(28 days)
The CastleLoc-S Posterior Cervical Fixation System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fosion 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 CastleLoc-S 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 CastleLoc-S Posterior Cervical Fixation System can be linked to the LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System and AccelFix Spinal Fixation System via rod to rod connector and transitional rod.
The CastleLoc-S Posterior Cervical Fixation System is a top-loading, multiple components, posterior (cervical-thoracic) spinal fixation system which consists of poly screw, Reduction poly screw, partially screw, semi-reduction partially screw, straight 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.
This document is a 510(k) Premarket Notification from L&K Biomed Co., Ltd. for their CastleLoc-S Posterior Cervical Fixation System. It asserts substantial equivalence to previously cleared predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria or provide new device performance data. Instead, it relies on the assertion of identicality and substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable because the device is stated to be identical to already cleared devices that met the necessary performance standards.
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Not explicitly stated (relies on substantial equivalence to predicates) | "The CastleLoc-S Posterior Cervical Fixation System is identical to the predicates; mechanical testing is not required to establish substantial equivalence." |
2. Sample Size Used for the Test Set and Data Provenance:
No new test set was used for this submission to establish substantial equivalence based on performance. The document states: "The CastleLoc-S Posterior Cervical Fixation System is 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." However, this testing was performed on predicate devices, and the data from those previous clearances (K103414, K120879, K143278, K162136, K200793) was leveraged.
Therefore, there is no distinct "test set" and no new data provenance for the CastleLoc-S system's performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable. No new studies requiring expert-established ground truth were performed for this submission, as the device's performance is asserted through substantial equivalence to predicate devices.
4. Adjudication Method for the Test Set:
Not applicable. No new studies requiring adjudication were performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done. This type of study is typically associated with AI/software devices and would measure the improvement of human readers with AI assistance. The CastleLoc-S system is a physical medical device (spinal fixation system), not an AI diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study:
Not applicable. The CastleLoc-S system is a physical medical device, not an algorithm or software.
7. Type of Ground Truth Used:
Not applicable, as no new performance studies for the CastleLoc-S system were conducted for this submission. The "ground truth" for the predicate devices' performance would have been established through mechanical testing standards (e.g., ASTM F1717 for static compression bending and static torsion) which define acceptable physical properties and performance characteristics for spinal fixation systems.
8. Sample Size for the Training Set:
Not applicable. The CastleLoc-S system is a physical medical device. It does not employ a "training set" in the context of machine learning or AI models.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As above, there is no "training set" for this physical device.
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are 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.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.