(28 days)
Not Found
No
The document describes a mechanical spinal fixation system and its components, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
Yes
The device is described as an implantable spinal system intended to help provide "immobilization and stabilization of spinal segments as an adjunct to fusion" for various medical conditions like degenerative disc disease, trauma, spinal stenosis, and curvatures. This directly addresses the treatment of diseases or abnormal conditions, qualifying it as a therapeutic device.
No
Explanation: The CD HORIZON® Spinal System is described as a system of implants (rods, hooks, screws, plates, etc.) intended for spinal immobilization and stabilization as an adjunct to fusion. Its purpose is to provide physical support and promote fusion, not to diagnose medical conditions.
No
The device description explicitly lists hardware components such as rods, hooks, screws, plates, staples, and other connecting components used to build a spinal construct.
Based on the provided text, the CD HORIZON® Spinal System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- CD HORIZON® Spinal System Description: The description clearly states that the CD HORIZON® Spinal System consists of implants (rods, hooks, screws, plates, etc.) intended for surgical implantation to provide immobilization and stabilization of spinal segments.
- Intended Use: The intended use describes the conditions for which the device is used within the body (e.g., degenerative disc disease, spondylolisthesis, trauma) and the surgical approach (posterior, anterolateral).
The CD HORIZON® Spinal System is a surgical implant, not a device used for testing samples outside the body.
N/A
Intended Use / Indications for Use
The CD HORIZON® Spinal System is intended for posterior, non-cervical fixation for the following indications: degenerative disc disease (defined as 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; curvatures (i.e., scoliosis, kynhonis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
When used in a percutaneous, non-cervical, posterior approach with the SEXTANT instrumentation, the CD HORIZON® screws are intended for the following indications: degenerative disc disease (defined as 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; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, CD HORIZON® components such as ECLIPSE® components are intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degencration 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.
The CD HORIZON® SPIRE Plate is posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1 - S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following cuaditions: degenerative disc disease - defined as back pain of discogenic origin with regeneration of the disc confirmed by history and radiographic studies; spondylolisthesis; trauma (i.e., fracture ro dislocation); and/or tumor.
In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX™ Reconstruction System with the VERTEXTM rod connector. Refer to the VERTEX™ Reconstruction System Package Insert for a list of the VERTEXTM indications of use.
Product codes (comma separated list FDA assigned to the subject device)
KWQ, KWP, 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.
The CD HORIZON® Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The CD HORIZON® Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. If necessary, the CD HORIZON® Spinal System can be connected to the VERTEX™ Reconstruction System through a rod connector.
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, CD HORIZON® 4.5mm rods and associated components may be used posteriorly.
The purpose of this 510(k) submission is to include additional hooks, multi axial screws, fixed angle screws and sagittal adjusting screws to the CD HORIZON® Spinal System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical, thoracic, lumbar, sacral spine, T1 - S1
Indicated Patient Age Range
Not Found
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.
K040583, K020709, K031655, K041118, K032265, K000094, K034056, K981676, K001532
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
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
KOH2025
CD HORIZON® Spinal System Summary of Safety and Effectiveness July 2004
- I. Medtronic Sofamor Danek, Inc. USA Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133 Contact: Richard W. Treharne, PhD
- Proposed Proprictary Trade Name: CD HORIZON® Spinal System II.
Sr. Vice President, Regulatory Affairs
- III. Classification Name: Spinal Interlaminal Fixation and Spinal Intervertebral Fixation Orthosis and/or l'edicle Screw Spinal System (per 21 CFR Section 888.3050, 888.3060 and/or 888.3070)
IV. Product Description
AUG 2 5 2004
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.
The CD HORIZON® Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The CD HORIZON® Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. If necessary, the CD HORIZON® Spinal System can be connected to the VERTEX™ Reconstruction System through a rod connector.
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, CD HORIZON® 4.5mm rods and associated components may be used posteriorly.
The purpose of this 510(k) submission is to include additional hooks, multi axial screws, fixed angle screws and sagittal adjusting screws to the CD HORIZON® Spinal System.
Page 1 of 2
000037
1
K042025
V. Indications
V. Co Indications
The CD HORIZON® Spinal System is intended for posterior, non-cervical fixation for the The CD HOROZON® Spinal System is intenate (defined as back pain of discogenic origin with following indications: degenerative discuse (uschies); spondylolisthesis; trauma
degeneration of the disc confirmed by history and radiographic studies); degeneration of the disc contifuled by instoly and tuckeraphic of the many of the materials and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
When used in a percutaneous, non-cervical, posterior approach with the SEXTANT when used in a perculancous, non oct rical, possessionended for the following indications: instrumentation, the CD HONZON® serews are intessogenic origin with degeneration of the disc
degenerative disc disease (defined as back pain of discogenic origin with of matu degeneralive discuse (demice as backed); spondylolisthesis; trauma (i.e., frauma (i.e., fracture or contrimed by instory and radiographio station, of 1977, scoliosis and/or lordosis); tumor, pseudoarthrosis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, CD HORIZON® Except for llocks, when used as an allercrates are intended for the following indications: (1) )
components such as ECLIPSE® components are intended for the following indica components such as ECLI'SE® components and interest origin with degeneration of the discussion of the disc degenerative disc disease (as delined by oater paint of answer (3) spondylolisthesis, (4)
confirmed by patient history and radiographic studies), (2) spondylolishesis, (7) confirmed by patient mistory and faciographie stazios), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
The CD HORIZON® SPIRE Plate is posterior, non-pedicle supplemental fixation device, intended The CD HOKIZON® SI INE Tate is posterior, non prace fixation/attachment to spinous for use in the non-cervical spille (11) - 17). The intenses as the following conditions: degenerative process for the purpose of acine in a supprements. Incomith degeneration of the disconfirmed by dise disease - delined as back pan of disougane origin was are or dislocation); and/or tumor.
In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be In order to achieve addition levels of fixanon, and OD Th the VERTEX™ rod connector. Refer to connected to the VERTEX - Reconstruction Dystem with and into VERTEX™ indications of
the VERTEX™ Reconstruction System Package Insert for a list of the VERTEX™ indications of use.
Substantial Equivalence VI.
VI. Substantial Equirinchee
Documentation was provided which demonstrated the CD HORIZON® Spinal shorest Documentally equivalent to CD HORIZON® Spinal System components previously cleared in substantially equivalent to CD HOREON® Opinal BJScon 94, K034056, K981676 and K001532.
K040583, K020709, K031655, K041118, K032265, K000094, K034056, K981676 and K001532.
00000008
2
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 5 2004
Richard W. Treharne, Ph.D. Sr. Vice President, Regulatory Affairs Medtronic Sofamor Danek, Inc. USA 1800 Pyramid Place Memphis. Tennessee 38132
Re: K042025
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: KWQ, KWP, MNH, MNI Dated: July 23, 2004 Received: July 28, 2004
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.
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
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. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Milburn
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
Page 1 of 1 July 2004
Device Name: CD HORIZON® Spinal System
Indications for Use:
The CD HORIZON® Spinal System is intended for posterior, non-cervical fixation for the following indications: degenerative disc disease (defined as 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; curvatures (i.e., scoliosis, kynhonis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
When used in a percutaneous, non-cervical, posterior approach with the SEXTANT instrumentation, the CD HORIZON® screws are intended for the following indications: degenerative disc disease (defined as 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; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, CD HORIZON® components such as ECLIPSE® components are intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degencration 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.
The CD HORIZON® SPIRE Plate is posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1 - S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following cuaditions: degenerative disc disease - defined as back pain of discogenic origin with regeneration of the disc confirmed by history and radiographic studies; spondylolisthesis; trauma (i.e., fracture ro dislocation); and/or tumor.
In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX™ Reconstruction System with the VERTEXTM rod connector. Refer to the VERTEX™ Reconstruction System Package Insert for a list of the VERTEXTM indications of use.
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)
(Division Sign-Off)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative, and Neurological Devices
510(k) Number K042035
000320