(80 days)
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.
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
This document describes the ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, and Spinema Lumbar Plate System. It is a 510(k) summary submitted by Aegis Spine, Inc. to the FDA. The purpose of this submission is to demonstrate substantial equivalence to previously cleared predicate devices.
1. A table of acceptance criteria and the reported device performance:
The document explicitly states that the subject devices are identical to the predicate devices in all characteristics with the exception of additional sizes (which are not worst-case) for the Paeon Posterior Cervical Fixation System. Therefore, the acceptance criteria and performance are inherently tied to the performance of the predicate devices. The primary characteristic assessed for substantial equivalence in this context is mechanical performance and material biocompatibility.
| Acceptance Criteria (Inferred from Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Mechanical Performance: Equivalent or superior to predicate devices (K210035, K200793) in static compression bending and static torsion (specifically for worst-case configurations). | The subject devices are stated to be identical to the predicate devices. A risk assessment, including ASTM F1717 testing for static compression bending and static torsion, was conducted to confirm that additional components (sizes) do not introduce new safety or effectiveness issues. The manufacturer explicitly states, "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)." This implies that the performance of the new sizes is considered acceptable by being within the safety margin established by the worst-case predicate. |
| Material Biocompatibility: Materials used are biocompatible and equivalent to those in predicate devices. | The materials used for all systems (Ti-6Al-4V ELI titanium alloy (ASTM F136) and Cobalt-28Chromium-6Molybdenum-4Vanadium ELI (ASTM F1537) for Paeon Posterior Cervical Fixation System) are explicitly stated to be the same materials used in the predicate devices (K210035). |
| Functional Equivalence: Performs the intended function (e.g., stabilization, fusion adjunct) similarly to predicate devices. | The document states: "The design feature, indications for use and manufacturing process for the subject devices are substantially equivalent to the predicate devices." and "Subject devices are shown to be substantially equivalent to the predicate devices in indications for use, design, same manufacturing process, function and materials used." This implies functional equivalence. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated as a distinct "test set" in the context of clinical or performance data. The evaluation primarily relies on bench testing (ASTM F1717) for mechanical performance and material equivalence, rather than a clinical "test set" of patients. The "sample" in this case refers to the physical devices tested during the validation of the predicate device and the risk assessment of the new components.
- Data Provenance: The mechanical test data "substituted" is from the predicate device (K210035). This suggests that the data originates from previous testing performed for the K210035 submission. The country of origin and whether it was retrospective or prospective is not specified in this document, but it would typically be from mechanical engineering bench testing conducted under controlled laboratory conditions, likely in the country of manufacture or a certified testing facility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable (N/A) for this type of 510(k) submission. The evaluation focuses on bench testing and material equivalence to a predicate device, not on clinical ground truth established by medical experts for a diagnostic or AI-assisted device.
4. Adjudication method for the test set:
- This information is not applicable (N/A). Adjudication methods like 2+1 or 3+1 refer to clinical consensus for ground truth establishment, which is not relevant for this engineering-focused substantial equivalence claim.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This information is not applicable (N/A). This submission is for mechanical spinal implants, not an AI-assisted diagnostic device. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was performed.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- This information is not applicable (N/A). As mentioned, this is for mechanical implants, not an algorithm or AI device.
7. The type of ground truth used:
- The "ground truth" in this context is established through laboratory bench testing standards (e.g., ASTM F1717) for mechanical properties, and industry standards for material specifications (e.g., ASTM F136, ASTM F1537) to ensure safety and performance. The comparison is made against the established performance of the legally marketed predicate devices.
8. The sample size for the training set:
- This information is not applicable (N/A). This submission does not involve machine learning or AI models, so there is no concept of a "training set."
9. How the ground truth for the training set was established:
- This information is not applicable (N/A). As there is no training set, there is no ground truth established for it in this context.
§ 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.