# K172437: CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer System

- Pathway: 510(k) (Special)
- Applicant: Orthofix, Inc.
- Decided: Nov 2, 2017 after 83 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K841189 (1984). 146 ancestors in all.
14 later devices descend from it; 1 cites it directly.
1 of 161 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161129: Pillar SA PTC, Orthofix, Inc. (2016) Summary page 5.
- K152475: FORZA PTC Spacer System, Orthofix, Inc. (2016) Summary page 5.
- K150619: CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System, Orthofix, Inc. (2015) Summary page 5.

## Most influential descendants
- K200052: CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System (2020), 13 descendants of its own
- K202666: CONSTRUX Mini PTC Spacer System (2020), 10 descendants of its own
- K203342: CONSTRUX Mini Ti Spacer System (2021), 9 descendants of its own
- K203576: FORZA Ti Spacer System (2021), 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

## Recalls of this device
- Nov 3, 2025 · Class III · Z-0892-2026: Labeling contains claims that are not consistently present.
- Nov 3, 2025 · Class III · Z-0893-2026: Labeling contains claims that are not consistently present.
- Nov 3, 2025 · Class III · Z-0891-2026: Labeling contains claims that are not consistently present.

## Indications for use
The CONSTRUX Mini PTC Spacer System is indicated for spinal fusion procedures at one or two contiguous levels within the cervical spine (C2-T1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. The CONSTRUX Mini PTC Spacer System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system (i.e., an anterior cervical plate such as the Orthofix Hallmark Anterior Cervical Plate System). Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PTC Spacer System in the cervical spine. The FORZA PTC 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 levels. The FORZA Spacer System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, e.g., the Firebird Spinal Fixation System. Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the FORZA PTC Spacer System. The PILLAR SA PTC 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). The PILLAR SA PTC Spacer System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The PILLAR SA PTC Spacer System is intended for use with four of the titanium alloy screws provided with the system. 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, a supplemental fixation system that may be used is the Orthofix Firebird® Spinal Fixation System. Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the PILLAR SA PTC Spacer System.

Source page: https://510kreport.com/device/K172437
Methodology: https://510kreport.com/methodology