# K120031: Chesapeake Spinal System

- Pathway: 510(k) (Special)
- Applicant: K2m, Inc.
- Decided: Mar 16, 2012 after 72 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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: 12 generations back to K841189 (1984). 57 ancestors in all.
334 later devices descend from it; 4 cite it directly.
0 of 392 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082698: Aleutian Ibf System, K2m, Inc. (2009) Summary page 2.
- K073109: Stalif TT Intervertebral Body Fusion System, Surgicraft, Ltd. (2008) Summary page 2.
- K062083: Synfix -LR, Synthes Spine Co.Lp (2007) Summary page 2.
- K072253: Synfix-LR Spacer, Synthes Spine Co.Lp (2007) Summary page 2.
- K083475: Lucent Magnum, Spinal Elements, Inc. (2009) Summary page 2.
- K081501: Solitaire Anterior Spinal System, Biomet Spine (2008)

## Cited in the summary but kept off the family tree
- K095454: K2M Aleutian Interbody Spacer Systems. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K133494: Chesapeake Spinal System (2014), 330 descendants of its own
- K160125: Cascadia Interbody System (2016), 315 descendants of its own
- K162264: Cascadia Interbody System (2016), 169 descendants of its own
- K171140: Matrixx System (2017), 145 descendants of its own
- K142940: Endoskeleton TCS System (2015), 111 descendants of its own

## Indications for use
When used as a cervical intervertebral body fusion device, the Chesapeake implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBE implants are intended for use at one level in the cervical spine, from C2 to TI, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment. When used as a lumbar intervertebral body fusion device, the Chesapeake implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Lumbar I implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to SI1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment. The Chesapeake spinal System may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device the Chesapeake spacers are intended to be used with the bone screws provided. When using a 2 screw implant, 2 screws must be used. When using a 3 screw implant 3 screws must be used.

Source page: https://510kreport.com/device/K120031
Methodology: https://510kreport.com/methodology