(116 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as an immobilization and stabilization system for spinal segments, used as an adjunct to fusion in the treatment of various acute and chronic instabilities or deformities, which directly addresses medical conditions.
No
The APEX Spine System is a surgical implant designed to provide immobilization and stabilization of spinal segments, acting as an adjunct to fusion. Its purpose is to treat various spinal instabilities and deformities, not to diagnose them.
No
The device description explicitly states the system consists of physical components like spinal rods, screws, and connectors, which are hardware.
Based on the provided text, 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, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description and intended use of the APEX Spine System clearly indicate it is a surgical implant used to stabilize and immobilize the spine. It is a physical device implanted in the body, not a test performed on a sample outside the body.
The text describes a system of rods, screws, and connectors used in spinal fusion surgery. This falls under the category of surgical implants or orthopedic devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The APEX Spine System is 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 (pseudoarthrosis).
The APEX Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The APEX Spine System is also a hook and sacral/iliac screw fixation system of the non-cervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis). tumor, and previous failed fusion (pseudo-arthrosis).
The APEX Spine System when used with pedicle screws are indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.
Product codes
KWP, MNH, MNI
Device Description
The APEX Spine System is a rod-based system designed to interface with various spinal anatomies. The system consists of spinal rods, monoaxial screws, polyaxial screws, bolt-type pedicle screws, various lateral connectors, and various cross (transverse) connectors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine, L5-S1 vertebra, non-cervical 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical and dynamic testing of the APEX Spine System was performed. The test results demonstrate that the mechanical performance of the APEX Spine System is at least comparable to, if not better than, those of the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K010576, K024348, K965145, K051971, K001668
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.
0
510(k) SUMMARY
| SUBMMITTER: | SpineCraft
2215 Enterprise Drive
Westchester, IL 60154-5819 | DEC 2 2 2006 |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| CONTACT PERSON: | Ami Akallal-Asaad, Regulatory Affairs Manager | |
| DATE PREPARED: | November 02, 2006 | |
| CLASSIFICATION NAME: | Spinal Interlaminal Fixation Orthosis - 888.3050
Spinal Pedicle Fixation - 888.3070(b)(1) | |
| PROPRIETARY NAME: | APEX Spine System | |
| COMMON NAME: | Spinal Fixation System | |
| PRODUCT CODE: | KWP, MNH, MNI | |
| CLASSIFICATION PANEL: | 87 | |
| PRODUCT DESCRIPTION: | The APEX Spine System is a rod-based system designed to
interface with various spinal anatomies. The system consists
of spinal rods, monoaxial screws, polyaxial screws, bolt-type
pedicle screws, various lateral connectors, and various cross
(transverse) connectors. | |
| MATERIALS: | The APEX Spine System is manufactured from implant grade
titanium Alloy (Ti-6Al-4V) conforming to ASTM standard F-136
and ISO 5832-3. | |
| INDICATIONS FOR USE: | The APEX Spine System 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 (pseudoarthrosis).
The APEX Spine System is also indicated for pedicle screw
fixation for the treatment of severe spondylolisthesis (Grades
3 and 4) of the L5-S1 vertebra in skeletally mature patients
receiving fusion by autogenous bone graft having implants
attached to the lumbar and sacral spine (L3 to sacrum) with
removal of the implants after the attainment of a solid fusion. | |
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and and and a man a control and consideration and model and and comments of the mail foundeline
The APEX Spine System is also a hook and sacral/iliac screw fixation system of the non-cervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis). tumor, and previous failed fusion (pseudo-arthrosis).
The APEX Spine System when used with pedicle screws are indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.
The APEX Spine System is substantially equivalent to the SUBSTANTIAL EQUIVALENCE: following predicate devices:
- 트 MONARCH Spine System: K010576, K024348 -DePuy AcroMed.
- .. MOSS MIAMI Spinal System: K965145 - DePuy, Inc.
- I OPTIMA Spinal System: K051971 - U&I Corp.
- 트 Global Spinal Fixation System: K001668 - D.K.M. Co., Ltd.
The substantial equivalence of the APEX spine system to the above mentioned predicate devices is based upon equivalence in design, material, manufacturing standards, intended use, as well as indications and contraindications. The fundamental scientific technology of this system is identical to previously cleared systems.
PERFORMANCE DATA: Mechanical and dynamic testing of the APEX Spine System was performed. The test results demonstrate that the mechanical performance of the APEX Spine System is at least comparable to, if not better than, those of the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SpineCraft, Inc. % Ms. Ami Akallal-Asaad Regulatory Affairs Manager 2215 Enterprise Drive Suite 1504 Westchester, Illinois 60154
DEC 2 2 2006
Re: K062513
Trade/Device Name: APEX Spine System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP, KWQ, MNI, MNH Dated: November 2, 2006 Received: November 6, 2006
Dear Ms. Akallal-Asaad:
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 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); 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.
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Page 2 - Ms. Ami Akallal-Asaad
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.
Sincerely vours.
Opaubere Buchund
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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A. Indication for Use Statement
510(k) Number (if known): K062513
Device Name: APEX Spine System
Indication for Use:
The APEX Spine System intended to provide immobilization 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; spinal tumor; and failed previous fusion (pseudoarthrosis).
The APEX Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (1.3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The APEX Spine System is also a hook and sacral/iliac screw fixation system of the non-cervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scollosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudo-arthrosis).
The APEX Spine System when used with pedicle screws are indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.
Prescription Use: ____________________________________________________________________________________________________________________________________________________________ (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 CDRH, Office of Device Evaluation (ODE)
Barbara Paulin
estorative. and Neurological Devices
510(k) Number K062513