510(k) · Cleared
ClearedPillar SA PTC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthofix, Inc. · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Sep 8, 2016 as substantially equivalent to K152475 (Orthofix, Inc., 2016) and 2 other predicates after a 140-day review. Its family tree reaches back 18 generations to 1984. 1 of the 138 devices in its family, counting itself, has a Class I recall. 19 later devices descend from it.
- Decided
- Sep 8, 2016
- Review
- 140 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 18 generations to K841189 (1984). 118 ancestors in all. 19 later devices descend from it, 3 citing it directly. 1 of the 138 devices in this family, counting this one, has a Class I recall.
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations between
- 3 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 2 generations backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- 1 generation backK152475 FORZA PTC Spacer SystemOrthofix, Inc. · 2016
- This deviceK161129 Pillar SA PTCOrthofix, Inc. · 2016
- Descendant · cites it directly · 14 of its ownK172437 CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR®…Orthofix, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 13 of its ownK200052 CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA…Orthofix, Inc. · 2020
- Descendant · 3 generations on · 10 of its ownK202666 CONSTRUX Mini PTC Spacer SystemOrthofix, Inc. · 2020
- Descendant · 4 generations on · 9 of its ownK203342 CONSTRUX Mini Ti Spacer SystemOrthofix, Inc. · 2021 · Recalled
- Descendant · 3 generations on · 6 of its ownK203576 FORZA Ti Spacer SystemOrthofix, Inc. · 2021 · Recalled
Show all 18 generations
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 17 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 16 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 15 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 12 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 11 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 8 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 7 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 6 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- 5 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- 4 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 3 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 2 generations backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- 1 generation backK152475 FORZA PTC Spacer SystemOrthofix, Inc. · 2016
- This deviceK161129 Pillar SA PTCOrthofix, Inc. · 2016
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer3 generations back · 2008
Most influential descendants
Showing 5 of 19 · See all- K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc. · 2017 · cites it directly14descendants
- K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc. · 2020 · 2 generations on13descendants
- K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc. · 2020 · 3 generations on10descendants
- K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc. · 2021 · 4 generations on9descendants
- K203576FORZA Ti Spacer SystemOrthofix, Inc. · 2021 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −17 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −16 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −15 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −12 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −11 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −8 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −7 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −6 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| −5 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| −4 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
| −3 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
| −2 | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | Centinel Spine, Inc. | 2015 | — |
| −1 | K152475 | FORZA PTC Spacer System | Orthofix, Inc. | 2016 | — |
| 0 (this device) | K161129 | Pillar SA PTC | Orthofix, Inc. | 2016 | — |
| +1 | K172437 | CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC… | Orthofix, Inc. | 2017 | 3 |
| +2 | K200052 | CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer… | Orthofix, Inc. | 2020 | — |
| +3 | K202666 | CONSTRUX Mini PTC Spacer System | Orthofix, Inc. | 2020 | — |
| +4 | K203342 | CONSTRUX Mini Ti Spacer System | Orthofix, Inc. | 2021 | 1 |
| +3 | K203576 | FORZA Ti Spacer System | Orthofix, Inc. | 2021 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 7 | 0 |
| 2003 | 8 | 0 |
| 2004 | 12 | 0 |
| 2005 | 10 | 0 |
| 2006 | 4 | 0 |
| 2007 | 9 | 0 |
| 2008 | 17 | 1 |
| 2009 | 6 | 0 |
| 2010 | 6 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 5 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K152475 | FORZA PTC Spacer SystemSummary page 4…ar Product Code: OVD Regulatory Classification: 21 CFR § 888.3080 Review Panel: Orthopedic Device Panel Predicate Devices: (K152475) – FORZA PTC Spacer System, Orthofix (primary predicate) (K150643) – ST… | 2016 |
| * | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiSummary page 4…c Device Panel Predicate Devices: (K152475) – FORZA PTC Spacer System, Orthofix (primary predicate) (K150643) – STALIF MIDLINE II-Ti, Centinel Spine (additional predicate) (K081849… | 2015 |
| * | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement DeviceSummary page 4…redicate) (K150643) – STALIF MIDLINE II-Ti, Centinel Spine (additional predicate) (K081849) – PILLAR SA PEEK Spacer System Orthofix (additional predicate) (K12164… | 2008 |
| † | K121649 | Construx Mini Peek TI Spacer System | 2012 |
What descends from it? (19)
See all 193 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 3 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 32 years and passes through 14 companies; a new generation was cleared every 9 months on median.
- 20 of the 118 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K172437 (Orthofix, Inc., 2017) has gone furthest, with 14 descendants of its own.
- 9 other devices also cite its predicate K152475.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
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…
Read the full statement (178 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161129 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161129: Pillar SA PTC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161129
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026