# K142487: Chesapeake Stabilization System

- Pathway: 510(k) (Traditional)
- Applicant: K2m, Inc.
- Decided: May 7, 2015 after 245 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar)
- 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: 15 generations back to K841189 (1984). 131 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 139 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 4.
- K111439: Chesapeake (Cervical Components), K2m, Inc. (2011) Summary page 4.
- K133494: Chesapeake Spinal System, K2m, Inc. (2014) Summary page 4.
- K082698: Aleutian Ibf System, K2m, Inc. (2009) Summary page 4.
- K133614: Aleutian Ibf System, K2m, Inc. (2014) Summary page 4.
- K123045: Brigade Standalone System, Nuvasive, Inc. (2013) Summary page 4.

## Most influential descendants
- K151481: Sahara Stabilization System (2015), 5 descendants of its own
- K201585: Monterey AL Interbody System (2020), 4 descendants of its own
- K250072: CONDUIT™ SYNFIX™ Evolution Secured Spacer System (2025), 1 descendant of its own
- K221490: Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage, Stryker Spine VLIFT Vertebral Body Replacement System, VLIFT-s Vertebral Body Replacement System, Ascential IBD PEEKc Spacer, Aero-AL Lumbar Cage System, Aero-LL Lumbar Cage System, Aero-C Cervical Cage System, AVS Aria PEEK Spacer, AVS Anchor-C Cervical Cage System, AVS Anchor-L Spacer (2023), 1 descendant of its own
- K262061: Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEM (2026), 0 descendants of its own

## Recalls of this device
- Sep 8, 2021 · Class II · Z-0104-2022: Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the instrument during a procedure may enter the surgical cavity, requiring intraoperative removal or revision 

## Indications for use
When used as a cervical intervertebral body fusion device, the CHESAPEAKE Stabilization System 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 Stabilization System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The Lumbar IBF 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 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 hyperlordotic lumbar implants (i.e., > 15°) must be used with supplemental fixation (i.e., posterior pedicle screw and rod system) cleared for use in the lumbar spine, in addition to the bone screws provided. Otherwise, the Chesapeake Stabilization System implants (i.e., < 15°) may be used as a stand-alone device, which is intended to be used with the bone screws provided (i.e., 2 or 3 screws for the 2-screw and 3-screw implants, respectively).

Source page: https://510kreport.com/device/K142487
Methodology: https://510kreport.com/methodology