(26 days)
Not Found
No
The device description focuses on mechanical components (hooks, screws, rods, connectors) for spinal fixation and fusion. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are mechanical tests, not algorithmic performance evaluations.
Yes
The device is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of various acute and chronic instabilities or deformities, which directly addresses a medical condition or disease.
No
Explanation: The InCompass Spinal Fixation System is a surgical implant designed to provide immobilization and stabilization of spinal segments as an adjunct to fusion. It consists of hooks, screws, rods, and connectors. There is no indication that it is used for diagnostic purposes.
No
The device description explicitly states that the system consists of various hooks, screws, rods, and connectors, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The InCompass Spinal Fixation System is described as consisting of "various hooks, screws, rods and connectors" intended to provide "temporary stabilization following surgery to fuse the spine." These are physical implants used within the body during a surgical procedure.
- Intended Use: The intended use describes the surgical application of these implants for spinal fixation and stabilization in various conditions. This is a surgical intervention, not a diagnostic test performed on a sample.
The device is a surgical implant used for spinal fixation, which is a type of medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
When intended for pedicle screw fixation from T1-S1, the InCompass Spinal Fixation 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: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, and failed previous fusion.
As a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is established.
When intended for non-pedicle, posterior screw fixation of the non-cervical spine (T1-S1), the indications are idiopathic scoliosis, neuromuscular scoliosis with associated paralysis or spasticity, scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele, spinal fractures (acute reduction or late deformity), degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), tumor, spondylolisthesis, spinal stenosis and failed previous fusion.
When intended for anterolateral screw, rod and or cable fixation of the T6-L5 spine the indications are degenerative discase (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, and/or lordosis), tumor and failed previous fusion
After solid fusion occurs, these devices serve no functional purpose and should be removed. In most cases, removal is indicated because the implants are not intended to transfer or support forces developed during normal activities. Any decision to remove the device must be made by the physician and the patient, taking into consideration the patient's general medical condition and the potential risk to the patient of a second surgical procedure.
The use of posterior spinal instrumentation in children has been reported in the literature. The InCompass Spinal Fixation System may be used for non-pedicle posterior use in this patient group.
Product codes (comma separated list FDA assigned to the subject device)
MNI, MNH, KWP, KWQ
Device Description
The Spinal Concepts, Inc. InCompass Spinal Fixation System consists of various hooks, screws, rods and connectors and is intended to provide temporary stabilization following surgery to fuse the spine. This system includes open styled hooks and screws, which allow the surgeon to use a top loading technique for dropping the spinal rod down to the fixation components. Closed styled implants are also provided. Offset connectors are included to provide both offset between the screw and rod and also and reduce the effort needed to contour the spinal rod. Crosslinks are provided to increase rotational stiffness to longer constructs. Two sizes of spinal rods are included with this system. Screws are provided in both fixed angle and polyaxial design.
This 510(k) covers the addition of polyaxial screws in The InCompass system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
T1-S1 (thoracic, lumbar, and sacral spine), L3-S1 (lumbosacral spine), T6-L5 spine
Indicated Patient Age Range
skeletally mature patients, children (for non-pedicle posterior use)
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)
Mechanical testing data, collected in accordance with ASTM 1717, were collected to verify the designs. Static and fatigue data were provided to demonstrate that the design met all functional requirements.
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
§ 888.3070 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
NOV 2 5 2002
InCompass Spinal Fixation System, with Polyaxial Screws
510(k) Summary
| SUBMITTED BY | Spinal Concepts, Inc.
12012 Technology Blvd., Suite 100
Austin, TX 78727 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| ESTABLISHMENT
REGISTRATION NUMBER | 1649384 |
| CONTACT PERSON | David M. Hooper, Ph.D.
Director, Regulatory and Clinical Affairs |
| DATE PREPARED | October 25, 2002 |
| CLASSIFICATION NAME | Spinal Intervertebral Body Fixation Orthosis
Spinal Interlaminal Fixation Orthosis
Pedicle Screw Spinal System |
| COMMON NAME | Spinal Fixation System |
| PROPRIETARY NAME | InCompass Spinal Fixation System, with polyaxial screws |
| PREDICATE DEVICE | InCompass Fixation System (K021564) |
DEVICE DESCRIPTION
The Spinal Concepts, Inc. InCompass Spinal Fixation System consists of various hooks, screws, rods and connectors and is intended to provide temporary stabilization following surgery to fuse the spine. This system includes open styled hooks and screws, which allow the surgeon to use a top loading technique for dropping the spinal rod down to the fixation components. Closed styled implants are also provided. Offset connectors are included to provide both offset between the screw and rod and also and reduce the effort needed to contour the spinal rod. Crosslinks are provided to increase rotational stiffness to longer constructs. Two sizes of spinal rods are included with this system. Screws are provided in both fixed angle and polyaxial design.
This 510(k) covers the addition of polyaxial screws in The InCompass system.
MATERIALS
The InCompass Spinal Fixation System includes components made from stainless steel (ASTM F-138) and titanium alloy Ti6Al4V ELI (ASTM F-136). The polyaxial screws are made of titanium alloy only.
WARNING: Stainless steel and titanium components should not be used in the same construct.
INDICATIONS
When intended for pedicle screw fixation from T1-S1, the InCompass Spinal Fixation 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: degenerative disc disease (defined as discogenic back pain with
1
degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, and failed previous fusion.
As a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is established.
When intended for non-pedicle, posterior screw fixation of the non-cervical spine (T1-S1), the indications are idiopathic scoliosis, neuromuscular scoliosis with associated paralysis or spasticity, scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele, spinal fractures (acute reduction or late deformity), degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), tumor, spondylolisthesis, spinal stenosis and failed previous fusion.
When intended for anterolateral screw, rod and or cable fixation of the T6-L5 spine the indications are degenerative discase (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, and/or lordosis), tumor and failed previous fusion
After solid fusion occurs, these devices serve no functional purpose and should be removed. In most cases, removal is indicated because the implants are not intended to transfer or support forces developed during normal activities. Any decision to remove the device must be made by the physician and the patient, taking into consideration the patient's general medical condition and the potential risk to the patient of a second surgical procedure.
The use of posterior spinal instrumentation in children has been reported in the literature. The InCompass Spinal Fixation System may be used for non-pedicle posterior use in this patient group.
MECHANICAL TEST DATA
Mechanical testing data, collected in accordance with ASTM 1717, were collected to verify the designs. Static and fatigue data were provided to demonstrate that the design met all functional requirements.
BASIS OF SUBSTANTIAL EQUIVALENCE
The modified InCompass Spinal Fixation System is substantially equivalent to the unmodified InCompass Spinal Fixation System in terms of fit, form and function, with no change to the intended use or fundamental scientific technology.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is horizontally aligned and appears to be the primary focus of the image. The words are stacked on a single line.
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NOV 2 5 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
David M. Hooper, Ph.D. Manager, Regulatory and Clinical Affairs Spinal Concepts, Inc. 12012 Technology Boulevard, Suite 100 Austin, Texas 78727
Re: K023644 Trade/Device Name: InCompass Spinal Fixation System Regulatory Number: 21 CFR 888.3070(b)(1), 888.3050, 888.3060 Regulation Name: Pedicle Screw Spinal System, Spinal Interlaminal Fixation Orthosis, Spinal Intervertebral Body Fixation Orthosis Regulatory Class: III; II Product Code: MNI, MNH, KWP, KWQ Dated: October 29, 2002 Received: October 30, 2002
Dear Dr. Hooper:
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.
3
Page 2 – Dr. David M. Hooper
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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
i-m-millean
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 2
510(k) Number (if known): LO 2 3644
Device Name: Spinal Concepts, Inc. InCompass Spinal Fixation System
Indications for Use:
When intended for pedicle screw fixation from T1-S1, the InCompass Spinal Fixation System is 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: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), tumor and failed previous fusion.
As a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is established.
When intended for non-pedicle, posterior screw fixation of the non-cervical spine (T1-S1), the indications are idjopathic scoliosis, neuromuscular scoliosis/kyphoscoliosis with associated paralysis or spasticity, scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele, spinal fractures (acute reduction or late deformity), degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), tumor, spondylolisthesis, spinal stenosis and failed previous fusion.
When intended for anterolateral screw, rod and or cable fixation of the T6-L5 spine the indications are degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, and/or lordosis). turnor and failed previous fusion
The use of posterior spinal instrumentation in children has been reported in the literature. The InCompass Spinal Fixation System may be used for non-pedicle posterior use in this patient group
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PA IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Prescription Use:
(Per 21 CFR 801.109)
OR
Over-The-Counter (Ontional Format 1
5
INIDICATIONS FOR USE STATEMENT
Page 2 of 2
510(k) Number (if known): K6236444
Device Name: Spinal Concepts, Inc. InCompass Spinal Fixation System
Indications for Use:
After solid fusion occurs, these devices serve no functional purpose and should be removed. In most cases, removal is indicated because the implants are not intended to transfer or support forces developed during normal activities. Any decision to remove the device must be made by the physician and the patient, taking into consideration the patient's general medical condition and the potential risk to the patient of a second surgical procedure.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter: (Per 21 CFR 801.109) (Optional Format 1-2-96)