510(k) · Cleared
ClearedConstrux Mini Peek TI Spacer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthofix · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Nov 29, 2012 as substantially equivalent to K101812 (Orthofix, Inc., 2010) and 1 other predicate after a 177-day review. Its family tree reaches back 13 generations to 2001. 289 later devices descend from it.
- Decided
- Nov 29, 2012
- Review
- 177 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K003155 (2001). 76 ancestors in all, the oldest K841189 (1984). 289 later devices descend from it, 3 citing it directly.
- Root · 13 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 9 generations between
- 3 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 2 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 1 generation backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- This deviceK121649 Construx Mini Peek TI Spacer SystemOrthofix · 2012
- 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
- Descendant · 4 generations on · 129 of its ownK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- Descendant · 2 generations on · 107 of its ownK150619 CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc. · 2015
Show all 13 generations
- Root · 13 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 12 generations backK012254 VBROsteotech, Inc. · 2001
- 11 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 10 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 9 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 8 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 7 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 6 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 5 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 4 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 3 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 2 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 1 generation backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- This deviceK121649 Construx Mini Peek TI Spacer SystemOrthofix · 2012
Showing 5 of 289 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 289 · See all- 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
- K171496Tritanium C Anterior Cervical CageStryker Spine · 2017 · 4 generations on129descendants
- K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc. · 2015 · 2 generations on107descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −12 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −11 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −10 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −9 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −8 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −7 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −6 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −5 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −4 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −3 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| −2 | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | Aesculap Implant Systems, Inc. | 2009 | — |
| −1 | K100889 | Endoskeleton TC | Titan Spine, LLC | 2010 | — |
| 0 (this device) | K121649 | Construx Mini Peek TI Spacer System | Orthofix | 2012 | — |
| +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 | — |
| +4 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| +2 | K150619 | CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System | Orthofix, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 6 | 0 |
| 2003 | 9 | 0 |
| 2004 | 14 | 0 |
| 2005 | 7 | 0 |
| 2007 | 4 | 0 |
| 2008 | 6 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K101812 | Construx Mini Peek Spacer SystemSummary page 1…Class 11- 21CFR 888.3080 - Intervertebral body fusion device Review Panel: .Orthopedic Device Panel Predicate Devices: K1 01812 - CONSTRUX Mini PEEK Spacer System, SE 9-27-10 K100… | 2010 |
| * | K100889 | Endoskeleton TCSummary page 1…dicate Devices: K1 01812 - CONSTRUX Mini PEEK Spacer System, SE 9-27-10 K100889 - Titan Spine Endoskeleton TC, SE 7-29-10 Reason for 51 0(k) Submission: New product offering Device Description… | 2010 |
What descends from it? (289)
See all 2893 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 11 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 5 of the 76 ancestors have a recall of any class.
- Of its descendants, K142152 (Orthofix, Inc., 2015) has gone furthest, with 280 descendants of its own.
- 2 other devices also cite its predicate K101812.
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. 2012, 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 PEEK Ti Spacer System is indicated for spinal fusion procedures at one level in the cervical spine (02-Ti), in skeletally mature patients with degenerative disc disease (DODD). DOD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.
The CONSTRUX Mini PEEK Ti Spacer System is intended for use with autograft and supplemental fixation system (i.e. anterior cervical plate such as the Orthofix ACPor Hallmark® 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 Ti Spacer System in the cervical spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121649 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121649: Construx Mini Peek TI 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/K121649
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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