1

. .

.

The Stryker Spine TRIO® Spinal System is intended for posterior, noncervical pedicle and nonpedicle fixation of the spine to provide immobilization 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

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

Prescription Use X AND/OR

Over-The-Counter Use

(21 CFR 801 Subpart D)

(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)

Zane W. Wyatt -S

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Indications for Use Statement

510(k) Number (if known): K133188

Device Name: TRIO® TRAUMA Spinal System

Indications for Use:

.

.

.

The Stryker Spine TRIO® TRAUMA Spinal System is intended for percutaneous, posterior, noncervical 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 (DD) (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 ●

Prescription Use X AND/OR

Over-The-Counter Use

(21 CFR 801 Subpart D)

(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)

Zane W. Wyatt -S

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Indications for Use Statement

510(k) Number (if known): K133188

Device Name: XIA® Spinal Systems

Indications for Use:

The XIA® Spinal System and XIA® 4.5 Spinal System are intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle 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.
• . Pseudoarthrosis and;
• . Failed previous fusion.

The 6mm diameter rods from the DIAPASON® Spinal System and OPUS® Spinal System are intended to be used with the other components of the XIA® Titanium Spinal System. The Titanium Multi-Axial Cross Connector are intended to be used with the other components of the XIA® Titanium Spinal System.

Prescription Use X

(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, Office of Device Evaluation (ODE)

l

Zane W. Wyatt -S

(Division Sign-Off) Division of Orthopedic Devices 510 (k) Number: K133188

Page 7 of 9

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Indications for Use Statement

510(k) Number (if known): K133188

Device Name: XIA@ 3 Spinal System

Indications for Use:

The XIA® 3 Spinal System is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle fixation system, the XIA® 3 Spinal System is intended to provide additional support during 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, .
• Pseudoarthorisis;
• . and Failed Pervious Fusion

The 05.5mm rods from the Stryker Spine Radius® Spinal System and the Ø6.0mm Vitallium Rods from the XIA@ Spinal System are intended to be used with the other components of the XIA® 3 Spinal System.

When used for posterior noncervical pedicle screw fixation in pediatric patients, the XIA® Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scollosis. The XIA@ 3 Spinal System for pediatic use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Prescription Use AND/OR X (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)

1

Zane W. Wyatt -S

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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

Indications for Use Statement

510(k) Number (if known): K133188

Device Name: XIA® 4.5 Spinal System

Indications for Use:

The XIA® 4.5 Spinal System is intended for anterior/anteriolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications:

• Degenerative Disc Disease (DD) (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

The Stryker Spine DIAPASON® Spinal System, OPUS® Spinal System and XIA® 4.5 Spinal

System can be linked to the XIA® 4.5 Spinal System via the rod-to-rod connector when used for

the aforementioned indications in skeletally mature patients as an adjunct to fusion.

Except for the staples, the XIA® 4.5 Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical pedicle screw fixation in pediatric patients. The XIA® 4.5 Spinal System for pediatric use in intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Prescription Use AND/OR Over-The-Counter Use

(21 CFR 801 Subpart D)

(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)

l

Zane W. Wyatt -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K133188

Page 9 of 9

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
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.
(b)
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.