(90 days)
Not Found
No
The document describes a physical medical device (a spinal implant) and its intended use and testing. There is no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is indicated for treating degenerative disc disease, restoring biomechanical integrity of the spinal column, decompressing the spinal cord, treating tumors, and restoring spinal alignment, all of which are medical conditions or functions.
No
The device is a medical implant (fusion device, partial vertebral body replacement) used in spinal fusion procedures, not for diagnosing conditions.
No
The device description explicitly states the components are a PEEK Spacer and cp Titanium Markers, which are physical hardware components. The intended use also describes a surgical implant.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion and vertebral body replacement. This is a therapeutic device, not a diagnostic one.
- Device Description: The device components are a PEEK Spacer and titanium markers, which are physical implants.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies described are related to the mechanical properties and stability of the implant (compression, torsion, subsidence), not diagnostic accuracy.
IVD devices are used in vitro (outside the body) to examine specimens from the human body. This device is implanted in vivo (inside the body) for structural support and fusion.
N/A
Intended Use / Indications for Use
When used as a cervical intervertebral body fusion device, the Construx Mini PEEK System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.
The Construx Mini PEEK System is intended for use with autograft and supplemental internal fixation, e.g.: the Blackstone Medical Ascent™ or Ascent LETM POCT System.
Patients must have undergone a regimen of at least six (6) weeks of non-operative r attention masterial with the Construx Mini PEEK System in the cervical spine.
The Construx Mini PEEK device is used singly and is implanted using an anterior approach.
When used as a Partial Vertebral Body Replacement (VBR) System, the Construx Mini When used as i Parliated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised replacement of tumors, to achieve anterior decompression of the spinal cord and for the treatment of tumors, to active an arrest aponed vertebral body. The Construx Mini neural issues, and to restore the freigen in a fractures of the thoracic and lumbar spine.
The Construx Mini PEEK System is designed to restore the biomechanical integrity of the The Collistian Minn I EEIN Bysterior spinal column even in the absence of fusion for a prolonged amenor, inidate, and posterier epinal se is intended to be used with autograft or allograft.
The Construx Mini PEEK System is intended for use with internal fixation. The The Collstux Internal fixation system that may be used with the Construx Mini PEEK System is the Blackstone Medical Spinal Fixation System (SFS) or the Firebird Spinal Fixation System.
Product codes (comma separated list FDA assigned to the subject device)
ODP - Intervertebral Fusion Device with Bone Graft, Cervical, MQP - Spinal Intervertebral Body Fixation Orthosis
Device Description
The Construx Mini PEEK Spacer System components consist of:
- A PEEK Spacer 2) cp Titanium Markers
The Construx Mini Spacer System is a Cervical IBFD device that is implanted using anterior surgical approach with the intention is to achieve intervertebral spinal fusion. In addition, the Construx Mini is intended to contain autologous bone graft to facilitate intervertebral fusion. The Construx Mini performance data, in combination with a dimensional comparison to predicate devices and testing, has been used to demonstrate substantial equivalence with devices that are cleared for both Cervical IBFD and Partial VBR indications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C2-T1), thoracolumbar spine (T1-L5)
Indicated Patient Age Range
skeletally mature patients
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 testing conducted for the Construx Mini included Static Compression, Dynamic Compression, Static Torsion, Dynamic Torsion, and Subsidence. The testing was conducted under ASTM F2077-03 and ASTM F2267-04 guidance.
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.
Blackstone Medical, Inc. Construx Mini (K051246 SE 6-14-05), Spinal Elements, Inc., Crystal Device, K073351 SE 1-4-2008, Custom Spine, Inc., Pathway ACIF, K092904 SE 12-22-2009, DePuy Spine, Inc. Bengal™ System, K081917 SE 5-22-2009
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
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
Page 13 of 16 Premarket Notification 510(k) Blackstone Medical, Inc. Blackstone Construx Mini PEEK Spacer System
101812
510(k) SUMMARY
BLACKSTONE CONSTRUX MINI™ PEEK SPACER SYSTEM
Sponsor:
Orthofix, Inc. 1720 Bray Central Dr. McKinney, TX 75069
SEP 2 7 2010
Registration Number:
Contact Person:
Telephone Number:
Fax Number:
Email:
Date Prepared: Submitter: Submitter Contact:
Manufacturer:
Registration Number:
Contract Manufacturer:
Trade Name:
System Name:
Product Codes:
Common Name:
1720 Bray Central Dr
McKinney, TX 75069
2183449
Russell Johnson, Regulatory Affairs Specialist
(972) 529-3177
'(469) 742-2556
9-20-2010 Martin G. Sprunck, Regulatory Affairs Manager 55 Lane Road, Suite 150 Fairfield, NJ 07004 973-406-2847 martinsprunck@orthofix.com
Orthofix, Inc. 1720 Bray Central Dr. McKinney, TX 75069
2183449
Marox Corporation 373 Whitney Avenue Holyoke, MA 01040-2766
Construx Mini Spacers
Construx Mini PEEK Spacer System
ODP - Intervertebral Fusion Device with Bone Graft, Cervical MQP - Spinal Intervertebral Body Fixation Orthosis
Intervertebral body fusion device
Construx Mini PEEK Spacer System – 510(k) SummaryPage 2 of 3
1
Page 14 of 16 Premarket Notification 510(k) Blackstone Medical, Inc. Blackstone Construx Mini PEEK Spacer System
2101812
Regulatory Classification:
Class II - 888.3080 - Intervertebral Body Fusion Device 888.3060 - Spinal Intervertebral Body Fixation Orthosis
Review Panel:
Orthopedic Device Panel
Blackstone Medical, Inc. Construx Mini (K051246 SE 6-14-05) Predicate Devices: Spinal Elements, Inc., Crystal Device, K073351 SE 1-4-2008 Custom Spine, Inc., Pathway ACIF, K092904 SE 12-22-2009 DePuy Spine, Inc. Bengal™ System, K081917 SE 5-22-2009
Intended Use / Indications for Use
When used as a cervical intervertebral body fusion device, the Construx Mini PEEK System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.
The Construx Mini PEEK System is intended for use with autograft and supplemental internal fixation, e.g.: the Blackstone Medical Ascent™ or Ascent LETM POCT System.
Patients must have undergone a regimen of at least six (6) weeks of non-operative r attention masterial with the Construx Mini PEEK System in the cervical spine.
The Construx Mini PEEK device is used singly and is implanted using an anterior approach.
When used as a Partial Vertebral Body Replacement (VBR) System, the Construx Mini When used as i Parliated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised replacement of tumors, to achieve anterior decompression of the spinal cord and for the treatment of tumors, to active an arrest aponed vertebral body. The Construx Mini neural issues, and to restore the freigen in a fractures of the thoracic and lumbar spine.
The Construx Mini PEEK System is designed to restore the biomechanical integrity of the The Collistian Minn I EEIN Bysterior spinal column even in the absence of fusion for a prolonged amenor, inidate, and posterier epinal se is intended to be used with autograft or allograft.
The Construx Mini PEEK System is intended for use with internal fixation. The The Collstux Internal fixation system that may be used with the Construx Mini PEEK
Construx Mini PEEK Spacer System – 510(k) SummaryPage 3 of 3
2
Page 15 of 16 Premarket Notification 510(k) Blackstone Medical, Inc. Blackstone Construx Mini PEEK Spacer System
101812
System is the Blackstone Medical Spinal Fixation System (SFS) or the Firebird Spinal Fixation System.
Technological Characteristics
The Construx Mini PEEK Spacer System components consist of:
- A PEEK Spacer 2) cp Titanium Markers
The Construx Mini Spacer System is a Cervical IBFD device that is implanted using anterior surgical approach with the intention is to achieve intervertebral spinal fusion. In addition, the Construx Mini is intended to contain autologous bone graft to facilitate intervertebral fusion. The Construx Mini performance data, in combination with a dimensional comparison to predicate devices and testing, has been used to demonstrate substantial equivalence with devices that are cleared for both Cervical IBFD and Partial VBR indications.
The testing conducted for the Construx Mini included Static Compression, Dynamic Compression, Static Torsion, Dynamic Torsion, and Subsidence. The testing was conducted under ASTM F2077-03 and ASTM F2267-04 guidance.
Substantial Equivalence
The Construx Mini Spacer System has been demonstrated to be substantially equivalent to predicate devices in their intended use, indications for use, technological characteristics and principles of operation. Any differences between the Construx Mini Spacer System and its predicates do not present new issues of safety or effectiveness, therefore, the Construx Mini Spacer System is substantially equivalent to its predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Orthofix, Inc. % Mr. Russell Johnson Regulatory Affairs Specialist 1720 Bray Central Drive McKinney, Texas 75069
SEP 2 7 2010
Re: K101812
Trade/Device Name: Construx Mini™ PEEK Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MOP Dated: June 25, 2010 Received: June 29, 2010
Dear Mr. Johnson:
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
4
Page 2 - Mr. Russell Johnson
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 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/CDRH/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.
http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.
Sincerely vours.
Sincerely yours,
Mark A. Millman
Mark N. Melkerson Director Division of Surgical. Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known):
Device Name: Construx Mini™ PEEK Spacer System
SEP 2 7 2010
Indications for Use:
When used as a cervical intervertebral body fusion device, the Construx Mini PEEK System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1). in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.
The Construx Mini PEEK System is intended for use with autograft and supplemental internal fixation, e.g .; the Blackstone Medical Ascent™ or Ascent LE™ POCT System.
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Construx Mini PEEK System in the cervical spine.
The Construx Mini PEEK device is used singly and is implanted using an anterior approach.
When used as a Partial Vertebral Body Replacement (VBR) System, the Construx Mini PEEK System is indicated for use in the thoracolumbar spine (TI-LS) 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 Mini PEEK System is also indicated for treating fractures of the thoracic and lumbar spine.
The Construx Mini PEEK 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 autograft or allograft.
The Construx Mini PEEK System is intended for use with internal fixation. The supplemental internal fixation system that may be used with the Construx Mini PEEK System is the Blackstone Medical Spinal Fixation System (SFS) or the Firebird Spinal Fixation System.
Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
_
(Division Sign Off)
(Division Sign-Oil) Division of Surgical, Orthopedic, and Restorative Devices
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KIO1812 510(k) Number_
Construx Mini™ PEEK Spacer System - Indications for Use