(138 days)
The FIREFLY® Pedicle Screw Navigation Guide can be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its cleared indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures (T1-S2/S2AI and ilium) intended for fusion, with the additional conditions listed below:
• Pedicle screw's shank is straight along its longitudinal axis (i.e. not curved)
• Pedicle screw's major and minor thread diameters are centered about the longitudinal axis
• Pedicle screw's longitudinal axis matches the direction of insertion
• Pedicle screw is intended to be inserted into a pilot hole
• Pedicle screw's diameter is larger than the pilot hole created with FIREFLY®
• Patient's pedicle must be dimensionally adequate to accommodate a pedicle screw, as determined on preoperative scan
• Compatible pedicle screw spinal system instruments may be used with the FIREFLY® Pedicle Screw Navigation Guide
- Pedicle sounding probes (a.k.a. feeler/ball-tip probes) may be used to confirm pedicle integrity
- Only OEM pedicle screw spinal system taps specified in the Approved Patient-Specific Surgical Plan may be guided to tap pilot holes
- All other pedicle screw spinal system components and accessories (including non-guided taps) are to be used, after removal of the FIREFLY® Pedicle Screw Navigation Guide, as directed by the pedicle screw spinal system's instructions for use
This device is intended for single use only.
The FIREFLY® Pedicle Screw Navigation Guide is intended to assist in the accurate placement of pedicle screws. It consists of single-use components designed for treatment of a specific patient as well as reusable non-patient-specific components.
The FIREFLY® Pedicle Screw Navigation Guide uses Patient-Specific Pedicle Screw Guides that fit on the patient's anatomy to guide surgical instruments in line with trajectories chosen presurgically, by the surgeon, based on the patient's CT imaging or MRI-Derived Synthetic CT data. Patient-Specific Bone Models may also be provided.
N/A
FDA 510(k) Clearance Letter - FIREFLY® Pedicle Screw Navigation Guide
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.04
February 25, 2026
Mighty Oak Medical
Mark Wylie
VP Quality and Regulatory
750 W. Hampden Avenue, Suite 120
Englewood, Colorado 80110
Re: K253472
Trade/Device Name: FIREFLY® Pedicle Screw Navigation Guide
Regulation Number: 21 CFR 888.3070
Regulation Name: Thoracolumbosacral Pedicle Screw System
Regulatory Class: Class II
Product Code: PQC
Dated: October 6, 2025
Received: October 10, 2025
Dear Mark Wylie:
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"
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K253472 - Mark Wylie Page 2
(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).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and 21 CFR 820.70) and document changes and approvals in the Medical Device File (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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
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K253472 - Mark Wylie Page 3
Sincerely,
EILEEN CADEL -S
for
Colin O'Neill, M.B.E.
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
Page 4
Indications for Use
Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.
Please provide the device trade name(s).
FIREFLY® Pedicle Screw Navigation Guide
Please provide your Indications for Use below.
The FIREFLY® Pedicle Screw Navigation Guide can be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its cleared indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures (T1-S2/S2AI and ilium) intended for fusion, with the additional conditions listed below:
• Pedicle screw's shank is straight along its longitudinal axis (i.e. not curved)
• Pedicle screw's major and minor thread diameters are centered about the longitudinal axis
• Pedicle screw's longitudinal axis matches the direction of insertion
• Pedicle screw is intended to be inserted into a pilot hole
• Pedicle screw's diameter is larger than the pilot hole created with FIREFLY®
• Patient's pedicle must be dimensionally adequate to accommodate a pedicle screw, as determined on preoperative scan
• Compatible pedicle screw spinal system instruments may be used with the FIREFLY® Pedicle Screw Navigation Guide
- Pedicle sounding probes (a.k.a. feeler/ball-tip probes) may be used to confirm pedicle integrity
- Only OEM pedicle screw spinal system taps specified in the Approved Patient-Specific Surgical Plan may be guided to tap pilot holes
- All other pedicle screw spinal system components and accessories (including non-guided taps) are to be used, after removal of the FIREFLY® Pedicle Screw Navigation Guide, as directed by the pedicle screw spinal system's instructions for use
This device is intended for single use only.
Please select the types of uses (select one or both, as applicable).
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
Page 1 of 1
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510(K) SUMMARY
FIREFLY® Pedicle Screw Navigation Guide
Submitter:
Mighty Oak Medical
750 W. Hampden Ave., Suite 120
Englewood, CO 80110
(720) 398-9703
Contact: Mark A. Wylie, VP of Quality and Regulatory
Date Prepared: 06OCT2025
Device
Trade Name: FIREFLY® Pedicle Screw Navigation Guide
Common Name: Pedicle Screw Placement Guide
Device Classification: Class II
Regulation, Name: 21 CFR 888.3070, Thoracolumbosacral pedicle screw system
Device Product Code: PQC
Type of 510(k)
Original Submission: Traditional.
Predicate Device(s):
| 510(k) | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| Primary Predicate Device | |||
| K181399 | PQC | FIREFLY® Pedicle Screw Navigation Guide | Mighty Oak Medical |
Introduction
This 510(k) filing seeks to expand the FIREFLY® indications for use with MRI-derived synthetic CT scans as an input. The FIREFLY® design is the same as was originally cleared in K143222, K162419, and K181399.
The FIREFLY® Pedicle Screw Navigation Guide uses Patient-Specific Pedicle Screw Guides that fit on the patient's anatomy to guide surgical instruments in line with trajectories chosen presurgically, by the surgeon, based on the patient's CT imaging or MRI-Derived Synthetic CT data.
K253472 - Page 1 of 5
Page 6
Description
The FIREFLY® Pedicle Screw Navigation Guide is intended to assist in the accurate placement of pedicle screws. It consists of single-use components designed for treatment of a specific patient as well as reusable non-patient-specific components.
The FIREFLY® Pedicle Screw Navigation Guide uses Patient-Specific Pedicle Screw Guides that fit on the patient's anatomy to guide surgical instruments in line with trajectories chosen presurgically, by the surgeon, based on the patient's CT or MRI-Derived Synthetic CT imaging data. Navigation guides are intended to guide instruments to create pilot holes in the pedicles for placing pedicle screws following the Approved Patient-Specific Surgical Plan.
Patient-Specific Bone Models may also be provided.
Indications for Use
The FIREFLY® Pedicle Screw Navigation Guide can be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its cleared indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures (T1-S2/S2AI and ilium) intended for fusion, with the additional conditions listed below:
- Pedicle screw's shank is straight along its longitudinal axis (i.e. not curved)
- Pedicle screw's major and minor thread diameters are centered about the longitudinal axis
- Pedicle screw's longitudinal axis matches the direction of insertion
- Pedicle screw is intended to be inserted into a pilot hole
- Pedicle screw's diameter is larger than the pilot hole created with FIREFLY®
- Patient's pedicle must be dimensionally adequate to accommodate a pedicle screw, as determined on preoperative scan
- Compatible pedicle screw spinal system instruments may be used with the FIREFLY® Pedicle Screw Navigation Guide
- Pedicle sounding probes (a.k.a. feeler/ball-tip probes) may be used to confirm pedicle integrity
- Only OEM pedicle screw spinal system taps specified in the Approved Patient-Specific Surgical Plan may be guided to tap pilot holes
- All other pedicle screw spinal system components and accessories (including non-guided taps) are to be used, after removal of the FIREFLY® Pedicle Screw Navigation Guide, as directed by the pedicle screw spinal system's instructions for use
This device is intended for single use only.
Materials
The material used to manufacture patient-specific components is an epoxy resin for use in stereolithography systems or polymer powder for use in multi-jet fusion systems. Patient contacting materials used for non-patient-specific components are manufactured in accordance with ASTM F899 or F136.
Performance Data
Quantitative and Qualitative validations were completed to demonstrate that MRI-Derived synthetic CT inputs generate equivalent FIREFLY Pedicle Screw Navigation Guide system components when compared to CT scan inputs, including: Segmentation Output Quantitative Comparison, Presurgical Plan Qualitative Comparison, and MRI-derived sCT Qualification. The results demonstrated that the acceptance criteria were met and that the FIREFLY® Pedicle Screw Navigation Guide's performance is adequate to perform as intended.
K253472 - Page 2 of 5
Page 7
Technological Characteristics
The subject FIREFLY® Pedicle Screw Navigation Guide possesses the same technological characteristics as the predicate device. These include:
- Performance
- Manufacturing process
- Sterilization
- Biocompatible materials
- Basic design
Technological characteristics which are different have been supported with descriptive information and/or performance data. Therefore the fundamental scientific technology of FIREFLY® is the same as the previously cleared device.
Substantial Equivalence Discussion
The table below provides a descriptive comparison of the similarities and differences for the subject and predicate device.
Table 1 - Comparison of Devices
| Device→ Features↓ | FIREFLY Pedicle Screw Navigation Guide (This Submission) | FIREFLY Pedicle Screw Navigation Guide | Equivalency |
|---|---|---|---|
| Premarket notification | K253472 (Current Submission) | K181399 | N/A |
| Manufacturer | Mighty Oak Medical | Mighty Oak Medical | No change |
| Device Description | The FIREFLY® Pedicle Screw Navigation Guide is intended to assist in the accurate placement of pedicle screws. It consists of single-use components designed for treatment of a specific patient as well as reusable non-patient-specific components.The FIREFLY® Pedicle Screw Navigation Guide uses Patient-Specific Pedicle Screw Guides that fit on the patient's anatomy to guide surgical instruments in line with trajectories chosen presurgically, by the surgeon, based on the patient's preoperative imaging data. Navigation guides are intended to guide instruments to create pilot holes in the pedicles for placing pedicle screws following the Approved Patient-Specific Surgical Plan.Patient-Specific Bone Models may also be provided. | The FIREFLY® Pedicle Screw Navigation Guide is intended to assist in the accurate placement of pedicle screws. It consists of single-use components designed for treatment of a specific patient as well as reusable non-patient-specific components.The FIREFLY® Pedicle Screw Navigation Guide uses Patient-Specific Pedicle Screw Guides that fit on the patient's anatomy to guide surgical instruments in line with trajectories chosen presurgically, by the surgeon, based on the patient's CT imaging data. Navigation guides are intended to guide instruments to create pilot holes in the pedicles for placing pedicle screws following the Approved Patient-Specific Surgical Plan.Patient-Specific Bone Models may also be provided. | Addition of MRI-Derived Synthetic CT imaging data as an input |
K253472 - Page 3 of 5
Page 8
| Device→ Features↓ | FIREFLY Pedicle Screw Navigation Guide (This Submission) | FIREFLY Pedicle Screw Navigation Guide | Equivalency |
|---|---|---|---|
| Indications for Use Statement | The FIREFLY® Pedicle Screw Navigation Guide can be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its cleared indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures (T1-S2/S2AI and ilium) intended for fusion, with the additional conditions listed below:• Pedicle screw's shank is straight along its longitudinal axis (i.e. not curved)• Pedicle screw's major and minor thread diameters are centered about the longitudinal axis• Pedicle screw's longitudinal axis matches the direction of insertion• Pedicle screw is intended to be inserted into a pilot hole• Pedicle screw's diameter is larger than the pilot hole created with FIREFLY®• Patient's pedicle must be dimensionally adequate to accommodate a pedicle screw, as determined on preoperative scan• Compatible pedicle screw spinal system instruments may be used with the FIREFLY® Pedicle Screw Navigation Guide - Pedicle sounding probes (a.k.a. feeler/ball-tip probes) may be used to confirm pedicle integrity - Only OEM pedicle screw spinal system taps specified in the Approved Patient-Specific Surgical Plan may be guided to tap pilot holes - All other pedicle screw spinal system components and accessories (including non-guided taps) are to be used, after removal of the FIREFLY® Pedicle Screw Navigation Guide, as directed by the pedicle screw spinal system's instructions for useThis device is intended for single use only. | The FIREFLY® Pedicle Screw Navigation Guide can be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its cleared indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures (T1-S2/S2AI and ilium) intended for fusion, with the additional conditions listed below:• Pedicle screw's shank is straight along its longitudinal axis (i.e. not curved)• Pedicle screw's major and minor thread diameters are centered about the longitudinal axis• Pedicle screw's longitudinal axis matches the direction of insertion• Pedicle screw is intended to be inserted into a pilot hole• Pedicle screw's diameter is larger than the pilot hole created with FIREFLY®• Patient's pedicle must be dimensionally adequate to accommodate a pedicle screw, as determined on preoperative scan• Compatible pedicle screw spinal system instruments may be used with the FIREFLY® Pedicle Screw Navigation Guide - Pedicle sounding probes (a.k.a. feeler/ball-tip probes) may be used to confirm pedicle integrity - Only OEM pedicle screw spinal system taps specified in the Approved Patient-Specific Surgical Plan may be guided to tap pilot holes - All other pedicle screw spinal system components and accessories (including non-guided taps) are to be used, after removal of the FIREFLY® Pedicle Screw Navigation Guide, as directed by the pedicle screw spinal system's instructions for useThis device is intended for single use only. | No change |
| General intended use | A pedicle screw placement guide is intended to be used as a surgical instrument to assist in the intra-operative placement of pedicle screws that are used to anchor pedicle screw spinal systems onto the posterior elements of the spine. The device utilizes anatomic landmarks that are identifiable on preoperative imaging scans. | A pedicle screw placement guide is intended to be used as a surgical instrument to assist in the intra-operative placement of pedicle screws that are used to anchor pedicle screw spinal systems onto the posterior elements of the spine. The device utilizes anatomic landmarks that are identifiable on CT imaging scans. | Update imaging scan language to be applicable to CT or MRI-Derived Synthetic CT imaging data |
| Product Classification | Pedicle Screw Placement Guide | Pedicle Screw Placement Guide | No change |
| Regulatory Class | Class II | Class II | No change |
| Product Code | PQC | PQC | No change |
K253472 - Page 4 of 5
Page 9
| Device→ Features↓ | FIREFLY Pedicle Screw Navigation Guide (This Submission) | FIREFLY Pedicle Screw Navigation Guide | Equivalency |
|---|---|---|---|
| Anatomic location | Posterior Spine (T1-S2/S2AI and ilium) | Posterior Spine (T1-S2/S2AI and ilium) | No change |
| Technological characteristics | Assists in placement of any pedicle screws that meet conditions specified in the indications for use.All Guides T1-S2/S2AI and ilium are included and remain unchanged from K181399 as it relates to form, fit and function. | Assists in placement of any pedicle screws that meet conditions specified in the indications for use. | No change |
| Manufacturing process | Additive manufacturing | Additive manufacturing | No change |
| Basic design | Patient-specific surgical guide | Patient-specific surgical guide | No change |
| Contact duration | Limited (< 24 hours) | Limited (< 24 hours) | No change |
| Sterilization | Non-sterile | Non-sterile | No change |
| Method of use | Pedicle preparation for pedicle screw placement | Pedicle preparation for pedicle screw placement | No change |
| Image Acquisition Modality | CT Scan and MRI–Derived synthetic CT Scan | CT Scan | Addition of MRI-Derived Synthetic CT imaging data as an input |
Conclusion
The FIREFLY® Pedicle Screw Navigation Guide possesses the same intended use and technological characteristics as the predicate device. Therefore the FIREFLY® Pedicle Screw Navigation Guide is substantially equivalent for its intended use
K253472 - Page 5 of 5
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.