FDA releases draft guidance for non-spinal orthopedic bone fixation devices

The US Food and Drug Administration (FDA) has released a new draft guidance outlining what information should be included in premarket submissions for orthopedic non-spinal bone plates, screws, and washers.

The draft guidance is intended to clarify information in 510(k) submissions for class II orthopedic non-spinal, non-resorbable medical devices, including bone plates, screw systems, standalone bone screws, and washers for bone fixation. The agency’s goal with the draft guidance is “to facilitate consistency in information provided in submissions by addressing common deficiencies related to device description and performance testing and by identifying applicable cross-cutting guidances and consensus standards.”

Recommendations in the draft guidance for premarket submission of these devices address indications for use, device description, predicate comparison, labeling, sterility, reprocessing, pyrogenicity, shelf life and packaging, biocompatibility, magnetic resonance compatibility for passive implants, and non-clinical testing. The draft guidance also contains a section on modifications to devices that may warrant a new 510(k) submission.

Medical devices that fall within the scope of the guidance include those made with titanium alloy, commercially pure titanium, stainless steel, cobalt-chrome alloy, polyetheretherketone, and chopped carbon fiber reinforced. What is not included within the scope of the draft guidance are devices with nitinol, that are coated or resorbable, have surface modification, incorporate antimicrobial agents, have complex geometries, differing granularities, unique geometric features, involvement in unconventional surgical techniques, that are additively manufactured, or have "other unique technological characteristics." If a device is on the list of non-qualifying device types, industry should submit a pre-submission for FDA’s feedback, the guidance noted.

“For each subject device, the intended use(s)/indications(s) should be stated, and a comparison of the intended use/indications for use to one or more legally marketed predicate device(s) should be included in your submission,” the agency wrote.

For intended use or indications of orthopedic medical devices in 510(k) submissions, FDA recommended avoiding vague language and clarifying appropriate device use when possible. Submissions for devices intended for use in osteopenic bone should have a comparison to a similar device in the same anatomical area for a similar indication, while devices intended for osteoporotic bone may require additional information on simulated implant use to be considered for an indication.

Devices should be identified using regulation numbers contained within the guidance, and the agency recommended including pictures for bone plates and screws in the submission and engineering pictures for all devices. Some devices are special cases and require additional information, such as devices that use polyetheretherketone.

510(k) submissions for these medical devices should also contain a comparison to a similar predicate device, and whether any similarities and differences could potentially impact safety and effectiveness. Labeling of the device should satisfy requirements from 21 CFR part 801 while also including information on device description and use, contraindications, warnings, magnetic resonance safety information, cleaning and sterilization instructions, and removal instructions.

“For devices provided sterile, you should provide a description of the packaging, including how it will maintain the device’s sterility, a description of the package integrity test methods, but not the package integrity test data,” FDA wrote. “We recommend that package integrity test methods include simulated distribution and associated package integrity testing, as well as simulated (and/or real time) aging and associated seal strength testing, to validate package integrity and shelf life claims.”

The agency also recommends including biocompatibility information in the submission, but noted that submissions can contain previous testing experience or data from the literature if the finalized finished device “is identical in chemical composition, manufacturing, and processing methods, and any differences in geometry or surface properties are not expected to adversely impact the biological response compared to a legally marketed bone plate(s), screw(s), washer(s), or instrument(s) with a history of successful use.”

Concerning the magnetic resonance compatibility of these devices, FDA recommends consulting the safety and compatibility information in its guidance on testing and labeling medical devices for safety for magnetic resonance environments.

Non-clinical testing information in the 510(k) submission should “demonstrate that the subject device provides substantially equivalent fixation of a fracture site” and devices that can be implanted in multiple anatomic locations, mechanical performance data may be needed for more than one worst-case device.

Comments on the draft guidance can be submitted to regulations.gov and labeled as Docket FDA-2023-D-0488. The public comment period closes on 30 May 2023.

Draft guidance

FDA releases draft guidance for non-spinal orthopedic bone fixation devices

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