510(k) · Cleared
Recalled · Class III · 2020InTice™-C Porous Ti Cervical Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
X-Spine Systems, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on May 17, 2018 as substantially equivalent to K171075 (X-Spine Systems, Inc., 2017) and 2 other predicates after a 150-day review. Its family tree reaches back 17 generations to 2001. 1 of the 228 devices in its family, counting itself, has a Class I recall. It has been recalled once.
- Decided
- May 17, 2018
- Review
- 150 days
- Class
- Class II
- Product code
- ODP
- Recalls
- 1
- Predicates
- 3
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. 1 of the 228 devices in this family, counting this one, has a Class I recall.
- 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 backK161280 Cervical Stand Alone SystemOrthofix, Inc. · 2016
- 1 generation backK162944 Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc. · 2016
- This deviceK173832 InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc. · 2018
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 backK161280 Cervical Stand Alone SystemOrthofix, Inc. · 2016
- 1 generation backK162944 Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc. · 2016
- This deviceK173832 InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc. · 2018
Class I recalls in this family
- K073202 Ardis Spacer3 generations back · 2008
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 | K161280 | Cervical Stand Alone System | Orthofix, Inc. | 2016 | — |
| −1 | K162944 | Irix-C Cervical Integrated Fusion System | X-Spine Systems, Inc. | 2016 | — |
| 0 (this device) | K173832 | InTice™-C Porous Ti Cervical Interbody System | X-Spine Systems, Inc. | 2018 | — |
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 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 11 | 0 |
| 2002 | 8 | 0 |
| 2003 | 15 | 0 |
| 2004 | 25 | 0 |
| 2005 | 14 | 0 |
| 2006 | 8 | 0 |
| 2007 | 16 | 0 |
| 2008 | 27 | 1 |
| 2009 | 17 | 0 |
| 2010 | 8 | 0 |
| 2011 | 11 | 0 |
| 2012 | 10 | 0 |
| 2013 | 7 | 0 |
| 2014 | 8 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 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.
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 |
|---|---|---|---|
| * | K171075 | Calix-C Cervical Interbody SpacerSummary page 5…s to submit a new medical device for review. VI. PRIMARY PREDICATE DEVICE Primary Predicate Device: X‐spine, Inc.: Calix‐C™ Cervical Interbody Spacer – K171075 VII. ADDITIONAL PREDICATE DEVICES • X‐spine, Inc.: Irix‐C™ Cervical Integrated Fusion System – K162944 •… | 2017 |
| * | K162944 | Irix-C Cervical Integrated Fusion SystemSummary page 5…X‐spine, Inc.: Calix‐C™ Cervical Interbody Spacer – K171075 VII. ADDITIONAL PREDICATE DEVICES • X‐spine, Inc.: Irix‐C™ Cervical Integrated Fusion System – K162944 • FortiCore™ ‐‐ K161485 [Cervical Intervertebral Body Fusion Device] VIII. REFERENCE DEVICE Arthrex BioSync… | 2016 |
| * | K161485 | Nanovis Intervertebral Body Fusion System and Forticore (R)Summary page 5…Interbody Spacer – K171075 VII. ADDITIONAL PREDICATE DEVICES • X‐spine, Inc.: Irix‐C™ Cervical Integrated Fusion System – K162944 • FortiCore™ ‐‐ K161485 [Cervical Intervertebral Body Fusion Device] VIII. REFERENCE DEVICE Arthrex BioSync Bone Wedge K151256 IX. INDI… | 2016 |
| † | K151256 | Arthrex BioSync® Bone Wedge | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 30, 2020 | Class III | Z-0429-2021 | Labeling mix-ups | Cervical Implants contain a label that incorrectly identifies the grade of titanium used. |
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 17 years and passes through 9 companies; a new generation was cleared every 10 months on median.
- 26 of the 227 ancestors have a recall of any class; 1 has a Class I recall.
- 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. 2018, 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 InTice™-C Porous Ti Cervical Interbody System is intended for spinal fusion procedures at one level (C2 – T1 inclusive) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autograft and/or allograft comprised of cancellous…
Read the full statement (128 words)
The InTice™-C Porous Ti Cervical Interbody System is intended for spinal fusion procedures at one level (C2 – T1 inclusive) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Patients should receive at least six (6) weeks non-operative treatment prior to treatment with the InTice™-C Porous Ti Cervical Interbody System.
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine (i.e. posterior cervical screw and rod systems and anterior cervical plate systems).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173832 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173832: InTice™-C Porous Ti Cervical Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173832
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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