(135 days)
Not Found
No
The 510(k) summary describes a spinal fixation system and its components. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on engineering analysis and testing related to the mechanical properties of the device.
Yes
The device is intended to provide additional support during fusion for various spinal conditions, indicating a direct role in treating or mitigating a disease or condition.
No
Explanation: The device is a spinal system intended for providing additional support during fusion in patients with various spine conditions. Its purpose is therapeutic (providing support and stabilization), not diagnostic (identifying or characterizing a disease).
No
The device description explicitly states the addition of "various screws, connectors and a hook," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system used to provide support during spinal fusion. This is a therapeutic intervention performed in vivo (within the body), not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The device is described as a spinal system including screws, connectors, and a hook. These are physical implants, not reagents, instruments, or software used for analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), diagnostic purposes, or any of the typical components or processes associated with IVD devices.
Therefore, the Stryker Spine XIA 3 Spinal System is a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Stryker Spine 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;
- Curvatures (i.e., scoliosis, kyphosis, and/or lordosis); .
- Tumor; .
- . Pseudoarthrosis; and
- Failed previous fusion. .
The Ø5.5 mm rods from the Stryker Spine Radius Spinal System and Ø6.0 mm Vitallium rods from XIA Spinal System are intended to be used with the other components of XIA 3 Spinal System.
Product codes (comma separated list FDA assigned to the subject device)
NKB, MNI, MNH, KWQ, KWP
Device Description
This 510(k) is intended to introduce an extension to the existing Xia® 3 Spinal System. The proposed line extension includes the addition of various screws, connectors and a hook.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
noncervical spine
Indicated Patient Age Range
skeletally mature patients
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)
Documentation is provided which demonstrates the new components of the Stryker Spine Xia® 3 Spinal System to be substantially equivalent to the predicate devices in terms of material, design, and indications for use. Engineering analysis and testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 were completed for the Stryker Spine Xia® 3 Spinal System, including the subject components.
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.
K071373, K062270, K013823, K950697
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of a symbol that resembles a caduceus, which is a traditional symbol associated with medicine and healthcare. The logo is presented in black and white.
Stryker Spine % Mr. Curtis Truesdale Regulatory Affairs Project Manager 2 Pearl Court Allendale, New Jersey 07401
APR 23 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K083393
Trade/Device Name: Stryker Spine XIA 3 Spinal System Regulation Number: 21 CFR 888.3070 Regulation Names: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, MNI, MNH, KWQ, KWP Dated: January 14, 2009 Received: January 16, 2009
Dear Mr. Truesdale:
This letter corrects the substantially equivalent letter dated April 1, 2009.
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your 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); 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
Page 2 - Mr. Curtis Truesdale
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buehrig
Mark N. N. elkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
XIA 3 Spinal System - Line Extension
Special 510(k) Premarket Notification
Indications for Use
510(k) Number (if known): K O 8 3 3 3 3 3 Device Name: Stryker Spine XIA 3 Spinal System - Line Extension
Indications for Use:
The Stryker Spine 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;
- Curvatures (i.e., scoliosis, kyphosis, and/or lordosis); .
- Tumor; .
- . Pseudoarthrosis; and
- Failed previous fusion. .
The Ø5.5 mm rods from the Stryker Spine Radius Spinal System and Ø6.0 mm Vitallium rods from XIA Spinal System are intended to be used with the other components of XIA 3 Spinal System.
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)
Noularebuem
. Restorative. and Neurological Devices
510(k) Number K083393
3
K083393
Page 1 of 2
Xia 3 Spinal System – Line Extension
Special 510(k) Premarket Notification
Special 510(k) Summary of Safety and Effectiveness: Xia® 3 Spinal System - Line Extension
| Proprietary Name: | Xia® 3 Spinal System – Line Extension |
|---|---|
| Common Name: | Spinal Fixation Appliances |
| Classification Name and Reference: | 1) 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) |
| Device Product Code: | NKB, KWP, KWQ, MNH, MNI |
| Proposed Regulatory Class: | Class III |
| For Information contact: | Curtis Truesdale
Regulatory Affairs Project Manager
2 Pearl Court
Allendale, NJ 07401
Telephone: (201) 760-8296
Fax: (201) 760-8496
Email: Curtis.Truesdale@Stryker.com |
| Date Summary Prepared: | November 14, 2008 |
| Predicate Devices | • Stryker Spine Xia® 3 Spinal System, K071373;
• Stryker Spine Radius® Spinal System, K062270;
• Stryker Spine Xia® II, K013823;
• Moss Miami System, K950697; |
| Description of Device Modification | This 510(k) is intended to introduce an extension to the existing
Xia® 3 Spinal System. The proposed line extension includes the
addition of various screws, connectors and a hook. |
| Intended Use | 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, 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; curvatures (i.e., scoliosis, kyphosis,
and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. |
| | The Ø5.5mm rods from the Stryker Spine Radius® Spinal System
and Ø6.0mm Vitallium rods from Xia® Spinal System are intended
to be used with the other components of Xia® 3 Spinal System. |
| Summary of the Technological
Characteristics | Documentation is provided which demonstrates the new components
of the Stryker Spine Xia® 3 Spinal System to be substantially
equivalent to the predicate devices in terms of material, design, and
indications for use. Engineering analysis and testing to demonstrate
compliance with FDA's Guidance for Spinal System 510(k)'s May
3, 2004 were completed for the Stryker Spine Xia® 3 Spinal System, |
4
:
Page 2 of
Special 510(k) Premarket Notification
including the subject components.