(58 days)
Not Found
No
The provided text describes a mechanical spinal fixation system and its intended use. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies are mechanical testing, not related to algorithmic performance.
Yes
The device is intended to immobilize spinal segments, restore integrity of the spinal column, and is used as an adjunct to fusion for treating various acute and chronic instabilities or deformities in the spine, which are all therapeutic functions.
No
This device is a surgical implant designed to provide immobilization and stability to spinal segments as an adjunct to fusion or to restore spinal column integrity. It is not used for diagnosing conditions.
No
The device description explicitly states that the Connector System includes "a variety of non-sterile implants manufactured from titanium alloy comprised of bypass connectors, rod to rod connectors, Z rods, and an axial in-line connector with an attached rod." These are physical hardware components, not software.
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 device used for the immobilization and stabilization of spinal segments as an adjunct to fusion or to restore spinal column integrity. This is a surgical implant used directly on the patient's body.
- Device Description: The device description details implants manufactured from titanium alloy (bypass connectors, rod to rod connectors, Z rods, axial in-line connector with attached rod) designed to be surgically implanted.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
The device is a spinal fixation system, which is a type of surgical implant.
N/A
Intended Use / Indications for Use
When used with the Centurion POCT System or Ascent POCT System for Posterior Occipital-Cervical-Cloc -T3) The Connector System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical spine (C1 to C7) and the thoracic spine (T1 - T3): traumatic spinal fraumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); 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 Connector 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.
When used with the Firebird System/Phoenix MIS Spinal Fixation System or Spinal Fixation System (SFS) for Thoracic, Lumbar, and Sacral Spine Fixation (T1-S2/Ilium) The Connector System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/Ilium), or as an anterolateral fixation system (T8-L5), in the treatment of the following acute and chronic instabilities or deformities:
- degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
- spondylolisthesis,
- trauma (i.e., fracture or dislocation),
- spinal stenosis,
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- tumor,
- pseudoarthrosis, and
- failed previous fusion
When used for posterior pedicle screw fixation in pediatric patients, the Connector System implants are indicated as an adjunct to fusion to treat adolescent idiopathic pedicle screw fixation is limited to a posterior aproach. The Connector System is intended to be used with autograft or allograft.
Product codes (comma separated list FDA assigned to the subject device)
NKG, NKB, KWP, KWQ
Device Description
The Connector System is designed to reduce the complexity of revising and extending existing constructs from the Occiput to the Ilium. The Connector System includes a variety of non-sterile implants manufactured from titanium alloy comprised of bypass connectors, rod to rod connectors, Z rods, and an axial in-line connector with an attached rod. The Connector System implant options offered eliminate the need to remove existing hardware while providing stability to adjacent levels. The Connector System is compatible with posterior spinal fixation systems (e.g. Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System, Spinal Fixation System, Centurion POCT System, and Ascent POCT System) which offer titanium and/or cobalt chrome rods ranging in sizes of 3.0mm to 6.35mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniocervical spine (C1 to C7), thoracic spine (T1 - T3), Thoracic, Lumbar, and Sacral Spine (T1-S2/Ilium), cervical spine
Indicated Patient Age Range
skeletally mature patients, pediatric patients (for posterior pedicle screw fixation for adolescent idiopathic scoliosis)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing was conducted on the subject devices as listed below in Table 1: Mechanical Performance Testing.
The subject new and modified medical devices within the previously cleared Connector System (K172194) are substantially equivalent to the predicate devices based upon the same intended use, indications for use, technological characteristics, design, materials and the same principles of operation.
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.
K172194 – Connector System - Orthofix
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
§ 888.3075 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/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the agency's name, "U.S. Food & Drug Administration."
May 22, 2019
Orthofix, Inc. Ms. Jacki Koch Senior Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056
Re: K190751
Trade/Device Name: Connector System Regulation Number: 21 CFR 888.3075 Regulation Name: Posterior cervical screw system Regulatory Class: Class II Product Code: NKG, NKB, KWP, KWQ Dated: March 22, 2019 Received: March 25, 2019
Dear Ms. Koch:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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,
- for CAPT Raquel Peat, PhD, MPH, USPHS Director OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190751
Device Name Connector System
Indications for Use (Describe)
When used with the Centurion POCT System or Ascent POCT System for Posterior Occipital-Cervical-Cloc -T3)
The Connector System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical spine (C1 to C7) and the thoracic spine (T1 - T3): traumatic spinal fraumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); 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 Connector 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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
3
Indications for Use
510(k) Number (if known) K190751
Device Name Connector System
Indications for Use (Describe)
When used with the Firebird System/Phoenix MIS Spinal Fixation System or Spinal Fixation System (SFS) for Thoracic, Lumbar, and Sacral Spine Fixation (T1-S2/Ilium)
The Connector System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/Ilium), or as an anterolateral fixation system (T8-L5), in the treatment of the following acute and chronic instabilities or deformities:
-
degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
-
spondylolisthesis,
-
- trauma (i.e., fracture or dislocation),
-
- spinal stenosis,
-
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
-
- tumor,
- pseudoarthrosis, and
-
- failed previous fusion
When used for posterior pedicle screw fixation in pediatric patients, the Connector System implants are indicated as an adjunct to fusion to treat adolescent idiopathic pedicle screw fixation is limited to a posterior aproach. The Connector System is intended to be used with autograft or allograft.
- failed previous fusion
| 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) SUMMARY
Connector System
| 510(k) Owner Information | |
|---|---|
| Name: | |
| Address: | Orthofix Inc. |
| 3451 Plano Parkway | |
| Lewisville, TX 75056 | |
| Telephone Number: | |
| Fax Number: | |
| Email: | 214-937-2100 |
| 214-937-3322 | |
| jackikoch@orthofix.com | |
| Registration Number: | 2183449 |
| Contact Person: | Jacki Koch, Senior Regulatory Affairs Specialist |
| Date Prepared: | March 22, 2019 |
| Name of Device | |
| Trade Name / Proprietary | |
| Name: | Connector System |
| Common Name: | 1. Posterior cervical screw system |
- Thoracolumbosacral pedicle screw system |
| Product Code: | 1. NKG - NKB; KWP; KWQ |
| Regulatory Classification: | 1. Class II - 21 CFR § 888.3075 - Class II - 21 CFR § 888.3070; 21 CFR § 888.3050; 21 CFR § 888. |
| Review Panel: | Orthopedic Device Panel |
| Predicate Devices: | K172194 – Connector System - Orthofix |
Reason for 510(k) Submission:
Due to the advancements in surgical techniques and surgeon requests, Orthofix is submitting this Traditional 510(k) request for the following additions and modification to the previously cleared devices listed below:
-
- Addition of 16mm and 18mm Side/Front Loading Connectors
-
- Addition of 16mm and 18mm Side/Side Loading Connectors
-
- Addition of 16mm and 18mm Front/Front Loading Connectors
-
- Addition of 16mm and 18mm Side/Top Loading Connectors
-
- Addition of 16mm and 18mm Offset Z-Rod, 300mm Long
-
- Addition of 16mm and 18mm Offset Z-Rod, 450mm Long
-
- Modification of 12mm Side/Top Loading Connector
-
- Modification of 12mm Side/Front Loading Connector
-
- Modification of 12mm Side/Side Loading Connector
-
- Modification of 12mm Front/Front Loading Connector
5
-
- Modification of Small Side/Front Loading Connector
-
- Modification of 16mm Bypass Connector. Left and Right
-
- Modification of 34mm Bypass Connector, Left and Right
-
- Modification of U-Style 16mm Bypass Connector, Left and Right
-
- Modification of Axial In-Line Connector with Rod
-
- Modification of 12mm Offset Z-Rod 150mm x 300mm and 150mm x 150mm
Device Description
The Connector System is designed to reduce the complexity of revising and extending existing constructs from the Occiput to the Ilium. The Connector System includes a variety of non-sterile implants manufactured from titanium alloy comprised of bypass connectors, rod to rod connectors, Z rods, and an axial in-line connector with an attached rod. The Connector System implant options offered eliminate the need to remove existing hardware while providing stability to adjacent levels. The Connector System is compatible with posterior spinal fixation systems (e.g. Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System, Spinal Fixation System, Centurion POCT System, and Ascent POCT System) which offer titanium and/or cobalt chrome rods ranging in sizes of 3.0mm to 6.35mm.
Intended Use / Indications for Use
-
When used with the Centurion POCT System or Ascent POCT System for Posterior Occipital-Cervical-Thoracic (Occ - T3) The Connector System is intended to provide immobilization and stabilization of spinal seqments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 – T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); 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 Connector 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.
-
When used with the Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System or Spinal Fixation System (SFS) for Thoracic, Lumbar, and Sacral Spine Fixation (T1-S2/Ilium) The Connector System is intended to provide immobilization and stabilization of spinal seqments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/Ilium), or as an anterolateral fixation system (T8-L5), in the treatment of the following acute and chronic instabilities or deformities:
-
degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
-
- spondvlolisthesis.
-
- trauma (i.e., fracture or dislocation),
-
- spinal stenosis,
-
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
-
- tumor.
-
- pseudoarthrosis, and
-
- failed previous fusion
When used for posterior pedicle screw fixation in pediatric patients, the Connector System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach. The Connector System is intended to be used with autograft or allograft.
Summary of the Technological Characteristics of the Device Compared to the Selected Predicate Devices
6
The technological characteristics of the subject new and modified medical devices within the previously cleared Connector System (K172194) utilize the same design, intended use, materials, and performance characteristics. There are no significant differences between the subject devices and the predicate devices which would adversely affect the use of the product.
PERFORMANCE DATA - Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence
Mechanical testing was conducted on the subject devices as listed below in Table 1: Mechanical Performance Testing
| Subject Device | Mechanical Performance Testing |
|---|---|
| 1. Addition of 16mm and 18mm Side/Front | |
| Loading Connectors | Justification based on worst case |
| analysis | |
| 2. Addition of 16mm and 18mm Side/Side | |
| Loading Connectors | |
| 3. Addition of 16mm and 18mm Front/Front | |
| Loading Connectors | |
| 4. Addition of 16mm and 18mm Side/Top | |
| Loading Connectors | |
| 5. Addition of 16mm and 18mm Offset Z- | |
| Rod, 300mm Long | |
| 6. Addition of 16mm and 18mm Offset Z- | |
| Rod, 450mm Long | |
| 7. Modification of 12mm Side/Top Loading | |
| Connector | |
| 8. Modification of 12mm Side/Front Loading | |
| Connector | |
| 9. Modification of 12mm Side/Side Loading | |
| Connector | |
| 10. Modification of 12mm Front/Front Loading | |
| Connector | |
| 11. Modification of Small Side/Front Loading | |
| Connector | |
| 12. Modification of 16mm Bypass Connector, | |
| Left and Right | ASTM F1798 Axial Grip Testing |
| 13. Modification of 34mm Bypass Connector, | |
| Left and Right | |
| 14. Modification of U-Style 16mm Bypass | |
| Connector, Left and Right | |
| 15. Modification of Axial In-Line Connector | |
| with Rod | |
| 16. Modification of 12mm Offset Z-Rod | |
| 150mm x 300mm and 150mm x 150mm | Justification - Modification is specification |
| clarification |
Table 1: Mechanical Performance Testing
Basis of Substantial Equivalence
The subject new and modified medical devices within the previously cleared Connector System (K172194) are substantially equivalent to the predicate devices based upon the same intended use, indications for use, technological characteristics, design, materials and the same principles of operation.