(61 days)
No
The document describes a collection of spinal fixation systems comprised of mechanical components (screws, rods, plates, etc.) and focuses on their intended use, materials, and sterilization method. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
Yes
The devices are intended to provide immobilization and stabilization of spinal segments, support during fusion, and treat various spinal conditions like degenerative disc disease, scoliosis, and trauma, which are therapeutic functions.
No
Explanation: This device is a spinal fixation system, which is an implant used to immobilize and stabilize spinal segments as an adjunct to fusion. Its intended use is therapeutic (treatment of conditions), not diagnostic.
No
The device description explicitly states it is comprised of physical components like screws, rods, plates, hooks, connectors, washers, and staples, made from materials like Titanium, Stainless Steel, or Cobalt-Chromium-Molybdenum Alloy. This indicates it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a spinal fixation system used for surgical implantation to provide immobilization and stabilization of spinal segments. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as being comprised of physical components like screws, rods, plates, hooks, connectors, washers, and staples, made from materials like Titanium, Stainless Steel, or Cobalt-Chromium-Molybdenum Alloy. These are all components of an implantable medical device used in surgery.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided text does not mention any interaction with biological specimens for diagnostic purposes.
- Performance Studies: The performance study mentioned focuses on the effectiveness of the sterilization process and packaging for maintaining sterility, which is relevant for an implantable surgical device, not an IVD.
Therefore, the MANTIS®, Radius®, TRIO®, and XIA® Spinal Systems described are medical devices intended for surgical implantation and stabilization of the spine, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for 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; 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 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 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 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.
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 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
XIA® 3 Spinal System (K113666)
The XIA® 3 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 XIA® 3 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 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 scoliosis. The XIA® 3 Spinal System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
XIA® 4.5 Spinal System (K121342)
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 (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 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.
Product codes (comma separated list FDA assigned to the subject device)
NKB, OSH, MNH, MNI, KWP, KWQ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spine (T10-S1)
Indicated Patient Age Range
skeletally mature patients, pediatric patients (for adolescent idiopathic scoliosis)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K061813, K073151, K092631, K102235, K062270, K07063, K082608, K101144, K052971, K062698, K070368, K100737, K103292, K982494, K013823, K031893, K043473, K052181, K060361, K060979, K071373, K083393, K091291, K113666, K050461, K060361, K060748, K060979, K092605, K121342
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
Building 59 / Route 17 South
Allendale, New Jersey 07401 | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person | Ms. Soraya King
Regulatory Affairs Specialist
Phone: 201-760-8296
Fax: 201-962-4296
Email: soraya.king@stryker.com | |
| Date Prepared | December 13, 2013 | |
| Trade/Device Name | 1. MANTIS® & MANTIS® Redux Spinal Systems
2. Radius® Spinal System
3. TRIO® & TRIO + Spinal Fixation Systems
4. TRIO® TRAUMA Spinal System
5. XIA® Spinal Systems
6. XIA® 3 Spinal System
7. 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 Device
Modifications | 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. | | |
| 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); | |
1
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
2
Bundled Submission STRYKER SPINE Thoraco-lumbar Spinal Systems –
MANTIS®, MANTIS® Redux, Radius®, TRIO® & TRIO® +, TRIO® Trauma, XIA®,
Page 3 of 10
3
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
4
:
.
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 |
| 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 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 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 |
.
:
5
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
.
.
.
Page 6 of 10
6
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; .
7
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 | |
| 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 | |
| XIA® 3 Spinal System (K113666) | |
| The XIA® 3 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 XIA® 3 | |
| 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 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 scoliosis. | |
| The XIA® 3 Spinal System for pediatric use is intended to be used | |
| with autograft and/or allograft. Pediatric pedicle screw fixation is | |
| limited to a posterior approach. | |
| XIA® 4.5 Spinal System (K121342) | |
| 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 (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 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. |
8
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
9
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 the
Technological
Characteristics | The sterile packed implant components for the spinal fixation systems
have the same technological characteristics as the non-sterile packed
predicate devices. These characteristics include same design, technical
requirements, materials of construction, and indications/ intended use.
Design modifications were not incorporated to facilitate sterile
packaging of the implants. |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | The subject devices that are intended to be sterile packed are safe and
effective as the predicate non-sterile devices. The subject devices
retain the same intended and indications for use, technological
characteristics, and mode of operation as the predicate non-sterile
devices. The accelerated aging data demonstrated that the sterilization
process and sterile barrier packaging system are effective in
maintaining sterility for the recommended 5 year shelf-life. |
i
10
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
11
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
12
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
13
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
14
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
15
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
16
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
17
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
18
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
19
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
20
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