(114 days)
Documentation was provided which demonstrated the CD HORIZON® Spinal System to be substantially equivalent to itself.
Not Found
No
The document describes a spinal fixation system composed of mechanical components and instrumentation. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
Explanation: The device is intended for various medical conditions of the spine, such as fractures, deformities, and degenerative disc disease, and is designed to fix or stabilize the spine, which are therapeutic interventions.
No
The device description clearly states that the CD HORIZON® Spinal System "consists of a variety of rods, hooks, screws, CROSSLINK® plates, staples, and other connecting components used to build a spinal construct." These are all components for physical fixation and fusion, not for diagnosing conditions. The "Intended Use / Indications for Use" section lists various spinal conditions for which the system is used as a fixation system, not for their diagnosis.
No
The device description clearly states it consists of physical components like rods, hooks, screws, plates, and staples, which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a spinal fixation system used for surgical implantation to treat various spinal conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the components of a spinal implant system (rods, hooks, screws, etc.) and instrumentation for implantation. This aligns with a surgical device, not a device used to test samples from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
Therefore, the CD HORIZON® system, as described in this text, is a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CD HORIZON® system is intended for the following indications:
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the CD HORIZON® 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 CD HORIZON® Spinal System is 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: (3) 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 CD HORIZON® 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 in a percutaneous posterior approach with the SEXTANT instrumentation, the CD HORIZON® Cannulated M8 Multi-Axial Screw components are intended for the following indications:
When used as a pedicle screw fixation system the CD HORIZON® Cannulated M8 Multi-Axial Screw components are 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); (d) who are having the device removed after the development of a solid fusion mass.
In addition, when used as a posterior spine thoracic/lumbar system, the CD HORIZON® Cannulated M8 Multi-Axial Screw components are intended for: (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. degenerative scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
The CD HORIZON® ECLIPSE® components are intended for the following indications: When used as an anterolateral thoracic/lumbar system, the CD HORIZON® 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 (comma separated list FDA assigned to the subject device)
KWP, KWQ, MNH, MNI
Device Description
The CD HORIZON® Spinal System consists of a variety of rods, hooks, screws, CROSSLINK® plates, staples, and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.
Certain implant components from other Medtronic Sofamor Danek spinal systems can be used with the CD HORIZON® Spinal System. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples and washers; GDLH® rods, hooks, connectors and CROSSLINK® bar and connectors: LIBERTY® rods and screws: DYNALOK PLUS® bolts: and Medtronic Sofamor Danek Multi-Axial rods and screws.
CD HORIZON® hooks are intended for posterior use only. CD HORIZON® staples and CD HORIZON® ECLIPSE rods and screws are intended for anterior use only. However, for patients of smaller stature, stainless steel CD HORIZON® 4.5mm rods and associated components may be used posteriorly.
The purpose of this 510(k) submission is to expand the length range of the CD HORUZON® ECLIPSE Cannulated Screws and to add an 8.5mm diameter CD HORIZON® ECLIPSE screw to the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical posterior spine, fifth lumbar-first sacral (L5-S1) vertebral joint, lumbar and sacral spine (L3 and below), posterior spine thoracic/lumbar, anterolateral thoracic/lumbar
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)
Not Found
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.
Documentation was provided which demonstrated the CD HORIZON® Spinal System to be substantially equivalent to itself.
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
§ 888.3050 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
K021061
page 1 of 2
CD HORIZON® Spinal System Summary of Safety and Effectiveness April 2002
Medtronic Sofamor Danek, Inc. USA Company: I. 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
Proposed Proprietary Trade Name: CD HORIZON® Spinal System II.
Product Description III.
The CD HORIZON® Spinal System consists of a variety of rods, hooks, screws, CROSSLINK® plates, staples, and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.
Certain implant components from other Medtronic Sofamor Danek spinal systems can be used with the CD HORIZON® Spinal System. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples and washers; GDLH® rods, hooks, connectors and CROSSLINK® bar and connectors: LIBERTY® rods and screws: DYNALOK PLUS® bolts: and Medtronic Sofamor Danek Multi-Axial rods and screws.
CD HORIZON® hooks are intended for posterior use only. CD HORIZON® staples and CD HORIZON® ECLIPSE rods and screws are intended for anterior use only. However, for patients of smaller stature, stainless steel CD HORIZON® 4.5mm rods and associated components may be used posteriorly.
The purpose of this 510(k) submission is to expand the length range of the CD HORUZON® ECLIPSE Cannulated Screws and to add an 8.5mm diameter CD HORIZON® ECLIPSE screw to the system.
IV. Indications
The CD HORIZON® system is intended for the following indications:
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the CD HORIZON® 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 CD HORIZON® Spinal System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebrai joint; · b) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (1,3 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 CD HORIZON® 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.
1
021061 page 2 of 2
When used in a percutaneous posterior approach with the SEXTANT instrumentation, the CD HORIZON® Cannulated M8 Multi-Axial Screw components are intended for the following indications:
When used as a pedicle screw fixation system the CD HORIZON® Cannulated M8 Multi-Axial Screw components are 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); (d) who are having the device removed after the development of a solid fusion mass.
In addition, when used as a posterior spine thoracic/lumbar system, the CD HORIZON® Cannulated M8 Multi-Axial Screw components are intended for: (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. degenerative scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
The CD HORIZON® ECLIPSE components are intended for the following indications: When used as an anterolateral thoracic/lumbar system, the CD HORIZON® 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
Documentation was provided which demonstrated the CD HORIZON® Spinal System to be substantially equivalent to itself.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal for the Department of Health & Human Services-USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. In the center of the seal are three stylized profiles of human faces, stacked on top of each other.
9200 Corporate Boulevard Rockville MD 20850
Food and Drug Administration
JUL 2 5 2002
Mr. Richard W. Treharne, PhD Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis. Tennessee 38132
Re: K021061
Trade/Device Name: CD HORIZON® Spinal System Regulation Number: 21 CFR §888.3050; §888.3060; §888.3070 Regulation Name: Spinal interlaminal fixation orthosis; spinal intervertebral body fixation orthosis; pedicle screw spinal system Regulatory Class: Class II Product Code: KWP, KWQ, MNH, MNI Dated: July 8, 2002 Received: July 10, 2002
Dear Dr. Treharne;
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.
3
Page 2 – Mr. Richard W. Treharne, PhD
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours.
Mark A. Milliman
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
4
Page 1 of 2 March 2002
| 510(k) Number (if known): | K021061 |
|---|---|
| --------------------------- | --------- |
CD HORIZON® Spinal System_____________________________________________________________________________________________________________________________________________________ Device Name: ______________
Indications for Use:
The CD HORIZON® system is intended for the following indications:
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the CD HORIZON® 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 CD HORIZON® Spinal System is 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: (3) 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 CD HORIZON® 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 in a percutaneous posterior approach with the SEXTANT instrumentation, the CD HORIZON® Cannulated M8 Multi-Axial Screw components are intended for the following indications:
When used as a pedicle screw fixation system the CD HORIZON® Cannulated M8 Multi-Axial Screw components are 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); (d) who are having the device removed after the development of a solid fusion mass.
for
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K021061
-00089
(Continued on the next page)
5
In addition, when used as a posterior spine thoracic/lumbar system, the CD HORIZON® Cannulated M8 Multi-Axial Screw components are intended for: (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. degenerative scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
The CD HORIZON® ECLIPSE® components are intended for the following indications: When used as an anterolateral thoracic/lumbar system, the CD HORIZON® 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-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-the-counter Use _
14021061
(Optional 1-2-96)
Mark N Melhuse
for (Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number K021061
-000900