# K212653: Catalyft LS Expandable Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Nov 19, 2021 after 88 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K841189 (1984). 276 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 279 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172328: SOVEREIGN™ Spinal System, Medtronic Sofamor Danek USA, Inc. (2017) Summary page 5.
- K091813: Intrepid Spinal System, Medtronic Sofamor Danek (2009) Summary page 5.

## Cited in the summary but kept off the family tree
- K201820: NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System and Brigade Hyperlordotic System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, 3DP Interfixated ALIF System, Nu Vasive, Incorporated (2020). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K094025: Crescent Spinal System, Medtronic Sofamor Danek (2010). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K142559: ELEVATE Spinal System, Medtronic Sofamor Danek USA, Inc. (2015). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K132897: Clydesdale Spinal System, Medtronic Sofamor Danek, Inc. (2013). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K210425: Catalyft PL Expandable Interbody System, Medtronic Sofamor Danek USA, Inc. (2021). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K241992: Catalyft™ LS Expandable Interbody System (2024), 0 descendants of its own
- K223153: Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology (2022), 0 descendants of its own

## Recalls of this device
- Jun 6, 2023 · Class II · Z-2118-2023: There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lum
- Jun 6, 2023 · Class II · Z-2117-2023: There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lum
- Jun 6, 2023 · Class II · Z-2119-2023: There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lum
- Jun 6, 2023 · Class II · Z-2122-2023: There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lum
- Jun 6, 2023 · Class II · Z-2121-2023: There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lum
- Jun 6, 2023 · Class II · Z-2120-2023: There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lum
- Jun 6, 2023 · Class II · Z-2123-2023: There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lum

## Indications for use
The Catalyft™ LS Expandable Interbody System 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 spinal 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 approaches. These approaches include anterior and or oblique approach. The Catalyft™ LS Expandable interbody system cages used with 4 titanium alloy screws may be used as a stand-alone device up to 20°lordosis. 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/K212653
Methodology: https://510kreport.com/methodology