(80 days)
Not Found
No
The document describes mechanical spinal implants and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
No.
All devices mentioned (ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, and Spinema Lumbar Plate System) are surgical implants intended to provide stabilization and immobilization of spinal segments or the sacroiliac joint, typically as an adjunct to fusion. They are structural devices, not devices that deliver therapy or provide a therapeutic effect in themselves.
No
These devices are intended for surgical fixation and fusion of spinal segments, and for sacroiliac joint fusion. They are implantable devices used to treat existing conditions, not to diagnose them.
No
The device description explicitly details physical implants made of titanium alloy and cobalt chromium, such as bone screws, rods, plates, and hooks, intended for surgical implantation. There is no mention of any software component.
Based on the provided text, none of the described devices are IVDs (In Vitro Diagnostics).
Here's why:
- IVDs are used to examine specimens from the human body. The text describes surgical implants (screws, plates, rods, etc.) that are directly implanted into the patient's body to provide structural support and aid in fusion.
- The intended use of these devices is for surgical fixation and stabilization of the spine and sacroiliac joint. This is a therapeutic intervention, not a diagnostic test performed on a sample outside the body.
- The device descriptions focus on the materials and physical characteristics of the implants. There is no mention of reagents, assays, or any components used for analyzing biological samples.
Therefore, these devices fall under the category of medical devices (specifically, orthopedic implants), but they are not IVDs.
N/A
Intended Use / Indications for Use
The ZESPIN SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The Paeon Posterior Cervical Fixation System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine (TI-T3): traumatic spinal fractures and or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Paeon Posterior Cervical Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
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 Spinema 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 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 spinal stenosis, or a failed previous spine surgery.
Product codes (comma separated list FDA assigned to the subject device)
OUR, NKG, KWP, KWQ
Device Description
The ZESPIN SI Joint Fusion System consists of different diameter bone screws in various lengths and thread configurations to accommodate variations in patient anatomy. The devices are manufactured from titanium alloy per ASTM F136.
- Arch Screw will be implanted in patient's bone then autograft will be inserted.
- Locking Screw can be used with washer or can be used on its own
- Self-tapping flute centers screw for easy insertion.
Posterior Cervical Fixation System is a top-loading, multiple components, The Paeon posterior (cervical-thoracic) spinal fixation system which consists of polyscrew, Reduction poly screw, partially screw, semi-reduction partially screw, straight rod, curved rod, set screw, hooks and accessories that can be used via an open surgical approach. The devices are manufactured from titanium alloy per ASTM F136 and cobalt chromium per ASTM F1537.
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, fourlevel 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 Spinema 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 Spinema 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Sacroiliac joint, cervical spine (C1 to C7), thoracic spine (T1-T3), 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)
The ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, and Spinema Lumbar Plate System are identical to the predicates; mechanical testing is not required to establish substantial equivalence.
A risk assessment, including ASTM F1717 testing for static compression bending and static torsion mechanical testing, was conducted to confirm that the additional components do not introduce new issues of safety or effectiveness. The additional components to be added through this submission do not require additional mechanical testing. None of the additional sizes is the worst case of the Paeon Posterior Cervical Fixation System. Therefore, we substitute mechanical test data of additional components of Paeon Posterior Cervical Fixation System with the predicate device (K210035).
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.
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left 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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 30, 2022
Aegis Spine, Inc. Kihyang Kim Regulatory Affairs 9781 South Meridian Boulevard, Suite 300 Englewood, Colorado 80112
Re: K221050
Trade/Device Name: ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: OUR, NKG, KWP, KWQ Dated: May 30, 2022 Received: June 13, 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.
1
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 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 medical devices and radiation-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.
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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K221050
Device Name
ZESPIN SI Joint Fusion System
Indications for Use (Describe)
The ZESPIN SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
| 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) |
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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K221050
Device Name
Paeon Posterior Cervical Fixation System
Indications for Use (Describe)
The Paeon Posterior Cervical Fixation System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine (TI-T3): traumatic spinal fractures and or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Paeon Posterior Cervical Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
| 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) |
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
4
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K221050
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 (Per 31 CFR 330.5) - Primary Residence |
|---|
| Secondary Use (Per 31 CFR 330.6) - Secondary Residence |
|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
5
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name
Spinema Lumbar Plate System
Indications for Use (Describe)
The Spinema 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 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 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
6
Image /page/6/Picture/0 description: The image shows the text "K221050 Page 1 of 4" at the top. Below the text is a logo with a blue circle and a white arrow pointing upwards. Underneath the logo, the text "AEGIS" is written in a stylized font.
510(k) SUMMARY
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):
1. Manufacturer
| 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 |
2. Device Identification
| Device Trade Name | ZESPIN SI Joint Fusion System |
|---|---|
| Common/Usual Name | Sacroiliac joint fixation, Bone Screw |
| Regulation Class /Number | Class II / 21 CFR 888.3040 |
| Regulation Name | Smooth or threaded metallic bone fixation fastener |
| Product Code | OUR |
| Classification Panel | Spinal Devices (DHT6B) |
| Device Trade Name | Paeon Posterior Cervical Fixation System |
|---|---|
| Common/Usual Name | Spinal Fixation System |
| Regulation Class /Number | Class II / 21 CFR 888.3075 / 21 CFR 888.3050 |
| Regulation Name | Posterior cervical screw system |
| Product Code | NKG, KWP |
| Classification Panel | Spinal Devices (DHT6B) |
| 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 | Spinema Lumbar Plate System |
|---|---|
| Common/Usual Name | Noncervical Spinal Implant |
| Regulation Class /Number | Class II/ 21 CFR 888.3060 |
| Regulation Name | Appliance, Fixation, Spinal Intervertebral Body |
| Product Code | KWQ |
| Classification Panel | Spinal Devices (DHT6B) |
7
Image /page/7/Picture/0 description: The image shows the text 'K221050' and 'Page 2 of 4' at the top. Below the text is a logo with a blue circle and a white triangle inside. Underneath the circle is the word 'AEGIS' in a stylized font.
3. Predicate or legally marketed devices which are substantially equivalent.
| 510k Number | Trade or Proprietary or Model Name | Predicate Type |
|---|---|---|
| K210035 | ZESPIN SI Joint Fusion System, | |
| MegaCerfix Posterior Cervical Fixation System, | ||
| MegaCerfix Anterior Cervical Plate System, | ||
| Spinema Lumbar Plate System. | Primary | |
| K200793 | CastleLoc-S & LnK Posterior Cervical System | Additional |
The subject devices are identical to the predicate devices in all characteristics
The design feature, indications for use and manufacturing process for the subject devices are substantially equivalent to the predicate devices.
4. Materials
| ZESPIN SI Joint Fusion System | Ti-6Al-4V ELI titanium alloy (ASTM F136) |
|---|---|
| Paeon Posterior Cervical Fixation System | Ti-6Al-4V ELI titanium alloy (ASTM F136) and |
| Cobalt-28Chromium-6Molybdenum-4Vanadium ELI | |
| (ASTM F1537) | |
| Paeon Anterior Cervical Plate System | Ti-6Al-4V ELI titanium alloy (ASTM F136) |
| Spinema Lumbar Plate System | Ti-6Al-4V ELI titanium alloy (ASTM F136) |
And the additional Paeon Posterior Cervical Fixation System are manufactured from Ti-6A1-4V ELI titanium alloy (ASTM F136) and Cobalt-28Chromium-6Molybdenum-4Vanadium ELI (ASTM F1537). This this is the same material used in the predicate devices (K210035).
ર. Description of the Device
The ZESPIN SI Joint Fusion System consists of different diameter bone screws in various lengths and thread configurations to accommodate variations in patient anatomy. The devices are manufactured from titanium alloy per ASTM F136.
- Arch Screw will be implanted in patient's bone then autograft will be inserted. .
- Locking Screw can be used with washer or can be used on its own ●
- Self-tapping flute centers screw for easy insertion .
Posterior Cervical Fixation System is a top-loading, multiple components, The Paeon posterior (cervical-thoracic) spinal fixation system which consists of polyscrew, Reduction poly screw, partially screw, semi-reduction partially screw, straight rod, curved rod, set screw, hooks and accessories that can be used via an open surgical approach. The devices are manufactured from titanium alloy per ASTM F136 and cobalt chromium per ASTM F1537.
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, fourlevel 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 Spinema 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 Spinema 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
8
Image /page/8/Picture/0 description: The image shows the text "K221050 Page 3 of 4" at the top. Below the text is a blue logo that appears to be a stylized letter A inside of a circle. The bottom of the logo has the text "GEGIS" in a stylized font.
6. INDICATION FOR USE
The ZESPIN SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The Paeon Posterior Cervical Fixation System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy. neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Paeon Posterior Cervical Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage turnors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
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 and stabilization 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 Spinema 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 studies), pseudoarthrosis, spondylolysis, spondylolisthesis, lordotic radiographic deformities of the spine, spinal stenosis, or a failed previous spine surgery.
7. Performance Testing
The ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, and Spinema Lumbar Plate System are identical to the predicates; mechanical testing is not required to establish substantial equivalence.
A risk assessment, including ASTM F1717 testing for static compression bending and static torsion mechanical testing, was conducted to confirm that the additional components do not introduce new issues of safety or effectiveness. The additional components to be added through this submission do not require additional mechanical testing. None of the additional sizes is the worst case of the Paeon Posterior Cervical Fixation System. Therefore, we substitute mechanical test data of additional components of Paeon Posterior Cervical Fixation System with the predicate device (K210035).
9
Image /page/9/Picture/0 description: The image shows the text 'K221050 Page 4 of 4' at the top. Below the text is a logo that features a stylized letter 'A' inside a circle. Underneath the logo, the word 'AEGIS' is written in a stylized font.
Summary of Technology Characteristics 8.
Subject devices are identical to the predicate devices in all characteristics with the exception of the additional size offering (that are not worst-case) described above.
9. Substantial Equivalence
Subject devices are shown to be substantially equivalent to the predicate devices in indications for use, design, same manufacturing process, function and materials used.
10. Conclusion
The overall technology characteristics lead to the conclusion that the ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, and Spinema Lumbar Plate System is substantially equivalent to the predicate devices.