(163 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any AI/ML components or capabilities.
No
Explanation: The CONQUEST Spinal System is an implantable device designed to provide stabilization and promote spinal fusion, which is a structural support function rather than a therapeutic treatment in itself. Its purpose is to aid in healing processes and alignment, not to deliver active therapy or treatment.
No
Explanation: The device is an internal fixation implant intended to stabilize and maintain alignment of the spine, not to diagnose a medical condition.
No
The device description explicitly states it is a "titanium alloy multiple component system comprised of a variety of non-sterile, single use implantable components" including rods, screws, hooks, cross connectors, and locking caps. These are physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The CONQUEST Spinal System is described as a system of implantable components (rods, screws, hooks, etc.) made of titanium alloy. These are surgically placed within the body.
- Intended Use: The intended use is for internal fixation and stabilization of spinal segments as an adjunct to fusion. This is a surgical procedure performed directly on the patient's anatomy.
The device is a surgical implant used in vivo (within the living body), not a device used to test in vitro (outside the living body) specimens.
N/A
Intended Use / Indications for Use
Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.
The CONQUEST Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion.
When used as a posterior spine thoracic/lumbar system, the CONQUEST Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis). (4) spinal tumor. (5) failed previous fusion (6) pseudarthrosis, (7) spinal stcnosis, (8) spondylolisthesis.
Product codes
MNH, MNI, NKB, KWP
Device Description
The CONQUEST Spinal System is a titanium alloy multiple component system comprised of a variety of non-sterile, single use implantable components. When assembled, the components create a rigid structure providing stabilization and promote spinal fusion. The system consists of an assortment of rods, screws, hooks, cross connectors and locking caps.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical posterior spine
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
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
Biomechanical testing in accordance with ASTM F1717 was conducted to demonstrate substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
K090320 age 1 of 2
JUL 222009
510(k) Summary
CONQUEST® Spinal System
Submitted By:
510(k) Contact:
Date Prepared:
Trade Name:
Common Name:
Device Product Code And Classification:
Life Spinc 2401 W. Hassell Road, Suite 1535 Hoffman Estates, IL 60169 Telephone: 847-884-6117 Fax: 847-884-6118
Mr. Murali Audipudy RA/QA Manager Life Spine 2401 W. Hassell Road, Suite 1535 Hoffman Estates, IL 60169 Telephone: 847-884-6117 Fax: 847-884-6118
March 20, 2009
CONQUEST® Spinal System
Appliance, Fixation, Spinal Interlaminal
MNH, 888.3070, Class II, Spondylolisthesis Spinal Fixation Device System MNI, 888.3070, Class II, Pedicle Screw Spinal System NKB, 888.3070, Class III, Pedicle Screw Spinal System, For Degenerative Disc Disease KWP, 888.3050, Class II, Spinal Interlaminal Fixation Orthosis
CONQUEST Spinal System (K080767) Predicate Devices: EBI Array Spinal System (K062685)
Device Description:
The CONQUEST Spinal System is a titanium alloy multiple component system comprised of a variety of non-sterile, single use implantable components. When assembled, the components create a rigid structure providing stabilization and promote spinal fusion. The system consists of an assortment of rods, screws, hooks, cross connectors and locking caps.
Intended Use of the Device:
Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.
1
The CONQUEST Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion.
When used as a postcrior spine thoracic/lumbar system, the CONQUEST Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis). (4) spinal tumor. (5) failed previous fusion (6) pseudarthrosis, (7) spinal stcnosis, (8) spondylolisthesis.
Material:
Manufactured from medical gradc titanium alloy described by ASTM F136 (Ti 6AL-4V-ELI) implant grade titanium alloy.
Performance Data:
Biomechanical testing in accordance with ASTM F1717 was conducted to demonstrate substantial equivalence.
Substantial Equivalence:
The CONQUEST® Spinal System was shown to be substantially equivalent to previously cleared devices in indications for use, design, function, and materials used.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with an abstract image of an eagle in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 2 2009
Life Spine, Inc. c/o Mr. Murali Audipudy RA/QA Manager 2401 W. Hassell Road, Suite 1535 Hoffmann Estates, IL 60169
Re: K090320
Trade/Device Name: CONQUEST® Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH, KWP Dated: June 19, 2009 Received: June 22, 2009
Dear Mr. Murali,
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 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. Murali Audipudy
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quand brovisions (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 11 you dostro pos.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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Barbara Buett
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K090320 510(k) number (if known):
Device Name: CONQUEST® Spinal System
Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.
The CONQUEST Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion.
When used as a posterior spine thoracic/lumbar system, the CONQUEST Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.
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)
$\varepsilon \varepsilon - (EXT for MKM)$
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090320