(166 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for posterior fixation of the cervical and thoracic spine for various conditions such as degenerative disc disease, spinal stenosis, and trauma, which are all therapeutic interventions.
No
This device is a spinal system intended for posterior fixation of the cervical and thoracic spine, which is a treatment device, not a diagnostic one.
No
The device description clearly outlines a system composed of physical components (screws, hooks, rods, connectors) made of titanium alloy, which are surgically implanted for spinal fixation. This is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device for posterior fixation of the cervical and thoracic spine to treat various spinal conditions. This is a surgical implant used directly on the patient's body.
- Device Description: The description details a system of fixation devices, screws, hooks, rods, and connectors made of titanium alloy. These are physical components implanted into the spine.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided text does not mention any testing of biological samples or diagnostic purposes.
The device described is a surgical implant used for structural support and stabilization of the spine.
N/A
Intended Use / Indications for Use
The Spinal Elements Posterior Cervical/Thoracic Spinal System is intended for posterior fixation of the cervical and thoracic spine (CI-T3) for the following conditions: degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; spinal stenosis; trauma (fracture/dislocation); failed previous fusion; tumors.
The use of polyaxial pedicle screws is limited to placement in T1-T3 for treating thoracic conditions only. The screws are not intended to be placed in the cervical spine.
Product codes (comma separated list FDA assigned to the subject device)
MNI, KWP, NKB
Device Description
The Spinal Elements Posterior Cervical/Thoracic System consists of a variety of fixation devices that are attached to the spine by means of screws and hooks placed in/or on the pedicles or posterior elements of the various vertebrae, rods that span the distance between the screws/hooks, and transverse connectors. Screws are intended for attachment to the thoracic (T1-T3) spine only. All components of the system are manufactured from titanium alloy (Ti-6Al-4V conforming to ASTM F 136 or ISO 5832-3). The system achieves fixation by the mechanical joining of the rods, screws, hooks, and connectors. A variety of constructs may be assembled to suit the individual pathology and anatomy of the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical and thoracic spine (CI-T3), T1-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)
Non-clinical, mechanical testing was performed in accordance with ASTM F1717 to determine the performance profile of the device. Testing included:
-
Static compression testing
-
Dynamic compression testing
-
Torsion testing
All test results indicate the system will perform as intended.
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.
K052201, K071380, K002733, K010681, K062934
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
§ 888.3070 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.
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K120467 Page 1 of 2
Spinal Elements, Inc. Premarket Notification - Spinal Elements Posterior Cervical / Thoracic Spinal System
J
510(k) Summary Spinal Elements Posterior Cervical / Thoracic Spinal System
JUL 30 2012
510(k) Number: K120467
Manufacturer Identification Submitted by:
Spinal Elements, Inc. 2744 Loker Ave. W., Suite 100 Carlsbad, CA 92010 760-607-0121 761-607-0125 (fax)
Contact Information:
Benjamin A. Kimball Regulatory Affairs Manager Spinal Elements, Inc. 2744 Loker Ave. W., Suite 100 Carlsbad, CA ·92010 760-607-1816 Bkimball@spinalelements.com
Date Prepared:
July 26, 2012
Device Indentification Proprietary Name
Spinal Elements Posterior Cervical / Thoracic Spinal System
Spinal Interlaminal Fixation and Spinal Intervetebral
Common Name
Device Classification
Classification Name
Fixation Orthosis and/or Pedicle Screw System 21 CFR 888.3050 and / or 21 CFR 888.3070
Spinal interlaminal fixation orthosis, Spinal intervertebral body fixation orthosis. Pedicle screw spinal system
Class III Proposed Regulatory Class
Device Product Code:
MNI, KWP, NKB
Purpose of this 510(k)
This 510(k) seeks clearance for a new system.
1
Device Description
The Spinal Elements Posterior Cervical/Thoracic System consists of a variety of fixation devices that are attached to the spine by means of screws and hooks placed in/or on the pedicles or posterior elements of the various vertebrae, rods that span the distance between the screws/hooks, and transverse connectors. Screws are intended for attachment to the thoracic (T1-T3) spine only. All components of the system are manufactured from titanium alloy (Ti-6A1-4V conforming to ASTM F 136 or ISO 5832-3). The system achieves fixation by the mechanical joining of the rods, screws, hooks, and connectors. A variety of constructs may be assembled to suit the individual pathology and anatomy of the patient.
Intended Use of the Device
The Spinal Elements Posterior Cervical/Thoracic Spinal System is intended for posterior fixation of the cervical and thoracic spine (CI-T3) for the following conditions: degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; spinal stenosis; trauma (fracture/dislocation); failed previous fusion; tumors.
The use of polyaxial pedicle screws is limited to placement in T1-T3 for treating thoracic conditions only. The screws are not intended to be placed in the cervical spine.
Performance Data
Non-clinical, mechanical testing was performed in accordance with ASTM F1717 to determine the performance profile of the device. Testing included:
-
Static compression testing
-
Dynamic compression testing
-
Torsion testing
All test results indicate the system will perform as intended.
Substantial Equivalence
Spinal Elements Posterior Cervical/Thoracic Spinal System is substantially equivalent to Alphatec's Solanas Posterior Stabilization System (K052201 and K071380), Depuy Spine's Summit® Ocipito-Cervico-Thoracic (OCT) Spinal System (K002733 and K010681), and SeaSpine's Sierra System (K062934) in indications, general design features, performance, function, and materials.
2
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 30 2012
Spinal Elements, Incorporated % Mr. Benjamin A. Kimball Regulatory Affairs Manager 2744 Loker Avenue West, Suite 100 Carlsbad, California 92010
Re: K120467
Trade/Device Name: Spinal Elements Posterior Cervical/Thoracic Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, KWP Dated: July 18, 2012 Received: July 19, 2012
Dear Mr. Kimball:
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.
3
Page 2 - Mr. Benjamin A. Kimball
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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/ReportalProblem/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. Mel 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) K:120467
Spinal Elements Posterior Cervical / Thoracic Spinal System Device Name:
Indications for Use:
The Spinal Elements Posterior Cervical/Thoracic Spinal System is intended for posterior fixation of the cervical and thoracic spine (CI-T3) for the following conditions: degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis: spinal stenosis; trauma (fracture/dislocation); failed previous fusion; tumors
The use of polyaxial pedicle screws is limited to placement in T1-T3 for treating thoracic conditions only. The screws are not intended to be placed in the cervical spine.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
signature
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
K120467 510(k) Number_