(408 days)
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No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a spinal system indicated for treating various spinal conditions such as fractures, dislocations, scoliosis, kyphosis, tumors, and degenerative disc disease, among others, which aim to alleviate symptoms or correct a medical condition.
No
This device is a spinal fixation system, consisting of implants and instruments designed to build a spinal construct for fusion and stabilization, not for diagnosis. Its "Intended Use / Indications for Use" describes conditions it treats, not diagnoses.
No
The device description explicitly states that the COLORADO™ II Spinal System consists of physical components such as rods, hooks, screws, plates, staples, and other connecting components, fabricated from stainless steel or titanium alloy. This indicates it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as a spinal fixation system used for surgical implantation in patients with various spinal conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as consisting of rods, hooks, screws, plates, staples, and connecting components made of stainless steel or titanium alloy. These are physical implants used to stabilize the spine.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or treatment.
Therefore, the COLORADO™ II Spinal System is a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the COLORADO™ II Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal turnor, and/or (7) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the COLORADO™ II Spinal System is also indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the COLORADO™ II Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
When used as an anterolateral thoracic/lumbar system, the COLORADO™ II Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
Product codes
MNH, MNI, KWP and K WQ
Device Description
The COLORADO™ II Spinal System consists of a variety of rods, hooks, screws, plates, staples, and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.
COLORADO™ II Spinal System implant components are fabricated from stainless steel conforming to ASTM F138 or ISO 5832-1 or ISO 5832-9. Alternatively, the implant components may be manufactured from titanium alloy conforming to ASTM F-136 titanium alloy, or ISO 5832-3 and may be sold sterile or non-sterile. Stainless steel implants are not to be used with titanium alloy implants in a spinal construct.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
non-cervical posterior spine, fifth lumbar-first sacral (L5-S1) vertebral joint, lumbar and sacral spine (L3 and below), non-cervical, anterolateral thoracic/lumbar
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing data were provided or referenced to demonstrate substantial equivalence
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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MAY 1 0 2000
COLORADO™ II Spinal System Summary of Safety and Effectiveness March 1999
142
- I. Company: Sofamor Danek USA 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
II. Proposed Proprietary Trade Name: COLORADO™ II Spinal System
III. Product Description
The COLORADO™ II Spinal System consists of a variety of rods, hooks, screws, plates, staples, and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.
COLORADO™ II Spinal System implant components are fabricated from stainless steel conforming to ASTM F138 or ISO 5832-1 or ISO 5832-9. Alternatively, the implant components may be manufactured from titanium alloy conforming to ASTM F-136 titanium alloy, or ISO 5832-3 and may be sold sterile or non-sterile. Stainless steel implants are not to be used with titanium alloy implants in a spinal construct.
IV. Indications
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the COLORADO™ II Spinal System Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the COLORADO™ II Spinal System is also indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below);
1
2 of 2 and (4) who are having the device removed after the development of a solid fusion. mass.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the COLORADO™ II Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
When used as an anterolateral thoracic/lumbar system, the COLORADO™ II Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion,
V. Substantial Equivalence
The COLORADO™ II Spinal System is substantially equivalent to other legally marketed devices. Mechanical testing data were provided or referenced to demonstrate substantial equivalence
2
Public Health Service
Image /page/2/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an abstract image of an eagle.
MAY 1 0 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Richard Treharne, Ph.D. Vice President, Research and Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132
Re: K991031
Trade Name: COLORADO II Spinal System (Ti Alloy version) Regulatory Class: II Product Code: MNH, MNI, KWP and K WQ Dated: February 15, 2000 Received: February 16, 2000
Dear Dr. Treharne:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
3
Page 2 - Richard Treharne, Ph.D.
If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and If you desire specific advice for your do rices), please contact the Office of Compliance at additionally 809.10 for m vito diagnosions on the promotion and advertising of your device, (201) 594-4037. Addinonary, for questions of (301) 594-4639. Also, please note the regulation prease contact the Office or Comphanee at (301) on the stime (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsibilities ander the rise number (800) 638-2041 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html" .
Sincerely yours,
Dune R. Lochner.
(j)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
4
510(k) Number (if known):
COLORADO™ II Spinal System Device Name: Indications for Use:
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the COLORADO™ II Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal turnor, and/or (7) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the COLORADO™ II Spinal System is also indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the COLORADO™ II Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
When used as an anterolateral thoracic/lumbar system, the COLORADO™ II Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
(PLEASE DO NOT WRITE BELOW THIS LINE------------------------------------------------------------------------------------------------------------------------------------------
| Concurrence of CDRH, Office of Evaluation (ODE) | ||
|---|---|---|
| Prescription Use | ||
| (Per 21 CFR 801.109) | ||
| (Optional 1-2-96) | OR | Over-the-counter Use ________ |
| (Division Sign-Off) | ||
| Division of General Restorative Devices | ||
| 510(k) Number K991031 |