(70 days)
Not Found
No
The summary describes a physical implant and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is an interbody fusion device intended for use as an adjunct to fusion in patients with degenerative disc disease, which is a condition involving the spine. It aims to treat a medical condition and restore function, hence qualifying as a therapeutic device.
No.
The device is an interbody implant used as an adjunct to fusion for degenerative disc disease, not a diagnostic device. Its purpose is treatment, not diagnosis.
No
The device description explicitly states it is comprised of "3D printed titanium interbody spacers with porous titanium end plates and a functional gradient porous structure, and bone screws," indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used to aid in spinal fusion for patients with degenerative disc disease. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant made of titanium with specific structural features designed for surgical implantation. It does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic results. The device's function is purely mechanical and structural within the body.
Therefore, the PILLAR SA Ti Spacer System is a medical device, specifically a surgical implant, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PILLAR SA Ti Spacer System when used with screws is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.
The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The The PILLAR SA Ti Interbody may be used as a standalone device only when at least two Screws are inserted with one inferior and one superior screw trajectory. If the surgeon chooses to use the PILLAR SA Ti Interbody with fewer than two Screws inserted with one inferior and one superior screw trajectory, then additional supplemental fixation system must be used. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation.
Product codes
OVD, MAX
Device Description
The PILLAR SA Ti Spacer System is an integrated in ody fusion device for use in anterior lumbar interbody fusion (ALIF) procedures. The PILLAR SA TI Spacer System is compised of 3D printed titanium interbody spacers with porous titanium end plates and a functional gradient porous structure, and bone screws. The implants are offered in multiple footprints and lordotic options to accommodate individual patient anatomy. Each porous interbody has a large central window for graft material and a threaded hole with a zero-step locking mechanism for screw retention.
The PILLAR SA TI Spacer System implants are provided sterile.
PILLAR SA TI Spacer System implants are designed to be used with PILLAR SA TI Spacer System instrumentation and are not compatible with components from any other manufacturer's system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to S1 (lumbar spine)
Indicated Patient Age Range
Skeletally mature patients
Intended User / Care Setting
Not Found - Implied: Surgeon / Clinical setting
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)
Orthofix conducted the following mechanical tests as detailed in FDA Guidance "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" comparing the subject and predicate devices:
- Static and Dynamic Axial Compression (ASTM F2077)
- Static and Dynamic Axial Compression Shear (ASTM F2077)
- Subsidence (ASTM F2267)
- Wear Evaluation (ASTM F1877)
The mechanical testing adequately demonstrated that the PLLAR SA Ti Spacer System implants (device under review) tested as well or better than the cited predicate 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
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The Department of Health & Human Services logo is a stylized representation of a human figure, while the FDA acronym and name are written in blue, with the word "ADMINISTRATION" appearing below the FDA acronym.
May 28, 2024
Orthofix, Inc. Tony John Regulatory Affairs Program Manager 3451 Plano Parkway Lewisville, Texas 75056
Re: K240749
Trade/Device Name: PILLAR SA Ti Spacer System (82-XXX) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: March 13, 2024 Received: March 19, 2024
Dear Tony John:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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2
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Brent Showalter -S
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Submission Number (if known)
Device Name
PILLAR SA Ti Spacer System (82-XXX)
Indications for Use (Describe)
The PILLAR SA Ti Spacer System when used with screws is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.
The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The The PILLAR SA Ti Interbody may be used as a standalone device only when at least two Screws are inserted with one inferior and one superior screw trajectory. If the surgeon chooses to use the PILLAR SA Ti Interbody with fewer than two Screws inserted with one inferior and one superior screw trajectory, then additional supplemental fixation system must be used. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation.
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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510(k) Summary
Prepared on: 2024-03-19
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | Orthofix, Inc. | |
|---|---|---|
| Applicant Address | 3451 Plano Pkwy Lewisville TX 75056 United States | |
| Applicant Contact Telephone | 214-937-2153 | |
| Applicant Contact | Mr. Tony John | |
| Applicant Contact Email | TonyJohn@orthofix.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | PILLAR SA Ti Spacer System (82-XXX) | |
| Common Name | Intervertebral body fusion device | |
| Classification Name | Intervertebral Fusion Device With Bone Graft, Lumbar | |
| Regulation Number | 888.3080 | |
| Product Code | MAX | |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K200052 | PILLAR SA PTC Spacer System | MAX |
| K222732 | WaveForm A Interbody System | MAX |
| K082235 | PILLAR AL Spacer System | MAX |
| Device Description Summary | 21 CFR 807.92(a)(4) |
escription Summary
The PILLAR SA Ti Spacer System is an integrated in ody fusion device for use in anterior lumbar interbody fusion (ALIF) procedures. The PILLAR SA TI Spacer System is compised of 3D printed titanium interbody spacers with porous titanium end plates and a functional gradient porous structure, and bone screws. The implants are offered in multiple footprints and lordotic options to accommodate individual patient anatomy. Each porous interbody has a large central window for graft material and a threaded hole with a zero-step locking mechanism for screw retention.
The PILLAR SA TI Spacer System implants are provided sterile.
PILLAR SA TI Spacer System implants are designed to be used with PILLAR SA TI Spacer System instrumentation and are not compatible with components from any other manufacturer's system.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The PLLAR SA Ti Spacer System when used with screws is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of nonoperative treatment prior to being treated with the device.
4
The interbody is intended to be used with autogenous bone graft composed of cancellous, cortical, and/or corticocancellous bone. The PILLAR SA Ti Interbody may be used as a standalone device only when at least two Screws are inserted with one inferior and one superior screw trajectory. If the surgeon chooses to use the PILLAR SA Ti Interbody with fewer than two Screws inserted with one inferior and one superior screw trajectory, then additional supplemental fixation system must be used. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation.
Indications for Use Comparison
The subject PILLAR SA Ti Spacer System has the same intended use and comparable indications for use to the cited predicate devices.
Technological Comparison
The subject PILLAR SA Ti Spacer System the same: intent population, method of fixation, surgical approach, sterilization, materials and general design elements as the cited PIC Spacer System (K200052) and Meridian Interbody System (K233694) predicate devices.
In addition, Orthofix conducted the following mechanical tests as detailed in FDA Guidance "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" comparing the subject and predicate device:
- · Static and Dynamic Axial Compression (ASTM F2077)
- · Static and Dynamic Axial Compression Shear (ASTM F2077)
· Subsidence (ASTM F2267)
· Wear Evaluation (ASTM F1877)
The mechanical testing adequately demonstrated that the PLLAR SA Ti Spacer System implants (device under review) tested as well or better than the cited predicate devices.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Orthofix conducted the following mechanical tests as detailed in FDA Guidance "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" comparing the subject and predicate devices:
· Static and Dynamic Axial Compression (ASTM F2077)
· Static and Dynamic Axial Compression Shear (ASTM F2077)
· Subsidence (ASTM F2267)
· Wear Evaluation (ASTM F1877)
The mechanical testing adequately demonstrated that the PLLAR SA Ti Spacer System implants (device under review) tested as well or better than the cited predicate devices.
The mechanical testing adequately demonstrated that the PLLAR SA Ti Spacer System implants (device under review) tested as well or better than the cited predicate devices.