# K220513: NITRO Interbody Fusion Cage System Family

- Pathway: 510(k) (Traditional)
- Applicant: Ctl Medical Corporation
- Decided: Apr 25, 2023 after 427 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- 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: 22 generations back to K841189 (1984). 256 ancestors in all.
No later device cites it as a predicate yet.
0 of 257 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143518: Valeo Spacer System and Valeo II Interbody Fusion Device System, Amedica Corp. (2015) Summary page 6.
- K161405: Valeo II Interbody Fusion Device System, Amedica Corp. (2016) Summary page 6.
- K121569: Matisse Anterior Cervical Interbody Fusion Cage System, Accel Spine (2012) Summary page 6.
- K162682: MATISSE Anterior Cervical Interbody Fusion Cage System, Ctl Medical Corporation (2017) Summary page 6.
- K172212: MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™, Ctl Medical Corporation (2018) Summary page 6.
- K172788: MONET™ Anterior Cervical Interbody Fusion Cage System, Ctl Medical Corporation (2018) Summary page 6.
- K182151: MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate, Ctl Medical Corporation (2018) Summary page 6.
- K192863: MONDRIAN Lumbar Interbody Fusion Cage System, Ctl Medical Corporation (2020) Summary page 6.

## Indications for use
“CERVICAL” NITRO Interbody Fusion Cage System Family (i.e., the MATISSE NITRO Anterior Cervical Interbody Fusion Cage System and the MONET NITRO Anterior Cervical Interbody Fusion Cage System) are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Cervical NITRO Interbody Fusion Cage System Family are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach from the C2-C3 disc space to C7-T1 disc space using autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Cervical NITRO Interbody Fusion Cage System Family are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. When the MONET Anterior Cervical Interbody Fusion Cage System is used with the Supplementary Fixation Plate assembly, the plate-spacer assembly is a stand-alone device intended for use at one disc level or two contiguous levels of the cervical spine (from the C2-C3 disc space to C7-T1 disc space). “LUMBAR” NITRO Interbody Fusion Cage System Family (i.e.; the MONDRIAN NITRO Lumbar Interbody Fusion Cage System consisting of ALIF/OLIF, DLIF, PLIF, and TLIF) are indicated for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Lumbar NITRO Interbody Fusion Cage System Family are intended to be used with supplemental spinal fixation systems. Patients should be skeletally mature and have six months of non-operative therapy prior to treatment with an intervertebral cage. Lumbar NITRO Interbody Fusion Cage System Family with hyperlordotic cage offerings (>20°) require the use of anterior fixation.

Source page: https://510kreport.com/device/K220513
Methodology: https://510kreport.com/methodology