# K103111: Forza Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix, Inc.
- Decided: Mar 23, 2011 after 153 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 1 (0 Class I)
- 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.
343 later devices descend from it; 6 cite it directly.
1 of 382 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081177: Blackstone Medical, Inc., Pillar Spacer System, Blackstone Medical, Inc. (2008) Summary page 1.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 1.
- K073202: Ardis Spacer, Abbott Spine, Inc. (2008) Summary page 1.
- K083626: Distractable Wave Cage, Advanced Medical Technology, Inc. (2009) Summary page 1.
- K073177: Pioneer Intervertebral Fusion Device System, Pioneer Surgical Technology (2008) Summary page 4.

## Most influential descendants
- K152475: FORZA PTC Spacer System (2016), 236 descendants of its own
- K143258: PLIF STS, TLIF STS, OLIF STS (Spinal Truss System) (2015), 211 descendants of its own
- K170503: EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages (2017), 199 descendants of its own
- K153495: Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System (2016), 189 descendants of its own
- K162103: Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™) (2016), 161 descendants of its own

## Recalls of this device
- Feb 6, 2012 · Not classified · Z-1037-2012: The 8mm and 10mm Rotating Cutters may fracture during use, specifically during disc space preparation. If an 8mm or 10mm Rotating Cutter does Fracture during use, it may result in a surgical delay est

## Indications for use
The FORZATM 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 I spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s). The FORZATM Spacer System is intended for use with autograft and supplemental fixation system. As an example, the supplemental fixation system that may be used is the Orthofix Inc. FirebirdTM Pedicle Screw System. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the FORZATM Spacer System.

Source page: https://510kreport.com/device/K103111
Methodology: https://510kreport.com/methodology