# K221172: FOCUS Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Oc Medical Devices
- Decided: Oct 14, 2022 after 172 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: 23 generations back to K841189 (1984). 441 ancestors in all.
No later device cites it as a predicate yet.
1 of 442 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212075: ShurFit Lumbar Interbody System, Precision Spine, Inc. (2021) Summary page 4.
- K160547: Cascadia Interbody System, K2m (2016) Summary page 4.
- K172009: Cascadia Interbody System, K2m, Inc. (2017) Summary page 4.
- K190959: ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology, Medtronic Sofamor Danek USA, Inc. (2019) Summary page 4.

## Indications for use
The FOCUS Interbody System is intended to be used as a lumbar intervertebral fusion device at one or two adjacent levels from L2 to S1. This system should be limited to skeletally mature patients who have had six months of non-operative care for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. In addition, the FOCUS Interbody System can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The FOCUS Interbody System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate. These implants are intended for use with supplemental fixation indicated for lumbar spinal fusion procedures such as the OrthoCircle Spine Pedicle Screw System.

Source page: https://510kreport.com/device/K221172
Methodology: https://510kreport.com/methodology