# K172696: FORZA® XP Expandable Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix, Inc.
- Decided: Jan 19, 2018 after 134 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: 19 generations back to K841189 (1984). 153 ancestors in all.
25 later devices descend from it; 5 cite it directly.
1 of 179 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162918: Atlas Spine Expandable Interbody System, Atlas Spine, Inc. (2017) Summary page 4.

## Most influential descendants
- K182114: FlareHawk Interbody Fusion System (2019), 6 descendants of its own
- K211704: CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervical Standalone System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, PILLAR SA PTC Spacer System, SKYHAWK Lateral Interbody Fusion System (2021), 5 descendants of its own
- K201024: Expandable Titanium PLIF/TLIF System (2021), 5 descendants of its own
- K191339: Zavation eZspand Interbody System (2019), 5 descendants of its own
- K220581: Zavation eZspand Interbody System (2022), 4 descendants of its own

## Indications for use
FORZA XP Expandable Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s). FORZA XP Expandable Spacer System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation (i.e. Firebird® Spinal Fixation System). Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with FORZA XP Expandable Spacer System.

Source page: https://510kreport.com/device/K172696
Methodology: https://510kreport.com/methodology