(136 days)
No
The device description and performance studies focus on the mechanical properties and materials of a spinal implant, with no mention of AI or ML.
Yes
The device is described as a surgical implant (FORZA® PTC Spacer System) intended for spinal fusion procedures to treat degenerative disc disease, which is a medical condition. Its purpose is to facilitate vertebral fusion, stabilize vertebrae, and maintain disc height, directly addressing a health issue to restore function.
No
The FORZA® PTC Spacer System is an implantable device used in spinal fusion procedures to stabilize vertebrae, maintain disc height, and facilitate fusion. Its function is therapeutic, not diagnostic.
No
The device description explicitly states it is comprised of physical implants made of PEEK and Titanium alloy, which are hardware components.
Based on the provided information, the FORZA® PTC Spacer System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The FORZA® PTC Spacer System is an implantable medical device used in spinal fusion surgery. It is surgically placed in the intervertebral disc space to stabilize vertebrae and facilitate fusion.
- The description focuses on the device's materials, mechanical properties, and surgical application. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
Therefore, the FORZA® PTC Spacer System falls under the category of a surgical implant rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The FORZA® PTC 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 I spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s).
The FORZA® PTC Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, e.g. Firebird Spinal Fixation System.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the FORZA® PTC Spacer System.
Product codes
MAX
Device Description
The ØUÜZŒ PTC Spacer System is comprised of a variety of implants that have a PEEK core as described by ASTM F-2026 with two integrated porous Titanium alloy (Ti-6Al-4V) endplates as described by ASTM F1580. The FORZA PTC Spacer System is implanted in the intervertebral disc space and is intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height, and preventing the collapsing of one vertebrate onto another.
The ØJÜZŒ ÍRTC Spacer System is not intended to be used as a standalone device. The ØUÜZŒ PTC Spacer System must be used with a supplemental fixation system. The ØJÜZŒ PTC Spacer System implants are provided sterile.
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
Mechanical test and analysis was performed to establish mechanical strength for FORZA® PTC Spacer system (Static and Dynamic Axial Compression Test (ASTM F2077-11), Static and Dynamic Compression Shear Test (ASTM F2077-11), Static Torsion Test (ASTM F2077-11), Subsidence Test (ASTM F2267-04) and Expulsion Test (draft ASTM F04.25.02.02). Test results demonstrated that FORZA® PTC Spacer System is substantially equivalent to the predicate FORZA Spacer System K103111.
Surface specific characterization and integrity testing were done per ASTM F1978 (Taber abrasion), ASTM F1147 (tensile testing), ASTM F1044 (coating shear strength) and ASTM F1877 (wear test).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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/1 description: The image contains the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, layered on top of each other to create a sense of depth and unity. The profiles are rendered in a dark color, contrasting with the white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 14, 2016
Orthofix Incorporated Ms. Natalia Volosen Senior Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056
Re: K152475
Trade/Device Name: FORZA® PTC Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: December 15, 2015 Received: December 17, 2015
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name FORZA® PTC Spacer System
Indications for Use (Describe)
The FORZA® PTC 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 I spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s).
The FORZA® PTC Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, e.g. Firebird Spinal Fixation System.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the FORZA® PTC 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) |
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3
510(k) SUMMARY
FORZA® PTC 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: | 3008524126 |
| Contact Person: | Natalia Volosen
Senior Regulatory Affairs Specialist |
| Date Prepared: | January 13, 2016 |
| Name of Device
Trade Name / Proprietary Name: | FORZA® PTC Spacer System |
| Common Name: | Intervertebral body fusion device |
| Product Code: | MAX |
| Regulatory Classification: | Class Qper 21 CFR § 888.3080 |
| Review Panel: | Orthopedic Device Panel |
| Predicate Devices: | K103111 - FORZA Spacer System, SE 03/23/2011, Orthofix
(primary predicate)
K141953 - Endoskeleton TO/TT, SE 10/27/2014, Titan
Spine (additional predicate)
K150643 – STALIF MIDLINE II-Ti, SE 06/08/2015, Centinel
Spine (additional predicate)
Reference devices - CONSTRUX Mini PEEK Ti Spacer
System K121649 |
| Reason for 510(k) Submission:
New product offering | |
Device Description
The ØUÜZŒ PTC Spacer System is comprised of a variety of implants that have a PEEK core as described by ASTM F-2026 with two integrated porous Titanium alloy (Ti-6Al-4V) endplates as described by ASTM F1580. The FORZA PTC Spacer System is implanted in the intervertebral disc space and is intended to facilitate vertebral fusion by stabilizing
4
adjacent vertebrae, maintaining disc height, and preventing the collapsing of one vertebrate onto another.
The ØJÜZŒ ÍRTC Spacer System is not intended to be used as a standalone device. The ØUÜZŒ PTC Spacer System must be used with a supplemental fixation system. The ØJÜZŒ PTC Spacer System implants are provided sterile.
Intended Use / Indications for Use
The FORZA® PTC Spacer System is indicated for spinal fusion procedures in skeletally mature patients with deqenerative 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 I spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s).
The FORZA® PTC Spacer System is intended for use with autograft and /or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, e.g. Firebird Spinal Fixation System.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the FORZA® PTC Spacer System.
Summary of the Technological Characteristics of the Device Compared to the Selected Predicate Devices
The technological characteristics of the FORZA® PTC Spacer system are similar to the predicate devices in terms of design, dimensions, intended use, materials, and performance characteristics.
PERFORMANCE DATA - Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence
Mechanical test and analysis was performed to establish mechanical strength for FORZA® PTC Spacer system (Static and Dynamic Axial Compression Test (ASTM F2077-11), Static and Dynamic Compression Shear Test (ASTM F2077-11), Static Torsion Test (ASTM F2077-11), Subsidence Test (ASTM F2267-04) and Expulsion Test (draft ASTM F04.25.02.02). Test results demonstrated that FORZA® PTC Spacer System is substantially equivalent to the predicate FORZA Spacer System K103111.
Surface specific characterization and integrity testing were done per ASTM F1978 (Taber abrasion), ASTM F1147 (tensile testing), ASTM F1044 (coating shear strength) and ASTM F1877 (wear test).
Conclusion
Based upon similarities in design, materials, intended use, indications for use and the results of mechanical testing, the FORZA® PTC Spacer system is substantially equivalent to the predicate devices.