# K131669: Perimeter Interbody Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Nov 1, 2013 after 147 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: 13 generations back to K841189 (1984). 42 ancestors in all.
234 later devices descend from it; 4 cite it directly.
1 of 277 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113642: Perimeter Interbody Fusion Device, Medtronic Sofamor Danek USA (2012) Summary page 3.

## Cited in the summary but kept off the family tree
- K090353: Perimeter Interbody Fusion Device, Medtronic Sofamor Danek (2009). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K150135: DIVERGENCE-L Anterior/Oblique Lumbar Fusion System (2015), 228 descendants of its own
- K152277: PIVOX (tm) Oblique Lateral Spinal System (2015), 190 descendants of its own
- K161379: ELSA Spacers (2016), 155 descendants of its own
- K162351: SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device (2016), 79 descendants of its own
- K173260: SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Spacer System -Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Vu e·POD System (2017), 67 descendants of its own

## Indications for use
The PERIMETER® Interbody Fusion Device is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L-2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed 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/K131669
Methodology: https://510kreport.com/methodology