(160 days)
Not Found
No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
Explanation: The device is intended for posterior fixation of the cervical and thoracic spine for various conditions, including degenerative disc disease, spondylolisthesis, and spinal stenosis, which are medical conditions that the device aims to treat or alleviate.
No
The device description indicates it is a system of fixation devices (screws, hooks, rods, connectors) used for posterior fixation of the cervical and thoracic spine and for mechanical stabilization, not for diagnosing conditions.
No
The device description clearly outlines physical components made of titanium alloy (screws, hooks, rods, connectors) intended for surgical implantation, indicating it is a hardware-based medical device.
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 device for posterior fixation of the cervical and thoracic spine for various spinal conditions. This is a surgical implant used directly on the patient's body.
- Device Description: The description details fixation devices, screws, hooks, rods, and connectors made of titanium alloy. These are all components of a surgical implant system.
- 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 in vitro. This device is a surgical implant used for structural support and fixation in vivo (within the body).
N/A
Intended Use / Indications for Use
The Spinal Elements Lotus Posterior Cervical/Thoracic Spinal System is intended for posterior fixation of the cervical and thoracic spine (C1-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 Spinal Elements Lotus Posterior Cervical/Thoracic Spinal System may be used in conjunction with the Spinal Elements Mercury system for transition at T1 - T3.
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)
KWP, MNI, MNH
Device Description
The Spinal Elements Lotus 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. Screws are intended for attachment to the thoracic (T1-T3) spine only. The system achieves fixation by the mechanical joining of the rods, screws, and hooks. 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 (C1-T3)
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)
The following testing was performed:
- Static Compression Bending per ASTM F1717 .
- Dynamic Compression Bending per ASTM F1717 .
- Static Torsion testing per ASTM F1717 .
- Torsion testing per ASTM F1798 o
- . Axial grip testing per ASTM F1798
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.
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
OCT 2 4 2013
Spinal Elements, Inc.
Premarket Notification - Spinal Elements Lotus® Posterior Cervical/Thoracic Spinal System
510(k) Summary Lotus"
510(k) Number K131427
Manufacturer Identification Submitted by:
Spinal Elements, Inc. 3115 Melrose Drive, Suite 200 Carlsbad, CA 92010 760-607-0121
Contact Information:
Benjamin A. Kimball Regulatory Affairs Manager Spinal Elements, Inc. 3115 Melrose Drive, Suite 200 Carlsbad. CA 92010 760-607-1816 Bkimball@spinalelements.com
Date Prepared:
Proprietary Name
Device Classification
Device Product Code
Common Name
May 15, 2013
Lotus®
Spinal Interlaminal Fixation and Spinal Intervetebral Fixation Orthosis and/or Pedicle Screw System 21 CFR 888.3050, and / or 21 CFR 888.3070 Proposed Regulatory Class Class II KWP, MNI. MNH
Purpose of this Traditional 510(k)
This 510(k) seeks clearance for a line addition to the previously cleared (K120467) Lotus system and a minor modification to the indication for use by adding language relative to the device's ability to be used in conjunction with Spinal Elements' Mercury® system.
Device Description
The Spinal Elements Lotus 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. Screws are intended for attachment to the thoracic (T1-T3) spine only. The system achieves fixation by the mechanical joining of the rods, screws, and hooks. A variety of constructs may be assembled to suit the individual pathology and anatomy of the patient.
1
Spinal Elements, Inc.
Premarket Notification - Spinal Elements Lotus® Posterior Cervical/Thoracic Spinal System
Connectors
Connectors are offered in a variety of sizes and configurations and are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F 1472 and / or F 136. The following connectors are being added to the system:
- Offset connector .
- Round offset connector .
- Axial rod to rod connector .
- 03.5mm Axial rod to rod connector o
- 0 5.5mm Axial rod to rod connector .
- Parallel rod to rod connector .
- . 0 3.5mm Parallel rod to rod connector
- 0 5.5mm Parallel rod to rod connector ●
- Transition rods .
Intended Use of the Device
The Spinal Elements Lotus Posterior Cervical/Thoracic Spinal System is intended for posterior fixation of the cervical and thoracic spine (C1-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 Spinal Elements Lotus Posterior Cervical/Thoracic Spinal System may be used in conjunction with the Spinal Elements Mercury system for transition at T1 - T3.
The use of polyaxial pedicle screws is limited to placement in TI-T3 for treating thoracic conditions only. The screws are not intended to be placed in the cervical spine.
Performance Data
The following testing was performed:
- Static Compression Bending per ASTM F1717 .
- Dynamic Compression Bending per ASTM F1717 .
- Static Torsion testing per ASTM F1717 .
- Torsion testing per ASTM F1798 o
- . Axial grip testing per ASTM F1798
Substantial Equivalence
Spinal Elements Posterior Cervical/Thoracic Spinal System is substantially equivalent to the previously cleared Spinal Elements Posterior Cervical/Thoracic Spinal System (Lotus) cleared in 510(k) K 120467.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 24, 2013
Spinal Elements, Incorporated Mr. Benjamin A. Kimball Regulatory Affairs Manager 3115 Melrose Drive, Suite 200 Carlsbad, California 92010
Re: K131427
Trade/Device Name: Lotus® Posterior Cervical/Thoracic Spinal System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP, MNI, MNI, MNI-I Dated: September 25. 2013 Received: September 26. 2013
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 docs 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 (sec 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 is 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
3
Page 2 - Mr. Benjamin A. Kimball
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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/Safetv/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/ResourcesforYou/Industrv/default.htm.
Sincercly yours,
Ronald P. Jean -S for
- Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K131427 510(k) K:
Spinal Elements Lotus® Posterior Cervical / Thoracic Spinal System Device Name:
Indications for Use:
The Spinal Elements Lotus Posterior Cervical/Thoracic Spinal System is intended for posterior fixation of the cervical and thoracic spine (CI-T3) for the following conditions: degenerative 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 Spinal Elements Lotus Posterior Cervical/Thoracic Spinal System may be used in conjunction with the Spinal Elements Mercury system for transition at TI - T3.
The use of polyaxial pedicle screws is limited to placement in TI-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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ronald P. Jean -S
Page 1 of 1
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K131427