# K092540: C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody Spacer

- Pathway: 510(k) (Special)
- Applicant: Rsb Spine, LLC
- Decided: Jan 27, 2010 after 161 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- 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: 10 generations back to K841189 (1984). 44 ancestors in all.
45 later devices descend from it; 2 cite it directly.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081194: Interplate Peek Cervical Interbody Fusion Device (Ifd), Rsb Spine, LLC (2008)
- K073177: Pioneer Intervertebral Fusion Device System, Pioneer Surgical Technology (2008) Summary page 2.
- K043206: Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer), Pioneer Surgical Technology (2005) Summary page 2.
- K071922: Interplate Interbody Fusion Device, Models C, CGC, L and LGC, Rsb Spine, LLC (2007) Summary page 2.
- K043479: MC+ Partial VBR, Ldr Spine USA (2005) Summary page 2.

## Most influential descendants
- K120656: Everest Spinal System (2012), 43 descendants of its own
- K132757: Everest Spinal System (2013), 41 descendants of its own
- K132361: Everest Spinal System (2013), 34 descendants of its own
- K133944: Range, Spinal System, Everest Spinal System (2014), 33 descendants of its own
- K140529: Everest Spinal System (2014), 31 descendants of its own

## Indications for use
The C-PS is indicated for intervertebral body fusion of the cervical spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. The C-PS is intended for use at one level in the cervical spine, from C3 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 to be used in patients who have had six weeks of non-operative treatment. The C-PS is intended to be used with a Supplemental internal fixation system. The L-PS is indicated for intervertebral body fusion of the lumbar spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. The L-PS System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to SI, for the treatment of degenerative disc disease (DDD) with Lip to Grade I spondylolisthesis. DIDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment. Thle L-PS is intended to be used with a supplemental internal fixation system.

Source page: https://510kreport.com/device/K092540
Methodology: https://510kreport.com/methodology