510(k) · Cleared
ClearedMecta-C with titanium markers and Mecta-C TiPEEK with titanium markers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Sep 18, 2017 as substantially equivalent to K112862 (Medacta International, 2011) and 1 other predicate after a 21-day review. Its family tree reaches back 16 generations to 1984. 1 of the 102 devices in its family, counting itself, has a Class I recall.
- Decided
- Sep 18, 2017
- Review
- 21 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 16 generations to K841189 (1984). 101 ancestors in all. No later device cites it as a predicate yet. 1 of the 102 devices in this family, counting this one, has a Class I recall.
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations between
- 3 generations backK131671 MectalifMedacta International · 2013
- 2 generations backK133192 Mectalif TipeekMedacta International · 2014
- 1 generation backK142744 Mecta-C TiPEEKMedacta International · 2015
- This deviceK172587 Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A. · 2017
Show all 16 generations
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 14 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 13 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 10 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 9 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 7 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 6 generations backK100175 Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010
- 5 generations backK110927 MectalifMedacta International · 2011 · Recalled
- 4 generations backK120024 Mectalif TransforaminalMedacta International S.A. · 2012
- 3 generations backK131671 MectalifMedacta International · 2013
- 2 generations backK133192 Mectalif TipeekMedacta International · 2014
- 1 generation backK142744 Mecta-C TiPEEKMedacta International · 2015
- This deviceK172587 Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A. · 2017
Class I recalls in this family
- K073202 Ardis Spacer4 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −15 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −14 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −13 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −10 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −9 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −7 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −6 | K100175 | Clydesdale Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −5 | K110927 | Mectalif | Medacta International | 2011 | 1 |
| −4 | K120024 | Mectalif Transforaminal | Medacta International S.A. | 2012 | — |
| −3 | K131671 | Mectalif | Medacta International | 2013 | — |
| −2 | K133192 | Mectalif Tipeek | Medacta International | 2014 | — |
| −1 | K142744 | Mecta-C TiPEEK | Medacta International | 2015 | — |
| 0 (this device) | K172587 | Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers | Medacta International S.A. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 8 | 0 |
| 2003 | 8 | 0 |
| 2004 | 12 | 0 |
| 2005 | 9 | 0 |
| 2006 | 2 | 0 |
| 2007 | 6 | 0 |
| 2008 | 13 | 1 |
| 2009 | 8 | 0 |
| 2010 | 3 | 0 |
| 2011 | 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? (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 |
|---|---|---|---|
| * | K112862 | Mecta-CSummary page 4…on Number: 21 CFR 888.3080 Device Classification 2 III. Predicate Device Substantial equivalence is claimed to the following devices: x Mecta-C, K112862, Medacta International SA x Mecta-C TiPEEK, K142744, Medacta International SA IV. Device Description The purpose of this… | 2011 |
| * | K142744 | Mecta-C TiPEEKSummary page 4…tion 2 III. Predicate Device Substantial equivalence is claimed to the following devices: x Mecta-C, K112862, Medacta International SA x Mecta-C TiPEEK, K142744, Medacta International SA IV. Device Description The purpose of this submission is to add the Mecta-C with titanium markers… | 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)
No FDA recall names this device.
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 · 4 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 11 companies; a new generation was cleared every 1.3 years on median.
- 15 of the 101 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K112862.
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 Mecta-C intervertebral body fusion device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with supplemental spinal fixation. The Mecta-C device is intended for use at one level in the cervical spine, from C2-T1, for the treatment of…
Read the full statement (116 words)
The Mecta-C intervertebral body fusion device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with supplemental spinal fixation.
The Mecta-C device is intended for use at one level in the cervical spine, from C2-T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment prior to treatment with the device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172587 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172587: Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172587
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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