(61 days)
Not Found
No
The 510(k) summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for posterior, non-cervical fixation as an adjunct to fusion for various medical conditions such as degenerative disc disease, spondylolisthesis, trauma, and spinal stenosis, which are therapeutic indications.
No
This device is a spinal system (implants like rods, hooks, screws, plates) intended for fusion and stabilization, not for diagnosis.
No
The device description explicitly lists various hardware components such as rods, hooks, screws, plates, staples, and connecting components, all fabricated from medical-grade materials. The submission also describes modifications to bolts, plates, and a nut. This clearly indicates a physical medical device, not a software-only one.
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 CD HORIZON® Spinal System is described as a system of rods, hooks, screws, plates, and connecting components made of various materials (stainless steel, titanium, cobalt-chromium-molybdenum alloy, PEEK). These are physical implants intended for surgical use.
- Intended Use: The intended use is for posterior and anterolateral fixation in the non-cervical spine as an adjunct to fusion for various spinal conditions. This is a surgical intervention, not a diagnostic test performed on a sample.
The device is clearly a surgical implant system used to stabilize the spine, which falls under the category of medical devices, but not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion 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; pseudarthritis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion.
With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion.
The CD HORIZON SPIRE™ Plate is a posterior, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (as previously defined); spondylolisthesis, trauma; and/or tumor.
In order to achieve additional levels of fixation as an adjunct to fusion, 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)
KWP, KWQ, MNH, MNI, NKB and NQP
Device Description
The CD HORIZON® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® Plates, staples and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
Certain implant components from other Medtronic spinal systems can be used with the CD HORIZON® Spinal System. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples and washer, GDLH® rods, hooks, connectors and CROSSLINK® bar and connectors; LIBERTY® rods and screws; DYNALOK® PLUS and DYNALOK CLASSIC® bolts along with rod/bolt connectors; and Medtronic Multi-Axial rods and screws. Please note that certain components are specifically designed to connect to 03.5mm, 04.5mm, 0 5.5mm rods or 06.35mm rods, while other components can connect to both 05.5mm rods and 06.35mm rods. Care should be taken so that the correct components are used in the spinal construct.
CD HORIZON® hooks are intended for posterior use only. CD HORIZON® staples and CD HORIZON® ECLIPSE® rods and associated 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 CD HORIZON® Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, medical grade cobaltchromium-molybdenum alloy, or medical grade PEEK OPTIMA-LT1. Certain CD HORIZON® Spinal System components may be coated with hydroxyapatite. No warranties express, or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. See the MDT Catalog for further information about warranties and limitations of liability.
Never use stainless steel and titanium implant components in the same construct. Medical grade titanium, titanium alloy and/or medical grade cobalt-chromiummolybdenum alloy may be used together. Never use titanium, titanium alloy and/or medical grade cobalt-chromium-molybdenum alloy with stainless steel in the same construct.
The CD HORIZON® Spinal System also includes anterior staples made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium. titanium alloy and cobalt-chromium-molybdenum alloy. Do not use with stainless steel.
PEEK OPTIMA-LT1 implants may be used with stainless steel, titanium or cobaltchromium-molybdenum alloy implants. CD HORIZON® PEEK Rods are not to be used with CROSSLINK® Plates.
To achieve best results, do not use any of the CD HORIZON® Spinal System implant components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document. As with all orthopaedic and neurosurgical implants, none of the CD HORIZON® Spinal System components should ever be reused under any circumstances.
The purpose of this 510(k) submission is to include modified bolts, plates, and a low profile nut 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 spine (T1-S1), 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.
K082236, K053101, K050981, K963655
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
KO91442
CD HORIZON® Spinal System 510(k) Summary
JUL 1 5 2009
May 2009
Company:
I.
Medtronic Sofamor Danek USA 1800 Pyramid Place Memphis, Tennessee 38132 Telephone: (901) 396-3133 Fax: (901) 346-9738
Contact:
Brad Sheals Regulatory Affairs Specialist
II. Proposed Proprietary Trade Name: CD HORIZON® Spinal System
- Classification Name(s): Spinal Interlaminal Fixation and Spinal Intervertebral Fixation III. Orthosis and/or Pedicle Screw Spinal System (per 21CFR Section 888.3050, 888.3060 and/or 888.3070); Product Code(s): KWP, KWQ, MNH, MNI, NKB and NQP
- IV. Description: The CD HORIZON® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® Plates, staples and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
Certain implant components from other Medtronic spinal systems can be used with the CD HORIZON® Spinal System. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples and washer, GDLH® rods, hooks, connectors and CROSSLINK® bar and connectors; LIBERTY® rods and screws; DYNALOK® PLUS and DYNALOK CLASSIC® bolts along with rod/bolt connectors; and Medtronic Multi-Axial rods and screws. Please note that certain components are specifically designed to connect to 03.5mm, 04.5mm, 0 5.5mm rods or 06.35mm rods, while other components can connect to both 05.5mm rods and 06.35mm rods. Care should be taken so that the correct components are used in the spinal construct.
CD HORIZON® hooks are intended for posterior use only. CD HORIZON® staples and CD HORIZON® ECLIPSE® rods and associated 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 CD HORIZON® Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, medical grade cobaltchromium-molybdenum alloy, or medical grade PEEK OPTIMA-LT1. Certain CD HORIZON® Spinal System components may be coated with hydroxyapatite. No warranties express, or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. See the MDT Catalog for further information about warranties and limitations of liability.
1-20
1
Never use stainless steel and titanium implant components in the same construct. Medical grade titanium, titanium alloy and/or medical grade cobalt-chromiummolybdenum alloy may be used together. Never use titanium, titanium alloy and/or medical grade cobalt-chromium-molybdenum alloy with stainless steel in the same construct.
The CD HORIZON® Spinal System also includes anterior staples made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium. titanium alloy and cobalt-chromium-molybdenum alloy. Do not use with stainless steel.
PEEK OPTIMA-LT1 implants may be used with stainless steel, titanium or cobaltchromium-molybdenum alloy implants. CD HORIZON® PEEK Rods are not to be used with CROSSLINK® Plates.
To achieve best results, do not use any of the CD HORIZON® Spinal System implant components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document. As with all orthopaedic and neurosurgical implants, none of the CD HORIZON® Spinal System components should ever be reused under any circumstances.
The purpose of this 510(k) submission is to include modified bolts, plates, and a low profile nut to the CD HORIZON® Spinal System.
- Indications for Use: The CD HORIZON® Spinal System with or without SEXTANT® V. instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion 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; pseudarthritis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion.
With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion.
The CD HORIZON SPIRE™ Plate is a posterior, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (as previously defined); spondylolisthesis, trauma; and/or tumor.
In order to achieve additional levels of fixation as an adjunct to fusion, 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.
2
- VI. Substantial Equivalence: The design features, material and indications for use of the CD HORIZON® Spinal System are substantially equivalent to the predicate CD HORIZON® components previously cleared in K082236 (S.E. 10/10/2008), K053101 (S.E. 01/05/2006), K050981 (S.E. 05/17/2005) and K963655 (S.E. 11/27/1996). The safety and effectiveness of the modified subject plates, bolts and nuts are adequately supported by documentation within this premarket notification.
CD HORIZON Spinal System
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 5 2009
Medtronic Sofamor Danek Regulatory Affairs Specialist % Mr. Brad Sheals 1800 Pyramid Place Memphis, Tennessee 38132
Re: K091442
Trade Name: CD HORIZON® Spinal System Regulation Number: 21 CFR 888.3070 Regulatory Name: Pedicle Screw Spinal System Regulatory Class: III Product Code: NKB, KWP, KWQ, MNH, MNI, NQP Dated: June 17, 2009 Received: June 18, 2009
Dear Mr. Brad Sheals:
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 for associated in the 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 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 I hat 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 or any I vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
4
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Qurbay Buehum
Mark M. Melkerson Director Division of Surgical, Orthopaedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known):
Device Name:_ CD HORIZON® Spinal System
Indications for Use:
The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the discussions unstitutive unst radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvanues (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthritis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion.
With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion.
The CD HORIZON SPIRETM Plate is a posterior, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion. It is intended for plate fixation/attochusento spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (as previously defined); spondylolisthesis, trauma; and/or tumor.
In order to achieve additional levels of fixation as an adjunct to fision, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod comnector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.
Prescription Use (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Oulba Buellp
(Division Sign-Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091442
CD HORIZON Spinal System