# K111439: Chesapeake (Cervical Components)

- Pathway: 510(k) (Traditional)
- Applicant: K2m, Inc.
- Decided: Aug 24, 2011 after 92 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K841189 (1984). 75 ancestors in all.
345 later devices descend from it; 4 cite it directly.
0 of 421 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)
- K051454: Aleutian Spacer System, K2m, LLC (2005) Summary page 1.
- K082698: Aleutian Ibf System, K2m, Inc. (2009) Summary page 1.
- K072415: Stalif (TM) C, Surgicraft, Ltd. (2008)
- K083389: Coalition Spacer, Globus Medical, Inc. (2009) Summary page 1.
- K100698: STCC, Cardinal Spine, LLC (2011) Summary page 1.

## 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

## Recalls of this device
- Mar 16, 2021 · Class II · Z-1410-2021: Interference condition between the 10mm Drill Guide Inserter and the inner shaft that mates with the inserters. As a result, inner shafts do not mate flush with the collet inserters, and splaying of t

## Indications for use
The Chesapeake Spinal System is intended to be used with the bone screws provided and requires no additional supplementary fixation. 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 T I, 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.

Source page: https://510kreport.com/device/K111439
Methodology: https://510kreport.com/methodology