510(k) · Cleared
ClearedMOD-C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthomod, LLC · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Apr 1, 2026 as substantially equivalent to K171075 (X-Spine Systems, Inc., 2017) and 3 other predicates after a 604-day review. Its family tree reaches back 17 generations to 2001.
- Decided
- Apr 1, 2026
- Review
- 604 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 17 generations to K003155 (2001). 227 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet.
- Root · 17 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 13 generations between
- 3 generations backK142152 Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand…Orthofix, Inc. · 2015
- 2 generations backK151064 Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System…Biomet Spine · 2015
- 1 generation backK171075 Calix-C Cervical Interbody SpacerX-Spine Systems, Inc. · 2017
- This deviceK242303 MOD-COrthomod, LLC · 2026
Show all 17 generations
- Root · 17 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 16 generations backK012254 VBROsteotech, Inc. · 2001
- 15 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 14 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 13 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 12 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 11 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 10 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 9 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 8 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 7 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 6 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 5 generations backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- 4 generations backK121649 Construx Mini Peek TI Spacer SystemOrthofix · 2012
- 3 generations backK142152 Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand…Orthofix, Inc. · 2015
- 2 generations backK151064 Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System…Biomet Spine · 2015
- 1 generation backK171075 Calix-C Cervical Interbody SpacerX-Spine Systems, Inc. · 2017
- This deviceK242303 MOD-COrthomod, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −16 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −15 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −14 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −13 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −12 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −11 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −10 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −9 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −8 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −7 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| −6 | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | Aesculap Implant Systems, Inc. | 2009 | — |
| −5 | K100889 | Endoskeleton TC | Titan Spine, LLC | 2010 | — |
| −4 | K121649 | Construx Mini Peek TI Spacer System | Orthofix | 2012 | — |
| −3 | K142152 | Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone System | Orthofix, Inc. | 2015 | — |
| −2 | K151064 | Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System… | Biomet Spine | 2015 | — |
| −1 | K171075 | Calix-C Cervical Interbody Spacer | X-Spine Systems, Inc. | 2017 | — |
| 0 (this device) | K242303 | MOD-C | Orthomod, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1996 | 6 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 11 | 0 |
| 2002 | 8 | 0 |
| 2003 | 15 | 0 |
| 2004 | 25 | 0 |
| 2005 | 14 | 0 |
| 2006 | 10 | 0 |
| 2007 | 15 | 0 |
| 2008 | 27 | 0 |
| 2009 | 19 | 0 |
| 2010 | 8 | 0 |
| 2011 | 12 | 0 |
| 2012 | 10 | 0 |
| 2013 | 6 | 0 |
| 2014 | 7 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 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 |
|---|---|---|---|
| * | K171075 | Calix-C Cervical Interbody SpacerSummary page 5…iewing Office Office of Health Technology 6 (Orthopedic Devices) Reviewing Division Division of Spinal Devices PREDICATE DEVICE INFORMATION K171075, Calix-C™ Cervical Interbody Spacer, X-Spine Systems, Inc. K181115, CxHA™ PEEK Cervical IBF System, Innovasis, Inc. K142264,… | 2017 |
| * | K181115 | CxHA PEEK Cervical IBF SystemSummary page 5…c Devices) Reviewing Division Division of Spinal Devices PREDICATE DEVICE INFORMATION K171075, Calix-C™ Cervical Interbody Spacer, X-Spine Systems, Inc. K181115, CxHA™ PEEK Cervical IBF System, Innovasis, Inc. K142264, Valeo™ Spacer System, Valeo™ II Interbody Fusion Device System, AME… | 2018 |
| * | K142264 | Valeo C Spacer System, Valeo II C IBF DeviceSummary page 5…al Devices PREDICATE DEVICE INFORMATION K171075, Calix-C™ Cervical Interbody Spacer, X-Spine Systems, Inc. K181115, CxHA™ PEEK Cervical IBF System, Innovasis, Inc. K142264, Valeo™ Spacer System, Valeo™ II Interbody Fusion Device System, AMEDICA® Corporation K111264 CORNERSTONE® PSR Cervical Fusi… | 2014 |
| * | K111264 | Cornerstone (R) PSR Cervical Fusion SystemSummary page 5…Systems, Inc. K181115, CxHA™ PEEK Cervical IBF System, Innovasis, Inc. K142264, Valeo™ Spacer System, Valeo™ II Interbody Fusion Device System, AMEDICA® Corporation K111264 CORNERSTONE® PSR Cervical Fusion System, Medtronic Sofamor Danek USA The primary predicate device is K171075. K181115, K14226… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 11 companies; a new generation was cleared every 10 months on median.
- 24 of the 227 ancestors have a recall of any class.
- 4 other devices also cite its predicate K171075.
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. 2026, 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 Orthomod MOD-C™ Cervical IBF System is indicated for cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The MOD-C device is to be used with supplemental fixation, such as a cervical plate system. The MOD-C device is designed for use with autogenous and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion and is to be implanted via an anterior approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242303 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242303: MOD-C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242303
Report an extraction error
Are you the manufacturer?
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