(28 days)
Not Found
No
The summary describes a mechanical spinal fixation system and its components. There is no mention of AI or ML technology in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
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, spinal stenosis, and curvatures. These are all conditions that require medical intervention to alleviate symptoms or correct anatomical issues.
No
Explanation: The provided text describes the CD Horizon™ Spinal System as an implantable device intended for posterior, non-cervical fixation as an adjunct to fusion for various spinal conditions. It lists components like rods, hooks, screws, and plates, and discusses its use in surgical procedures. There is no mention of the device being used for diagnosis, disease detection, or medical condition identification. Instead, it is a therapeutic device used for structural support and fusion.
No
The device description explicitly lists hardware components such as rods, hooks, screws, plates, staples, and connecting components. The submission is for allowing the use of patient-specific rods with an existing spinal system, which is a hardware system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system for spinal fixation and fusion. This is a physical device used in the body, not a test performed on samples taken from the body.
- Device Description: The description details physical components like rods, hooks, screws, plates, and connectors. These are all surgical implants.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
The CD Horizon™ Spinal System is a surgical device used to treat spinal conditions, not a diagnostic test.
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 (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™ 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 turnor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft. Pediatric pediative 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 (1.2 - 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 size of rods, hooks, screws, CROSSLINK(R) Plates, staples, and connecting components, and 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.
The purpose of this submission is to allow the use of the patient specific UNiD Rods cleared as a part of the PASS LP Spinal System with the CD Horizon™ Spinal System to allow additional surgeon options.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical fixation, thoracic, lumbar, or sacral spine, T1-S1, lumbosacral spine (L2 - 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)
Rationales were provided confirming that the use of the PASS LP Spinal System UNiD Rods did not introduce a new worst case when used with the subject CD Horizon™ Spinal System. However, confirmatory testing in accordance with ASTM F1717 (static and dynamic compression bending and static torsion) and ASTM F1798 (static axial grip, static flexion extension, and dynamic flexion extension) was provided and met the pre-determined acceptance criteria. Therefore, Medtronic believes that the testing confirmed that the subject devices are substantially equivalent to the predice devices.
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.
K113174, K140738, K042025, K201407
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.
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October 19, 2020
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Medtronic Raphael McInnis Sr. Manager, Regulatory Affairs 1800 Pyramid Pl Memphis, Tennessee 38132
Re: K202771
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: September 18, 2020 Received: September 21, 2020
Dear Mr. McInnis:
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
1
801 and Part 809; medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 (QS) 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 Assistant Director Division of Spinal Devices Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
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 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, 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™ 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 turnor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft. Pediatric pediative 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 (1.2 - 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.
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510(k) SUMMARY
MEDTRONIC CD Horizon™ Spinal System
September 2020
| Submitter: | Medtronic Sofamor Danek, USA Inc.
1800 Pyramid Place
Memphis, Tennessee 38132
Telephone: (901) 396-3133
Fax: (901) 346-9738 |
|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Raphael McInnis
Senior Regulatory Affairs Manager
Telephone: (901) 396-3133 |
| Name of Device | CD Horizon™ Spinal System |
| Common Name | Spinal Fixation Appliance, Spinal Fixation Orthosis |
| Classification Name | NKB, KWP, KWQ |
| Classification | Class II |
| Product Codes | NKB, KWP, KWQ
21 CFR 888.3070 - Thoracolumbosacral Pedicle Screw System
21 CFR 888.3060 - Spinal intervertebral body fixation orthosis
21 CFR 888.3050 - Spinal interlaminal fixation orthosis |
| Predicate Devices | Primary Predicate:
CD Horizon Spinal System (K113174, S.E. 11/21/2011)
Secondary Predicates:
PASS LP Spinal System (K140738, S.E. 11/04/2014)
CD Horizon™ Spinal System (K042025, S.E. 08/25/2004)
CD Horizon™ Spinal System (K201407, S.E. 09/10/2020) |
| Description of Devices | The predicates have not been subject to a design related recall.
The CD Horizon™ Spinal System consists of a variety of shapes
and size of rods, hooks, screws, CROSSLINK(R) Plates, staples,
and connecting components, and well as implant components from
other Medtronic spinal systems, which can be rigidly locked into a |
| | |
| Indications for Use | variety of configurations, with each construct being tailor-made
for the individual case. |
| | The purpose of this submission is to allow the use of the patient
specific UNiD Rods cleared as a part of the PASS LP Spinal
System with the CD Horizon™ Spinal System to allow additional
surgeon options. |
| | 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. |
| | 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. |
| | 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. |
| | When used with the PASS LP Spinal System UNiD Rods, the CD
Horizon Spinal System have the same fundamental scientific |
| | technology, indications for use, intended use, materials, and levels
of attachment as the predicate CD Horizon™ Spinal System
devices. |
| Comparison of
Technological
Characteristics with the
Predicate Devices | The difference between the primary predicate and subject devices
is that rods used with the predicate CD Horizon™ Spinal System
are cut and bent by the surgeon based on the need of the individual
case, while the PASS LP Spinal System UNiD Rods are directly
adapted to a unique patient. However, both the subject and
predicate systems are intended to help provide immobilization and
stabilization of spinal segments as an adjunct to fusion of the
thoracic, lumbar, or sacral spine. |
| | In accordance with the 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. |
| Performance Data | Rationales were provided confirming that the use of the PASS LP
Spinal System UNiD Rods did not introduce a new worst case
when used with the subject CD Horizon™ Spinal System.
However, confirmatory testing in accordance with ASTM F1717
(static and dynamic compression bending and static torsion) and
ASTM F1798 (static axial grip, static flexion extension, and |
| | dynamic flexion extension) was provided and met the pre-
determined acceptance criteria. Therefore, Medtronic believes
that the testing confirmed that the subject devices are substantially
equivalent to the predice devices. |
| Conclusion | Based on the test results and additional supporting information
provided in this premarket notification, Medtronic believes the
subject CD Horizon™ Spinal System devices when used with the
PASS LP Spinal System Patient Specific Rods are at least as safe
as and effective as the legally marketed predicate devices. |
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