(214 days)
Not Found
No
The description focuses on the mechanical properties and physical design of the device components (wafers, bone cement) for fracture reduction. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is described as being used for "reduction of spinal fractures," which is a direct treatment for a medical condition.
No
The device is described as a "vertebral fracture reduction device" and its intended use is "in the reduction of spinal fractures." This indicates a therapeutic or interventional function, not a diagnostic one.
No
The device description clearly states it is composed of physical components (wafers fabricated from PMMA and PEEK-OPTIMA) and is a vertebral fracture reduction device, not a software application.
Based on the provided information, the StaXx™ FX System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "in the reduction of spinal fractures." This is a therapeutic procedure performed directly on a patient's body.
- Device Description: The device is a physical implant (wafers) made of PMMA and PEEK, designed to be inserted into the vertebral body. This is a surgical device, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The StaXx™ FX System does not fit this description.
N/A
Intended Use / Indications for Use
The StaXx™ FX System is indicated for use in the reduction of spinal fractures. It is intended to be used in combination with Stryker Spineplex™ Radiopaque Bone Cement.
Product codes
LXH; NDN
Device Description
The StaXx™ FX System is a vertebral fracture reduction device composed of stackable wafers fabricated from preformed PMMA. The System includes a base wafer fabricated from PEEK-OPTIMA with 6% Barium Sulfate. The wafers are designed to be inserted incrementally into the vertebral body to form a column that provides the desired fracture reduction. Twenty-four wafers are provided per package. The wafers are provided in one width (8mm) with three lengths (20mm, 25mm, 30mm)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spinal
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)
mechanical testing demonstrated that the StaXx™ FX System meets the performance requirements for its intended use. Any differences between the StaXx™ FX and the predicate devices do no affect the safety or effectiveness of this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K041454, K040612, K041584, K032945, K033303
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
0
SPINE WAVE
K05.3336
Page 1 of 2
JUL - 3 2006
510(k) Summary StaXxTM FX System
I. Submitter Information
Spine Wave, Inc. Two Enterprise Drive Suite 302 Shelton, CT 06484 Telephone: 203-944-9494 203-944-9493 Telefax:
Contact: Ronald K. Smith Date Prepared: April 28, 2006
II. Device Information
| Trade name: | StaXx™ FX System |
|---|---|
| Common name: | Internal Fracture Reduction System |
| Classification: | Class II per 21 CFR 888.4540; Class II per 888.3027 |
| Classification Name: | Orthopedic manual surgical instrument; |
| Polymethylmethacrylate (PMMA) bone cement | |
| Product Code: | LXH; NDN |
III. Device Information
The StaXx™ FX System is a vertebral fracture reduction device composed of stackable wafers fabricated from preformed PMMA. The System includes a base wafer fabricated from PEEK-OPTIMA with 6% Barium Sulfate. The wafers are designed to be inserted incrementally into the vertebral body to form a column that provides the desired fracture reduction. Twenty-four wafers are provided per package. The wafers are provided in one width (8mm) with three lengths (20mm, 25mm, 30mm)
IV. Intended Use
The StaXx™ FX System is indicated for use in the reduction of spinal fractures. It is intended to be used in combination with Stryker Spineplex™ Radiopaque Bone Cement.
1
US 3336
:
V. Substantial equivalence¹
: . The StaXxTM FX System was demonstrated to be substantially equivalent to the following devices:
| Predicate Device | Manufacturer | 510(k) No. |
|---|---|---|
| KyphX® Xpander Inflatable Bone Tamps | Kyphon, Inc. | K041454 |
| SKy Bone Expander System | Disc-O-Tech, Ltd. | K040612 |
| KyphX® HV-R™ Bone Cement | Kyphon, Inc. | K041584 |
| Stryker Spineplex™ Radiopaque Bone Cement | Stryker Corporation | K032945 |
| The Wafer System | Spine Wave, Inc. | K033303 |
In addition, mechanical testing demonstrated that the StaXx™ FX System meets the performance requirements for its intended use. Any differences between the StaXx™ FX and the predicate devices do no affect the safety or effectiveness of this device.
.
:
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Image /page/2/Picture/1 description: The image shows a stylized drawing of what appears to be a bird in flight. The bird is represented with simple, bold lines, giving it an abstract and minimalist appearance. The lines suggest the shape of the bird's body, wings, and tail, with a sense of movement and dynamism conveyed through the curved and flowing lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 3 2006
Spine Wave, Inc. c/o Mr. Ronald K. Smith Director. Quality Systems and Regulatory Affairs Two Enterprise Drive Shelton, CT 06484
Re: K053336
Trade/Device Name: StaXx™ FX System Regulation Number: 21 CFR 888.3027, 21 CFR 888.4540 Regulation Name: PMMA bone cement; orthopedic manual surgical instrument Regulatory Class: Class II Product Code: NDN, HXG Dated: April 28, 2006 Received: May 1, 2006
Dear Mr. Smith:
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 Federall Food, Dr w 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 1.01 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 100-1050.
3
Page 2 - Mr. Ronald K. Smith
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
C Barbare Buchup
for
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
A. Indications for Use
510(k) Number (if known): _K053336
Device Name: _ .______________________________________________________________________________________________________________________________________________________________
Indications for Use:
The StaXx™ FX System is indicated for use in the reduction of spinal fractures. It is intended to be used in combination with Stryker Spiner Fractions. " (11)
Prescription Use (Part 21 CFR 801 Subpart D)
. :
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
:
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buchum
. Restorative. Division of Gr and Neurological Devices
Page 1 of 1
510(k) Number K053336