(56 days)
Not Found
No
The summary describes a mechanical fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended to buttress allografts in the spine to prevent expulsion or spinal cord impingement, which are therapeutic actions aimed at treating a medical condition.
No
The device is described as a fixation system intended to hold or buttress an allograft in place after a laminoplasty, and its components are implants. There is no indication that it is used to diagnose a condition or disease.
No
The device description explicitly states it is a "posterior implant system comprised of laminoplasty plates, hinge plates, and mounting screws" and includes "instrumentation to aid with implantation." These are physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "Laminoplasty Fixation System" used in the spine to hold or buttress an allograft. This is a surgical implant used in vivo (within the body).
- Device Description: The description details surgical implants (plates, screws) made of titanium alloy, designed for implantation into the spine.
- Anatomical Site: The specified anatomical site is the "lower cervical and upper thoracic spine (C3-T3)," which is part of the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples in vitro (outside the body), such as blood, urine, or tissue. It does not perform diagnostic tests or provide information about a patient's health status based on analysis of biological samples.
This device is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Xspan™ Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Xspan Laminoplasty Fixation System holds or buttresses the allograft in place in order to prevent expulsion of the allograft or impingement of the spinal cord.
Product codes
NQW
Device Description
The Xspan™ Laminoplasty Fixation System is a posterior implant system comprised of laminoplasty plates, hinge plates, and mounting screws. Various forms and sizes of these implants are available so that adaptations can be made to take into account the pathology and anatomy of an individual patient. The system components are manufactured from Titanium based alloy in accordance with ASTM F136. The single use only implants are provided sterile [gamma radiation] and should not be reused under any circumstances.
The system also includes instrumentation to aid with implantation. The instruments are supplied in a tray which is used for instrument sterilization and storage.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower cervical and upper thoracic spine (C3-T3)
Indicated Patient Age Range
Not Found
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)
Biocompatibility Evaluation: The implants are made of titanium alloy (ASTM F136), which has a long history of use as surgical implants and is proven to be biocompatible, corrosion-resistant, and non-toxic.
Mechanical Testing: Performed with reference to ASTM F2193 and ASTM F382. The Xspan™ Laminoplasty Fixation System demonstrated equivalent performance to predicate systems through static and dynamic 4-point bend testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 15, 2016
X-spine Systems, Incorporated Kriss Anderson Director, Regulatory Affairs 452 Alexandersville Road Miamisburg, Ohio 45342
Re: K160114
Trade/Device Name: Xspan™ Laminoplasty Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: NQW Dated: January 15, 2016 Received: January 19, 2016
Dear Kriss Anderson:
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 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 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/Resourcesfor You/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 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,
Lori A. Wiggins -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) K160114
R10011+
Device Name Xspan™ Laminoplasty Fixation System
Indications for Use (Describe)
The Xspan™ Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Xspan Laminoplasty Fixation System holds or buttresses the allograft in place in order to prevent expulsion of the allograft or impingement of the spinal cord.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
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510(K) SUMMARY (21 CFR 807.92)
Xspan™ Laminoplasty Fixation System January 15, 2016
l. SUBMITTER/MANUFACTURER:
X-spine Systems, Inc. 452 Alexandersville Rd. Miamisburg, OH 45342
Telephone (937) 847-8400 FAX (937) 847-8410
Establishment Registration Number: 3005031160
Mr. Kriss Anderson Official Contact: Director, Requlatory Affairs Email: kanderson@X-spine.com Telephone (937) 847-8400, ext. 137
ll. OWNER/OPERATOR:
Xtant Medical Inc. 604 Cruiser Lane Belgrade, MT 59714
Owner/Operator Number: 10028385
Official Correspondent:
Stephen Smith, Vice President Regulatory Assurance/ Quality Assurance Xtant Medical, Inc. Telephone (406) 388-0480
lll. DEVICE
Trade/Proprietary Name: Xspan™ Laminoplasty Fixation System Device Common Name: Orthosis, Spine, Plate, Laminoplasty, Metal Device Class: Class II Requlation Number: 21 CFR §888.3050 NQW - Orthosis, Spine, Plate, Laminoplasty, Product Code: Metal Orthopedic
Review Panel:
X-Spine Systems, Inc.
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IV. PREDICATE DEVICES
- Aesculap Implant Systems (AIS): AIS Laminoplasty Plating System (K103284; . K090354) (Primary Predicate)
- o This predicate has not been subject to a design related recall.
- NuVasive Laminoplasty Fixation System (K091623) o
- o This predicate has not been subject to a design related recall.
V. INTENDED USE
The Xspan™ Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Xspan™ Laminoplasty Fixation System holds or buttresses the allograft in place in order to prevent expulsion of the allograft or impingement of the spinal cord.
VI. DEVICE DESCRIPTION
The Xspan™ Laminoplasty Fixation System is a posterior implant system comprised of laminoplasty plates, hinge plates, and mounting screws. Various forms and sizes of these implants are available so that adaptations can be made to take into account the pathology and anatomy of an individual patient. The system components are manufactured from Titanium based alloy in accordance with ASTM F136. The single use only implants are provided sterile [gamma radiation] and should not be reused under any circumstances.
The system also includes instrumentation to aid with implantation. The instruments are supplied in a tray which is used for instrument sterilization and storage.
VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
The technological principle for both the subject and predicate devices is posterior fixation in the lower cervical and upper thoracic spine (C3 to T3), used in laminoplasty procedures. At a high level, the subject device Xspan™ Laminoplasty Fixation System and the predicate devices AIS Laminoplasty Plating System (K103284; K090354) and NuVasive Laminoplasty Fixation System (K091623) are based on the following same or equivalent technological elements:
- FDA Product Code: NQW Orthosis, Spine, Plate, Laminoplasty, Metal. .
- Implants use the same material: Titanium alloy. ●
- Equivalent intended uses. ●
- Variety of implant sizes and forms providing a range of options to accommodate variations in patient anatomy.
- Same anatomical region. ●
- Same surgical approach. ●
- Equivalent mechanical performance. ●
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The following difference exists between the subject device and the predicate devices:
- . Sterility - the Xspan™ implants are provided in sterile, single use packages. The predicate devices are provided non-sterile, and are sterilized by the user.
VIII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Evaluation
The implants of the Xspan™ Laminoplasty Fixation System are made of titanium allov. The titanium alloy conforms to ASTM F136 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. The titanium material has a long history of use as surgical implants and has been proven to be biocompatible, corrosion-resistant, and not toxic to the biologic environment. The comprehensive history of biocompatibility of the implant materials provides a rationale basis for not specifically performing additional testing for each additional biological effect.
Mechanical Testing
Mechanical testing was performed with reference to ASTM F2193 Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System and ASTM F382 Standard Specification and Test Method for Metallic Bone Plates. Performance data is provided in support of the substantial equivalence determination. The Xspan™ Laminoplasty Fixation System demonstrated equivalent performance to the predicate systems through static and dynamic 4-point bend testing.
IX. CONCLUSION
Based on a review of the information provided, X-spine finds that the Xspan™ Laminoplasty Fixation System is substantially equivalent to the referenced predicate device systems. The Xspan™ Laminoplasty Fixation System was found to have an equivalent safety and effectiveness profile compared to the referenced predicate systems.