# K161129: Pillar SA PTC

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix, Inc.
- Decided: Sep 8, 2016 after 140 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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). 118 ancestors in all.
19 later devices descend from it; 3 cite it directly.
1 of 138 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 4.
- K150643: Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti, Centinel Spine, Inc. (2015) Summary page 4.
- K081849: Blackstone Pillar SA Partial Vertebral Body Replacement Device, Blackstone Medical, Inc. (2008) Summary page 4.

## Most influential descendants
- K172437: CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer System (2017), 14 descendants of its own
- 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

## Indications for use
The PILLAR SA PTC 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 is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The PILLAR SA PTC 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 Firebird Spinal Fixation System. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PILLAR SA PTC.

Source page: https://510kreport.com/device/K161129
Methodology: https://510kreport.com/methodology