(56 days)
No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended to provide additional support during fusion for various spinal instabilities and deformities, which is a therapeutic purpose.
No
The device description clearly states that the Xia® 3 and Xia® 4.5 Spinal Systems are comprised of screws, blockers, hooks, rods, and connectors that affix to vertebrae for stabilization or corrective action, indicating its function as an implantable surgical device for treatment, not diagnosis. The indications for use list various spinal conditions that the device treats, rather than diagnoses.
No
The device description explicitly states it is comprised of screws, blockers, hooks, rods, and connectors, which are physical hardware components intended for surgical implantation.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Xia® 3 and Xia® 4.5 Spinal Systems are described as implants comprised of screws, blockers, hooks, rods, and connectors that are surgically affixed to the vertebrae of the spinal column.
- Intended Use: The intended use is to provide structural support and stabilization to the spine during fusion procedures for various spinal conditions. This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
The device is a surgical implant used for treatment, not a diagnostic tool used to analyze biological samples.
N/A
Intended Use / Indications for Use
Xia® 3 Spinal System
The Xia® 3 Spinal System is intended for use in the non-cervical spine. When used as an anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the Xia® 3 Spinal System is intended to provide additional support during fusion using autograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
• Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- · Spondylolisthesis
- · Trauma (i.e. fracture of dislocation)
- · Spinal stenosis
- · Curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- Tumor
- Pseudarthrosis
- · Failed previous fusion
The 5.5 mm rods from the Stryker Spine Radius™ Spinal System and 6.0 mm 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, non-cervical, pedicle screw fixation in pediatric patients, the Xia® 3 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Xia® 3 Spinal System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system 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
The Xia® 4.5 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation for the following indications:
· Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- · Spondylolisthesis
- · Trauma (i.e. fracture of dislocation)
- · Spinal stenosis
- · Curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- Tumor
- Pseudarthrosis
- · Failed previous 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, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the Xia® 4.5 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis. kyphosis, or lordosis) including idiopathic scoliosis, and congenital scoliosis. Additionally, the Xia® 4.5 Spinal System is intended to treat pediatic patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Product codes
NKB, OSH, MNH, MNI, KWP, KWQ
Device Description
Xia® 3 Spinal System
The Xia® 3 Spinal System is comprised of screws, blockers, and hooks that affix rods and connectors to vertebrae of the spinal column for purposes of stabilization, or corrective action through the application of force.
Xia® 4.5 Spinal System
The Xia® 4.5 Spinal System is comprised of monoaxial and polyaxial bone and reduction screws, hooks, dual staples, and blockers that affix rods, rod-to-rod connectors, and cross connectors to vertebrae of the spinal column.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spine
Indicated Patient Age Range
skeletally mature patients, pediatric patients
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
This submission seeks to build upon predicate Xia® 3 and Xia® 4.5 Spinal Systems through expansion of indications only. Therefore, no additional performance data is necessary.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Medtronic Sofamor Danek, CD HORIZON® Spinal System: K140276, Stryker Spine Xia® 3 Spinal System: K113666, Stryker Spine Xia® 4.5 Spinal System: K121342, 133188
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol composed of three stylized human profiles facing right, with flowing lines extending from the heads.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 21, 2014
Stryker Spine Garry T. Hayeck, Ph.D. Senior Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401
Re: K142381 Trade/Device Name: Xia® 3 and Xia® 4.5 Spinal Systems 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: August 25, 2014 Received: August 28, 2014
Dear Dr. Hayeck:
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 vour 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Ronald#Alean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K142381
Device Name Xia® 3 Spinal System
Indications for Use (Describe)
The Xia® 3 Spinal System is intended for use in the non-cervical spine. When used as an anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the Xia® 3 Spinal System is intended to provide additional support during fusion using autograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
• Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- · Spondylolisthesis
- · Trauma (i.e. fracture of dislocation)
- · Spinal stenosis
- · Curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- Tumor
- Pseudarthrosis
- · Failed previous fusion
The 5.5 mm rods from the Stryker Spine Radius™ Spinal System and 6.0 mm 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, non-cervical, pedicle screw fixation in pediatric patients, the Xia® 3 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Xia® 3 Spinal System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Indications for Use
510(k) Number (if known) K142381
Device Name Xia® 4.5 Spinal System
Indications for Use (Describe)
The Xia® 4.5 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation for the following indications:
· Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- · Spondylolisthesis
- · Trauma (i.e. fracture of dislocation)
- · Spinal stenosis
- · Curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- Tumor
- Pseudarthrosis
- · Failed previous 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, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the Xia® 4.5 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis. kyphosis, or lordosis) including idiopathic scoliosis, and congenital scoliosis. Additionally, the Xia® 4.5 Spinal System is intended to treat pediatic patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
5
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
6
| 510(k) Summary: Xia® 3 and Xia® 4.5 Spinal Systems | |
|---|---|
| Submitter | Stryker Spine |
| 2 Pearl Court | |
| Allendale, NJ 07401 | |
| Contact Person | Garry T. Hayeck, Ph.D. |
| Senior Regulatory Affairs Specialist | |
| Phone: 201-760-8043 | |
| Fax: 201-760-8406 | |
| E-mail: garry.hayeck@stryker.com | |
| Date Prepared | October 2, 2014 |
| Trade Names | 1. Xia® 3 Spinal System |
-
Xia® 4.5 Spinal System |
| Common Name | 1. Xia® 3 Spinal System
Spinal Fixation Appliances -
Xia® 4.5 Spinal System
Spinal Fixation Appliances |
| Proposed Class | 1. Xia® 3 Spinal System
Class III -
Xia® 4.5 Spinal System
Class III |
| Classification Name,
Codification | 1. Xia® 3 Spinal System Spinal Interlaminal Fixation Orthosis, 21 CFR § 888.3050 Spinal Intervertebral Body Fixation Orthosis, 21 CFR § 888.3060 Pedicle Screw Spinal System, 21 CFR § 888.3070 (b) (1) & (b) (2) 2. Xia® 4.5 Spinal System Spinal Interlaminal Fixation Orthosis, 21 CFR § 888.3050 Spinal Intervertebral Body Fixation Orthosis, 21 CFR § 888.3060 Pedicle Screw Spinal System, 21 CFR § 888.3070 (b) (1) & (b) (2) |
| Product Codes | 1. Xia® 3 Spinal System
OSH, NKB, KWP, KWQ, MNH, MNI -
Xia® 4.5 Spinal System
OSH, NKB, KWP, KWQ, MNH, MNI |
| Predicate Devices | 1. Xia® 3 Spinal System Primary Predicate: Medtronic Sofamor Danek, CD HORIZON®
Spinal System: K140276 Additional Predicate: Stryker Spine Xia® 3 Spinal System: K113666,
133188 2. Xia® 4.5 Spinal System Primary Predicate: Medtronic Sofamor Danek, CD HORIZON®
Spinal System: K140276 Additional Predicate: Stryker Spine Xia® 4.5 Spinal System:
K121342, 133188 |
| Device Description | 1. Xia® 3 Spinal System
The Xia® 3 Spinal System is comprised of screws, blockers, and |
| | hooks that affix rods and connectors to vertebrae of the spinal
column for purposes of stabilization, or corrective action through
the application of force. |
| | 2. Xia® 4.5 Spinal System
The Xia® 4.5 Spinal System is comprised of monoaxial and polyaxial
bone and reduction screws, hooks, dual staples, and blockers that
affix rods, rod-to-rod connectors, and cross connectors to
vertebrae of the spinal column. |
| Indications for Use | 1. Xia® 3 Spinal System
The Xia® 3 Spinal System is intended for use in the non-cervical
spine. When used as an anterior/anterolateral and posterior, non-
cervical 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 (as defined by back pain of
discogenic origin with degeneration of the disc confirmed by
patient history and radiographic studies)
• Spondylolisthesis
• Trauma (i.e. fracture of dislocation)
• Spinal stenosis
• Curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Tumor
• Pseudarthrosis
• Failed previous fusion |
| | The 5.5 mm rods from the Stryker Spine Radius™ Spinal System and
6.0 mm 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, non-cervical, pedicle screw fixation in
pediatric patients, the Xia® 3 Spinal System implants are indicated
as an adjunct to fusion to treat progressive spinal deformities (i.e.,
scoliosis, kyphosis, or lordosis) including idiopathic scoliosis,
neuromuscular scoliosis, and congenital scoliosis. Additionally, the
Xia® 3 Spinal System is intended to treat pediatric patients
diagnosed with: spondylolisthesis/spondylolysis, fracture caused by
tumor and/or trauma, pseudarthrosis, and/or failed previous fusion.
This system is intended to be used with autograft and/or allograft.
Pediatric pedicle screw fixation is limited to a posterior approach. |
| | 2. Xia® 4.5 Spinal System
The Xia® 4.5 Spinal System is intended for anterior/anterolateral
and posterior, non-cervical pedicle and non-pedicle fixation for
the following indications: |
| | • Degenerative Disc Disease (as defined by back pain of
discogenic origin with degeneration of the disc confirmed by
patient history and radiographic studies) |
| | • Spondylolisthesis
• Trauma (i.e. fracture of dislocation)
• Spinal stenosis
• Curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Tumor
• Pseudarthrosis
• Failed previous 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, when used for posterior non-cervical pedicle
screw fixation in pediatric patients, the Xia® 4.5 Spinal System
implants are indicated as an adjunct to fusion to treat progressive
spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including
idiopathic scoliosis, neuromuscular scoliosis, and congenital
scoliosis. Additionally, the Xia® 4.5 Spinal System is intended to
treat pediatric patients diagnosed with:
spondylolisthesis/spondylolysis, fracture caused by tumor and/or
trauma, pseudarthrosis, and/or failed previous fusion. This system is
to be used with autograft and/or allograft. Pediatric pedicle screw
fixation is limited to a posterior approach. |
| Summary of
Technological
Characteristics | 1. Xia® 3 Spinal System
The subject Xia® 3 Spinal System shares the same materials,
geometries, and fundamental scientific technologies as the
predicate Xia® 3 Spinal System. None of the aforementioned
characteristics have been altered, augmented, or otherwise
changed. |
| | 2. Xia® 4.5 Spinal System
The subject Xia® 4.5 Spinal System shares the same materials,
geometries, and fundamental scientific technologies as the
predicate Xia® 4.5 Spinal System. None of the aforementioned
characteristics have been altered, augmented, or otherwise
changed. |
| Summary of
Performance Data | This submission seeks to build upon predicate Xia® 3 and Xia® 4.5
Spinal Systems through expansion of indications only. Therefore, no
additional performance data is necessary. |
| Conclusion | 1. Xia® 3 Spinal System
The devices of the subject Xia® 3 Spinal System are equivalent in
materials, geometries, and intended use to the previously cleared
Xia® 3 Spinal System and CD Horizon System. The expanded
indications of the Xia® 3 Spinal System are identical to the
indications of the predicate CD Horizon System. We therefore
conclude that the subject Xia® 3 Spinal System is substantially
equivalent to the identified predicate systems. |
| | The devices of the subject Xia® 4.5 Spinal System are equivalent in
materials, geometries, and intended use to the previously cleared
Xia® 4.5 Spinal System and CD Horizon System. The expanded
indications of the Xia® 4.5 Spinal System are identical to the
indications of the predicate CD Horizon System. We therefore
conclude that the subject Xia® 4.5 Spinal System is substantially
equivalent to the identified predicate systems. |
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