(103 days)
Not Found
Not Found
No
The device description focuses on the mechanical components (plates and screws) and their material properties, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as a plating system intended for stabilization and buttressing of bone graft, which is a structural and mechanical function, not directly therapeutic (e.g., treating a disease or condition).
No
The device is a plating system used for screw fixation and stabilization of bone graft, which are therapeutic interventions, not diagnostic ones.
No
The device description clearly outlines physical components made of titanium alloy (plates and screws), indicating it is a hardware medical device, not software-only.
Based on the provided information, the Butrex Plating System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for stabilizing the spine. This is a medical device used in vivo (within the body) for structural support and fixation.
- Device Description: The description details physical components like plates and screws made of titanium alloy, designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used for diagnostic purposes by analyzing samples outside the body. The Butrex Plating System is a therapeutic device used for surgical intervention.
N/A
Intended Use / Indications for Use
The Butrex Plating System is intended for anterior intravertebral body screw fixation/attachment to the LI-S1 spine over one vertebral body extending onto the adjacent intervertebral space. Due to variations in the anatomy, the plate is designed for applications caudal to the bifurcation of the great vessels. Specifically, the device is intended for stabilization and buttressing of bone graft over one motion segment following anterior structural reconstruction for degenerative disc disease (DDD). DDD is defined as follows: back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies.
Product codes (comma separated list FDA assigned to the subject device)
KWQ, KWO
Device Description
Butrex plates are titanium alloy plates containing two sockets for screw placement on one end of the plate and a buttressing surface one the other end. The plate incorporates a locking mechanism to prevent screw back-out. The plates are provided in lengths of 22 mm, 26 mm, and 32 mm. Butrex screws are titanium alloy screw with a self tapping thread design. Screw lengths of 16mm. 18mm and 20mm are available. The screws heads are dimensioned for either fixed or variable placement into the Butrex plate sockets.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L1-S1 spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Not Found
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.
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
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
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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
JAN 28 2002 |
| Official Contact: | David Kirschman, MD
Chief Medical Officer |
DEVICE NAME
| Classification Names: | Spinal Intervertebral Body Fixation Orthosis |
|---|---|
| Trade/Proprietary Name: | Butrex ™ Buttress Plating System |
| Common Name: | Buttress Plating System |
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.
DEVICE CLASSIFICATION
FDA has classified Spinal Intervertebral Body Fixation Orthoses as Class II devices (21 CFR 888.3060). The product code for spinal intervertebral body fixation Orthosis is KWQ. This device classification is reviewed by the Orthopedic Devices Branch.
INTENDED USE
The intended use of the Butrex Plating system and associated components is substantially equivalent to the intended use of predicate devices. The Butrex Plating System is intended for anterior intravertebral body screw fixation/attachment to the LI-S1 spine over one vertebral body extending onto the adjacent intervertebral space. Due to variations in the anatomy, the plate is designed for applications caudal to the bifurcation of the great vessels. Specifically, the device is intended for stabilization and buttressing of bone graft over one motion segment following
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anterior structural reconstruction for degenerative disc disease (DDD). DDD is defined as follows: back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies.
DEVICE DESCRIPTION
Butrex Plates
Butrex plates are titanium alloy plates containing two sockets for screw placement on one end of the plate and a buttressing surface one the other end. The plate incorporates a locking mechanism to prevent screw back-out. The plates are provided in lengths of 22 mm, 26 mm, and 32 mm.
Butrex Screws
Butrex screws are titanium alloy screw with a self tapping thread design. Screw lengths of 16mm. 18mm and 20mm are available. The screws heads are dimensioned for either fixed or variable placement into the Butrex plate sockets.
Material composition
The components of the Buttress Plating System are made of titanium alloy conforming to ASTM F136.
EQUIVALENCE TO MARKETED PRODUCT
X-spine Systems, Inc. has submitted information to demonstrate that, for the purposes of FDA's regulation of medical devices, the Buttress Plating System is substantially equivalent in indications and design principles to predicate devices, which have been determined by FDA to be substantially equivalent to pre-amendment devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Public Health Service
JAN 28 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
X-spine Systems, Inc. % David Kirschman, M.D. Chief Medical Officer 452 Alexandersville, Rd. Miamisburg, OH 45342
Re: K072943
Trade/Device Name: ButrexTM Buttress Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWO Dated: December 5, 2007 Received: December 6, 2007
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.
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.
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Page 2 - David Kirschman, M.D.
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 Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Mulkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Butrex Buttress Plating System
510(k): Premarket Notification
Indications for Use
510(k) Number (if known): KO72943
Device Name: Butrex™ Buttress Plating System
Indications for Use:
The Butrex Buttress Plating System is intended for anterior intravertebral body screw fixation/attachment to the L1-S1 spine over one vertebral body extending onto the adjacent intervertebral space. Due to variations in the anatomy, the plate is designed for applications caudal to the bifurcation of the great vessels. Specifically, the device is intended for stabilization and buttressing of bone graft over one motion segment following anterior structural reconstruction for degenerative disc disease (DDD). DDD is defined as follows: back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Mark N. Wilkerson
510(k) N
(revised 12/2/07)
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