(22 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any AI or ML components or functionalities.
Yes
The device is described as an "adjunct to fusion" for various spinal conditions, and its components include rods, hooks, and screws, indicating it is an implant designed to treat or alleviate spinal disorders.
No
The device description and intended use clearly state that the CD Horizon™ Spinal System is an implant used for posterior spinal fixation as an adjunct to fusion, treating various spinal conditions. It is a surgical implant, not a diagnostic tool.
No
The device description explicitly states it consists of physical components like rods, hooks, screws, plates, and connecting components, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system used for spinal fixation as an adjunct to fusion. This is a therapeutic device used directly on the patient's body.
- Device Description: The device description details physical components like rods, hooks, screws, and plates, which are all physical implants.
- 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 compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for structural support and fixation.
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 fosion for the following indications: degenerative disc disease (DDD - 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, tumor, pseudarthrosis, and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion. With the exception of DDD, the CD Horizon™ LEGACY™ 3.5mm rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft. Pediatric pediatric pedicle screw fixation is limited to a posterior approach.
The CD Horizon™ PEEK Rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.
The CD Horizon™ SPIRE™ Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD (as previously defined), spondylolisthesis, trauma, 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, KWP, KWQ
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.
A subset of CD Horizon™ Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods (ranging in diameter from 3.5mm to 6.35mm), hooks, screws, Crosslink™ plates and connecting components. Similar to the CD Horizon™ implants used in adult cases, these components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal, non-cervical, lumbosacral spine (L2 – S1), non-cervical spine (T1-S1)
Indicated Patient Age Range
Skeletally mature patients, pediatric 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)
Mechanical Testing: In accordance with, "Guidance for Industry and FDA Staff – Spinal System 510(k)'s", Medtronic has evaluated the subject devices to demonstrate substantial equivalence to the predicate devices. Medtronic completed both an engineering rationale and a risk analysis in accordance with Medtronic design control procedures. Both evaluations demonstrated that the subject devices do not introduce a new worst case to the CD HORIZON™ Spinal System.
Biocompatibility: The subject CD HORIZON™ Spinal System implants are permanent implants (> 30 days) and will be classified as body contacting devices according to FDA's Draft Guidance for Industry and FDA Staff "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". The subject implants are manufactured from identical materials as the predicate devices, in accordance with the following standards: ASTM F136 -Standard Specification for Wrought Titanium – 6Aluminum – 4Vanadium ELI (Extra-Low-Interstitial) Alloy for Surgical Implants ASTM F67 - Standard Specification for Unalloyed Titanium for Surgical Implant Applications ASTM F1537 - Standard Specification for Wrought Cobalt – 28Chromium 6Molybdenum Alloys for Surgical Implants. The materials used for manufacturing the subject device have a long history of safe and effective use identical to predicate spinal implants.
Bacterial Endotoxin Testing: The bacterial endotoxin test, also known as Limulus amebocyte lysate (LAL) test, was performed utilizing worst case subject implants to verify that the subject implants meet the 20 endotoxin units (EU)/device pyrogen limit specification. Testing was successfully performed, and it was confirmed that the subject implants meet the 20 EU/device testing limit for general medical devices that are implanted as outlined in ANSI/AAMI ST72, Bacterial endotoxins – Test methods, routine monitoring, and alternatives to batch testing and USP , Medical Devices – Bacterial Endotoxin and Pyrogen Tests.
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
September 8, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services seal. To the right of the seal is the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bold blue font. Below that is the word "ADMINISTRATION" in a smaller, non-bold blue font.
Medtronic Sofamor Danek USA, Inc. Venkata Sandeep Manne Associate Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K202328
Trade/Device Name: CD Horizon™ Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP, KWQ Dated: August 10, 2020 Received: August 17, 2020
Dear Mr. Manne:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Colin O'Neill, MBE Assistant Director DHT6B: Division of Spine Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202328
Device Name CD Horizon™ Spinal System
Indications for Use (Describe)
The CD Horizon™ Spinal System with or without SEXTANT™ instrumentation is intended for posterior, non-cervical fixation as an adjunct to fosion for the following indications: degenerative disc disease (DDD - 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, tumor, pseudarthrosis, and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion. With the exception of DDD, the CD Horizon™ LEGACY™ 3.5mm rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft. Pediatric pediatric pedicle screw fixation is limited to a posterior approach.
The CD Horizon™ PEEK Rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.
The CD Horizon™ SPIRE™ Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD (as previously defined), spondylolisthesis, trauma, 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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) SUMMARY
MEDTRONIC Sofamor Danek USA, Inc.
CD HORIZON™ Spinal System
August 2020
| I. | Submitter | Medtronic Sofamor Danek, USA Inc. |
|---|---|---|
| 1800 Pyramid Place | ||
| Memphis, Tennessee 38132 | ||
| Telephone: (901) 396-3133 | ||
| Contact: | Venkata Sandeep Manne | |
| Associate Regulatory Affairs Specialist | ||
| Email: venkatasandeep.manne@medtronic.com | ||
| Date Prepared: | August 10, 2020 | |
| II. | Subject Device | |
| Name of Device: | CD HORIZON™ Spinal System | |
| Product Codes: | NKB, KWP, KWQ | |
| Common name: | Spinal Fixation Appliance, Spinal Fixation Orthosis | |
| Classification | ||
| Name: | Thoracolumbosacral pedicle screw system (21 CFR 888.3070); | |
| Spinal Interlaminal Fixation Orthosis (21 CFR 888.3050); | ||
| Spinal Intervertebral Body Fixation Orthosis (21 CFR 888.3060) | ||
| Classification | Class II | |
| III. | Predicate | |
| Devices: | Predicate 1 (Primary Predicate): | |
| CD HORIZON™ Spinal System- K182928 (S.E. 01/11/2019) | ||
| Predicate 2 (Additional Predicate): | ||
| CD HORIZON™ Spinal System- K113174 (S.E. 11/21/2011) | ||
| Predicate 3 (Additional Predicate): | ||
| CD HORIZON™ Spinal System- K162379 (S.E.11/16/2016) | ||
| The predicate devices were not subjected to any Recall. | ||
| 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. |
A subset of CD Horizon™ Spinal System components may be used for
posterior pedicle screw fixation in pediatric cases. These constructs may
be comprised of a variety of shapes and sizes of rods (ranging in diameter
from 3.5mm to 6.35mm), hooks, screws, Crosslink™ plates and
connecting components. Similar to the CD Horizon™ implants used in
adult cases, these components can be rigidly locked into a variety of
configurations, with each construct being tailor-made for the individual
case. |
| V. | 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
(DDD - 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, or lordosis), tumor, pseudarthrosis, and/or failed
previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system,
the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless-
steel implants may also be used for the same indications as an adjunct to
fusion.
With the exception of DDD, the CD Horizon™ Legacy™ 3.5mm rods and
associated components may be used for the aforementioned indications
in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may
be used for the specific pediatric indications noted below. |
5
6
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless-steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
When used with CD Horizon™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.
The CD Horizon™ Spire™ plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD (as previously defined), spondylolisthesis, trauma, 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.
7
| VI. | Comparison of
Technological
Characteristics
with the
Predicate
Devices | The subject CD HORIZON™ Spinal System have the same intended use,
indications, fundamental scientific technology, material, and sterilization
method as the previously FDA cleared CD HORIZON™ Spinal System
predicates. The primary difference between predicate devices and
subject devices is that the subject devices are provided Sterile. The
materials, thread forms, and sizes of the subject devices fall within the
cleared range of the CD HORIZON™ Spinal system predicate devices and
does not raise any issues on safety and effectiveness. | |
|-------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | |
| | Both Subject and Predicate devices are based on the same technological
characteristics of providing posterior, non-cervical fixation as an adjunct
to fusion for the following indications: degenerative disc disease (DDD -
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, or lordosis), tumor, pseudarthrosis, and/or failed previous
fusion. | | |
| | | | |
| | The design features, materials and indications for use of the subject
devices are substantially equivalent to the previously cleared predicates
CD HORIZON™ Spinal System K182928(S.E. 01/11/2019), and CD
HORIZON™ SOLERA™ Spinal System K113174 (S.E. 11/21/2011)
Therefore, the technological characteristics of the subject devices are
identical to the predicate devices. The subject devices are provided
gamma sterilized similar to the predicate devices cleared in CD Horizon™
Spinal system K162379 (S.E.11/16/2016). | | |
| | | | |
| | VII. | Performance
Data | Mechanical Testing:
In accordance with, "Guidance for Industry and FDA Staff – Spinal
System 510(k)'s", Medtronic has evaluated the subject devices to
demonstrate substantial equivalence to the predicate devices.
Medtronic completed both an engineering rationale and a risk analysis
in accordance with Medtronic design control procedures. Both |
| | | | |
| | | | |
| | evaluations demonstrated that the subject devices do not introduce a
new worst case to the CD HORIZON™ Spinal System.
Biocompatibility:
The subject CD HORIZON™ Spinal System implants are permanent
implants (> 30 days) and will be classified as body contacting devices
according to FDA's Draft Guidance for Industry and FDA Staff "Use of
International Standard ISO-10993, Biological Evaluation of Medical
Devices Part 1: Evaluation and Testing". The subject implants are
manufactured from identical materials as the predicate devices, in
accordance with the following standards:
ASTM F136 -Standard Specification for Wrought Titanium –
6Aluminum – 4Vanadium ELI (Extra-Low-Interstitial) Alloy for
Surgical Implants ASTM F67 - Standard Specification for Unalloyed Titanium
for Surgical Implant Applications ASTM F1537 - Standard Specification for Wrought Cobalt –
28Chromium 6Molybdenum Alloys for Surgical Implants. The materials used for manufacturing the subject device have a long
history of safe and effective use identical to predicate spinal implants.
Bacterial Endotoxin Testing:
The bacterial endotoxin test, also known as Limulus amebocyte lysate
(LAL) test, was performed utilizing worst case subject implants to verify
that the subject implants meet the 20 endotoxin units (EU)/device
pyrogen limit specification. Testing was successfully performed, and it
was confirmed that the subject implants meet the 20 EU/device testing
limit for general medical devices that are implanted as outlined in
ANSI/AAMI ST72, Bacterial endotoxins – Test methods, routine
monitoring, and alternatives to batch testing and USP , Medical
Devices – Bacterial Endotoxin and Pyrogen Tests. | | |
| VIII. | Conclusion: | Based on the supporting information provided in this pre-market
notification, the subject CD Horizon™ Spinal System is substantially
equivalent to the following predicates:
Predicate 1 (Primary Predicate) CD HORIZON™ Spinal System K182928 (S.E. 01/11/2019) Predicate 2 (Additional Predicate) CD HORIZON™ Spinal System K113174 (S.E. 11/21/2011) Predicate 3 (Additional Predicate) CD HORIZON™ Spinal System K162379 (S.E.11/16/2016) | |
8
9
1