(14 days)
Not Found
No
The description focuses on the material properties and mechanical design of a spinal implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for partial replacement of a diseased vertebral body for the treatment of tumors and fractures, to achieve anterior decompression of the spinal cord, and to restore height, which are therapeutic functions.
No.
The device is a partial vertebral body replacement system, which is an implant used to restore the spinal column, not to diagnose a condition.
No
The device description explicitly states it is comprised of implants fabricated from PEEK, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Construx™ PL/TL PEEK Partial VBR System is an implantable device used in surgery to replace a portion of a vertebral body in the spine. Its purpose is to restore structural integrity and decompress neural tissues. It is a physical implant, not a device that analyzes biological samples.
The description clearly indicates it's a surgical implant for structural support in the spine, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Construx™ PL/TL PEEK Partial VBR System is indicated for use in the thoracolumbar spine (TI-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Construx™ PL/TL PEEK Partial VBR System is also indicated for treating fractures of the thoracic and lumbar spine.
The Construx™ PL/TL PEEK Partial VBR System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period of time. The Partial VBR device is intended to be used with bone graft material.
The Construx™ PL/TL PEEK Partial VBR System is intended for use with supplemental internal fixation. The supplemental internal fixation system that may be used with the Construx™ PL/TL PEEK Partial VBR System is the Blackstone Medical Spinal Fixation System.
Product codes (comma separated list FDA assigned to the subject device)
MQP
Device Description
Blackstone Medical, Inc. Construx™ PL/TL. PEEK Partial Vertebral Body Replacement (VBR) System is comprised of a variety of implants fabricated and manufactured from Polyetheretherketone (PEEK Optima LT1) as described by ASTM F-2026. This material is utilized due to its radiolucent properties, which aid the surgeon in determining if fusion in the operative site has occurred. The teeth on the superior and inferior surfaces of the construct provide increased stability and help prevent anterior/posterior movement of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (TI-L5)
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)
Not Found
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.
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
Blackstone Medical, Inc.
Premarket Notification Special 51
Construx™ PL/TL PEEK Partial VBR System
FFB 2 4 2006
510(K) SUMMARY
| Name of Firm: | Blackstone Medical, Inc.
1211 Hamburg Turnpike
Wayne, NJ 07470 |
|------------------------------------------|----------------------------------------------------------------------|
| 510(k) Contact: | Whitney Törning, Director of Regulatory Affairs |
| Trade Name: | Construx™ PL/TL PEEK Partial VBR System |
| Common Name: | Spinal Vertebral Body Replacement Device |
| Device Product Code
& Classification: | MQP - 888.3060 - Spinal Intervertebral Body Fixation Orthosis |
Substantially Equivalent Devices:
Blackstone™ PEEK Mini Vertebral Body Replacement System (K051246) Blackstone™ PEEK Vertebral Body Replacement System (K033702)
Device Description:
Blackstone Medical, Inc. Construx™ PL/TL. PEEK Partial Vertebral Body Replacement (VBR) System is comprised of a variety of implants fabricated and manufactured from Polyetheretherketone (PEEK Optima LT1) as described by ASTM F-2026. This material is utilized due to its radiolucent properties, which aid the surgeon in determining if fusion in the operative site has occurred. The teeth on the superior and inferior surfaces of the construct provide increased stability and help prevent anterior/posterior movement of the device.
Intended Use / Indications for Use:
The Construx™ PL/TL PEEK Partial VBR System is indicated for use in the thoracolumbar spine (TI-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Construx™ PL/TL PEEK Partial VBR System is also indicated for treating fractures of the thoracic and lumbar spine.
The Construx™ PL/TL PEEK Partial VBR System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period of time. The Partial VBR device is intended to be used with bone graft material.
The Construx™ PL/TL PEEK Partial VBR System is intended for use with supplemental internal fixation. The supplemental internal fixation system that may be used with the Construx™ PL/TL PEEK Partial VBR System is the Blackstone Medical Spinal Fixation System.
- 1
1
KC6035C
Premarket Notification Special 510(1 Blackstone Medical, Inc. Construx™ PL/TL PEEK Partial VBR System Cattle antial
Basis of Substantial Equivalence:
The Construx™ PL/TL PEEK Partial VBR System is substantially equivalent to the Blackstone™ Construx™ Mini PEEK VBR System (K051246) and the Blackstone™ PEEK Vertebral Body Replacement System (K033702) which have been cleared by FDA for use in patients with tumor, trauma or fractures.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 4 2006
Ms. Whitney G. Törning Director of Regulatory Affairs Blackstone Medical, Inc. 90 Brookdale Drive Springfield, MA 01104
Re: K060350
: 1800530
Trade/Device Name: Construx™ PL/TL PEEK Partial VBR System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: February 7, 2006 Received: February 10, 2006
Dear Ms. Törning:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 docs not mean r rease oe avrilour 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); good manufacturing practice requirements as set
3
Page 2 - Ms. Whitney Törning
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro risess (evening your device as described in your Section 510(k) This letter will anow you to ogin maing of substantial equivalence of your device to a legally prematication: "The PDF intentigation for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire spocente advision at (240) 276-0120. Also, please note the regulation entitled, Conider the Office of Comptiments market notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your respended its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Helmut Lemus
Mark N. Melkerson, M.S. Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
6060350 510(k) Number (if known): __
Device Name: Construx™ PL/TL PEEK Partial VBR System
Indications for Use:
The Construx™ PL/TL PEEK Partial VBR System is indicated for use in the The Ounstrax - PETETES for partial replacement of a diseased vertebral body thoracolumbur opino ( the treatment of tumors, to achieve anterior decompression resected of excised for the troutinent spare the height of a collapsed or the Spinal Cord and Hourar (ISSue), and the Partial VBR System is also indicated for treating fractures of the thoracic and lumbar spine.
The Construx™ PL/TL PEEK Partial VBR System is designed to restore the The Construx - - | Ercof the anterior, middle and posterior spinal column even in blomeonaniour freship for a prolonged period of time. The Partial VBR device is intended to be used with bone graft material.
The Construx™ PL/TL PEEK Partial VBR System is intended for use with supplemental internal fixation. The supplemental internal fixation system that may supplemental internal included "the PEEK Partial VBR System is the Blackstone Medical Spinal Fixation System.
Prescription Use _ X ___ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRM, Office of Device Evaluation (ODE)
Haki Leung
Page 1 of
(Division Sign-Of Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________