(30 days)
K 221050, K 210035, K 143271, K 190425, K 142699, K 143626
Not Found
No
The device description and intended use clearly describe a mechanical implant system for spinal fixation, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as an adjunct to fusions for immobilization of the spine in patients with various conditions such as degenerative disc disease, trauma, tumors, and deformities, which directly addresses medical conditions.
No
The device description clearly states that these are plate systems (plates, screws, and lockers) intended for fixation and immobilization of the spine as an adjunct to fusions. This is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is composed of plates, screws, and lockers made from titanium alloy, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the Paeon Anterior Cervical Plate System and the Elatus Lumbar Plate System are composed of plates, screws, and lockers made from titanium alloy. These are physical implants intended for surgical fixation of the spine.
- Intended Use: The intended use is for anterior screw fixation to the cervical and lumbar/lumbosacral spine as an adjunct to fusions. This is a surgical procedure, not a diagnostic test performed on a sample.
The device is a surgical implant used to stabilize the spine, not a test to diagnose a condition using a biological sample.
N/A
Intended Use / Indications for Use
The Paeon Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization of the spine as an adjunct to fusions in patients with:
- · degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
- · spondylolisthesis.
- · trauma (i.e. fractures or dislocations),
- tumors,
- · deformity (defined as kyphosis, lordosis, or scoliosis),
- · pseudoarthrosis,
- · failed previous fusion,
- · spinal stenosis.
The Elatus Lumbar Plate System is indicated for use via the anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an aqunct to fusion. This system is indicated in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, scoliosis, spondylolisthesis, lordotic deformities of the spinal stenosis, or a failed previous spine surgery.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Paeon Anterior Cervical Plate System is composed of plates, screws and lockers which are made from titanium alloy per ASTM F136. These plates attach to the anterior cervical spine with a minimum of four screws per plate. The plates are offered in one-level, three-level, four-level fusion configurations (19~97mm). The plate screws are 3.5mm and 4.0mm diameter head screws. They are self-tapping and self-drilling threaded. This device can be provided both as non-sterile and sterile.
The Elatus Lumbar Plate System's implants are Lumbar Plate System intended for use as an aid in spinal fixation. They are made from titanium alloy per ASTM F136. The Elatus Lumbar Plate System consists of a variety of shapes and sizes of plates and screws. The plate has been designed to include spikes for added stability and alignment during screw insertion. The plates feature a curvature for anatomic fit. The diameter of screw is available from 5.5 to 6.0 mm and the length from 20 to 55 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C2-C7), Lumbar and lumbosacral (L1-S1) spine
Indicated Patient Age Range
Not Found
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)
Paeon Anterior Cervical Plate System: The additional components added in this submission do not require additional mechanical testing. None of the additional components is the worst case of the Paeon Anterior Cervical Plate System.
Elatus Lumbar Plate System: The additional components added in this submission do not require additional mechanical testing. None of the additional components is the worst case of the Elatus Lumbar Plate System.
Therefore, we substitute mechanical test data of Paeon Anterior Cervical Plate System and Elatus Lumbar Plate System for additional components with the predicate device data (K210035/K221050).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K 221050, K 210035, K 143271, K 190425, K 142699, K 143626
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
January 11, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Aegis Spine, Inc. Kihyang Kim RA 9781 S. Meridian Blvd. Ste 300 Englewood, Colorado 80112
Re: K223719
Trade/Device Name: Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: December 9, 2022 Received: December 12, 2022
Dear Kihyang Kim:
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 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
1
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,
Anne D. Talley -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
2
Indications for Use
510(k) Number (if known) K223719
Device Name
Paeon Anterior Cervical Plate System
Indications for Use (Describe)
The Paeon Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization of the spine as an adjunct to fusions in patients with:
- · degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
- · spondylolisthesis.
- · trauma (i.e. fractures or dislocations),
- tumors,
- · deformity (defined as kyphosis, lordosis, or scoliosis),
- · pseudoarthrosis,
- · failed previous fusion,
- · spinal stenosis.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Residential Use (24 CFR 982 Subpart M)
Day Care Operation (24 CFR 982 Subpart G)
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K223719
Device Name
Elatus Lumbar Plate System
Indications for Use (Describe)
The Elatus Lumbar Plate System is indicated for use via the anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an aqunct to fusion. This system is indicated in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, scoliosis, spondylolisthesis, lordotic deformities of the spinal stenosis, or a failed previous spine surgery.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
4
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510(k) SUMMARY
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):
1.
| Submitter's Name: | Aegis Spine, INC. |
|---|---|
| Submitter's Address: | 9781 S. Meridian Blvd, Ste 300 |
| Englewood, CO 80112 | |
| Submitter's Telephone: | +1.303.741.4123 |
| Contact Person: | Kihyang Kim |
| +1.303.741.4123 | |
| khkim@aegisspine.com khkim3747@gmail.com | |
| Date Prepared: | January 10, 2023 |
DEVICE IDENTIFICATION 2.
| Device Trade Name | Paeon Anterior Cervical Plate System |
|---|---|
| Common/Usual Name | Appliance, Fixation, Spinal Intervertebral Body |
| Regulation Class /Number | Class II / 21 CFR 888.3060 |
| Regulation Name | Spinal Intervertebral Body Fixation Orthosis |
| Product Code | KWQ |
| Classification Panel | Spinal Devices (DHT6B) |
| Device Trade Name | Elatus Lumbar Plate System |
|---|---|
| Common/Usual Name | Lumbar Spinal Plate |
| Regulation Class /Number | Class II/ 21 CFR 888.3060 |
| Regulation Name | Spinal Intervertebral Body Fixation Orthosis |
| Product Code | KWQ |
| Classification Panel | Spinal Devices (DHT6B) |
3. PREDICATE OR LEGALLY MARKETED DEVICES WHICH ARE SUBSTANTIALLY EQUIVALENT.
The subject devices are identical to the predicate devices in all characteristics.
| Subject Device Name | 510K NO. | Trade or Proprietary or Model Name | Predicate Type |
|---|---|---|---|
| PAEON Anterior | |||
| Cervical Plate System | K 221050 | Paeon Anterior Cervical Plate System, | |
| Spinema Lumbar Plate System. | Primary | ||
| K 210035 | Paeon Anterior Cervical Plate System, | ||
| Spinema Lumbar Plate System. | Additional | ||
| K 143271 | CastleLoc Anterior Plate System | Additional | |
| K 190425 | |||
| Elatus Lumbar Plate | |||
| System | K 221050 | Paeon Anterior Cervical Plate System, | |
| Spinema Lumbar Plate System. | Primary | ||
| K 210035 | Paeon Anterior Cervical Plate System, | ||
| Spinema Lumbar Plate System. | Additional | ||
| K 142699 | LITe Plate System | Additional | |
| K 143626 | Trinica® Anterior Lumbar Plate System | Additional |
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The design feature, indications for use and manufacturing process for the subject devices are substantially equivalent to the predicate devices.
4. MATERIALS
| Paeon Anterior Cervical Plate System | Ti-6Al-4V ELI titanium alloy (ASTM F136) |
|---|---|
| Elatus Lumbar Plate System | Ti-6Al-4V ELI titanium alloy (ASTM F136) |
And the additional components material is the same material used in the predicate devices (K 210035 K 221050).
న్. DESCRIPTION OF THE DEVICE
The Paeon Anterior Cervical Plate System is composed of plates, screws and lockers which are made from titanium alloy per ASTM F136. These plates attach to the anterior cervical spine with a minimum of four screws per plate. The plates are offered in one-level, three-level, four-level fusion configurations (19~97mm). The plate screws are 3.5mm and 4.0mm diameter head screws. They are self-tapping and self-drilling threaded. This device can be provided both as non-sterile and sterile.
The Elatus Lumbar Plate System's implants are Lumbar Plate System intended for use as an aid in spinal fixation. They are made from titanium alloy per ASTM F136. The Elatus Lumbar Plate System consists of a variety of shapes and sizes of plates and screws. The plate has been designed to include spikes for added stability and alignment during screw insertion. The plates feature a curvature for anatomic fit. The diameter of screw is available from 5.5 to 6.0 mm and the length from 20 to 55 mm.
6. INDICATION FOR USE
The Paeon Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization of the spine as an adjunct to fusions in patients with:
- degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
- . spondylolisthesis,
- . trauma (i.e., fractures or dislocations),
- . tumors.
- . deformity (defined as kyphosis, lordosis, or scoliosis),
- . pseudoarthrosis,
- . failed previous fusion,
- spinal stenosis.
The Elatus Lumbar Plate System is indicated for use via the anterior, lateral, or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an adjunct to fusion. This system is indicated in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, scoliosis, spondylolisthesis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.
7. PERFORMANCE TESTING
Paeon Anterior Cervical Plate System
The additional components added in this submission do not require additional mechanical testing. None of the additional components is the worst case of the Paeon Anterior Cervical Plate System.
6
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Elatus Lumbar Plate System
The additional components added in this submission do not require additional mechanical testing. None of the additional components is the worst case of the Elatus Lumbar Plate System.
Therefore, we substitute mechanical test data of Paeon Anterior Cervical Plate System and Elatus Lumbar Plate System for additional components with the predicate device data (K210035/K221050).
8. SUMMARY OF TECHNOLOGY CHARACTERISTICS
Subject devices are identical to the predicate devices in all (design feature, indications for use, surgical approach and manufacturing process) characteristics.
9. SUBSTANTIAL EQUIVALENCE
Subject devices are shown to be substantially equivalent to the predicate devices in indications for use, design, function, and materials used.
10. CONCLUSION
The overall technology characteristics lead to the conclusion that the Paeon Anterior Cervical Plate System, and Elatus Lumbar Plate System is substantially equivalent to the predicate devices (K210035/K221050).