# K092211: Chesapeake Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: K2m, Inc.
- Decided: Mar 5, 2010 after 226 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.
450 later devices descend from it; 5 cite it directly.
0 of 508 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051454: Aleutian Spacer System, K2m, LLC (2005) Summary page 2.
- 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) Summary page 2.

## Most influential descendants
- K111439: Chesapeake (Cervical Components) (2011), 345 descendants of its own
- K133494: Chesapeake Spinal System (2014), 330 descendants of its own
- K160125: Cascadia Interbody System (2016), 315 descendants of its own
- K131122: S128 Anterior Lumbar Interbody Fusion (Alif) System (2013), 269 descendants of its own
- K140106: S128 Anterior Lumbar Interbody Fusion (Alif) System (2014), 265 descendants of its own

## Indications for use
The Chesapeake Spinal System is intended to be used with the bone screws provided and requires no additional supplementary fixation. The Chesapeake implants are intended for spinal fusion procedures in skeletally mature patients who have had six months of non-operative treatment. When used as intervertebral body fusion devices, the implants are indicated for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, 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. This device is intended to be used with autogenous bone graft. When used as vertebral body replacement devices the Chesapeake implants are indicated for use in the thoracolumbar spine (T1 to L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body, resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Chesapeake implants are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The interior of the spacer may be packed with allograft or autograft.

Source page: https://510kreport.com/device/K092211
Methodology: https://510kreport.com/methodology