(146 days)
No
The device description and intended use are purely mechanical, describing plates and screws for spinal fixation. There is no mention of software, algorithms, or data processing that would suggest AI/ML.
Yes
The device is described as a "Plating System" intended to "hold the allograft in place" to prevent "expulsion or impinging on the spinal cord" after a laminoplasty. This indicates it is used for structural support and stability within the body to aid in treatment, aligning with the definition of a therapeutic device.
No
The device, a laminoplasty plating system, is intended to hold an allograft in place post-surgery, which is a structural and supportive function, not a diagnostic one.
No
The device description explicitly states it is comprised of physical components (plates and screws) and describes mechanical testing, indicating it is a hardware-based medical device.
No, 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: The Spectrum Spine Laminoplasty Plating System is a surgical implant designed to be physically placed within the body to hold bone grafts in place during spinal surgery.
- Intended Use: The intended use clearly describes a surgical procedure and the physical function of the device within the body.
The information provided describes a surgical implant, not a device used for testing biological samples outside of the body.
N/A
Intended Use / Indications for Use
The Spectrum Spine Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Spectrum Spine Laminoplasty Plating System holds the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.
Product codes
NQW
Device Description
The Spectrum Spine Laminoplasty Plating System is comprised of various sized, pre-bent plates that are designed to fit the anatomy of the vertebral arch (i.e., between the pedicle and spinous process). The plates have screw holes located at both ends of the plate to allow for attachment to the bone. The screws intended for use with the plates are available in a variety of lengths and diameter and are designed to match the anatomical requirements.
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-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 Spectrum Spine Laminoplasty Plating System screws were tested in static axial pullout per ASTM F543-07 Standard Specification and Test Methods for Metallic Medical Bone Screws. The system was also tested in static and dynamic four-point bend per ASTM F2193-02 Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Synthes Arch™ Fixation System (AFS) (K032534), Medtronic™ Centerpiece™ Plate Fixation System (K050082)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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5. 510(K) Summary
| Submitter's Name: | Spectrum Spine IP Holdings, LLC |
|---|---|
| Submitter's Address: | 3045 Paces Lake Court |
| Atlanta, GA 30339 | |
| Submitter's Telephone: | (404) 550-1335 |
| Contact Name: | Dr. James Robinson |
| Date Summary was Prepared: | 01 August 2012 |
| Trade or Proprietary Name: | Spectrum Spine Laminoplasty Plating System |
| Common or Usual Name: | Orthosis, Spine, Plate, Laminoplasty, Metal |
| Classification: | Class II per 21 CFR §888.3050 |
| Product Codes: | NQW |
| Classification Panel: | Orthopedic and Rehabilitation Devices Panel |
| Predicate Devices: | Synthes Arch™ Fixation System (AFS) (K032534) |
| Medtronic™ Centerpiece™ Plate Fixation System (K050082) |
Description of the Device Subject to Premarket Notification:
The Spectrum Spine Laminoplasty Plating System is comprised of various sized, pre-bent plates that are designed to fit the anatomy of the vertebral arch (i.e., between the pedicle and spinous process). The plates have screw holes located at both ends of the plate to allow for attachment to the bone. The screws intended for use with the plates are available in a variety of lengths and diameter and are designed to match the anatomical requirements.
INDICATIONS FOR USE
The Spectrum Spine Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Spectrum Spine Laminoplasty Plating System holds the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.
TECHNICAL CHARACTERISTICS
The Spectrum Spine Laminoplasty Plating System plates and screws are manufactured from titanium alloy (ASTM F136), similar to the referenced predicate devices. No new technical characteristics are being introduced with this product.
PERFORMANCE DATA
The Spectrum Spine Laminoplasty Plating System screws were tested in static axial pullout per ASTM F543-07 Standard Specification and Test Methods for Metallic Medical Bone Screws. The system was also tested in static and dynamic four-point bend per ASTM F2193-02 Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System.
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CONCLUSION
:
The overall technology characteristics and mechanical performance data lead to the conclusion that Spectrum Spine Laminoplasty Plating System is substantially equivalent to the predicate devices.
. . . .
and the control of the county of
:
. . . . .
:
: 1. 1. 1. 1. 1.
Spectrum Spine Laminoplasty System
.
.
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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human profiles or abstract shapes, creating a sense of unity and connection.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: February 7, 2013
Spectrum Spine IP Holdings, LLC % Empirical Testing Corporation Ms. Meredith May 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K122822
Trade/Device Name: Spectrum Spine Laminoplasty Plating System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: NQW Dated: January 14, 2013 Received: January 16, 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. Iisting 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
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Page 2 - Ms. Meredith May
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 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 N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. Indications for Use Statement
Device Name: Spectrum Spine Laminoplasty Plating System
The Spectrum Spine Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (C3-T3)' after a laminoplasty has been performed. The Spectrum Spine Laminoplasty Plating System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ronald P. Jean -S
(Division Sign-off) Division of Orthopedic Devices 510(k) Number: K122822
Spectrum Spine Laminoplasty System
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