# K082260: Integra Cervical and Petra Plif Lumbar Cages

- Pathway: 510(k) (Traditional)
- Applicant: Calvary Spine, LLC
- Decided: Oct 17, 2008 after 70 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, 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
No predicates in its family tree.
562 later devices descend from it; 2 cite it directly.
0 of 563 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K110733: Daytona Anterior Cervical Cage (2011), 481 descendants of its own
- K123206: Maxim Surgical X-Treme Interbody Fusion System (2013), 454 descendants of its own
- K140003: Coroent Small Interbody System (2014), 453 descendants of its own
- K142050: Nuvasive Coroent Small Contoured Interbody System (2014), 449 descendants of its own
- K140921: Coroent Small Interbody System (2014), 444 descendants of its own

## Indications for use
The Integra Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Integra Cervical Cage implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C-3 to T-1 disc levels using autogenous bone graft. Integra Cervical implant is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. The Petra PLIF Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Petra PLIF Cage implants are to be used with autogenous bone graft and implanted via an open posterior approach. The Petra PLIF Cages are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K082260
Methodology: https://510kreport.com/methodology