(49 days)
No
The summary describes a mechanical spinal fixation system and its components. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are mechanical tests and a literature analysis, not studies of algorithmic performance.
Yes
The device is intended to treat various medical conditions affecting the spine such as degenerative disc disease, spondylolisthesis, trauma, and scoliosis, which are therapeutic indications.
No
The device is a spinal system (implants like screws, hooks, and connectors) intended for fixation in spinal surgeries to treat various conditions. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states that the XIA® 4.5 Spinal System consists of physical components such as bone screws, hooks, blockers, and connectors, which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system for spinal fixation. This involves physically stabilizing the spine for various conditions.
- Device Description: The device is described as a system of screws, hooks, rods, and connectors made of titanium. These are physical components used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / 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 (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 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 posterior noncervical pedicle screw fixation in pediatric patients, the XIA 4.5 Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The XIA 4.5 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.
Product codes (comma separated list FDA assigned to the subject device)
OSH, NKB, KWP, KWQ, MNH, MNI
Device Description
The XIA® 4.5 Spinal System consists of a variety of titanium Monoaxial & Polyaxial Bone Screws, Monoaxial & Polyaxial Reduction Screws, Hooks, Blockers, Rod Connectors, Dual Staples and Connectors. The existing components of the XIA 4.5 Spinal System were determined substantially equivalent through K050461 for class II indications consistent with 21 CFR 888.3070 (b) (1). The indications were expanded through K060361 to include class III indications per product code NKB, 21 CFR 888.3070 (b) (2). Subsequent line extensions have been cleared through K060748, and K092605.
The expansion of indications for the XIA 4.5 Spinal System is proposed for the inclusion of adolescent idiopathic scoliosis alone, and not other indications for a pediation. As pediatric patients are unlikely to exhibit symptoms of degenerative disc disease (DDD) or stenosis due to the wear and tear on the spine necessary to develop these diseases, expansion of these indications to a pediation is not warranted.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
noncervical pedicle and non-pedicle (spinal)
Indicated Patient Age Range
Pediatric patients, 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)
Testing performed on this device that the XIA 4.5 Spinal System is substantially equivalent to predicate devices. Mechanical testing of the system included static and dynamic compression bending testing and static torsion testing per ASTM F1717and interconnection strength testing per ASTM F1798, as well as, a clinical literature analysis.
The XIA 4.5 Spinal System was shown to be substantially equivalent to previously cleared devices with respect to its indications for use, design, function, and materials.
The Xia 4.5 Spinal System substantial equivalence determination to the predicate systems is based on dimensional comparisons and engineering analyses in addition to preclinical testing.
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.
K091445, K102807, K994121, K103287, K092605, K060361
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.
K050461, K060361, K060748, K092605
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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K121342 Page 1 of 3
510(K) SUMMARY
1.1 Applicant
Stryker Spine 2 Pearl Court. Allendale, NJ 07401 Phone: (201)-760-8206 Fax: (201)-760-8406 E-mail: tiffani.rogers@stryker.com
Contact Information:
Tiffani Rogers Regulatory Affairs Manager Stryker Spine Two Pearl Court Allendale, NJ 07401 Phone: (201)- 760-8206 Fax: (201)-760-8406 E-mail: tiffani.rogers@stryker.com
1.2 Device Trade Name:
XIA® 4.5 Spinal System
1.3 Device Common Name:
Spinal Fixation Appliances
1.4 Establishment Registration Number 3004024955
Manufacturer Address 1.5
Stryker Spine Zone Industrielle Demarticot Cestas, France 33610 Phone: + 33 577 97 08 40 Manufacturer Establishment Number: 9617544 JUN 2 2 2 2012
1
And
Stryker Spine Le Cret Du Locle 10a La Chaux De Fonds Switzerland 2300 Establishment Registration Number: 3005525032
1.6 Device Classification:
Primary Classification - Class: II Classification: 21 CFR 888.3070 (b) (1) & (b) (2) Classification Name: Pedicle Screw Spinal System
Additional Classification (K60361, K060979) - Class: II/III Classification: 21 CFR §888.3060 Classification Name: Pedicle Screw Spinal Intervertebral Body Fixation Orthosis
Additional Classification (K060748) - Class: II/III Classification: 21 CFR 888.3050 Classification Name: Pedicle Screw Spinal System, Spinal Interlaminal Fixation Orthosis
1.7 Device Product Codes: OSH, NKB, KWP, KWQ, MNH, MNI
Device Description/Modification: 1.8
The XIA® 4.5 Spinal System consists of a variety of titanium Monoaxial & Polyaxial Bone Screws, Monoaxial & Polyaxial Reduction Screws, Hooks, Blockers, Rod Connectors, Dual Staples and Connectors. The existing components of the XIA 4.5 Spinal System were determined substantially equivalent through K050461 for class II indications consistent with 21 CFR 888.3070 (b) (1). The indications were expanded through K060361 to include class III indications per product code NKB, 21 CFR 888.3070 (b) (2). Subsequent line extensions have been cleared through K060748, and K092605.
The expansion of indications for the XIA 4.5 Spinal System is proposed for the inclusion of adolescent idiopathic scoliosis alone, and not other indications for a pediation. As pediatric patients are unlikely to exhibit symptoms of degenerative disc disease (DDD) or stenosis due to the wear and tear on the spine necessary to develop these diseases, expansion of these indications to a pediation is not warranted.
2
1.9 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 (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
- I Spondvlolisthesis:
- D Trauma (i.e. fracture or dislocation);
- Spinal stenosis;
- 미 Curvatures (i.e. scoliosis, kyphosis, and/or lordosis);
- 미 Tumor;
- Pseudoarthrosis: and
- 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 posterior noncervical pedicle screw fixation in pediatric patients, the XIA 4.5 Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The XIA 4.5 Spinal System for pediatric use is intended to be used with autograft and/or allografi. Pediatric pedicle screw fixation is limited to a posterior approach.
Predicate Devices 1.10
- I Medtronic Sofamor Danek, CD Horizon Spinal System, K091445 and K102807
- 피 Synthes Spine USS Small Structure System, K994121 and K103287;
- D Stryker Spine XIA 4.5 Spinal System, K092605 and K060361;
Substantial Equivalence 1.11
Testing performed on this device that the XIA 4.5 Spinal System is substantially equivalent to predicate devices. Mechanical testing of the system included static and dynamic compression bending testing and static torsion testing per ASTM F1717and interconnection strength testing per ASTM F1798, as well as, a clinical literature analysis.
The XIA 4.5 Spinal System was shown to be substantially equivalent to previously cleared devices with respect to its indications for use, design, function, and materials.
The Xia 4.5 Spinal System substantial equivalence determination to the predicate systems is based on dimensional comparisons and engineering analyses in addition to preclinical testing.
3
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 27, 2013
Stryker Corporation % Ms. Tiffani Rogers Regulatory Affairs Manager 2 Pearl Court Allendale, New Jersey 07401
Re: K121342
Trade/Device Name: Xia 4.5 Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, OSH, KWP, KWQ, MNH, MNI Dated: May 2, 2012 Received: May 4, 2012
Dear Ms. Rogers:
This letter corrects our substantially equivalent letter of June 22, 2012.
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. 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
4
Page 2 - Ms. Tiffani Rogers
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 (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.
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" (21CFR 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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/4/Picture/7 description: The image shows the name "Erin DKeith" in a bold, sans-serif font. The letters "Erin" and "ith" are clear and easily readable. The letters "DKe" are stylized with overlapping lines and shapes, making them appear more abstract and decorative.
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K121342
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:
- 트 Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
- Spondylolisthesis: l
- Trauma (i.e. fracture or dislocation); B
- Spinal stenosis; I
- Curvatures (i.e. scoliosis, kyphosis, and/or lordosis);
- 1 Tumor;
- . Pseudoarthrosis; and
- 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, the Xia 4.5 Spinal System .is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical pediation in pediatic patients. The XIA 4.5 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.
Over-The-Counter Prescription Use Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KI21342 510(k) Number.