(89 days)
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Not Found
No
The 510(k) summary describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as an "Interspinous Fusion System" intended for "supplemental fixation" and "supplemental fusion" in the spine for conditions such as degenerative disc disease, spondylolisthesis, trauma, and tumor. These uses clearly indicate a therapeutic purpose to treat or alleviate these medical conditions.
No
The device is described as a "supplemental fixation device" intended for "achieving supplemental fusion" and "supplemental stabilization of the spinous processes to support fusion." It is an implant used for treatment, not for diagnosis.
No
The device description clearly states it consists of physical components (plates and inserts made of titanium alloy and PEEK) intended for surgical implantation.
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 for spinal fusion, which is an in-vivo procedure (performed within the living body).
- Device Description: The description details physical components (plates and inserts) made of materials suitable for implantation.
- Performance Studies: The performance studies focus on biomechanical testing of the implant's structural integrity and performance within a simulated spinal environment, not on analyzing biological samples.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
N/A
Intended Use / Indications for Use
The Axle PEEK Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1 inclusive). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: 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); and/or tumor. The Axle PEEK Interspinous Fusion System is intended for use with bone graft material, and not for stand-alone use.
Product codes (comma separated list FDA assigned to the subject device)
KWP
Device Description
The Axle PEEK Interspinous Fusion System consists of plates and inserts of various sizes that are used to provide supplemental stabilization of the spinous processes to support fusion. The system components can be assembled in a variety of configurations so that adaptations can be made to take into account pathology and individual patient anatomy. The implant components are provided clean and non-sterile.
The plate components of the device are made from titanium alloy per ASTM F136 and the insert components are made from polyetheretherketone (Invibio PEEK-Optima LT1).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
non-cervical spine (T1-S1 inclusive)
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)
The implant components were tested using the following standards:
ASTM F1717 – Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
- Static Compression Bending .
- . Static Torsion
- Fatigue Compression Bending .
In conclusion, biomechanical testing results indicate that the Axle PEEK Interspinous Fusion System is substantially equivalent to predicate device performance and is capable of safely and effectively performing in accordance with its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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
§ 888.3050 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.
0
2112592
DEC - 5 2011
510(k) Summary
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | X-spine Systems, Inc. |
|---|---|
| 452 Alexandersville Rd. | |
| Miamisburg, OH 45342 | |
| Telephone (937) 847-8400 | |
| FAX (937) 847-8410 | |
| Official Contact: | David Kirschman, MD |
| Chief Medical Officer | |
| Date Prepared: | September 6, 2011 |
DEVICE NAME
| Trade/Proprietary Name: | Axle PEEK Interspinous Fusion System |
|---|---|
| Common Name(s): | Interspinous Process Fixation System |
| Classification Name(s): | Spinal Interlaminal Fixation Orthosis |
| Device Class: | Class II |
$888.3050
KWP
ESTABLISHMENT REGISTRATION NUMBER
X-spine Systems, Inc. has submitted an Establishment Registration to FDA. The Establishment Registration number is 3005031160. The owner/operator number for X-spine Systems, Inc. is 9063903.
INTENDED USE
Classification(s):
Product Codes(s):
The Axle PEEK Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1 inclusive). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: 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); and/or tumor. The Axle PEEK Interspinous Fusion System is intended for use with bone graft material, and not for stand-alone use.
1
DEVICE DESCRIPTION
The Axle PEEK Interspinous Fusion System consists of plates and inserts of various sizes that are used to provide supplemental stabilization of the spinous processes to support fusion. The system components can be assembled in a variety of configurations so that adaptations can be made to take into account pathology and individual patient anatomy. The implant components are provided clean and non-sterile.
The plate components of the device are made from titanium alloy per ASTM F136 and the insert components are made from polyetheretherketone (Invibio PEEK-Optima LT1).
COMPARISON TO CLEARED DEVICE
X-spine Systems, Inc. has submitted information to demonstrate that, for the purposes of FDA's regulation of medical devices, the Axie PEEK Interspinous Fusion System substantially meets the performance criteria established by the cleared parent device. The modified device is substantially equivalent to predicate device based on a comparison including the following characteristics:
- . FDA Product Code
- . Intended Uses
- . Surgical Approach
- . Anatomical Region
- . Product Dimensions
- . Mechanical Performance
PERFORMANCE DATA
The implant components were tested using the following standards:
ASTM F1717 – Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
- Static Compression Bending .
- . Static Torsion
- Fatigue Compression Bending .
In conclusion, biomechanical testing results indicate that the Axle PEEK Interspinous Fusion System is substantially equivalent to predicate device performance and is capable of safely and effectively performing in accordance with its intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC - 5 2011
X-spine Systems, Inc. % David Kirschman, MD Chief Medical Officer 452 Alexandersville Road Miamisburg, Ohio 45342
Re: K112592
Trade/Device Name: Axle PEEK Interspinous Fusion System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: November 04, 2011 Received: November 07, 2011
Dear Dr. Kirschman:
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
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Page 2 - David Kirschman, MD
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K112592
Device Name: Axle PEEK Interspinous Fusion System
Indications for Use:
The Axle PEEK Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1 inclusive). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: 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); and/or tumor. The Axle PEEK Interspinous Fusion System is intended for use with bone graft material, and not for standalone use.
Prescription Use __ × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
17 1.4 21 0.80
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KI12592 510(k) Number_