ES2 SPINAL SYSTEM MODEL 48280XXXX

• K Number: K122845
• Device Name: ES2 SPINAL SYSTEM MODEL 48280XXXX
• Manufacturer: STRYKER SPINE
• Date Cleared: 2012-12-07 ( 81 days)
• Product Code: NKB , KWP , MNH , MNI
• Regulation Number: 888.3070
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: K111478 , K120434 , K092631 , K102235

Intended Use

The ES2TM Spinal System is intended for percutaneous, posterior, non-cervical pedicle and non-pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications:

• Degenerative Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
• Spondylolisthesis.
• Trauma (i.e. fracture or dislocation),
• Spinal stenosis.
• Curvatures (i.e. scoliosis, kyphosis, and/or lordosis),
• Tumor.
• Pseudoarthrosis, and
• Failed previous fusion.

The Titanium and Vitallium® rods from the Stryker Spine RADIUS® Spinal System are also intended to be used with other components of the MANTIS® Spinal System, MANTIS® Redux Spinal Systems and ES27M Spinal System.

To facilitate the placement of pedicle screws using the power technique (corded and cordless), the use of the Stryker Spine Power Adaptor is intended for exclusive use with the Stryker Instruments Hudson Modified Trinkle Reamer and the Stryker Instruments CD3 Cordless Driver 3 and the Stryker Instruments RemB Universal Driver. When the power adaptors are attached, the CD3 Cordless Driver 3 and RemB Universal Driver provide power (corded and cordless) to rotate screwdrivers for the insertion of pedicle screws.

Pedicle screws from select Stryker Spine implant systems may be implanted in the skeletally mature non-cervical spine using powered (corded and cordless) instrumentation. The systems included are the family of Xia Spinal Systems (Xia Stainless Steel, Xia II, Xia Anterior, and Xia Precision), Xia 3 Spinal System, Xia 4.5 Spinal System, Radius Spinal System and MANTIS® Spinal System, MANTIS® Redux Spinal System and the ES2TM Spinal System.

Device Description

This 510(k) is intended to introduce an extension to the existing MANTIS® Redux Spinal System. The proposed line extension pertains to the integration of the retractor blades to the removable Tab portion of screw head. The MANTIS® Redux Spinal System with the integrated blades will also be rebranded as the ES2TM Spinal System. This submission also seeks clearance of the ES2™ Spinal System with the powered accessory instruments cleared through 510(k) submissions K111478 and K120434

AI/ML Overview

This document is a Special 510(k) Premarket Notification for a line extension of the ES2™ Spinal System. It does not contain information about a study proving the device meets acceptance criteria. The document claims substantial equivalence to predicate devices based on material, design, and indications for use, supported by engineering analysis and testing to demonstrate compliance with FDA guidance.

Therefore, many of the requested details, such as specific acceptance criteria, reported device performance, sample sizes for test and training sets, expert qualifications, and ground truth methodologies, are not available in this filing. This type of filing typically focuses on demonstrating equivalence rather than presenting a performance study with acceptance criteria in the way a de novo or PMA application might.

Here's a breakdown of what information can be extracted from the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not available in this document. This 510(k) submission focuses on demonstrating substantial equivalence to predicate devices, not on presenting specific performance metrics against pre-defined acceptance criteria from a clinical or analytical study in the same way a device with novel technology might. The document states: "Engineering analysis and testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 were completed for the systems." This implies that the engineering and testing verified the device met relevant safety and performance standards outlined in that guidance, but the specific criteria and results are not detailed.

2. Sample Size Used for the Test Set and Data Provenance:

• Not available. As above, no performance study with a test set, in the traditional sense, is described. The "engineering analysis and testing" likely involved mechanical and material testing, but details on sample sizes or data provenance are not provided.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not applicable. No ground truth establishment by experts for a test set is described, as there isn't a study involving expert review for performance evaluation in this document.

4. Adjudication Method for the Test Set:

• Not applicable. No adjudication method is mentioned as there is no described test set or expert review process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

• Not applicable. This device is a spinal fixation system, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI is not relevant and was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is a spinal fixation system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable. No ground truth, in the context of diagnostic or interpretive performance, is mentioned. The primary "ground truth" for this type of device's safety and effectiveness relies on adherence to engineering standards and comparison to previously cleared, substantially equivalent devices.

8. The sample size for the training set:

• Not applicable. This device is a spinal fixation system, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable. See point 8.

Regulation Number and Section

§ 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.