(23 days)
Artic-L 3D Ti Spinal System with . Tionic, K171689
No
The document describes a mechanical spinal fixation system and does not mention any AI or ML components or functionalities.
Yes.
The device is a spinal system intended for fixation of the spine to treat various spinal conditions, which are therapeutic purposes.
No
This device is described as an implantable spinal system intended for fixation and adjunct to fusion, not for diagnosing medical conditions.
No
The device description clearly states it consists of physical components like rods, hooks, screws, plates, and connectors, which are hardware.
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 and Intended Use: The CD HORIZON™ Spinal System is a collection of implants (rods, hooks, screws, plates, etc.) designed for surgical implantation into the spine to provide structural support and aid in fusion. This is a surgical device used in vivo (within the body), not a test performed in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic testing procedures.
Therefore, the CD HORIZON™ Spinal System is a surgical implant device, not an In Vitro Diagnostic device.
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, 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 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 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 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 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, pseudarthosis, 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™ 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 VERTEXT™ rod connector. Refer to the VERTEX™ Reconstruction System Package Insert for a list of the VERTEX™ indications of use.
Product codes
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. Similarly, 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.
The purpose of this Special 510(k) is to add additional components to the Medtronic's CD HORIZON™ Spinal System. The devices being added are sterile domino connectors made using Titanium Alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Non-cervical spine (T1-S1), Thoracolumbar/lumbar
Indicated Patient Age Range
Pediatric patients, 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)
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 Ti-6AI-4V ELI Alloy for Surgical Implant
The materials used for manufacturing the subject device have a long history of safe and effective use in predicate spinal implants and biocompatibility testing is not required.
Mechanical Testing:
Non-clinical mechanical testing was not performed on the sterile implants. The subject implants are identical to the predicate devices in terms of material, rod compatibility sizes, rod interconnection features, intended use and indications for use. The predicate devices were tested in accordance to ASTM F1798 including Axial Grip, Axial Torsion and ASTM F1717 static compression, static torsion and compression fatigue. The subject devices do not introduce a new worst case, hence testing conducted on predicate devices is sufficient for subject rods and are substantially equivalent to the predicate device.
Non-Pyrogenicity 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 Results:
A risk analysis was completed, and the modified Domino Connectors do not introduce a new worst case. Based on the test results and additional supporting information provided in this pre-market notification, the subject CD Horizon™ Spinal System is substantially equivalent to the following predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
• CD HORIZON Spinal System, K090390
• CD HORIZON Spinal System, K113174
• CD HORIZON Spinal System, K132328
• CD HORIZON Spinal System K091974
Reference Device(s)
Artic-L 3D Ti Spinal System with . Tionic, K171689
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
August 29, 2018
Medtronic Sofamor Danek USA, Inc. Ankit K. Shah Principal Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K182119
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, KWO Dated: August 3, 2018 Received: August 6, 2018
Dear Mr. Shah:
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); 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ronald P. Jean -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K182119
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 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 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 3.5mm rods may be used for the specific indications noted below.
When used for posterior non-cervical pediation in pediatric patients, the CD HORIZON™ Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, 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, pseudarthosis, 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™ SPIREIM 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)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY MEDTRONIC Sofamor Danek CD HORIZON™ Spinal System August 2018
| I. | Submitter | Medtronic Sofamor Danek, USA Inc. |
|---|---|---|
| 1800 Pyramid Place | ||
| Memphis, Tennessee 38132 | ||
| Telephone: (901)396-3133 | ||
| Fax: (901) 346-9738 | ||
| Contact: | Ankit K. Shah | |
| Principal Regulatory Affairs Specialist | ||
| Phone: (901) 344-1272 | ||
| Date Prepared: | August 29, 2018 | |
| II. | Device | |
| Name of Device: | CD HORIZON™ Spinal System | |
| Classification Names: | Thoracolumbosacral Pedicle Screw System | |
| (21 CFR 888.3070) | ||
| Class: | Class II | |
| Product Code: | NKB, KWP, KWQ | |
| III. | Predicate Devices: | Primary Predicate: |
| • CD HORIZON Spinal System, K090390 | ||
| (S.E. 05/15/2009) | ||
| Additional Predicates: | ||
| • CD HORIZON Spinal System, | ||
| K113174 (S.E. 11/21/2011) | ||
| • CD HORIZON Spinal System, | ||
| K132328 (S.E 12/06/2013) | ||
| • CD HORIZON Spinal System |
- K091974 (S.E. 09/02/2009)
4
Reference Predicate:
- Artic-L 3D Ti Spinal System with . Tionic, K171689 (S.E. 10/05/2017)
Reference predicates have been mentioned in certain sections. The predicates have not been subject to a design related recall.
Description: IV.
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. Similarly, 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.
The purpose of this Special 510(k) is to add additional components to the Medtronic's CD HORIZON™ Spinal System. The devices being added are sterile domino connectors made using Titanium Alloy.
Indications for Use: V.
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.
5
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 DDD, 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 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 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, pseudarthosis, 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™ 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 VERTEXT™ rod connector. Refer to the VERTEX™ Reconstruction System Package Insert for a list of the VERTEX™ indications of use.
6
VI. Comparison of Technological Characteristics with the Predicate Devices:
The subject CD HORIZON™ Spinal System has the same indications, intended use, fundamental scientific technology, materials, and sterilization method as the previously FDA cleared predicates. The indications and the fundamental technology is identical to the FDA cleared CD HORIZON™ Spinal System, 510(k) K090390 (S.E. 05/15/2009). Other features and materials of the device within this subject CD HORIZON Spinal System submission are identical to the following predicates:
Predicate 2: CD HORIZON Spinal System, K113174 (S.E. 11/21/2011) Predicate 3: CD HORIZON Spinal System, K132328 (S.E 12/06/2013) Predicate 4: CD HORIZON Spinal System, K091974 (S.E. 09/02/2009)
Reference Predicate:
Predicate 5: Artic-L 3D Ti Spinal System with Tionic, K171689 (S.E. 10/05/2017)
VII. Performance Data:
The following information is provided in support of substantial equivalence. 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 Ti-6AI-4V ELI Alloy for ● Surgical Implant
The mateials used for manufacturing the subject device have a long history of safe and effective use in predicate spinal implants and biocompatibility testing is not required.
Mechanical Testing
7
Non-clinical mechanical testing was not performed on the sterile implants. The subject implants are identical to the predicate devices in terms of material. rod compatibility sizes, rod interconnection features, intended use and indications for use. The predicate devices were tested in accordance to ASTM F1798 including Axial Grip, Axial Torsion and ASTM F1717 static compression, static torsion and compression fatigue. The subject devices do not introduce a new worst case, hence testing conducted on predicate devices is sufficient for subject rods and are substantially equivalent to the predicate device.
Non-Pyrogenicity 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.
Conclusion: VIII.
A risk analysis was completed, and the modified Domino Connectors do not introduce a new worst case. Based on the test results and additional supporting information provided in this pre-market notification, the subject CD Horizon™ Spinal System is substantially equivalent to the following predicates:
Primary Predicate
Predicate 1: CD HORIZON Spinal System, K090390 (S.E. 05/15/2009) Additional Predicates: Predicate 2: CD HORIZON Spinal System, K113174 (S.E. 11/21/2011) Predicate 3: CD HORIZON Spinal System. K132328 (S.E 12/06/2013) Predicate 4: CD HORIZON Spinal System, K091974 (S.E. 09/02/2009) Reference Predicate:
Predicate 5: Artic-L 3D Ti Spinal System with Tionic, K171689 (S.E. 10/05/2017)