(170 days)
Not Found
No
The 510(k) summary describes a purely mechanical device for surgical fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as an implant used for temporary stabilization and not for treating or rehabilitating a disease or injury.
No
The device is a temporary implant used for stabilization during surgery, not for diagnosing medical conditions.
No
The device description clearly outlines physical components made of PEEK and tantalum, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Spinal Elements Cerclage System is a physical implant designed for surgical use to provide temporary stabilization of bone structures (sternum and spine). It is a mechanical device used in vivo (within the body) during surgery.
- No Mention of Samples or Testing: The description focuses on the material, design, and surgical application of the implant. There is no mention of analyzing biological samples or performing diagnostic tests.
Therefore, the Spinal Elements Cerclage System falls under the category of a surgical implant or device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Spinal Elements Cerclage System is intended for use in cardiovascular surgery. The indications for use include cardiovascular surgery for closure of the sternotomy. The system is intended to provide temporary stabilization during the development of solid bony fusion.
The Spinal Elements Cerclage System is a temporary implant to be used in orthopedic surgery. The Spinal Elements Cerclage System is a bony anchor designed to provide temporary stabilization of the spine for bony fusion or consolidation of a fracture. The Spinal Elements Cerclage System is designed for a posterior approach. The indications for use include the following applications:
- Spinal trauma surgery: The Spinal Elements Cerclage implants can be used in sublaminar wiring techniques;
- Spinal degenerative surgery: The Spinal Elements Cerclage implants may be used as an adjunct to spinal fusions with bone graft (autograft or allograft) at level(s) of use.
Product codes
OWI, JDQ
Device Description
The Spinal Elements Cerclage System consists of a strap manufactured from PEEK conforming to ASTM F2026 compounded with 7.5% barium sulphate for radiopacity. The leading tip of the device is comprised of a spherical feature followed by a tapered neck to allow for an instrument to assist in advancing the strap around the bony structures to be secured. The spherical tip contains a tantalum pin for visualization when fluoroscopic imaging is used. The device has teeth along its length that interact with a latching mechanism at the opposite end of the strap. The latch allows a loop created by feeding the strap through the latch to be made consecutively shorter or taught by continuing to pull the strap through the latch. Prior to creating the loop, the spherical tip of the device is cut off and discarded to allow for the strap to pass through the latch. The latch resists the lengthening of the loop due to forces that would pull the strap in the opposite direction, thereby securing the structures intended to be fixed.
Once the desired loop length is reached, the unneeded portion of the strap may be cut off and discarded.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopic imaging
Anatomical Site
sternum, spine
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)
In support of this 510(k) Premarket Notification, Spinal Elements has conducted non-clinical testing demonstrating that the Spinal Elements Cerclage System provides adequate mechanical strength for its intended use and is substantially equivalent to its predicate device. The testing included static and dynamic testing of the Cerclage construct strength as well as relative abrasion testing to determine the propensity for the implant to cut into bone. Creep testing was also performed, and the Cerclage implant showed adequate resistance to plastic deformation.
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
Not Found
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 6, 2018
Spinal Elements, Inc. Julie Lamothe, Ph.D., MBA Senior Director, Regulatory Affairs 3115 Melrose Drive, Suite 200 Carlsbad. California 92010
Re: K180728
Trade/Device Name: Spinal Elements Cerclage System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: OWI, JDQ Dated: July 9, 2018 Received: July 10, 2018
Dear Dr. Lamothe:
We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ronald P. Jean -S
for 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) K180728
Device Name Spinal Elements Cerclage System
Indications for Use (Describe)
The Spinal Elements Cerclage System is intended for use in cardiovascular surgery. The indications for use include cardiovascular surgery for closure of the sternotomy. The system is intended to provide temporary stabilization during the development of solid bony fusion.
The Spinal Elements Cerclage System is a temporary implant to be used in orthopedic surgery. The Spinal Elements Cerclage System is a bony anchor designed to provide temporary stabilization of the spine for bony fusion or consolidation of a fracture. The Spinal Elements Cerclage System is designed for a posterior approach. The indications for use include the following applications:
- Spinal trauma surgery: The Spinal Elements Cerclage implants can be used in sublaminar wiring techniques; 2. Spinal degenerative surgery: The Spinal Elements Cerclage implants may be used as an adjunct to spinal fusions with bone graft (autograft or allograft) at level(s) of use.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image is a logo for Spinal Elements. The logo consists of a red square with a white spine-like design inside, followed by the word "SPINAL" in black, and the word "elements" in gray. The spine-like design in the red square is made up of three white shapes that resemble vertebrae.
510(k) Summary Spinal Elements Cerclage System
510(k) Number: K180728
| Manufacturer Identification
Submitted By: | Spinal Elements, Inc.
3115 Melrose Drive, Suite 200
Carlsbad, CA 92010
760-607-0121
760-607-0125 (fax) |
|---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Julie Lamothe
Spinal Elements, Inc.
3115 Melrose Drive, Suite 200
Carlsbad, CA 92010
760-607-1816
760-607-0125 (fax)
jlamothe@spinalelements.com |
| Date Prepared: | July 9th, 2018 |
| Device Identification
Proprietary Name
Common Name
Device Classification
Proposed Regulatory Class
Device Product Code | Spinal Elements Cerclage System
Cerclage
21 CFR 888.3010 - Bone fixation cerclage
Class II
OWI, JDQ |
Device Description
The Spinal Elements Cerclage System consists of a strap manufactured from PEEK conforming to ASTM F2026 compounded with 7.5% barium sulphate for radiopacity. The leading tip of the device is comprised of a spherical feature followed by a tapered neck to allow for an instrument to assist in advancing the strap around the bony structures to be secured. The spherical tip contains a tantalum pin for visualization when fluoroscopic imaging is used. The device has teeth along its length that interact with a latching mechanism at the opposite end of the strap. The latch allows a loop created by feeding the strap through the latch to be made consecutively shorter or taught by continuing to pull the strap through the latch. Prior to creating the loop, the spherical tip of the device is cut off and discarded to allow for the strap to pass through the latch. The latch resists the lengthening of the loop due to forces that would pull the strap in the opposite direction, thereby securing the structures intended to be fixed.
4
Image /page/4/Picture/1 description: The image contains the logo for Spinal Elements. The logo consists of a red square with rounded corners on the left side, containing a white stylized image of a spine. To the right of the square is the word "SPINAL" in large, bold, black letters, and below that is the word "elements" in smaller, light gray letters.
Once the desired loop length is reached, the unneeded portion of the strap may be cut off and discarded.
Indications for Use
The Spinal Elements Cerclage System is intended for use in cardiovascular surgery. The indications for use include cardiovascular surgery for closure of the sternum following sternotomy. The system is intended to provide temporary stabilization during the development of solid bony fusion.
The Spinal Elements Cerclage System is a temporary implant to be used in orthopedic surgery. The Spinal Elements Cerclage System is a bony anchor designed to provide temporary stabilization of the spine for bony fusion or consolidation of a fracture. The Spinal Elements Cerclage System is designed for a posterior approach. The indications for use include the following applications:
-
- Spinal trauma surgery: The Spinal Elements Cerclage implants can be used in sublaminar wiring techniques;
-
- Spinal degenerative surgery: The Spinal Elements Cerclage implants may be used as an adjunct to spinal fusions with bone graft (autograft or allograft) at level(s) of use.
Substantial Equivalence
The subject device is substantially equivalent to the primary predicate device Implanet Jazz Lock cleared in K153348.
Technological Characteristics
The subject device was established as substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the Untied States. The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, operating principle and function.
Performance Data
In support of this 510(k) Premarket Notification, Spinal Elements has conducted non-clinical testing demonstrating that the Spinal Elements Cerclage System provides adequate mechanical strength for its intended use and is substantially equivalent to its predicate device. The testing included static and dynamic testing of the Cerclage construct strength as well as relative abrasion testing to determine the propensity for the implant to cut into bone. Creep testing was also performed, and the Cerclage implant showed adequate resistance to plastic deformation.
Conclusion
Based on the indication for use, technological characteristics, and comparison to predicate devices, the Spinal Elements Cerclage System has been shown to be substantially equivalent to legally marketed predicate devices.