(84 days)
Not Found
No
The summary describes a mechanical implant system (plates and screws) for spinal surgery and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is intended to hold or buttress graft material in place in the spine, which is a therapeutic function aimed at preventing the material from expelling or impinging the spinal cord and thus promoting healing or stability.
No
The device description clearly states its purpose is to hold or buttress graft material, and the system consists of plates and screws for fixation. This describes a surgical implant, not a device used to diagnose a medical condition.
No
The device description explicitly states that the system consists of various sized plates and screws fabricated from medical grade titanium alloy, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The LESPlasty™ Posterior Cervical Laminoplasty System is a surgical implant (plates and screws) used to physically support bone grafts during a specific surgical procedure on the spine. It is a structural device, not a diagnostic tool that analyzes biological samples.
- Lack of Diagnostic Information: The description does not mention any analysis of biological samples or the generation of diagnostic information about a patient's condition.
Therefore, the LESPlasty™ Posterior Cervical Laminoplasty System falls under the category of a surgical implant or device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The LESPlasty™ Posterior Cervical Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The system is used to hold or buttress the allograft or autograft material in place in order to prevent the allograft or autograft material from expelling or impinging the spinal cord.
Product codes (comma separated list FDA assigned to the subject device)
NQW
Device Description
The SpineFrontier® LESPlasty™ System consists of various sized plates and screws designed for a systematic posterior approach to cervical laminoplasty procedures. The plates have screw holes which allow for attachment to the lamina and the lateral mass. The system is provided with primary and recovery bone screws for fixation. Plates and screws are fabricated from medical grade titanium alloy (ASTM F136).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower cervical and upper thoracic spine (C3 to 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)
The LESPlasty™ Posterior Cervical Laminoplasty System has been tested in the following test modes:
- . Static Axial Pullout (ASTM F-543)
- Static Four-Point Bending (ASTM F-2193) .
- Dynamic Four-Point Bending (ASTM F-2193) o
The results of this non-clinical testing show that the strength of the LESPlasty™ System is sufficient for its intended use and legally marketed predicate devices.
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.
Synthes Arch™ Fixation System (AFS) (K032534), MedtronicCenterpiece™ Plate Fixation System (K050082)
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
| Submitter's Name: | SpineFrontier, Inc. |
|---|---|
| Submitter's Address: | 500 Cummings Center, Suite 3500 |
| Beverly, MA 01915, U.S.A. | |
| Submitter's Telephone: | 978.232.3990 x116 |
| Contact Person: | Paul L. Speidel |
| Regulatory Affairs Manager | |
| Tel: 978.279.9272 | |
| Fax: 978.232.3991 | |
| Prepared by: | Meredith L. May, MS |
| Empirical Testing Corp. | |
| 719.337.7579 | |
| Date Summary was | |
| Prepared: | August 30th, 2013 |
| Trade or Proprietary Name: | SpineFrontier® LESPlasty™ Posterior Cervical |
| Laminoplasty System | |
| Common or Usual Name: | Orthosis, Spine, Plate, Laminoplasty, Metal |
| Classification: | Class II per 21 CFR §888.3050 |
| Product Code: | NQW |
| Classification Panel: | Orthopedic and Rehabilitation Devices Panel |
| Predicate Devices: | Synthes Arch™ Fixation System (AFS) (K032534) |
| MedtronicCenterpiece™ Plate Fixation System | |
| (K050082) |
5.510(K) SUMMARY
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The SpineFrontier® LESPlasty™ System consists of various sized plates and screws designed for a systematic posterior approach to cervical laminoplasty procedures. The plates have screw holes which allow for attachment to the lamina and the lateral mass. The system is provided with primary and recovery bone screws for fixation. Plates and screws are fabricated from medical grade titanium alloy (ASTM F136).
INDICATIONS FOR USE
The LESPlasty™ Posterior Cervical Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The system is used to
SpineFrontier® LESPlasty™ Posterior Cervical Laminoplasty System
1
hold or buttress the allograft or autograft material in place in order to prevent the allograft or autograft material from expelling or impinging the spinal cord.
The indication for use for the SpineFrontier® LESPlasty™ System is similar to that of the Synthes Arch™ Fixation System (AFS) (K032534) and MedtronicCenterpiece™ Plate Fixation System (K050082).
TECHNICAL CHARACTERISTICS
All components are fabricated from medical grade titanium alloy (ASTM F136). Titanium alloys have a successful history of use in the spinal implant industry and use of it in these devices does not introduce any previously unaccepted patient risks. The Synthes Arch™ Fixation System (AFS) (K032534) and MedtronicCenterpiece™ Plate Fixation System (K050082) are manufactured from titanium or titanium alloy.
PERFORMANCE DATA
The LESPlasty™ Posterior Cervical Laminoplasty System has been tested in the following test modes:
- . Static Axial Pullout (ASTM F-543)
- Static Four-Point Bending (ASTM F-2193) .
- Dynamic Four-Point Bending (ASTM F-2193) o
The results of this non-clinical testing show that the strength of the LESPlasty™ System is sufficient for its intended use and legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the LESPlastyTM System is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Contro! Center - WO66-G609 Silver Spring, MD 20993-0002
SpineFrontier, Incorporated . % Empirical Testing Corporation Meredith May, MS, RAC 4628 Northpark Drive Colorado Springs, Colorado 80918 November 26, 2013
Re: K132740
Trade/Device Name: SpineFrontier® LESPlasty™ Posterior Cervical Laminoplasty System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: NQW Dated: November 21, 2013 Received: November 25, 2013
Dear Ms. May:
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Justin Eggleton
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/McdicalDevices/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/McdicalDevices/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark Nielkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: December 31, 2013
See PRA Statement on last page. |
|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Indications for Use | |
| 510(k) Number (if known) | K132740 |
|---|---|
| DEVICE NAME | |
| SpineFrontier® LESPlasty™ Posterior Cervical Laminoplasty System | |
| Indications for Use (Describe) | |
| The LESPlasty™ Posterior Cervical Laminoplasty System is intended for use in the lower cervical and upper | |
| thoracic spine (C3 to T3) in laminoplasty procedures. The system is used to hold or buttress the allograft or | |
| autograft material in place in order to prevent the allograft or autograft material from expelling or impinging | |
| the spinal cord. |
| 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) |
| PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. |
| FOR FDA USE ONLY |
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) |
| Ronald P. Jean -S |
.
SpineFrontier® LESPlasty™ Posterior Cervical Laminoplasty System