K Number
K232996
Date Cleared
2024-09-06

(350 days)

Product Code
Regulation Number
888.3080
Panel
OR
Reference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Iatrical Lumbar Interbody Fusion Systems are indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or cortical cancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems (e.g., pedicle screw/rod systems) cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.

The Iatrical Lumbar Interbody Fusion Systems are intended for use in interbody fusions at the thoracolumbar junction (T12-L1), and are intended for use in the lumbar spine, from L1 to S1, for the treatment of degenerative disc disease (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Iatrical Lumbar Interbody Fusion Systems can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

Device Description

The IatricalLumbar Interbody Fusion Systems are intervertebral body fusion systems used in the spine. The Iatrical Lumbar Interbody Fusion Systems (LLIF, TLIF, and ALIF) are comprised of various sizes and configurations to accommodate individual patient anatomy. They may be implanted bilaterally using an anterior (ALIF) approach, a lateral (LLF) approach, or as a single device employing a transformational (TLIF) approach.

3D printing technology is used in the manufacture of Iatrical Lumbar Interbody Fusion Systems using titanium alloy. The devices have large central graft windows which can be used with autogenous bone graft and/or allogenic bone graft, composed of cancellous, cortical, and/or corticocancellous bone prior to implantation

Iatrical Lumbar Interbody Fusion Systems are available in various heights, footprints, and lordotic angles to suit the individual patient's pathology and anatomical conditions.

Iatrical Lumbar Interbody Fusion Systems are delivered in a sterile condition and can be used without any further preparations. The devices are packaged in accordance with ISO 11607.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Iatrical Interbody Lumbar Fusion Systems." This submission is for a physical medical device (intervertebral body fusion system) and not for an AI/ML powered software or diagnostic device. Therefore, the information requested regarding acceptance criteria, study details, human reader performance, ground truth, and training set is not applicable to this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on indications for use, technological characteristics, and performance data from mechanical testing. The performance data listed (e.g., Static Compression per ASTM F2077) are engineering tests for the physical device, not clinical or algorithmic performance metrics.

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.