(106 days)
No
The document describes a mechanical spinal implant system and its intended use, materials, and performance testing. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
Yes
The device is intended to provide immobilization and stabilization of spinal segments, which is a therapeutic function for treating various spinal instabilities and deformities.
No
The descriptions of the device, its intended use, and performance studies indicate it is an implantable system for spinal stabilization and fusion, not for diagnosing medical conditions.
No
The device description explicitly states the system components are manufactured from titanium and cobalt chromium, indicating it is a hardware device.
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 Gibralt® Spine System is a surgical implant designed to provide immobilization and stabilization of spinal segments. It is a physical device used in vivo (within the body) during surgery, not a test performed on samples 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.
Therefore, the Gibralt® Spine System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Gibralt® Spine System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1-C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Gibralt® Spine System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the Gibralt® Spine System may be connected to the Gibralt® Occipital Spine System with rod-to-rod connectors. The Gibralt® Spine System may also be connected to the Exactech® Proliant® System, Exactech® Silverbolt® and Mainframe® Spinal Screw Systems, or Exactech® Hydralok® Exactech, using rod-to-rod connectors and transitional rods. Refer to the specific system package inserts for a list of their indications for use.
When used with the Gibralt® Spine System, the Gibralt® Occipital Spine System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1- C7), and the thoracic spine from T1 - T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Gibralt® Occipital Spine System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the Gibralt® Occipital Spine System may be connected to the Gibralt® Spine System, using rod-to-rod connectors. Refer to the Gibralt® Spine System package insert for a list of the Gibralt® Spine System indications of use.
The Occipital Bone Screws are limited to occipital fixation only.
Product codes (comma separated list FDA assigned to the subject device)
NKG, KWP
Device Description
The line extension and device modifications for the Gibralt® Spine System are intended to provide immobilization and stabilization of spinal segments in the upper thoracic, cervical, and occipital spine. The system components are manufactured from titanium and cobalt chromium. The modifications included in the scope of this submission are: expanded indications for use for both systems, incorporation of design changes, and addition of new components.
Gibralt® Spine System components are made from materials that conform to titanium per ASTM F136 and cobalt chromium per ASTM F1537. The Gibralt® Occipital Spine System components are made from materials that conform to titanium per ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C1-C7), thoracic spine (T1-T3), craniocervical junction, occipital (for Occipital Bone Screws)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
The proposed line extensions and modified Gibralt® Spine System have been tested in the following test modes:
- Static axial compression per ASTM F1717-14
- Static axial compression bending per ASTM F1717-14
- Dynamic axial compression per ASTM F1717-14
- Dynamic axial compression bending per ASTM F1717-14
Key results: The results of this non-clinical testing show that the strength of the Gibralt® Spine System is sufficient for its intended use and is substantially equivalent to legally marketed predicate 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.
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.
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
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 28, 2016
Exactech, Incorporated % Mr. Kenneth C. Maxwell II Regulatory and Quality Specialist Empirical Testing Corporation 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K160697
Trade/Device Name: Gibralt® Spine System and Gibralt® Occipital Spine System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: May 31, 2016 Received: June 1, 2016
Dear Mr. Kenneth C. Maxwell II:
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 Parts 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" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 | ||
|---|---|---|---|
| Food and Drug Administration | Expiration Date: January 31, 2017 | ||
| Indications for Use | See PRA Statement on last page. | ||
| 510(k) Number (if known) | K160697 | ||
| Device Name | Gibralt® Spine System | ||
| Indications for Use (Describe) | The Gibralt® Spine System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1-C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The GibraltⓇ Spine System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. | ||
| In order to achieve additional levels of fixation, the Gibralt® Spine System may be connected to the Gibralt® Occipital Spine System with rod-to-rod connectors. The Gibralt® Spine System may also be connected to the Exactech® Proliant® System, Exactech® Silverbolt® and Mainframe® Spinal Screw Systems, or Exactech® Hydralok® Exactech, using rod-to-rod connectors and transitional rods. Refer to the specific system package inserts for a list of their indications for 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) | [X] Prescription Use (Part 21 CFR 801 Subpart D) | [ ] Over-The-Counter Use (21 CFR 801 Subpart C) |
| [X] Prescription Use (Part 21 CFR 801 Subpart D) | [ ] Over-The-Counter Use (21 CFR 801 Subpart C) | ||
| PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED. | |||
| FOR FDA USE ONLY | |||
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) |
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
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on last page. |
| ------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------- |
|---|
Indications for Use
| 510(k) Number (if known) | K160697 |
|---|---|
| Device Name | Gibralt® Occipital Spine System |
| Indications for Use (Describe) |
When used with the Gibralt® Spine System, the Gibralt® Occipital Spine System is intended
to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the
following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-
C7), and the thoracic spine from T1 - T3: traumatic spinal fractures and/or traumatic
dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors
involving the cervical/thoracic spine; and degenerative disease, including intractable
radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by
radiographic studies, and degenerative disease of the facets with instability. The GibraltⓇ
Occipital Spine System is also intended to restore the integrity of the spinal column even in the
absence of fusion for a limited time period in patients with advanced stage tumors involving
the cervical spine in whom life expectancy is of insufficient duration to permit achievement of
fusion.
In order to achieve additional levels of fixation, the Gibralt® Occipital Spine System may be
connected to the Gibralt® Spine System, using rod-to-rod connectors. Refer to the Gibralt®
Spine System package insert for a list of the Gibralt® Spine System indications of use.
The Occipital Bone Screws are limited to occipital fixation only.
| 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) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
| FORM FDA 3881 (9/13)
| Page 1 of 2 | PSC Publishing Services (301) 443-6740 EF |
|---|---|
| ------------------------------------- | ------------------------------------------- |
5
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."
6
5.510(K) SUMMARY
| Submitter's Name: | Exactech, Inc. |
|---|---|
| Submitter's Address: | 2320 NW 66th Court |
| Gainesville, FL 32658 | |
| Submitter's Telephone: | 352.377.1140 |
| Contact Person: | Kenneth C. Maxwell II |
| Empirical Testing Corp. | |
| 719.291.6874 | |
| Date Summary was Prepared: | 23 June 2016 |
| Trade or Proprietary Name: | Gibralt® Spine System |
| Gibralt® Occipital Spine System | |
| Common or Usual Name: | Orthosis, Cervical Spinal Pedicle Fixation |
| Appliance, Fixation, Spinal Interlaminal | |
| Classification: | Unclassified, Class II per 21 CFR §888.3050 |
| Product Code: | NKG, KWP |
| Classification Panel: | Orthopedic Devices |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The line extension and device modifications for the Gibralt® Spine System are intended to provide immobilization and stabilization of spinal segments in the upper thoracic, cervical, and occipital spine. The system components are manufactured from titanium and cobalt chromium. The modifications included in the scope of this submission are: expanded indications for use for both systems, incorporation of design changes, and addition of new components.
INDICATIONS FOR USE
Gibralt® Spine System:
The Gibralt® Spine System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1-C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Gibralt® Spine System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the Gibralt® Spine System may be connected to the Gibralt® Occipital Spine System with rod-to-rod connectors. The Gibralt®
7
Spine System may also be connected to the Exactech® Proliant® System. Exactech® Silverbolt® and Mainframe® Spinal Screw Systems, or Exactech® Hydralok® Exactech, using rod-to-rod connectors and transitional rods. Refer to the specific system package inserts for a list of their indications for use.
Gibralt® Occipital Spine System:
When used with the Gibralt® Spine System, the Gibralt® Occipital Spine System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7), and the thoracic spine from T1 - T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Gibralt® Occipital Spine System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the Gibralt® Occipital Spine System may be connected to the Gibralt® Spine System, using rod-to-rod connectors. Refer to the Gibralt® Spine System package insert for a list of the Gibralt® Spine System indications of use.
The Occipital Bone Screws are limited to occipital fixation only.
The indications for use for the Gibralt® Spine System and the Gibralt® Occipital Spine System are similar to that of the predicate devices in Table 5-1.
TECHNOLOGICAL CHARACTERISTICS
Gibralt® Spine System components are made from materials that conform to titanium per ASTM F136 and cobalt chromium per ASTM F1537. The Gibralt® Occipital Spine System components are made from materials that conform to titanium per ASTM F136. The subject and predicate devices have similar technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are similar between the subject and predicates:
- Indications for Use
- Materials of Manufacture ●
8
| 510k Number | Trade or Proprietary or
Model Name | Manufacturer | Type |
|-------------|------------------------------------------------|-----------------|----------------------|
| K142838 | Synapse Occipital-Cervical-
Thoracic System | Synthes USA | Primary
Predicate |
| K083071 | VERTEXTM Reconstruction
System | Medtronic | Reference |
| K050979 | S4 Spinal System | Aesculap®, Inc. | Reference |
Table 5-1 Predicate Devices
PERFORMANCE DATA
The proposed line extensions and modified Gibralt® Spine System have been tested in the following test modes:
- Static axial compression per ASTM F1717-14
- Static axial compression bending per ASTM F1717-14 ●
- Dynamic axial compression per ASTM F1717-14 ●
- o Dynamic axial compression bending per ASTM F1717-14
The results of this non-clinical testing show that the strength of the Gibralt® Spine System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Gibralt® Spine System and Gibralt® Occipital Spine System are substantially equivalent to the predicate devices.