(45 days)
Not Found
No
The description focuses on the mechanical components and intended use of a spinal plating system, with no mention of AI or ML capabilities.
Yes
The device is intended to provide immobilization of spinal segments as an adjunct to fusion in the treatment of various instabilities and conditions of the thoracic and lumbar spine, such as degenerative disc disease, spondylolisthesis, and trauma, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
Explanation: The device is a plating system intended for fixation and immobilization of spinal segments as an adjunct to fusion, which is a treatment, not a diagnostic purpose.
No
The device description explicitly states it consists of physical components (plates and screws made of titanium alloy) and utilizes standard orthopedic instruments, 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 surgical implant system used to provide immobilization and aid in fusion of spinal segments. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details plates and screws made of titanium alloy, designed for surgical implantation. This aligns with a medical device used for treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the 2 Hole Lateral Plating System is a medical device used for surgical intervention, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The 2 Hole Lateral Plating System is intended to be used as a non-pedicle lateral fixation system in skeletally mature patients and is intended to provide immobilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic and lumbar spine. It may be used from levels T1-L5 with the following indications:
-
Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
-
Spondylolisthesis
-Spinal stenosis
- -Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis)
-Tumor
-Pseudoarthrosis
-Failed previous fusion
-Trauma (i.e., fracture or dislocation)
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The 2 Hole Lateral Plating System consists of a variety of plates and screws to suit the individual pathology and anatomical conditions of the patient. All components are fabricated and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136.
The plates are manufactured in a variety of configurations with options including lengths of 16mm-26mm. The screws are manufactured in variable and fixed configurations with diameters of 5.5mm and 6.5mm and lengths of 25mm-60mm. The responsible surgeon will determine the correct size of the implant in accordance with the size of the individual patient.
The 2 Hole Lateral Plating System also utilizes a variety of standard orthopedic instruments to assist in the placement of the devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and lumbar spine (T1-L5)
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)
Static compression, dynamic compression and static torsion testing according ASTM F1717, as well as benchtop screw push out testing, was presented to demonstrate the substantial equivalency of The 2 Hole Lateral Plating System.
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.
K140260, K133194, K120092, K091071, K132589
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.
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Life Spine, Inc. Mr. Randy Lewis General Manager 13951 South Ouality Drive Huntley, Illinois 60142
August 28, 2017
Re: K172131
Trade/Device Name: 2 Hole Lateral Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: July 13, 2017 Received: July 14, 2017
Dear Mr. Lewis:
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 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
1
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 contact the Division of Industry and Consumer Education (DICE) 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. 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/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 Division of Industry and Consumer Education (DICE) 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172131
Device Name
2 Hole Lateral Plating System
Indications for Use (Describe)
The 2 Hole Lateral Plating System is intended to be used as a non-pedicle lateral fixation system in skeletally mature patients and is intended to provide immobilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic and lumbar spine. It may be used from levels T1-L5 with the following indications:
-
Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
-
Spondylolisthesis
-Spinal stenosis
- -Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis)
-Tumor
-Pseudoarthrosis
-Failed previous fusion
-Trauma (i.e., fracture or dislocation)
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary 2 Hole Lateral Plating System
| Submitted By: | Life Spine, Inc.
13951 S. Quality Drive
Huntley, IL 60142
Telephone: 847-884-6117
Fax: 847-884-6118 |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Randy Lewis
Life Spine, Inc.
13951 S. Quality Drive
Huntley, IL 60142
Telephone: 847-884-6117
Fax: 847-884-6118 |
| Date Prepared: | July 13th, 2017 |
| Trade Name: | 2 Hole Lateral Plating System |
| Common Name: | Spinal intervertebral body fixation orthosis |
| Classification: | KWQ, 21 CFR 888.3060, Class II |
| Primary Predicate : | Orthofix Skyhawk (K140260) |
| Additional Predicate: | Eminent Spine Black Diamond (K133194)
Globus Plymouth (K120092)
Nuvasive Lateral Plate (K091071)
Presidio Anterior Lumbar Plate (K132589) |
Device Description:
The 2 Hole Lateral Plating System consists of a variety of plates and screws to suit the individual pathology and anatomical conditions of the patient. All components are fabricated and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136.
The plates are manufactured in a variety of configurations with options including lengths of 16mm-26mm. The screws are manufactured in variable and fixed configurations with diameters of 5.5mm and 6.5mm and lengths of 25mm-60mm. The responsible surgeon will determine the correct size of the implant in accordance with the size of the individual patient.
The 2 Hole Lateral Plating System also utilizes a variety of standard orthopedic instruments to assist in the placement of the devices.
4
Intended Use of the Device:
The 2 Hole Lateral Plating System is intended to be used as a non-pedicle lateral or anterolateral fixation system in skeletally mature patients and is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic and lumbar spine. It may be used from levels T1-L5 with the following indications:
-
Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
-
Spondylolisthesis
-
-Spinal stenosis
-
-Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis)
-
-Tumor
-
-Pseudoarthrosis
-
-Failed previous fusion
-
-Trauma (i.e., fracture or dislocation)
Technological Characteristics:
The 2 Hole Lateral Plating System is substantially equivalent to the predicate systems in terms of design, materials, indications for use and sizing.
Performance Data:
Static compression, dynamic compression and static torsion testing according ASTM F1717, as well as benchtop screw push out testing, was presented to demonstrate the substantial equivalency of The 2 Hole Lateral Plating System.
Conclusions:
The 2 Hole Lateral Plating System was shown to be substantially equivalent to the predicate devices in indications for use, design, function, materials used and mechanical performance.