K170647 · Orthofix, Inc. · NKG · May 11, 2017 · Orthopedic
Device Facts
Record ID
K170647
Device Name
Connector System
Applicant
Orthofix, Inc.
Product Code
NKG · Orthopedic
Decision Date
May 11, 2017
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3075
Device Class
Class 2
Attributes
Therapeutic, Pediatric
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 segments 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 Svstem (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: 1. degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) 2. spondylolisthesis, 3. trauma (i.e., fracture or dislocation), 4. spinal stenosis, 5. deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), 6. tumor. 7. pseudoarthrosis, and 8. 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.
Device Story
Connector System; non-sterile titanium alloy implants; includes bypass connectors, rod-to-rod connectors, Z rods, and axial in-line connectors. Designed for revision/extension of existing spinal constructs (Occiput to Ilium) without removing existing hardware. Used in clinical settings by surgeons; provides stability to adjacent spinal levels. Compatible with various Orthofix posterior spinal fixation systems (e.g., Firebird, Phoenix, Centurion, Ascent) using 3.0mm to 6.35mm rods. Output is mechanical stabilization of spinal segments; facilitates fusion or provides temporary structural integrity.
Clinical Evidence
Bench testing only. Mechanical performance testing conducted per ASTM F1717 (static compression bending, static torsion, dynamic compression bending) and ASTM F1798 (axial gripping force). No clinical data provided.
Indicated for immobilization/stabilization of spinal segments as adjunct to fusion in patients with acute/chronic instabilities or deformities of the craniocervical junction, cervical, thoracic, lumbar, and sacral spine (Occ-S2/Ilium). Includes treatment for trauma, tumors, degenerative disc disease, spondylolisthesis, spinal stenosis, deformities (scoliosis, kyphosis, lordosis), pseudoarthrosis, and failed fusions. Pediatric use indicated for adolescent idiopathic scoliosis via posterior approach. Also indicated for temporary spinal column integrity in advanced cervical tumor patients with limited life expectancy.
Regulatory Classification
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.
Special Controls
*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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 11, 2017
Image /page/0/Picture/4 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a traditional symbol of medicine, with three figures representing health and human services.
Orthofix Inc. Ms. Jacki Koch Senior Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, TX 75056
Re: K170647
Trade/Device Name: Connector System Regulatory Class: Unclassified Product Code: NKG, KWP, NKB, KWQ Dated: March 2, 2017 Received: March 3, 2017
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. 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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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/ResourcesforYou/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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K170647
Device Name Connector System
#### Indications for Use (Describe)
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 of spinal segments 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 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.
| 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)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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### *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."
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# Indications for Use
510(k) Number (if known) K170647
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:
1. degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
2. spondylolisthesis,
- 3. trauma (i.e., fracture or dislocation),
- 4. spinal stenosis,
- 5. deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- 6. tumor.
7. pseudoarthrosis, and
- 8. 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 screw fixation is limited to a posterior approach. The Connector System is intended to be used with autograft or allograft.
Type of Use (Select one or both, as applicable)
| <span></span> | Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|----------------------------------------------|
| <span></span> | 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."
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Image /page/4/Picture/1 description: The image shows the word "ORTHOFIX" in black, with a blue abstract shape to the left of the word. The word is in all capital letters and appears to be a logo. The font is sans-serif and bold.
Connector System
# 510(k) SUMMARY
______________________________________________________________________________________________________________________________________________________________________________
# Connector System
| 510(k) Owner Information<br>Name:<br>Address: | Orthofix Inc.<br>3451 Plano Parkway<br>Lewisville, TX 75056 | | |
|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Telephone Number:<br>Fax Number:<br>Email: | 214-937-2100<br>214-937-3322<br>jackikoch@orthofix.com | | |
| Registration Number: | 2183449 | | |
| Contact Person: | Jacki Koch, Senior Regulatory Affairs Specialist | | |
| Date Prepared: | May 9, 2017 | | |
| Name of Device<br>Trade Name / Proprietary<br>Name: | Connector System | | |
| Common Name: | 1. Spinal interlaminal fixation orthosis<br>2. Pedicle screw spinal system | | |
| Product Code: | 1. NKG<br>2. NKB; KWP; KWQ | | |
| Regulatory Classification: | 1. Unclassified<br>2. Class II – 21 CFR § 888.3070, 21 CFR § 888.3050, and 21 CFR<br>\$ 888.3060 | | |
| Review Panel: | Orthopedic Device Panel | | |
| Primary Predicate Devices: | 1. K150822 – Centurion POCT System – Orthofix<br>2. K080407 - Spinal Fixation System - Orthofix | | |
| Additional Predicate Devices:<br>K111183 - Ascent POCT System - Orthofix | | | |
| | K153428 - Firebird Spinal Fixation System/Phoenix MIS Spinal<br>Fixation System - Orthofix<br>K110070 - TSRH Spinal System - Medtronic Sofamor Danek USA | | |
| Reference Device: | K133350 - Revere Stabilization System - Globus Medical Inc.<br>K130877 - EXPEDIUM Universal Connector Set - Depuy | | |
Reason for 510(k) Submission:
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# ORTHOFIX
Orthofix is submitting this Traditional 510(k) premarket notification for the clearance of the Connector System.
# 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, 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
- 1. 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 segments 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.
- 2. When used with the Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System or Spinal Fixation Svstem (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:
1. degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
- 2. spondylolisthesis,
- 3. trauma (i.e., fracture or dislocation),
- 4. spinal stenosis,
- 5. deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- 6. tumor.
- 7. pseudoarthrosis, and
- 8. 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.
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Image /page/6/Picture/1 description: The image contains the logo for Orthofix. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in black, bold letters. The "®" symbol is present to the right of the word, indicating that it is a registered trademark.
## Summary of the Technological Characteristics of the Device Compared to the Selected Predicate Devices
The technological characteristics of the subject Connector System are similar to the predicate devices in terms of design, dimensions, intended use, materials, and performance characteristics. There are no significant differences between the subject Connector System 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
## Table 1: Mechanical Performance Testing
| Subject Device | Mechanical Performance Testing |
|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Side/Top Loading Connector with one large<br>set screw and one small set screw | ASTM F1717, static compression bending,<br>static torsion and dynamic compression<br>bending |
| Side/Front Loading Connector with two small<br>set screws | ASTM F1717, static compression bending,<br>static torsion and dynamic compression<br>bending |
| Small Side/Front Loading Connector with two<br>small set screws | Cervical components, ASTM F1798 axial<br>gripping force test |
| Z Rod, 150mm x 150mm | ASTM F1717, static compression bending,<br>static torsion and dynamic compression<br>bending |
## Basis of Substantial Equivalence
The subject Connector System is substantially equivalent to the predicate device based upon the indication for use, the technological characteristics, and the data submitted.
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