(19 days)
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.
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.
The FORZA XP Expandable Spacer System is comprised of an assortment of single use spacers made from titanium alloy and PEEK Polymer with height expansion capability. The implants feature a bulleted nose for ease of insertion and anti-migration ripples on both the inferior and superior surfaces to provide increased stability and help prevent anterior/posterior movement of the device.
The implants are offered in non-lordotic, lordotic, and hyperlordotic configurations to help restore the natural curvature of the spine. The implants can be used in single placement or pairs with typical approaches being transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF).
The FORZA XP Expandable Spacer System is not intended to be used as a stand-alone device and must be used with a supplemental fixation system.
The provided text describes a 510(k) premarket notification for the FORZA XP Expandable Spacer System. However, it does not contain any information about acceptance criteria or a study proving the device meets performance criteria, especially regarding AI/algorithm performance.
The document explicitly states:
- "No new mechanical testing was performed for the FORZA XP Expandable Spacer System because there were no design changes to the device."
- "The proposed sterile package offering does not change the design, materials, function, performance for the FORZA XP implants most recently cleared thru 510(k) K211704."
- "FORZA XP Expandable Spacer System has the same intended use, indications for use, technological characteristics, materials, the same principles of operation and same design as the predicate device FORZA XP Expandable Spacer System (K211704)."
This 510(k) submission is a "Product Line Extension" for a physical medical device (an expandable spinal spacer), primarily addressing a sterile packaging configuration change from a previously cleared device (K211704). It does not involve any AI/algorithm component.
Therefore, I cannot fulfill your request for information about acceptance criteria or a study related to AI/algorithm performance, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment for AI, as this information is not present in the provided document.
If you have a document describing an AI/algorithm-based device, please provide that document, and I would be happy to describe the acceptance criteria and study as requested.
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January 5, 2022
Orthofix US LLC Natalia Volosen Regulatory Affairs Program Manager 3451 Plano Parkway Lewisville, Texas 75056
Re: K213951
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 16, 2021 Received: December 17, 2021
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. 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 located 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.
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
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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) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; 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 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, 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
Enclosure
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Indications for Use
510(k) Number (if known) K213951
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.
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) |
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510(k) Summary
Device Trade Name: FORZA XP Expandable Spacer System
| Manufacturer: | Orthofix US LLC3451 Plano ParkwayLewisville, TX 75056, USAPhone: (214) 937-2145Fax: (214) 937-3322 |
|---|---|
| Contact Person: | Ms. Natalia VolosenRegulatory Affairs Program Managernataliavolosen@orthofix.com |
| Date Prepared: | December 16, 2021 |
| Registration Number: | 2183449 |
| Product Code: | MAX |
| Classifications: | Class II - 21 CFR §888.3080, Intervertebral body fusion device |
| Primary Predicate: | K211704 – FORZA XP Spacer System, SE 8/31/2021 |
Reason for the 510(k) Submission: Product Line Extension
Device Description:
The FORZA XP Expandable Spacer System is comprised of an assortment of single use spacers made from titanium alloy and PEEK Polymer with height expansion capability. The implants feature a bulleted nose for ease of insertion and anti-migration ripples on both the inferior and superior surfaces to provide increased stability and help prevent anterior/posterior movement of the device.
The implants are offered in non-lordotic, lordotic, and hyperlordotic configurations to help restore the natural curvature of the spine. The implants can be used in single placement or pairs with typical approaches being transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF).
The FORZA XP Expandable Spacer System is not intended to be used as a stand-alone device and must be used with a supplemental fixation system.
Indications for Use and Intended Use:
FORZA XP Expandable 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 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surqery at the involved level(s).
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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.
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.
Performance Testing Summary:
No new mechanical testing was performed for the FORZA XP Expandable Spacer System because there were no design changes to the device.
The proposed sterile package offering does not change the design, materials, function, performance for the FORZA XP implants most recently cleared thru 510(k) K211704. FORZA XP sterile packaging confiquration use Orthofix standard sterile packaging confiquration recently cleared thru FORZA Ti Spacer System (K211704).
Substantial Equivalence:
The proposed sterile package offering does not change the design, materials, function, performance, indications for use of the device; does not alter the intended use of the implants therefore the subject FORZA XP Expandable sterile packaged devices is substantially equivalent to the FORZA XP Expandable Spacer System (K211704) predicate device
Conclusion:
FORZA XP Expandable Spacer System has the same intended use, indications for use, technological characteristics, materials, the same principles of operation and same design as the predicate device FORZA XP Expandable Spacer System (K211704).
§ 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.