(100 days)
No
The document describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or AI/ML capabilities.
No
This device is a spinal implant system used for temporary stabilization and fusion, not a therapeutic device in the sense of delivering treatment or therapy itself.
No
This device is a surgical implant (anterior cervical plating system) intended for the temporary stabilization of the cervical spine during fusions. It is used for treatment, not for diagnosing conditions.
No
The device description explicitly states it consists of plates, screws, and associated instruments made from titanium alloy, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is for "anterior interbody screw fixation of the cervical spine" and "temporary stabilization of the anterior spine... during the development of cervical spinal fusions." This describes a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The description details plates, screws, and instruments made from titanium alloy, designed for insertion into the vertebral body. This is consistent with a surgical implant.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The provided text does not mention any such use or interaction with biological specimens outside the body.
Therefore, the Life Spine Cam Lock Anterior Cervical Plating System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This system is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: 1.) Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); 2). Spondylolisthesis; 3.) Trauma (including fractures or dislocations); 4.) Spinal cord stenosis; 5.) Deformity or curvatures (i.e. kyphosis or scoliosis); 6.) Tumors; 7.) Pseudarthrosis; and/or 8.) Failed previous fusions.
Nota Bene: This device system is intended for anterior cervical interverterbral body fusions only.
Product codes
KWO
Device Description
The Life Spine Cam Lock Anterior Cervical Plating System consists of a variety of sizes of plates, screws, and associated instruments. Fixation is provided by bone screws inserted through the plates and into the vertebral body of the cervical spine using an anterior approach.
The Life Spine Cam Lock Anterior Cervical Plating System implant components are made from titanium alloy described by ASTM F136. Stainless steel and titanium implant components must not be used together in a construct.
Do not use any of The Life Spine Cam Lock Anterior Cervical Plating System components with the components from any other system or manufacturer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, C2 to T1
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
Mechanical testing was included to demonstrate the substantial equivalency of the Life Spine CAM LOCK Plating System. The testing included static compression, dynamic compression and static torsion testing per ASTM F1717 in addition to a benchtop screw push-out test.
Key Metrics
Not Found
Predicate Device(s)
Life Spine NEO SL ACP (K070285), Globus Providence ACP (K070775), The Life Spine IRIS ACP (K130202)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, with a flowing ribbon-like element below them. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 20, 2015
Life Spine, Incorporated Mr. Randy Lewis General Manager 13951 South Quality Drive Huntley, Illinois 60142
Re: K152282
Trade/Device Name: Cam Lock Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: October 30, 2015 Received: November 2, 2015
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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
Page 2 - Mr. Randy Lewis
the quality systems (OS) 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 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 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.
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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Page 1 of 1
510(k) Number (if known) K152282
Device Name Cam Lock Plating System
Indications for Use (Describe)
This system is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: 1.) Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); 2). Spondylolisthesis; 3.) Trauma (including fractures or dislocations); 4.) Spinal cord stenosis; 5.) Deformity or curvatures (i.e. kyphosis or scoliosis); 6.) Tumors; 7.) Pseudarthrosis; and/or 8.) Failed previous fusions.
Nota Bene: This device system is intended for anterior cervical interverterbral body fusions only.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
510(k) Summary CAM LOCK 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
13951 S. Quality Drive
Huntley, IL 60142
Telephone: 847-884-6117
Fax: 847-884-6118 |
| Date Prepared: | November 19th, 2015 |
| Trade Name: | Cam Lock Plating System |
| Regulation Name: | 888.3060 Spinal Intervertebral Body Fixation Orthosis |
| Classification: | Class II |
| Product Code: | KWQ, Appliance, Fixation, Spinal Intervertebral Body |
| Primary Predicate: | Life Spine NEO SL ACP (K070285) |
| Additional Predicates: | Globus Providence ACP (K070775)
The Life Spine IRIS ACP (K130202) |
Device Description:
The Life Spine Cam Lock Anterior Cervical Plating System consists of a variety of sizes of plates, screws, and associated instruments. Fixation is provided by bone screws inserted through the plates and into the vertebral body of the cervical spine using an anterior approach.
The Life Spine Cam Lock Anterior Cervical Plating System implant components are made from titanium alloy described by ASTM F136. Stainless steel and titanium implant components must not be used together in a construct.
Do not use any of The Life Spine Cam Lock Anterior Cervical Plating System components with the components from any other system or manufacturer.
4
Indications for Use of the Device:
This system is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: 1.) Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); 2). Spondylolisthesis; 3.) Trauma (including fractures or dislocations); 4.) Spinal cord stenosis; 5.) Deformity or curvatures (i.e. kyphosis, lordosis or scoliosis); 6.) Tumors; 7.) Pseudarthrosis; and/or 8.) Failed previous fusions.
Nota Bene: This device system is intended for anterior cervical interverterbral body fusions only.
Technological Characteristics:
The Life Spine CAM LOCK Plating System is substantially equivalent to the predicate system in terms of design, materials, indications for use and sizing.
Material:
The Life Spine CAM LOCK Plating System is 6AL-4V-ELI titanium manufactured according to ASTM F136. The device is comprised of a variety of non-sterile titanium, single use components.
Performance Data:
Mechanical testing was included to demonstrate the substantial equivalency of the Life Spine CAM LOCK Plating System. The testing included static compression, dynamic compression and static torsion testing per ASTM F1717 in addition to a benchtop screw push-out test.
Conclusion:
The information presented demonstrates the substantial equivalency of the Life Spine CAM LOCK Plating System.