# K152200: SurgTech Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Surgtech, Inc.
- Decided: Mar 25, 2016 after 232 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 K003155 (2001). 59 ancestors in all.
No later device cites it as a predicate yet.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113478: Plif Cage, Eisertech, LLC (2012) Summary page 4.
- K073470: Avs PL Peek Spacers, Models 48351XXX and 48353XXX, Stryker Spine (2008) Summary page 4.
- K082014: Stryker Spine Avs PL Peek Spacers, Stryker Corp. (2008) Summary page 4.
- K093704: Avs PL Peek Spacers, Stryker Corp. (2009) Summary page 4.

## Indications for use
The SurgTech Interbody System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These patients may have had a previous non-fusion spinal surgery and may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). These devices are intended to be used with supplemental fixation which has been cleared for use in the lumbar spine.

Source page: https://510kreport.com/device/K152200
Methodology: https://510kreport.com/methodology