# K090353: Perimeter Interbody Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek
- Decided: Sep 29, 2009 after 230 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
Longest line of descent: 10 generations back to K841189 (1984). 38 ancestors in all.
796 later devices descend from it; 12 cite it directly.
1 of 835 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083026: Clydesdale Spinal System, Medtronic Sofamor Danek (2008) Summary page 2.
- P970015: Inter Fix Threaded Fusion Device, Sofamor Danek (1999) Summary page 2.
- P950002: Bak Interbody Fusion System, Zimmer Spine, Inc. (1996) Summary page 2.
- P950019: Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation, Stryker Spine (1996) Summary page 2.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 2.
- K073291: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2008) Summary page 2.
- K041452: Modification to Verte-Stack Spinal System, Medtronic Sofamor Danek (2004) Summary page 2.

## Most influential descendants
- K120368: Capstone Control Spinal System (2012), 761 descendants of its own
- K121760: Capstone Spinal System (2012), 723 descendants of its own
- K123027: Capstone (R) Spinal System (2013), 709 descendants of its own
- K141896: Coroent System (2014), 480 descendants of its own
- K151472: NuVasive CoRoent Lumbar System (2015), 479 descendants of its own

## Indications for use
The PERIMETER® Interbody Fusion Device is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to SI. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confinned by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and oblique. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

Source page: https://510kreport.com/device/K090353
Methodology: https://510kreport.com/methodology