# K223153: Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Dec 16, 2022 after 71 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 30 generations back to K841189 (1984). 602 ancestors in all.
No later device cites it as a predicate yet.
1 of 603 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212653: Catalyft LS Expandable Interbody System, Medtronic Sofamor Danek USA, Inc. (2021) Summary page 4.
- K214010: Anteralign Spinal System with Titan nanoLOCK Surface Technology, Medtronic Sofamor Danek USA (2022) Summary page 4.
- K094025: Crescent Spinal System, Medtronic Sofamor Danek (2010) Summary page 4.
- K133216: Crescent Spinal System, Medtronic Sofamor Danek, Inc. (2013) Summary page 4.
- K171031: CRESCENT™ Spinal System, Medtronic Sofamor Danek (2017) Summary page 4.
- K100175: Clydesdale Spinal System, Medtronic Sofamor Danek (2010) Summary page 4.
- K132897: Clydesdale Spinal System, Medtronic Sofamor Danek, Inc. (2013) Summary page 5.
- K133577: Clydesdale (R) Spinal System, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 5.
- K142559: ELEVATE Spinal System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 5.

## Indications for use
The Catalyft™ LS Expandable Interbody System device, including those with or without micro- and nano-roughened surface textured features, is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD - defined by discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the Catalyft™ LS Expandable Interbody System can be used with patients diagnosed with multilevel degenerative scoliosis and sagittal deformities as an adjunct to fusion. When used in patients as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity conditions, additional supplemental fixation (e.g. posterior fixation) must be used. These patients should be skeletally mature and have undergone 6 months of non-operative treatment prior to surgery. Implants are used to facilitate fusion in the lumbar spine using autogenous bone graft and/or allograft bone graft comprised of cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate. These implants may be implanted via a variety of open or minimally invasive anterior or oblique approach. The Catalyft™ LS Expandable Interbody System device may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the Catalyft™ LS Expandable Interbody System device is intended to be used with 4 titanium alloy screws. If the physician chooses to use less than 4 or none of the provided screws, additional supplemental fixation in the lumbar spine must be used to augment stability. Implants with lordosis angles greater than 20° are intended to be used with 4 screws and supplemental fixation.

Source page: https://510kreport.com/device/K223153
Methodology: https://510kreport.com/methodology