(226 days)
No
The device description and performance studies focus solely on the mechanical properties and equivalence of the pedicle screw system components. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No
The device is described as a "Pedicle Screw System" intended for "posterior, non-cervical pedicle fixation" to provide "stabilization during the development of fusion." It is an implantable mechanical device used in surgery, not a therapeutic device designed to treat a condition through means like drug delivery, radiation, or electrical stimulation. Its purpose is structural support during a healing process.
No
This device is a pedicle screw system intended for spinal fixation and stabilization as an adjunct to fusion. It is a therapy device, not a diagnostic one, as it does not diagnose medical conditions but rather treats them.
No
The device description explicitly states it is comprised of physical components like screws, rods, and set screws, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system used for spinal fixation. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details physical components like screws, rods, and set screws made of titanium alloy. These are surgical implants.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on mechanical testing of the implants, which is relevant for surgical devices, not IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The XENON Pedicle Screw System does not fit this description.
N/A
Intended Use / Indications for Use
The XENON Pedicle Screw System is intended for posterior, non-cervical pedicle fixation in skeletally mature patients as an adjunct to fusion 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 and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. It is intended to provide stabilization during the development of fusion utilizing autograft or allograft bone graft.
Product codes
NKB, MNI, MNH
Device Description
The system is comprised of XENON standard polyaxial screws, hightop polyaxial screws, set screws, rods. The XENON polyaxial screw features a dual lead thread, 3 prong drive instrument interface and is self tapping. The polyaxial screws are offered in various diameters ranging from 4.5mm to 8.0mm and lengths ranging from 25mm and 80mm. The polyaxial screws range of motion is 50 degrees Medial/Lateral and 50 degrees Inferior/superior. The 5.5mm diameter rods are offered in lengths 35mm to 600mm. The rods are also offered in two profiles, straight and precontoured. The adjustable bridges are offered in 4 different sizes. The implants are manufactured from surgical grade titanium alloy (Ti6AI-4V).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical pedicle
Indicated Patient Age Range
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)
Mechanical static and dynamic testing was performed which provides reasonable assurance of safety and effectiveness for its intended use. Performance testing was performed per the recognized consensus standards and per the guidance document, Spinal 510(k)s- Guidance for Instustry and FDA Staff. The following testing was performed per ASTM F1717:
- Dynamic Compression Bending
- Static Torsion
- Static Compression Bending
The testing demonstrated that XENON Pedicle Screw System is substantially equivalent to the predicate Zodiac Polyaxial Spinal Fixation System device. It is similar in terms of general design, intended use, and technological characteristics to the predicate devices.
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 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.
0
Image /page/0/Picture/1 description: The image shows the Greek letter alpha in bold font above the words "Uptake Spine" in a stylized font. The letter alpha is in a sans-serif font and is larger than the words below it. The words "Uptake Spine" are in a serif font with a slight slant to the right. The image is in black and white.
JAN 2 5 2012
510(k) SUMMARY
XENON™ Pedicle Screw System November 2011
Company:
Alphatec Spine, Inc. 5818 El Camino Real Carlsbad, CA 92008 Direct: (760) 494-6770 (760) 431-0289 Fax:
| Contact Person: | Cheryl Allen, Sr. Regulatory Affairs Submissions Specialist |
|---|---|
| Trade/Proprietary Name: | XENON™ Pedicle Screw System |
| Common Name: | Pedicle Screw Spinal Device |
| Classification Names: | Pedicle Screw Spinal System |
| Device Classification: | Class III per 21 CFR 888.3070 |
| Product Code(s): | NKB, MNL, MNH |
Product Code(s): NKB, MNI, MNH
Product Description:
The system is comprised of XENON standard polyaxial screws, hightop polyaxial screws, set screws, rods. The XENON polyaxial screw features a dual lead thread, 3 prong drive instrument interface and is self tapping. The polyaxial screws are offered in various diameters ranging from 4.5mm to 8.0mm and lengths ranging from 25mm and 80mm. The polyaxial screws range of motion is 50 degrees Medial/Lateral and 50 degrees Inferior/superior. The 5.5mm diameter rods are offered in lengths 35mm to 600mm. The rods are also offered in two profiles, straight and precontoured. The adjustable bridges are offered in 4 different sizes. The implants are manufactured from surgical grade titanium alloy (Ti6AI-4V).
Indications for Use:
The XENON Pedicle Screw System is intended for posterior, non-cervical pedicle fixation in skeletally mature patients as an adjunct to fusion 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 and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. It is intended to provide stabilization during the development of fusion utilizing autograft or allograft bone graft.
1
Image /page/1/Picture/1 description: The image shows the text "510(k) Number K111634 Page 2/2". It appears to be a page number and a 510(k) number, which is a premarket submission to the FDA to demonstrate that the device to be marketed is as safe and effective as a legally marketed device. The page number indicates that this is page 2 of 2.
Image /page/1/Picture/2 description: The image contains the text "Alphatec Spine" in a stylized, bold font. The text appears to be a logo or brand name, possibly for a medical or healthcare company specializing in spinal products or services. The font is distinctive and easily recognizable, suggesting a strong brand identity.
Substantial Equivalence:
Alphatec Spine has submitted information to demonstrate that, for the purposes of FDA's regulation of medical devices, the XENON Pedicle Screw System is substantial equivalent in the intended use, design materials, mechanical and functional characteristics compatred to the predicate devices. The XENON Pedicle Screw System is substantially equivalent to the following predicate devices:
Trade/Proprietary Model Name
Zodiac® 4.0 Polyaxial Spinal Fixation System Zodiac® Polyaxial Spinal Fixation System Apelo" Pedicle Screw System
Manufacturer Alphatec Spine, Inc. Alphatec Spine, Inc. Atlas Spine, Inc.
510(k) No. K071890 K100685 K110842
Performance Data:
Mechanical static and dynamic testing was performed which provides reasonable assurance of safety and effectiveness for its intended use. Performance testing was performed per the recognized consensus standards and per the guidance document, Spinal 510(k)s- Guidance for Instustry and FDA Staff. The following testing was performed per ASTM F1717:
- Dynamic Compression Bending �
- . Static Torsion
- Static Compression Bending .
The testing demonstrated that XENON Pedicle Screw System is substantially equivalent to the predicate Zodiac Polyaxial Spinal Fixation System device. It is similar in terms of general design, intended use, and technological characteristics to the predicate devices.
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an eagle-like bird with three stripes forming its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 2 5 2012
Alphatec Spine, Inc. % Ms. Cheryl Allen 5818 El Camino Real Carlsbad, California 92008
Re: K111634
Trade/Device Name: XENON™ Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: January 18, 2012 Received: January 20, 2012
Dear Ms. Allen:
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
3
Page 2 - Ms. Cheryl Allen
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 CI IT rated adverse events) (21 CFR 803); good manufacturing practice requirements as set de rice-related daverse overse (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 11 you desire specific ad rice to: your conters Offices/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 note the regulation intiness ding 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 Tou may other bant. Beforeturers, 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,
ely yours,
Mark N. Melke Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/2 description: The image shows the words "Alphatec Spine" in a stylized font. The word "Alphatec" is written in a bold, slightly slanted font, with each letter clearly visible. Below "Alphatec", the word "Spine" is written in a similar font, completing the phrase. The text appears to be part of a logo or branding material, possibly for a medical company specializing in spinal products or treatments.
INDICATIONS FOR USE
510k) Number (if known):
Device Name: XENON™ Pedicle Screw System
Indications for Use:
The XENON Pedicle Screw System is intended for posterior, non-cervical pedicle fixation in skeletally mature patients as an adjunct to fusion 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 and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. It is intended to provide stabilization during the development of fusion utilizing autograft or allograft bone graft.
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________
Page 1 of 1
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Crthopedic, and Restorative Devices
KIII634 510(k) Number_