(77 days)
Not Found
No
The summary describes a mechanical spinal fixation system and its components. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are focused on mechanical and biocompatibility testing.
Yes
The device is described as a "Spinal System" with components like rods, hooks, screws, and plates, intended for posterior, non-cervical fixation as an adjunct to fusion for various spinal conditions such as degenerative disc disease, spondylolisthesis, trauma, and curvatures. Its purpose is to provide "immobilization and stabilization of spinal segments," which directly addresses therapeutic goals by treating or alleviating these medical conditions.
No
The device is a spinal system (rods, hooks, screws, plates) intended for surgical fusion as an adjunct to treatment of various spinal conditions, not for diagnosing them.
No
The device description explicitly states it consists of physical components like rods, hooks, screws, plates, and connecting components, which are implants made of titanium alloy.
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 therapeutic device used in vivo (within the body) to treat physical conditions.
- Device Description: The description details physical components like rods, hooks, screws, and plates made of titanium alloy. These are all components of a surgical implant.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The provided text makes no mention of analyzing biological specimens or providing diagnostic information.
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 (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, 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 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 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, 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® 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: degenerative disc disease (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
NKB, OSH, MNH, MNI, 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 submission is to add additional components to the CD HORIZON® Spinal System, specifically multi-axial screws (MAS), fixed angled Screws (FAS), and break-off set screws (BOSS).
The subject devices are intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and /or sacral spine. The multi-axial screw is a polyaxial screw, which allows the screw to be angled in any direction. This feature makes it easier for the surgeon to implant rods. The fixed angle screw is a monoaxial screw, which is used when the surgeon needs a more rigid construct. The break-off set screw is used with both the multi-axial screw and fixed angle screw to tighten the rod into the screw head.
The subject devices are manufactured from titanium alloy or titanium alloy/ commercially pure titanium, per ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Allov for Surgical Implant Applications and ASTM F67-13 - Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700), which are identical to the materials used to manufacture the predicate devices.
The subject multi-axial screws, fixed angle screws, and break-off set screws are implants that are single use only. The subject multi-axial screws, fixed angle screws, and break-off set screws are provided non-sterile and steam sterilized by the hospital. Additionally, the subject multi-axial screws and break-off set screws are also provided sterile by gamma irradiation.
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, sacral spine
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)
Biocompatibility: The biocompatibility evaluation for the subject CD HORIZON® Spinal System multi-axial screws, fixed angled screws, and break-off set screws was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, Biological Evaluation Method Devices Part 1: Evaluation and Testing" issued April 23, 2013. The subject multi-axial screws, fixed angle screws, and break-off set screws are permanent implants and classified as "Implant Devices - Tissue/bone - C Permanent (>30 days)". Titanium Alloy and Commercially Pure Titanium have a long history of safe and effective use in predicate spinal implants, therefore, biocompatibility testing is not required.
Mechanical Testing: Tested in accordance with ASTM F1717 - Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, and ASTM F1798 -"Standard Guide to Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants. Tests completed were Axial Grip, Axial Torsion, Flexion Extension Static Testing, Flexion Extension Fatigue, Construct Static Compression Bending, Construct Static Torsion, and Construct Compression Bending Fatigue. The subject devices met the pre-determined acceptance criteria for all tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K141494, K042025, K031655, K052187
Reference Device(s)
Not Found
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked on top of each other, representing the human element of the department's work.
December 1, 2014
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medtronic Sofamor Danek USA, Incorporated Ms. Lila Joe Principal Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tenseness 38132
Re: K142591
Trade/Device Name: CD HORIZON® Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: Class III Product Code: NKB, OSH, MNH, MNI, KWP, KWQ Dated: September 12, 2014 Received: September 15, 2014
Dear Ms. Joe:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Mark N. Melkerson -S
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) K142591
Device Name CD HORIZON(R) 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 (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 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 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® System 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® 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. 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: degenerative disc disease (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)
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CD HORIZON® Spinal System 510(k) SUMMARY November 2014
| I. | Submitter | Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
(901)396-3133 |
|------|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact | Lila Joe
Principle Regulatory Affairs Specialist |
| | Date Prepared | November 26, 2014 |
| II. | Device | |
| | Name of Device | CD HORIZON® Spinal System |
| | Classification Name | Spinal Interlaminal Fixation Orthosis, Spinal Intervertebral Body Fixation Orthosis, and Pedicle
Screw Spinal System (21 CFR 888.3050, 888.3060
and 888.3070) |
| | Classification | Class III (Pre-amendment) |
| | Product Codes | OSH, NKB, MNH, MNI, KWP, &KWQ |
| III. | Predicates | CD HORIZON® Spinal System
K042025 (S.E. Aug 25, 2004),
K031655 (S.E. Jun 27, 2003),
K052187 (S.E. Aug 22, 2005), and
K141494 (S.E. Aug 08, 2014) - primary predicate |
IV. Product 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,
5
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 submission is to add additional components to the CD HORIZON® Spinal System, specifically multi-axial screws (MAS), fixed angled Screws (FAS), and break-off set screws (BOSS).
The subject devices are intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and /or sacral spine. The multi-axial screw is a polyaxial screw, which allows the screw to be angled in any direction. This feature makes it easier for the surgeon to implant rods. The fixed angle screw is a monoaxial screw, which is used when the surgeon needs a more rigid construct. The break-off set screw is used with both the multi-axial screw and fixed angle screw to tighten the rod into the screw head.
The subject devices are manufactured from titanium alloy or titanium alloy/ commercially pure titanium, per ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Allov for Surgical Implant Applications and ASTM F67-13 - Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700), which are identical to the materials used to manufacture the predicate devices.
The subject multi-axial screws, fixed angle screws, and break-off set screws are implants that are single use only. The subject multi-axial screws, fixed angle screws, and break-off set screws are provided non-sterile and steam sterilized by the hospital. Additionally, the subject multi-axial screws and break-off set screws are also provided sterile by gamma irradiation.
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 (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, 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 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 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,
6
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® 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: degenerative disc disease (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.
VI. Comparison of Technological Characteristics
The subject CD HORIZON® Spinal System has the same indications, intended use, fundamental scientific technology and material as the previously FDA cleared predicates. CD HORIZON® Spinal System multi-axial screws, fixed-angled screws, and break-off set screws cleared in K042025 (S.E. Aug 25, 2004), K031655 (S.E. Jun 27, 2003), and K052187 (S.E. Aug 22, 2005), respectively. At a high level, the subject and predicate devices are based on the following same technological elements:
- Implanted into the patient
- Used with rods, hooks, cross-links, and other instrumentation to build a construct ●
- . The subject devices are intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and /or sacral spine.
VII. Performance Data
The following performance data are provided in support of the substantial equivalence determination.
Biocompatibility
The biocompatibility evaluation for the subject CD HORIZON® Spinal System multi-axial screws, fixed angled screws, and break-off set screws was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, Biological Evaluation Method Devices Part 1: Evaluation and Testing" issued April 23, 2013.
The subject multi-axial screws, fixed angle screws, and break-off set screws are permanent implants and will be classified as "Implant Devices - Tissue/bone - C Permanent (>30 days)" according to FDA's Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, Biological Evaluation Method Devices Part 1: Evaluation and Testing.
7
The subject devices are manufactured from titanium alloy or titanium alloy/ commercially pure titanium, per ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications and ASTM F67-13 - Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700), which are identical to the materials used to manufacture the predicate devices.
Titanium Alloy and Commercially Pure Titanium have a long history of safe and effective use in predicate spinal implants. Therefore, biocompatibility testing is not required.
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.
Design verification testing was completed in accordance with ASTM F1717 - Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, and ASTM F1798 -"Standard Guide to Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants. The tests completed were:
- । Axial Grip
- -Axial Torsion
- Flexion Extension Static Testing ।
- -Flexion Extension Fatigue
- -Construct Static Compression Bending
- -Construct Static Torsion
- Construct Compression Bending Fatigue -
The subject devices met the pre-determined acceptance criteria for all tests.
VIII. Conclusions
A risk analysis was completed and design verification testing was completed in accordance with ASTM F1717 and ASTM F1798. Based on the test results and additional supporting information provided in this pre-market notification, the subject devices demonstrated substantial equivalence to the legally marketed predicate devices, including the predicate CD HORIZON® Spinal System.