(112 days)
Not Found
No
The document describes physical implants and instruments for spinal fusion and vertebral body replacement. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as a "Spacer System" for "intervertebral body fusion" and "Partial Vertebral Body Replacement" used in patients with degenerative disk disease, tumors, or fractures of the spine. These are all therapeutic applications aimed at treating medical conditions.
No
Explanation: The provided text describes several "Spacer Systems" (FORZA, PILLAR, SKYHAWK) which are implants used for spinal fusion or vertebral body replacement. Their stated uses are surgical correction and stabilization of the spine, not diagnosis. While they aid in determining if fusion has occurred (due to radiolucent properties and marker pins), this is a post-operative assessment of the implant's function, not a diagnostic capability of the device itself.
No
The device description explicitly states that the system consists of implants, trials, and instruments, which are physical hardware components made from materials like PEEK and tantalum.
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 description clearly states that the FORZA, PILLAR, and SKYHAWK systems are implants made of PEEK and tantalum markers. Their intended use is for spinal fusion and vertebral body replacement in patients with degenerative disk disease and fractures. These are surgical implants designed to be placed within the body, not used to test samples outside the body.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples, detection of biomarkers, or diagnostic testing procedures.
Therefore, the device described is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
FORZA Spacer System:
The FORZA Spacer System is indicated for use with bone graft (autograft bone or allogenic bone graft composed of cancellous or corticocancellous bone graft) in patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may have up to Grade I Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated.
The FORZA Spacer System is intended to be used with supplemental fixation systems. As an example, the supplemental fixation that may be used is the Orthofix Firebird Spinal Fixation System.
The FORZA Spacer System must be used with autograft or allogenic bone graft composed of cancellous or corticocancellous bone graft.
PILLAR PEEK Spacer System:
When used as an intervertebral body fusion device, the PILLAR PEEK Spacer System is indicated for use with bone graft (autograft bone or allogenic bone graft composed of cancellous or corticocancellous bone graft) in patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated.
The PILLAR PEEK Spacer System is intended to be used with supplemental fixation. As an example, the supplemental fixation that may be used is the Orthofix Spinal Fixation System (SFS).
The PILLAR PL PEEK Spacer is used singly or in pairs and is implanted using a posterior approach.
The PILLAR TL PEEK Spacer is used singly or in pairs and is implanted using a transforaminal approach.
The PILLAR AL PEEK Spacer is used singly and is implanted using an anterior approach.
The PILALR XL PEEK Spacer is used singly and is implanted using a lateral approach.
The PILLAR PEEK Spacer System must be used with autograft or allogenic bone graft composed of cancellous or corticocancellous bone graft.
When used as a Partial Vertebral Body Replacement (VBR), The PILLAR PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and to restore the height of a collapsed vertebral body. The PILLAR Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.
The PILLAR PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of a fusion for a prolonged period of time. The Partial VBR device is intended to be used with autograft or allograft.
The PILLAR PEEK Spacer System is intended for use with supplemental fixation. As an example, the supplemental fixation that may be used is the Orthofix Spinal Fixation System (SFS).
PILLAR SA PEEK Spacer System:
When used as an intervertebral body fusion device, the PILLAR SA PEEK Spacer System is indicated for use with bone graft (autograft bone or allogenic bone graft composed of cancellous or corticocancellous bone graft) in patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated.
The PILLAR SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental fixation must be used to augment stability. As an example, the supplemental fixation system that may be used is the Orthofix Spinal Fixation System (SFS).
The PILLAR SA PEEK Spacer System must be used with autograft or allogenic bone graft composed of cancellous or corticocancellous bone graft.
When used as a Partial Vertebral Body Replacement (VBR) the PILLAR SA PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PILLAR SA PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.
The PILLAR SA PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The PILLAR SA PEEK Spacer System is intended to be used with autograft or allograft.
The PILLAR SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental fixation must be used to augment stability. As an example, the supplemental fixation that may be used is the Orthofix Spinal Fixation System (SFS).
SKYHAWK Lateral Interbody Fusion System:
When used as an intervertebral body fusion device, the SKYHAWK Lateral Interbody Fusion System is indicated for use with bone graft (autograft bone or allogenic bone graft composed of cancellous bone graft) in patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated.
The SKYHAWK Lateral Interbody Fusion System is intended to be used with supplemental fixation systems that are cleared by the FDA for use in the lumbar spine.
The SKYHAWK Lateral Interbody Fusion System must be used with autograft or allogenic bone graft composed of cancellous or corticocancellous bone graft.
Product codes (comma separated list FDA assigned to the subject device)
MAX, MQP
Device Description
FORZA Spacer System:
The FORZA Spacer System consists of implants, trials, and instruments. The FORZA Spacer System is comprised of a variety of implants fabricated and manufactured from polyetheretherketone (PEEK) as described by ASTM F2026 with tantalum markers as described by ASTM F560. PEEK was utilized due to its radiolucent properties, which aids the surgeon in determining if fusion is the operative site has occurred. Since PEEK is transparent in x-rays, tantalum marker pins are inserted into the implants in order to give surgeons a visual aid in determining the location of the implants, both intra and postoperatively.
PILLAR PEEK Spacer System:
The PILLAR Spacer System is comprised of a variety of implants manufactured from PEEK (Polyetheretherketone), as described by ASTM F2026, with tantalum markers as described by ASTM F560. The implants are available in a variety of footprint sizes. Additionally, they are offered in parallel and lordotic profiles in order to restore the natural curvature of the spine. The implants are available in various heights, in either one or two millimeter increments. The superior and interior surfaces of the implant have a pattern of ripples to provide increased stability and help prevent anterior/posterior movement of the device.
The PILLAR Spacer System is intended for intervertebral body fusion or partial vertebral body replacement to aid in the surqical correction and stabilization of the spine.
The PILLAR Spacer System is not intended to be used as a stand-alone device. The PILLAR Spacer System must be used with supplemental internal fixation. The PILLAR Spacer System is provided non-sterile.
PILLAR SA PEEK Spacer System:
The PILLAR SA PEEK Spacer System is comprised of a variety of implants manufactured from PEEK (Polyetheretherketone), as described by ASTM F2026, with tantalum markers as described by ASTM F560. The implants are available in multiple footprint sizes, a variety of heights, and two angles of lordosis: 7° and 12°. The implants incorporate integrated anterior screw holes to allow for medial placement of screws, as well as titanium plate for securing the screws once in place. The superior and inferior surfaces of the implant have a pattern of ripples that provide increased stability and help prevent movement of the device.
The PILLAR SA PEEK Spacer System is provided non-sterile.
SKYHAWK Lateral Interbody Fusion System:
The SKYHAWK Interbody Fusion System consists of implants, trials, and instruments. The system is comprised of a variety of implants fabricated and manufactured from polyetheretherketone (PEEK) as described by ASTM F2026 with tantalum markers as described by ASTM F560. PEEK is utilized due to its radiolucent properties, which aids the surgeon in determining if fusion is the operative site has occurred. Since PEEK is transparent in x-rays, tantalum marker pins are inserted into the implants in order to give surgeons a visual aid in determining the location of the implants, both intra and postoperatively.
The SKYHAWK Interbody Fusion System implants are offered in parallel and lordotic profiles to restore the natural curvature of the spine; the device may be implanted using a later or anterolateral approach.
The SKYHAWK Interbody Fusion System implants, trials and instruments are provided nonsterile. They require sterilization prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to S1 (lumbar spine), Thoracolumbar spine (T1-L5)
Indicated Patient Age Range
skeletally mature
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
PERFORMANCE DATA - Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence
The FORZA Spacer System Pyrogen Testing:
The FORZA Spacer System STERILE packed implants were tested using Bacterial endotoxin testing (BET) as specified in ANSI/AAMI ST-72:2011 to achieve an Endotoxin limit less than 20EU per device.
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.
K152475, K081177, K081849, K140709
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
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
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 stylized eagle with three heads facing right, representing health, human services, and the USA. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 22, 2016
ORTHOFIX Inc. Ms. Jacki Koch Regulatory Affairs Specialist, II 3451 Plano Parkway Lewisville, Texas 75056
Re: K162446
Trade/Device Name: FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MQP Dated: September 26, 2016 Received: September 28, 2016
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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,
Vincent J. Devlin -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page 1 of 6
510(k) Number (if known) K162446
Device Name FORZA Spacer System
Indications for Use (Describe)
The FORZA Spacer System is indicated for use with bone graft (autograft bone or allogenic bone graft composed of cancellous or corticocancellous bone graft) in patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may have up to Grade I Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated.
The FORZA Spacer System is intended to be used with supplemental fixation systems. As an example, the supplemental fixation that may be used is the Orthofix Firebird Spinal Fixation System.
The FORZA Spacer System must be used with autograft or allogenic bone graft composed of cancellous or corticocancellous bone graft.
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
3
Page 2 of 6
510(k) Number (if known) K162446
Device Name PILLAR PEEK Spacer System
Indications for Use (Describe)
When used as an intervertebral body fusion device, the PILLAR PEEK Spacer System is indicated for use with bone graft (autograft bone or allogenic bone graft composed of cancellous or corticocancellous bone graft) in patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated.
The PILLAR PEEK Spacer System is intended to be used with supplemental fixation. As an example, the supplemental fixation that may be used is the Orthofix Spinal Fixation System (SFS).
The PILLAR PL PEEK Spacer is used singly or in pairs and is implanted using a posterior approach.
The PILLAR TL PEEK Spacer is used singly or in pairs and is implanted using a transforaminal approach.
The PILLAR AL PEEK Spacer is used singly and is implanted using an anterior approach.
The PILALR XL PEEK Spacer is used singly and is implanted using a lateral approach.
The PILLAR PEEK Spacer System must be used with autograft or allogenic bone graft composed of cancellous or corticocancellous bone graft.
When used as a Partial Vertebral Body Replacement (VBR), The PILLAR PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and to restore the height of a collapsed vertebral body. The PILLAR Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.
The PILLAR PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of a fusion for a prolonged period of time. The Partial VBR device is intended to be used with autograft or allograft.
The PILLAR PEEK Spacer System is intended for use with supplemental fixation. As an example, the supplemental fixation that may be used is the Orthofix Spinal Fixation System (SFS).
| 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.
FORM FDA 3881 (8/14)
4
This section applies only to requirements of the Paperwork Reduction Act of 1995.
the of the occident applies only to toquientients of the Processor Pool 1000.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. Page 3 of 6
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
5
Page 4 of 6
510(k) Number (if known) K162446
Device Name PILLAR SA PEEK Spacer System
Indications for Use (Describe)
When used as an intervertebral body fusion device, the PILLAR SA PEEK Spacer System is indicated for use with bone graft (autograft bone or allogenic bone graft composed of cancellous or corticocancellous bone graft) in patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated.
The PILLAR SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental fixation must be used to augmt stability. As an example, the supplemental fixation system that may be used is the Orthofix Spinal Fixation System (SFS).
The PILLAR SA PEEK Spacer System must be used with autograft or allogenic bone graft composed of cancellous or corticocancellous bone graft.
When used as a Partial Vertebral Body Replacement (VBR) the PILLAR SA PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PILLAR SA PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.
The PILLAR SA PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The PILLAR SA PEEK Spacer System is intended to be used with autograft or allograft.
The PILLAR SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental fixation must be used to augment stability. As an example, the supplemental fixation that may be used is the Orthofix Spinal Fixation System (SFS).
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.
6
This section applies only to requirements of the Paperwork Reduction Act of 1995.
Page 5 of 6 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
7
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Page 6 of 6
510(k) Number (if known) K162446
Device Name
SKYHAWK Lateral Interbody Fusion System
Indications for Use (Describe)
When used as an intervertebral body fusion device, the SKYHAWK Lateral Interbody Fusion System is indicated for use with bone graft (autograft bone or allogenic bone graft composed of cancellous bone graft) in patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated.
The SKYHAWK Lateral Interbody Fusion System is intended to be used with supplemental fixation systems that are cleared by the FDA for use in the lumbar spine.
The SKYHAWK Lateral Interbody Fusion System must be used with autograft or allogenic bone graft composed of cancellous or corticocancellous bone graft.
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
8
Image /page/8/Picture/1 description: The image contains the word "ORTHOFIX" in bold, black letters. To the left of the word is a blue, abstract symbol that resembles a stylized letter "O" or a spiral. The overall design is clean and professional, suggesting a corporate logo or brand identity.
510(k) SUMMARY
FORZA Spacer System PILLAR PEEK Spacer System PILLAR SA PEEK Spacer System SKYHAWK Lateral Interbody Fusion 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, Regulatory Affairs Specialist, II |
| Date Prepared: | December 8, 2016 |
| Name of Device | |
| Trade Name / Proprietary | |
| Name: | FORZA Spacer System |
| PILLAR PEEK Spacer System | |
| PILLAR SA PEEK Spacer System | |
| SKYHAWK Lateral Interbody Fusion System | |
| Common Name: | Spinal Vertebral Body Replacement Device |
| Spinal Partial Vertebral Body Replacement Device | |
| Intervertebral Body Fusion Device | |
| Product Code: | FORZA Spacer System - MAX |
| PILLAR PEEK Spacer System – MAX, MQP | |
| PILLAR SA PEEK Spacer System – MAX, MQP | |
| SKYHAWK Lateral Interbody Fusion System - MAX | |
| Regulatory Classification: | Class II – 21 CFR § 888.3080 – Intervertebral body fusion device |
| Class II - 21 CFR § 888.3060 – Spinal intervertebral body fixation orthosis | |
| Review Panel: | Orthopedic Device Panel |
| Primary Predicate Device: | FORZA Spacer System - Orthofix – K152475 |
Additional Predicate Devices: PILLAR PEEK Spacer System - Orthofix - K081177
9
Image /page/9/Picture/1 description: The image shows the Orthofix logo. The logo consists of a blue abstract shape on the left and the word "ORTHOFIX" in black capital letters on the right. The "®" symbol is located in the upper right corner of the word "ORTHOFIX".
PILLAR SA PEEK Spacer System - Orthofix - K081849 SKYHAWK Lateral Interbody Fusion System - Orthofix - K140709
Reason for 510(k) Submission:
Expanded Indications for Use to include the use with allograft material composed of cancellous or corticocancellous bone graft material.
Device Description
FORZA Spacer System:
The FORZA Spacer System consists of implants, trials, and instruments. The FORZA Spacer System is comprised of a variety of implants fabricated and manufactured from polyetheretherketone (PEEK) as described by ASTM F2026 with tantalum markers as described by ASTM F560. PEEK was utilized due to its radiolucent properties, which aids the surgeon in determining if fusion is the operative site has occurred. Since PEEK is transparent in x-rays, tantalum marker pins are inserted into the implants in order to give surgeons a visual aid in determining the location of the implants, both intra and postoperatively.
PILLAR PEEK Spacer System:
The PILLAR Spacer System is comprised of a variety of implants manufactured from PEEK (Polyetheretherketone), as described by ASTM F2026, with tantalum markers as described by ASTM F560. The implants are available in a variety of footprint sizes. Additionally, they are offered in parallel and lordotic profiles in order to restore the natural curvature of the spine. The implants are available in various heights, in either one or two millimeter increments. The superior and interior surfaces of the implant have a pattern of ripples to provide increased stability and help prevent anterior/posterior movement of the device.
The PILLAR Spacer System is intended for intervertebral body fusion or partial vertebral body replacement to aid in the surqical correction and stabilization of the spine.
The PILLAR Spacer System is not intended to be used as a stand-alone device. The PILLAR Spacer System must be used with supplemental internal fixation. The PILLAR Spacer System is provided non-sterile.
PILLAR SA PEEK Spacer System:
The PILLAR SA PEEK Spacer System is comprised of a variety of implants manufactured from PEEK (Polyetheretherketone), as described by ASTM F2026, with tantalum markers as described by ASTM F560. The implants are available in multiple footprint sizes, a variety of heights, and two angles of lordosis: 7° and 12°. The implants incorporate integrated anterior screw holes to allow for medial placement of screws, as well as titanium plate for securing the screws once in place. The superior and inferior surfaces of the implant have a pattern of ripples that provide increased stability and help prevent movement of the device.
The PILLAR SA PEEK Spacer System is provided non-sterile.
SKYHAWK Lateral Interbody Fusion System:
10
Image /page/10/Picture/1 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in black, sans-serif font. The "®" symbol is located to the upper right of the word "ORTHOFIX".
The SKYHAWK Interbody Fusion System consists of implants, trials, and instruments. The system is comprised of a variety of implants fabricated and manufactured from polyetheretherketone (PEEK) as described by ASTM F2026 with tantalum markers as described by ASTM F560. PEEK is utilized due to its radiolucent properties, which aids the surgeon in determining if fusion is the operative site has occurred. Since PEEK is transparent in x-rays, tantalum marker pins are inserted into the implants in order to give surgeons a visual aid in determining the location of the implants, both intra and postoperatively.
The SKYHAWK Interbody Fusion System implants are offered in parallel and lordotic profiles to restore the natural curvature of the spine; the device may be implanted using a later or anterolateral approach.
The SKYHAWK Interbody Fusion System implants, trials and instruments are provided nonsterile. They require sterilization prior to use.
Indications for Use
FORZA Spacer System:
The FORZA Spacer System is indicated for use with bone graft (autograft bone or allogenic bone graft composed of cancellous or corticocancellous bone graft) in patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated.
The FORZA Spacer System is intended to be used with supplemental fixation systems. As an example, the supplemental fixation that may be used is the Orthofix Firebird Spinal Fixation System.
The FORZA Spacer System must be used with autograft or allogenic bone graft composed of cancellous or corticocancellous bone graft.
PILLAR PEEK Spacer System:
When used as an intervertebral body fusion device, the PILLAR PEEK Spacer System is indicated for use with bone graft (autograft bone or allogenic bone graft composed of cancellous or corticocancellous bone graft) in patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated.
The PILLAR PEEK Spacer System is intended to be used with supplemental fixation. As an example, the supplemental fixation that may be used is the Orthofix Spinal Fixation System (SFS).
11
Image /page/11/Picture/1 description: The image shows the word "ORTHOFIX" in black letters. To the left of the word is a blue symbol that looks like a stylized letter O. The word is in all caps and has a registered trademark symbol after it.
The PILLAR PL PEEK Spacer is used singly or in pairs and is implanted using a posterior approach.
The PILLAR TL PEEK Spacer is used singly or in pairs and is implanted using a transforaminal approach.
The PILLAR AL PEEK Spacer is used singly and is implanted using an anterior approach.
The PILALR XL PEEK Spacer is used singly and is implanted using a lateral approach.
The PILLAR PEEK Spacer System must be used with autograft or allogenic bone graft composed of cancellous or corticocancellous bone graft.
When used as a Partial Vertebral Body Replacement (VBR), The PILLAR PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PILLAR Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.
The PILLAR PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of a fusion for a prolonged period of time. The Partial VBR device is intended to be used with autograft or allograft.
The PILLAR PEEK Spacer System is intended for use with supplemental fixation. As an example, the supplemental fixation that may be used is the Orthofix Spinal Fixation System (SFS).
PILLAR SA PEEK Spacer System:
When used as an intervertebral body fusion device, the PILLAR SA PEEK Spacer System is indicated for use with bone graft (autograft bone or allogenic bone graft composed of cancellous or corticocancellous bone graft) in patients with degenerative disk disease (DDD) at one or two contiquous levels from L2 to S1. These DDD patients may have up to Grade I Spondvlolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated.
The PILLAR SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental fixation must be used to augment stability. As an example, the supplemental fixation system that may be used is the Orthofix Spinal Fixation System (SFS).
The PILLAR SA PEEK Spacer System must be used with autograft or allogenic bone graft composed of cancellous or corticocancellous bone graft.
12
Image /page/12/Picture/1 description: The image shows the word "ORTHOFIX" in bold, black letters. To the left of the word is a blue, abstract shape that resembles a stylized leaf or wing. The word "ORTHOFIX" appears to be the logo for a company or organization. The logo is simple and modern, with a clean typeface and a distinctive graphic element.
When used as a Partial Vertebral Body Replacement (VBR) the PILLAR SA PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PILLAR SA PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.
The PILLAR SA PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The PILLAR SA PEEK Spacer System is intended to be used with autograft or allograft.
The PILLAR SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental fixation must be used to augment stability. As an example, the supplemental fixation that may be used is the Orthofix Spinal Fixation System (SFS).
SKYHAWK Lateral Interbody Fusion System:
When used as an intervertebral body fusion device, the SKYHAWK Lateral Interbody Fusion Svstem is indicated for use with bone graft (autograft bone or allogenic bone graft composed of cancellous or corticocancellous bone graft) in patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with deqeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated.
The SKYHAWK Lateral Interbody Fusion System is intended to be used with supplemental fixation systems that are cleared by the FDA for use in the lumbar spine.
The SKYHAWK Lateral Interbody Fusion System must be used with autograft or allogenic bone graft composed of cancellous or corticocancellous bone graft.
Summary of the Technological Characteristics of the Device Compared to the Selected Predicate Devices
The technological characteristics of the FORZA Spacer System (K103111), PILLAR PEEK Spacer System (K082235), PILLAR SA PEEK Spacer System (K081849) and the SKYHAWK Lateral Interbody Fusion System (K140709) are all similar to the predicate devices in terms of design, dimensions, intended use, materials, and performance characteristics. There are no significant differences between the FORZA Spacer System (K103111), PILLAR PEEK Spacer System (K082235), PILLAR SA PEEK Spacer System (K081849) and the SKYHAWK Lateral Interbody Fusion System (K140709) and the predicate device which would adversely affect the use of the product.
PERFORMANCE DATA - Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence
13
Image /page/13/Picture/1 description: The image shows the word "ORTHOFIX" in bold, black letters. To the left of the word is a blue, abstract shape. The shape is curved and has a pointed end. The word "ORTHOFIX" is written in all capital letters. There is a trademark symbol to the right of the word.
The purpose of this 510(k) submission is to obtain clearance for the modified Indications for Use for Intervertebral Body Fusion Devices (IBFD), to include the use of alloqenic bone graft composed of cancellous or corticocancellous bone graft in the spine. The subject FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System and the SKYHAWK Lateral Interbody Fusion System technological characteristics, design, material and principles of operation are all unchanged from when they were previously cleared.
The FORZA Spacer System Pyrogen Testing:
The FORZA Spacer System STERILE packed implants were tested using Bacterial endotoxin testing (BET) as specified in ANSI/AAMI ST-72:2011 to achieve an Endotoxin limit less than 20EU per device.
Basis of Substantial Equivalence
The FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System and the SKYHAWK Lateral Interbody Fusion System technological characteristics, design, material and principles of operation are all unchanged from when they were previously cleared.
Furthermore the subject devices have similar intended use, indications for use, technological characteristics, design, same materials and the same principles of operation as the to the predicate FORZA PTC Spacer System (K152475).