# K133494: Chesapeake Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: K2m, Inc.
- Decided: Jun 10, 2014 after 208 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: 14 generations back to K841189 (1984). 104 ancestors in all.
330 later devices descend from it; 4 cite it directly.
0 of 435 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092211: Chesapeake Spinal System, K2m, Inc. (2010) Summary page 1.
- K111439: Chesapeake (Cervical Components), K2m, Inc. (2011)
- K120031: Chesapeake Spinal System, K2m, Inc. (2012) Summary page 1.
- K073285: Peek Prevail Cervical Interbody Device, Medtronic Sofamor Danek USA, Inc. (2008) Summary page 1.
- K072415: Stalif (TM) C, Surgicraft, Ltd. (2008) Summary page 1.
- K122630: IN:C2 Spinal Fixation System, Spine Smith Partners L.P. (2012) Summary page 1.

## Most influential descendants
- 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
- K151596: Endoskeleton TCS Interbody Fusion Device (2015), 110 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 IBF implants are intended for use at one level in the cervical spine, from C2 to T1, 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 implants are intended 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 I 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/K133494
Methodology: https://510kreport.com/methodology