(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 related to AI or ML.
Yes
The device is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion for various medical conditions like degenerative disc disease, spondylolisthesis, and trauma, which falls under therapeutic use.
No
Explanation: The CD HORIZON® Spinal System is described as a system of implants (rods, hooks, screws, plates, etc.) intended for immobilization and stabilization of spinal segments as an adjunct to fusion, which are therapeutic functions, not diagnostic.
No
The device description explicitly lists physical components like rods, hooks, screws, plates, and staples, indicating it is a hardware-based medical device.
Based on the provided text, the CD HORIZON® Spinal System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes the device as being used for posterior, non-cervical fixation and immobilization and stabilization of spinal segments as an adjunct to fusion. These are surgical procedures performed directly on the patient's body.
- Device Description: The device components are described as rods, hooks, screws, plates, staples, and other connecting components used to build a spinal construct. These are physical implants designed to be placed within the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The CD HORIZON® Spinal System does not perform any such analysis of biological specimens.
The CD HORIZON® Spinal System is a surgical implant used to treat various spinal conditions.
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, kyphosis 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 in 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 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.
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 conditions: 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); 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 VERTEX™ rod connector. Refer to the VERTEX™ Reconstruction System Package Insert for a list of the VERTEX™ indications of use.
Product codes (comma separated list FDA assigned to the subject device)
NKB, MNI, MNH, KWP, KWQ
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 modified CD HORIZON® hooks 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
thoracic, lumbar, and/or sacral spine, non-cervical 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.
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
042167
page lofa
CD HORIZON® Spinal System Summary of Safety and Effectiveness August 2004
Medtronic Sofamor Danek, Inc. USA I. Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133 .
Proposed Proprietary Trade Name: CD HORIZON® Spinal System II.
- Classification Name: Spinal Interlaminal Fixation and Spinal Intervertebral Fixation III. Orthosis and/or Pedicle Screw Spinal System (per 21 CFR Section 888.3050, 888.3060 and/or 888.3070)
Product Description IV.
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 modified CD HORIZON® hooks to the CD HORIZON® Spinal System.
V. Indications
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, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
When used in a percutaneous, non-cervical, posterior approach with the SEXTANT
1
K042167
page 2 of 2
instrumentation, the CD HORIZON® screws are intended for the following in 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 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.
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 conditions: 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); 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 VERTEX™ rod connector. Refer to the VERTEX™ Reconstruction System Package Insert for a list of the VERTEX™ indications of use.
VI. Substantial Equivalence
Documentation was provided which demonstrated the CD HORIZON® Spinal System to be substantially equivalent to CD HORIZON® Spinal System components previously cleared in K041460 and K031655.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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" arranged around the perimeter. Inside the circle is a stylized graphic of three abstract shapes, resembling human figures or flowing lines, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 8 2004
Richard W. Treharne, Ph.D. Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132
Re: K042167
K042167
Trade/Device Name: CD HORIZON™ Spinal System Trade/Device Name: OB TFC 888.3070, 21 CFR 888.3050, 21 CFR 888.3060 Regulation Name: Pedicle screw spinal system, Spinal interlaminal fixation orthosis, Spinal intervertebral body fixation orthosis Regulatory Class: III Product Code: NKB, MNI, MNH, KWP, KWQ Dated: August 9, 2004 Received: August 11, 2004
Dear Dr. Treharne:
We have reviewed your Section 510(k) premarket notification of intent to market the indice we nave reviewed your becaon 310(x) premised the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regary manetoe por the Medical Device Americal Food - Frye commerce prior to May 20, 1970, the excordance with the provisions of the Federal Food, Drug, devices that have been recuired in asses approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. of the You may, uncreive, market the act include requirements for annual registration, listing of general controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (soc above) ins. Existing major regulations affecting your device can may be subject to suen additional controllations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous acements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that I DF Crisoanter or our device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of any iredical statutes and regulations and using, but not limited to: registration and listing (21 Comply with an the Fee 370 cart 801); good manufacturing practice requirements as set
3
Page 2 - Richard W. Treharne, Ph.D.
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin makeming of substantial equivalence of your device to a legally premarket notification. The PDA miding of Subscribed of the more
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 Patt 801), please If you desire specific advice for your at (301) 594-4692. Also, please note the regulation entitled, contact the Office of Compullion at (501) 37 + 750 (21CFR Part 807.97). You may obtain " Misoralianing by Cierches to premainteensbilities under the Act from the Division of Small other general information on your responsible and its toll-free number (800) 638-2041 or Manufacturers, International and Octas http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
O. Mch. M. Melleum
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 August 2004
510(k) Number (if known): K042167
CD HORIZON® Spinal System Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The CD HORIZON® Spinal System is intended for posterior, non-cervical fixation for the The CD HORIZON® Spinal System is Intence (defined as back pain of discogenic origin with
following indications: degenerative disc disease (defined scopedialisthesis; following indications: degeneralive discuse (domied as studies); spondylolisthesis;
degeneration of the disc confirmed by history and radiographic socialist, by phosis and degeneration of the disc confirmed by instory and starty, "
trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or trauma (t.C., fracture of eistere of eisers and/or failed previous fusion.
When used in a percutaneous, non-cervical, posterior approach with the SEXTANT When used in a perculatious, non ect rical, possesses of r instrumentation, the CD HORZON® setcws in of discusses origin with deceneration of the disc
degenerative disc disease (defined as back pain of discusses (i.o., fracture or degenerative disc disease (defined as back pain or and ogsist is a ma (i.e., fracture of contirmed by history and fadiographis studios, open ...
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® Except for nooks, when used as an ameronate are intended for the following indications: (1)
components such as ECLIPSE® components are intended for the mith deconomical of components such as ECLIF SE® componens are motifiscogenic origin with degeneration of the degenerative disc disease (as defined of basis phic studies), (2) spinal stenosis, (3)
disc confirmed by patient history and radiographic studies), (2) spinal selection disc confirmed by patient instory and natiographis statists, and/or lordosis), (5) fracture, spondylonsthesis, (4) spinal defection, 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 (TI – SI). It is intended for plate fixation/attachment intended for use in the non-cervical spine (11) - 3). - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - to spinous process for the purpose of acmoving suppression origin with degeneration of the disc
degenerative disc disease - defined as back pain of discogenic origin with of degenerative disculiseas = demica as sactif pain of the stature of trauma (i.e., fracture or dislocation); and/or tumor.
In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be In order to active addinonal levels of thation, the earling the VERTEXTM rod comector. Refer connected to the VERTEX - Reconstruction of the VERTEX™ indications
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)
ConcuDivision Offeral, Device Fratiivien (ODE)
and Neurological Devices
510(k) Number K042167