510(k) · Cleared
ClearedConstrux Mini Peek 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 Sep 27, 2010 as substantially equivalent to K051246 (Blackstone Medical, Inc., 2005) and 3 other predicates after a 90-day review. Its family tree reaches back 9 generations to 1984. 291 later devices descend from it.
- Decided
- Sep 27, 2010
- Review
- 90 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K841189 (1984). 48 ancestors in all. 291 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 5 generations between
- 3 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 1 generation backK081917 Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc. · 2009
- This deviceK101812 Construx Mini Peek Spacer SystemOrthofix, Inc. · 2010
- Descendant · cites it directly · 289 of its ownK121649 Construx Mini Peek TI Spacer SystemOrthofix · 2012
- Descendant · cites it directly · 281 of its ownK132999 Cervical Stand Alone SystemOrthofix, Inc. · 2014
- Descendant · cites it directly · 280 of its ownK142152 Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand…Orthofix, Inc. · 2015
- Descendant · 2 generations on · 202 of its ownK150788 Talos Intervertebral Body Fusion Devices, Talos -C Cervical…Meditech Spine, LLC · 2015
- Descendant · 3 generations on · 166 of its ownK160924 Amendia Interbody Fusion DevicesAmendia, Inc. · 2016
Show all 9 generations
- Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 7 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 6 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 5 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 4 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- 3 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 1 generation backK081917 Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc. · 2009
- This deviceK101812 Construx Mini Peek Spacer SystemOrthofix, Inc. · 2010
Showing 5 of 291 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 291 · See all- K121649Construx Mini Peek TI Spacer SystemOrthofix · 2012 · cites it directly289descendants
- K132999Cervical Stand Alone SystemOrthofix, Inc. · 2014 · cites it directly281descendants
- K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc. · 2015 · cites it directly280descendants
- K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC · 2015 · 2 generations on202descendants
- K160924Amendia Interbody Fusion DevicesAmendia, Inc. · 2016 · 3 generations on166descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −8 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −7 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −6 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −5 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −4 | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −3 | K041722 | Modification to VBR Spinal System | Depuy Spine, Inc. | 2004 | — |
| −2 | K052746 | Concorde VBR Spinal System | Depuy Spine, Inc. | 2005 | — |
| −1 | K081917 | Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems | Depuy Spine, Inc. | 2009 | — |
| 0 (this device) | K101812 | Construx Mini Peek Spacer System | Orthofix, Inc. | 2010 | — |
| +1 | K121649 | Construx Mini Peek TI Spacer System | Orthofix | 2012 | — |
| +1 | K132999 | Cervical Stand Alone System | Orthofix, Inc. | 2014 | — |
| +1 | K142152 | Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone System | Orthofix, Inc. | 2015 | — |
| +2 | K150788 | Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral… | Meditech Spine, LLC | 2015 | — |
| +3 | K160924 | Amendia Interbody Fusion Devices | Amendia, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 6 | 0 |
| 2003 | 6 | 0 |
| 2004 | 7 | 0 |
| 2005 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 6 | 0 |
| 2016 | 5 | 0 |
| 2017 | 15 | 0 |
| 2018 | 12 | 0 |
| 2019 | 22 | 0 |
| 2020 | 23 | 0 |
| 2021 | 25 | 0 |
| 2022 | 23 | 0 |
| 2023 | 33 | 0 |
| 2024 | 39 | 0 |
| 2025 | 47 | 0 |
| 2026 | 38 | 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.
Planning a device in ODP? 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? (4)
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 |
|---|---|---|---|
| * | K051246 | Construx Mini Peek VBR System | 2005 |
| * | K073351 | CrystalSummary page 2…dic Device Panel Predicate Devices: Blackstone Medical, Inc. Construx Mini (KO5 1246 SE 6-14-05) Spinal Elements, Inc., Crystal Device, K073351 SE 1-4-2008 Custom Spine, Inc., Pathway ACIF, K092904 SE 12-22-2009 DePuy Spi… | 2008 |
| * | K092904 | Pathway Ivb/VBRSummary page 2…ni (KO5 1246 SE 6-14-05) Spinal Elements, Inc., Crystal Device, K073351 SE 1-4-2008 Custom Spine, Inc., Pathway ACIF, K092904 SE 12-22-2009 DePuy Spine, Inc. BengalTM System, K081917 SE 5-22-2009 Intended Use / Indications for U… | 2009 |
| * | K081917 | Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsSummary page 2…evice, K073351 SE 1-4-2008 Custom Spine, Inc., Pathway ACIF, K092904 SE 12-22-2009 DePuy Spine, Inc. BengalTM System, K081917 SE 5-22-2009 Intended Use / Indications for Use When used as a cervical intervertebral body fusion device, the Construx Mini PE… | 2009 |
What descends from it? (291)
See all 2913 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 48 ancestors have a recall of any class.
- Of its descendants, K121649 (Orthofix, 2012) has gone furthest, with 289 descendants of its own.
- 3 other devices also cite its predicate K051246.
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. 2010, 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?
When used as a cervical intervertebral body fusion device, the Construx Mini PEEK System is indicated for spinal fusion procedures at one level in 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 PEEK System is intended for use with autograft and supplemental…
Read the full statement (294 words)
When used as a cervical intervertebral body fusion device, the Construx Mini PEEK System is indicated for spinal fusion procedures at one level in 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 PEEK System is intended for use with autograft and supplemental internal fixation, e.g.: the Blackstone Medical Ascent or Ascent LE POCT System.
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Construx Mini PEEK System in the cervical spine.
The Construx Mini PEEK device is used singly and is implanted using an anterior approach.
When used as a Partial Vertebral Body Replacement (VBR) System the Construx Mini PEEK System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Construx Mini PEEK System is also indicated for treating fractures of the thoracic and lumbar spine.
The Construx Mini PEEK System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. The Partial VBR device is intended to be used with autograft or allograft.
The Construx Mini PEEK System is intended for use with internal fixation. The supplemental internal fixation system that may be used with the Construx Mini PEEK System is the Blackstone Medical Spinal Fixation System (SFS) or the Firebird Spinal Fixation System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101812 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101812: Construx Mini Peek Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101812
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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