# K162446: FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix, Inc.
- Decided: Dec 22, 2016 after 112 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: 18 generations back to K841189 (1984). 130 ancestors in all.
6 later devices descend from it; 1 cites it directly.
1 of 137 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152475: FORZA PTC Spacer System, Orthofix, Inc. (2016) Summary page 9.
- K082235: Blackstone Pillar XL Peek Spacers, Blackstone Medical, Inc. (2008) Summary page 13.
- K081849: Blackstone Pillar SA Partial Vertebral Body Replacement Device, Blackstone Medical, Inc. (2008) Summary page 10.
- K140709: Skyhawk Interbody Fusion System, Orthofix, Inc. (2014) Summary page 10.

## Most influential descendants
- 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
- K213951: FORZA XP Expandable Spacer System (2022), 4 descendants of its own
- K240830: Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System (2024), 2 descendants of its own
- K253420: Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy (2026), 0 descendants of its own
- K251617: X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System (2025), 0 descendants of its own

## Indications for use
The FORZA Spacer System is indicated for use with bone graft (autograft bone or allogenic bone graft composed of cancellous or corticocancellous bone graft) in patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may 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. Patients with previous non-fusion spinal surgery at the treated level may be treated. The FORZA Spacer System is intended to be used with supplemental fixation systems. As an example, the supplemental fixation that may be used is the Orthofix Firebird Spinal Fixation System. The FORZA Spacer System must be used with autograft or allogenic bone graft composed of cancellous or corticocancellous bone graft. When used as an intervertebral body fusion device, the PILLAR PEEK Spacer System is indicated for use with bone graft (autograft bone or allogenic bone graft composed of cancellous or corticocancellous bone graft) in patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may 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. Patients with previous non-fusion spinal surgery at the treated level may be treated. The PILLAR PEEK Spacer System is intended to be used with supplemental fixation. As an example, the supplemental fixation that may be used is the Orthofix Spinal Fixation System (SFS). The PILLAR PL PEEK Spacer is used singly or in pairs and is implanted using a posterior approach. The PILLAR TL PEEK Spacer is used singly or in pairs and is implanted using a transforaminal approach. The PILLAR AL PEEK Spacer is used singly and is implanted using an anterior approach. The PILALR XL PEEK Spacer is used singly and is implanted using a lateral approach. The PILLAR PEEK Spacer System must be used with autograft or allogenic bone graft composed of cancellous or corticocancellous bone graft. When used as a Partial Vertebral Body Replacement (VBR), The PILLAR PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PILLAR Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The PILLAR PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of a fusion for a prolonged period of time. The Partial VBR device is intended to be used with autograft or allograft. The PILLAR PEEK Spacer System is intended for use with supplemental fixation. As an example, the supplemental fixation that may be used is the Orthofix Spinal Fixation System (SFS). When used as an intervertebral body fusion device, the PILLAR SA PEEK Spacer System is indicated for use with bone graft (autograft bone or allogenic bone graft composed of cancellous or corticocancellous bone graft) in patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may 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. Patients with previous non-fusion spinal surgery at the treated level may be treated. The PILLAR SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental fixation must be used to augment stability. As an example, the supplemental fixation system that may be used is the Orthofix Spinal Fixation System (SFS). The PILLAR SA PEEK Spacer System must be used with autograft or allogenic bone graft composed of cancellous or corticocancellous bone graft. When used as a Partial Vertebral Body Replacement (VBR) the PILLAR SA PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PILLAR SA PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The PILLAR SA PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The PILLAR SA PEEK Spacer System is intended to be used with autograft or allograft. The PILLAR SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental fixation must be used to augment stability. As an example, the supplemental fixation that may be used is the Orthofix Spinal Fixation System (SFS). When used as an intervertebral body fusion device, the SKYHAWK Lateral Interbody Fusion System is indicated for use with bone graft (autograft bone or allogenic bone graft composed of cancellous or corticocancellous bone graft) in patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may 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. Patients with previous non-fusion spinal surgery at the treated level may be treated. The SKYHAWK Lateral Interbody Fusion System is intended to be used with supplemental fixation systems that are cleared by the FDA for use in the lumbar spine. The SKYHAWK Lateral Interbody Fusion System must be used with autograft or allogenic bone graft composed of cancellous or corticocancellous bone graft.

Source page: https://510kreport.com/device/K162446
Methodology: https://510kreport.com/methodology