# K160418: PERIMETER Interbody Fusion Device

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Mar 7, 2016 after 20 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: 12 generations back to K841189 (1984). 40 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111525: Perimeter Interbody Fusion Device, Medtronic Sofamor Danek (2011) Summary page 4.
- K090353: Perimeter Interbody Fusion Device, Medtronic Sofamor Danek (2009) Summary page 4.

## Most influential descendants
- K192502: Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System, Capstone™ Spinal System, Capstone PTC™ Spinal System, Capstone Control™ Spinal System, Capstone Control PTC™ Spinal System, Clydesdale™ Spinal System, Clydesdale PTC™ Spinal System, Cornerstone™ PSR Cervical Fusion System, Crescent™ Spinal System, Crescent™ Spinal System Titanium, Divergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-L™ Anterior/Oblique Lumbar Fus (2020), 4 descendants of its own
- K241164: IB3D™ PL Spinal System (2024), 1 descendant of its own
- K253577: IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) (2025), 0 descendants of its own
- K251431: FIX-C PEEK ACIF SA System (2025), 0 descendants of its own
- K230936: Anatomic PEEK™ Cervical Fusion System with Nanotechnology (2023), 0 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 L2 to S1. 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 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/K160418
Methodology: https://510kreport.com/methodology