# K240749: PILLAR SA Ti Spacer System (82-XXX)

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix, Inc.
- Decided: May 28, 2024 after 70 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 32 generations back to K841189 (1984). 600 ancestors in all.
No later device cites it as a predicate yet.
1 of 601 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200052: CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System, Orthofix, Inc. (2020) Summary page 4.
- K222732: WaveForm A Interbody System, SeaSpine Orthopedics Corporation (2022) Summary page 4.
- K082235: Blackstone Pillar XL Peek Spacers, Blackstone Medical, Inc. (2008) Summary page 4.
- K233694: Meridian Interbody System; WaveForm A Interbody System, SeaSpine Orthopedics Corporation (2024) Summary page 5.

## Recalls of this device
- Jun 24, 2025 · Class II · Z-2555-2025: A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box. The 37 m
- Feb 20, 2025 · Class II · Z-1432-2025: The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm.

## Indications for use
The PILLAR SA Ti Spacer System when used with screws is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The The PILLAR SA Ti Interbody may be used as a standalone device only when at least two Screws are inserted with one inferior and one superior screw trajectory. If the surgeon chooses to use the PILLAR SA Ti Interbody with fewer than two Screws inserted with one inferior and one superior screw trajectory, then additional supplemental fixation system must be used. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation.

Source page: https://510kreport.com/device/K240749
Methodology: https://510kreport.com/methodology