510(k) · Cleared
Recalled · Class III · 2025CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthofix, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Nov 2, 2017 as substantially equivalent to K161129 (Orthofix, Inc., 2016) and 2 other predicates after an 83-day review. Its family tree reaches back 19 generations to 1984. 1 of the 161 devices in its family, counting itself, has a Class I recall. 14 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 2, 2017
- Review
- 83 days
- Class
- Class II
- Product code
- ODP
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 19 generations to K841189 (1984). 146 ancestors in all. 14 later devices descend from it, 1 citing it directly. 1 of the 161 devices in this family, counting this one, has a Class I recall.
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations between
- 3 generations backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- 2 generations backK152475 FORZA PTC Spacer SystemOrthofix, Inc. · 2016
- 1 generation backK161129 Pillar SA PTCOrthofix, Inc. · 2016
- This deviceK172437 CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR®…Orthofix, Inc. · 2017
- Descendant · cites it directly · 13 of its ownK200052 CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA…Orthofix, Inc. · 2020
- Descendant · 2 generations on · 10 of its ownK202666 CONSTRUX Mini PTC Spacer SystemOrthofix, Inc. · 2020
- Descendant · 3 generations on · 9 of its ownK203342 CONSTRUX Mini Ti Spacer SystemOrthofix, Inc. · 2021 · Recalled
- Descendant · 2 generations on · 6 of its ownK203576 FORZA Ti Spacer SystemOrthofix, Inc. · 2021 · Recalled
- Descendant · 2 generations on · 5 of its ownK211704 CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System…Orthofix, Inc. · 2021
Show all 19 generations
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 17 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 16 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 13 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 12 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 9 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 8 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 7 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- 6 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- 5 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 4 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 3 generations backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- 2 generations backK152475 FORZA PTC Spacer SystemOrthofix, Inc. · 2016
- 1 generation backK161129 Pillar SA PTCOrthofix, Inc. · 2016
- This deviceK172437 CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR®…Orthofix, Inc. · 2017
Showing 5 of 14 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 14 · See all- K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc. · 2020 · cites it directly13descendants
- K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc. · 2020 · 2 generations on10descendants
- K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc. · 2021 · 3 generations on9descendants
- K203576FORZA Ti Spacer SystemOrthofix, Inc. · 2021 · 2 generations on6descendants
- K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc. · 2021 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −18 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −17 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −16 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −13 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −12 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −9 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −8 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −7 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| −6 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| −5 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
| −4 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
| −3 | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | Centinel Spine, Inc. | 2015 | — |
| −2 | K152475 | FORZA PTC Spacer System | Orthofix, Inc. | 2016 | — |
| −1 | K161129 | Pillar SA PTC | Orthofix, Inc. | 2016 | — |
| 0 (this device) | K172437 | CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC… | Orthofix, Inc. | 2017 | — |
| +1 | K200052 | CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer… | Orthofix, Inc. | 2020 | — |
| +2 | K202666 | CONSTRUX Mini PTC Spacer System | Orthofix, Inc. | 2020 | — |
| +3 | K203342 | CONSTRUX Mini Ti Spacer System | Orthofix, Inc. | 2021 | 1 |
| +2 | K203576 | FORZA Ti Spacer System | Orthofix, Inc. | 2021 | 1 |
| +2 | K211704 | CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini… | Orthofix, Inc. | 2021 | — |
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 | 8 | 0 |
| 2003 | 11 | 0 |
| 2004 | 14 | 0 |
| 2005 | 12 | 0 |
| 2006 | 4 | 0 |
| 2007 | 9 | 0 |
| 2008 | 20 | 1 |
| 2009 | 12 | 0 |
| 2010 | 7 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 6 | 0 |
| 2015 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 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 ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 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 |
|---|---|---|---|
| * | K161129 | Pillar SA PTCSummary page 5…PILLAR SA PTC Spacer System Intervertebral body fusion device ODP, MAX, OVD Class Il — 21 CFR § 888.3080 — Intervertebral body fusion device Orthopedic Device Panel K161129 — PILLAR SA PTC, SE 9/8/2016 K152475 — FORZA PTC Spacer System, SE 1/14/2016 K150619 — CONSTRUX Mini PEEK Ti Spacer System, SE 1… | 2016 |
| * | K152475 | FORZA PTC Spacer SystemSummary page 5…tebral body fusion device ODP, MAX, OVD Class Il — 21 CFR § 888.3080 — Intervertebral body fusion device Orthopedic Device Panel K161129 — PILLAR SA PTC, SE 9/8/2016 K152475 — FORZA PTC Spacer System, SE 1/14/2016 K150619 — CONSTRUX Mini PEEK Ti Spacer System, SE 11/29/2012 Reason for 510(k) Submissio… | 2016 |
| * | K150619 | CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemSummary page 5…l — 21 CFR § 888.3080 — Intervertebral body fusion device Orthopedic Device Panel K161129 — PILLAR SA PTC, SE 9/8/2016 K152475 — FORZA PTC Spacer System, SE 1/14/2016 K150619 — CONSTRUX Mini PEEK Ti Spacer System, SE 11/29/2012 Reason for 510(k) Submission: Manufacturing / Product Description Change D… | 2015 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200052 | CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System | 2020 | 13 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 3, 2025 | Class III | Z-0892-2026 | Device Design | Labeling contains claims that are not consistently present. |
| Nov 3, 2025 | Class III | Z-0893-2026 | Device Design | Labeling contains claims that are not consistently present. |
| Nov 3, 2025 | Class III | Z-0891-2026 | Device Design | Labeling contains claims that are not consistently present. |
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 33 years and passes through 14 companies; a new generation was cleared every 9 months on median.
- 21 of the 146 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K200052 (Orthofix, Inc., 2020) has gone furthest, with 13 descendants of its own.
- 2 other devices also cite its predicate K161129.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
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…
Read the full statement (439 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K172437 · printed Nov 4, 2026
Cite this page
510(k) Report. “K172437: CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K172437
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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