(83 days)
Not Found
No
The document describes physical spinal implants made of PEEK and titanium, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is intended to facilitate spinal fusion and stabilize vertebrae, which are therapeutic actions addressing degenerative disc disease.
No
The device description clearly states that these systems are "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." This indicates a therapeutic, rather than diagnostic, function.
No
The device description clearly states the system is comprised of physical implants made of PEEK and Titanium alloy, which are hardware components.
Based on the provided text, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- IVDs are used to examine specimens from the human body. The descriptions clearly state that these devices are implants intended for surgical insertion into the spine to facilitate fusion. They are not used to test or analyze biological samples.
- The intended use is for spinal fusion procedures. This is a surgical intervention, not a diagnostic test performed on a sample.
- The device descriptions detail the physical composition and function of the implants. They do not describe any components or processes related to analyzing biological specimens.
Therefore, the CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, and PILLAR SA PTC Spacer System are medical devices, but they fall under the category of implantable surgical devices rather than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
CONSTRUX Mini PTC Spacer System
The CONSTRUX Mini PTC Spacer System is indicated for spinal fusion procedures at one or two contiguous levels within the cervical spine (C2-T1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.
The CONSTRUX Mini PTC Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system (i.e., an anterior cervical plate such as the Orthofix Hallmark Anterior Cervical Plate System).
Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PTC Spacer System in the cervical spine.
FORZA PTC Spacer System
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 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved levels.
The FORZA Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, e.g., the Firebird Spinal Fixation System.
Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the FORZA PTC Spacer System.
PILLAR SA PTC Spacer System
The PILLAR SA 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 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s).
The PILLAR SA PTC Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft.
The PILLAR SA PTC Spacer System is intended for use with four of the titanium alloy screws provided with the system. 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, a supplemental fixation system that may be used is the Orthofix Firebird® Spinal Fixation System.
Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the PILLAR SA PTC Spacer System.
Product codes
ODP, MAX, OVD
Device Description
CONSTRUX Mini PTC Spacer System
The CONSTRUX Mini PTC Spacer System is comprised of a variety of implants that has a PEEK core (conforming to ASTM F2026) with integrated porous Titanium alloy (Ti-6AI-4V) endplates (conforming to ASTM F1580). The implant superior and inferior Titanium plate surface provides increased stability for the implant. The CONSTRUX Mini PTC spacer is implanted in the cervical 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 CONSTRUX Mini PTC Spacer System is not intended to be used as a standalone device. The CONSTRUX Mini PTC Spacer System must be used with a supplemental fixation system. The CONSTRUX Mini PTC Spacer System implants are provided sterile.
FORZA PTC Spacer System
The FORZA PTC Spacer System is comprised of a variety of implants that have a PEEK core (conforming to ASTM F2026) with two integrated porous Titanium alloy (Ti-6Al-4V) endplates (conforming to ASTM F1580). The implant superior and inferior Titanium plate surface provides increased stability for the implant. 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 FORZA PTC Spacer System is not intended to be used as a standalone device. The FORZA PTC Spacer System must be used with a supplemental fixation system. The FORZA PTC Spacer System implants are provided sterile.
PILLAR SA PTC Spacer System
The PILLAR SA PTC is a standalone intervertebral body implant that is comprised of a PEEK core (conforming to ASTM F2026) with integrated porous Titanium alloy (Ti-6AI-4V) endplates (conforming to ASTM F1580). The implant superior and inferior Titanium plate surface provides increased stability for the implant. The PILLAR SA PTC device 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 PILLAR SA PTC is designed to be used as a standalone device, when implanted with accompanying stabilizing screws. The PILLAR SA PTC spacers are provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C2-T1), 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 manufacturing change and risk assessment the mechanical tests performed are Static and Dynamic Axial Compression Test, Static and Dynamic Compression Shear Test and Static and Dynamic Torsion Test in accordance to ASTM F2077-14 standard for Test Method for Intervertebral Body Fusion Devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Orthofix Inc. Ms. Natalia Volosen Regulatory Affairs Principal 3451 Plano Parkway Lewisville, Texas 75056
November 2, 2017
Re: K172437
Trade/Device Name: CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, MAX, OVD Dated: October 10, 2017 Received: October 11, 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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
1
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 (DICE) 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 (DICE) 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
2
Indications for Use
510(k) Number (if known)
K172437
Device Name CONSTRUX® Mini PTC Spacer System FORZA® PTC Spacer System PILLAR® SA PTC Spacer System
Indications for Use (Describe)
CONSTRUX Mini PTC Spacer System
The CONSTRUX Mini PTC Spacer System is indicated for spinal fusion procedures at one or two contiguous levels within the cervical spine (C2-T1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.
The CONSTRUX Mini PTC Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system (i.e., an anterior cervical plate such as the Orthofix Hallmark Anterior Cervical Plate System).
Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PTC Spacer System in the cervical spine.
FORZA PTC Spacer System
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 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved levels.
The FORZA Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, e.g., the Firebird Spinal Fixation System.
Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the FORZA PTC Spacer System.
PILLAR SA PTC Spacer System
The PILLAR SA 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 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s).
The PILLAR SA PTC Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft.
The PILLAR SA PTC Spacer System is intended for use with four of the titanium alloy screws provided with the system. 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, a supplemental fixation system that may be used is the Orthofix Firebird® Spinal Fixation System.
Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the PILLAR SA 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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Image /page/4/Picture/0 description: The image shows the word "ORTHOFIX" in black font. To the left of the word is a blue symbol that looks like three curved lines. The word "ORTHOFIX" is written in all capital letters. The symbol is a lighter shade of blue than the word.
CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System
510(k) SUMMARY
CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System PILLAR® SA 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: | 2183449 |
| Contact Person: | Natalia Volosen
Requlatory Affairs Principal |
| Date Prepared: | October 10, 2017 |
| Name of Device
Trade Name / Proprietary
Name: | CONSTRUX Mini PTC Spacer System
FORZA PTC Spacer System
PILLAR SA PTC Spacer System |
| Common Name: | Intervertebral body fusion device |
| Product Code: | ODP, MAX, OVD |
| Regulatory Classification: | Class II - 21 CFR § 888.3080 - Intervertebral body fusion
device |
| Review Panel: | Orthopedic Device Panel |
| Predicate Devices:
Additional Predicate Devices | K161129 – PILLAR SA PTC, SE 9/8/2016
K152475 – FORZA PTC Spacer System, SE 1/14/2016
K150619 - CONSTRUX Mini PEEK Ti Spacer System, SE |
Reason for 510(k) Submission: Manufacturing / Product Description Change
11/29/2012
Device Description
CONSTRUX Mini PTC Spacer System
The CONSTRUX Mini PTC Spacer System is comprised of a variety of implants that has a PEEK core (conforming to ASTM F2026) with integrated porous Titanium alloy (Ti-6AI-4V) endplates (conforming to ASTM F1580). The implant superior and inferior Titanium plate surface provides increased stability for the implant. The CONSTRUX Mini PTC spacer is implanted in the cervical 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.
5
Image /page/5/Picture/0 description: The image shows the Orthofix logo. The logo consists of a blue circular shape on the left and the word "ORTHOFIX" in black letters on the right. The circular shape is made up of three curved lines that form a circle.
CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System
The CONSTRUX Mini PTC Spacer System is not intended to be used as a standalone device. The CONSTRUX Mini PTC Spacer System must be used with a supplemental fixation system. The CONSTRUX Mini PTC Spacer System implants are provided sterile.
FORZA PTC Spacer System
The FORZA PTC Spacer System is comprised of a variety of implants that have a PEEK core (conforming to ASTM F2026) with two integrated porous Titanium alloy (Ti-6Al-4V) endplates (conforming to ASTM F1580). The implant superior and inferior Titanium plate surface provides increased stability for the implant. 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 FORZA PTC Spacer System is not intended to be used as a standalone device. The FORZA PTC Spacer System must be used with a supplemental fixation system. The FORZA PTC Spacer System implants are provided sterile.
PILLAR SA PTC Spacer System
The PILLAR SA PTC is a standalone intervertebral body implant that is comprised of a PEEK core (conforming to ASTM F2026) with integrated porous Titanium alloy (Ti-6AI-4V) endplates (conforming to ASTM F1580). The implant superior and inferior Titanium plate surface provides increased stability for the implant. The PILLAR SA PTC device 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 PILLAR SA PTC is designed to be used as a standalone device, when implanted with accompanying stabilizing screws. The PILLAR SA PTC spacers are provided sterile.
Intended Use / Indications for Use
CONSTRUX Mini PTC Spacer System
The CONSTRUX Mini PTC Spacer System is indicated for spinal fusion procedures at one or two contiguous levels within the cervical spine (C2-T1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.
The CONSTRUX Mini PTC Spacer System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system (i.e., an anterior cervical plate such as the Orthofix Hallmark Anterior Cervical Plate System).
Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PTC Spacer System in the cervical spine.
FORZA PTC Spacer System
The FORZA PTC Spacer System is indicated for spinal fusion procedures in skeletally mature patients with deqenerative 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 levels.
6
Image /page/6/Picture/0 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 abstract shape is a stylized representation of a bone or joint. The word "ORTHOFIX" is written in all capital letters.
CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System
The FORZA Spacer System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, e.g., the Firebird Spinal Fixation System.
Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the FORZA PTC Spacer System.
PILLAR SA PTC Spacer System
The PILLAR SA 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 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s).
The PILLAR SA PTC Spacer System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
The PILLAR SA PTC Spacer System is intended for use with four of the titanium alloy screws provided with the system. 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, a supplemental fixation system that may be used is the Orthofix Firebird® Spinal Fixation System.
Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the PILLAR SA PTC Spacer System.
Summary of the Technological Characteristics of the Device Compared to the Selected Predicate Devices
The technological characteristics of the CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC 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 manufacturing change and risk assessment the mechanical tests performed are Static and Dynamic Axial Compression Test, Static and Dynamic Compression Shear Test and Static and Dynamic Torsion Test in accordance to ASTM F2077-14 standard for Test Method for Intervertebral Body Fusion Devices.
Basis of Substantial Equivalence
CONSTRUX Mini PTC Spacer System. FORZA PTC Spacer System, PILLAR SA PTC Spacer System have the same intended use, indications for use, technological characteristics, materials, the same principles of operation and same design as the predicate device CONSTRUX Mini PEEK Ti Spacer System (K150619), FORZA PTC Spacer System (K152475), and PILLAR SA PTC (K161129).