(134 days)
Not Found
Not Found
No
The document describes a mechanical implant for spinal fusion and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device, FORZA XP Expandable Spacer System, is used in spinal fusion procedures to treat degenerative disc disease, which is a medical condition. This makes it a therapeutic device as it directly addresses and aims to alleviate a medical condition.
No
The FORZA XP Expandable Spacer System is a surgical implant designed for spinal fusion procedures, not for diagnosing medical conditions. Its purpose is to treat degenerative disc disease by providing stability and promoting fusion, not to identify or assess the disease.
No
The device description clearly states that the FORZA XP Expandable Spacer System is a physical implant manufactured from Ti6Al4V alloy and PEEK Optima LT1, designed to be surgically implanted in the lumbar spine. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the FORZA XP Expandable Spacer System is for spinal fusion procedures in patients with degenerative disc disease. This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as an implantable spacer system made of titanium alloy and PEEK, designed to be surgically placed in the lumbar spine. This is a medical device used for treatment, not for diagnosing a condition.
- Lack of Diagnostic Elements: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information.
- Performance Studies: The performance studies mentioned are mechanical tests (Static and Dynamic Axial Compression Tests, Static and Dynamic Compression Shear Tests) to assess the structural integrity of the implant, which is typical for surgical devices. There are no studies related to diagnostic accuracy or performance on biological samples.
In summary, the FORZA XP Expandable Spacer System is a surgical implant used for treating a condition (degenerative disc disease) through spinal fusion, not a device used for diagnosing a condition.
N/A
Intended Use / Indications for Use
FORZA® XP Expandable Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s).
FORZA XP Expandable Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation (i.e. Firebird® Spinal Fixation System).
Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with FORZA XP Expandable Spacer System.
Product codes
MAX
Device Description
The FORZA XP Expandable Spacer System consists of various size and style options to address the clinical and anatomic needs of individual patients. The implant is rectangular in its general shape with the capability to expand in height continuously within its design limitations. The implant incorporates bone graft cavities through the superior and inferior surfaces to allow fusion between adjacent vertebral bodies. The implant incorporates a posterior opening to allow the addition of bone graft material post expansion. The implants are manufactured from implantable grade Ti6Al4V alloy and PEEK Optima LT1. The implants are delivered pre-assembled, unexpanded and are designed with textured bone contacting surface to resist migration /expulsion post operatively.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine (L2-S1)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Based on design change and risk assessment the mechanical tests performed were Static and Dynamic Axial Compression Tests and Static and Dynamic Compression Shear Tests in accordance to the ASTM F2077-14 standard for Test Method for Intervertebral Body Fusion Devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 19, 2018 Orthofix Inc. Natalia Volosen Regulatory Affairs Principal 3451 Plano Parkway Lewisville, Texas 75056
Re: K172696
Trade/Device Name: FORZA® XP Expandable Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: December 21, 2017 Received: December 22, 2017
Dear Ms. Volosen:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
labeling requirements (Sections 531.542 of the Act). 21 CFR
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-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,
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
Indications for Use
510(k) Number (if known) K172696
Device Name FORZA® XP Expandable Spacer System
Indications for Use (Describe)
FORZA XP Expandable Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s).
FORZA XP Expandable Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation (i.e. Firebird® Spinal Fixation System).
Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with FORZA XP Expandable Spacer System.
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."
3
510(k) SUMMARY
FORZA® XP Expandable Spacer System
| 510(k) Owner Information
Name:
Address: | Orthofix Inc.
3451 Plano Parkway
Lewisville, TX 75056 |
|-----------------------------------------------------|---------------------------------------------------------------------|
| Telephone Number:
Fax Number:
Email: | 214-937-2145
214-937-3322
nataliavolosen@orthofix.com |
| Registration Number: | 2183449 |
| Contact Person: | Natalia Volosen
Regulatory Affairs Principal |
| Date Prepared: | December 13, 2017 |
| Name of Device
Trade Name / Proprietary
Name: | FORZA XP Expandable Spacer System |
| Common Name: | Intervertebral body fusion device |
| Product Code: | MAX - Intervertebral Fusion Device with Bone Graft, Lumbar |
| Regulatory Classification: | Class II – 21 CFR § 888.3080 – Intervertebral body fusion
device |
| Review Panel: | Orthopedic Device Panel |
Reason for 510(k) Submission: Design Change
4
K172696 Page 2 of 2
Device Description
The FORZA XP Expandable Spacer System consists of various size and style options to address the clinical and anatomic needs of individual patients. The implant is rectangular in its general shape with the capability to expand in height continuously within its design limitations. The implant incorporates bone graft cavities through the superior and inferior surfaces to allow fusion between adjacent vertebral bodies. The implant incorporates a posterior opening to allow the addition of bone graft material post expansion. The implants are manufactured from implantable grade Ti6Al4V alloy and PEEK Optima LT1. The implants are delivered pre-assembled, unexpanded and are designed with textured bone contacting surface to resist migration /expulsion post operatively.
Intended Use / Indications for Use
FORZA XP Expandable Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiquous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s).
FORZA XP Expandable Spacer System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation (i.e. Firebird® Spinal Fixation System).
Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with FORZA XP Expandable Spacer System.
Summary of the Technological Characteristics of the Device Compared to the Selected Predicate Devices
The technological characteristics of the modified FORZA XP Expandable Spacer System are similar to the predicate devices in terms of design, size, intended use, materials, and performance characteristics.
PERFORMANCE DATA - Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence
Based on design change and risk assessment the mechanical tests performed were Static and Dynamic Axial Compression Tests and Static and Dynamic Compression Shear Tests in accordance to the ASTM F2077-14 standard for Test Method for Intervertebral Body Fusion Devices.
Conclusion
FORZA XP Expandable Spacer System has the same intended use, indications for use, technological characteristics, materials, the same principles of operation and similar design as the predicate devices.