510(k) · Cleared
ClearedMecta-C Stand Alone
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Mar 4, 2020 as substantially equivalent to K112459 (Synthes Spine Co.Lp, 2011) and 7 other predicates after a 141-day review. Its family tree reaches back 17 generations to 1984. 1 of the 160 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Mar 4, 2020
- Review
- 141 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 17 generations to K841189 (1984). 158 ancestors in all, the oldest K792352 (1979). 1 later device descends from it, 1 citing it directly. 1 of the 160 devices in this family, counting this one, has a Class I recall.
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations between
- 3 generations backK133192 Mectalif TipeekMedacta International · 2014
- 2 generations backK142744 Mecta-C TiPEEKMedacta International · 2015
- 1 generation backK160605 MectaLIF Anterior Stand-AloneMedacta International · 2016
- This deviceK192906 Mecta-C Stand AloneMedacta International S.A. · 2020
- Descendant · cites it directly · 0 of its ownK203076 Mecta-C Stand Alone ExtensionMedacta International S.A. · 2020
Show all 17 generations
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 15 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 14 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 11 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 10 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 7 generations backK100175 Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010
- 6 generations backK110927 MectalifMedacta International · 2011 · Recalled
- 5 generations backK120024 Mectalif TransforaminalMedacta International S.A. · 2012
- 4 generations backK131671 MectalifMedacta International · 2013
- 3 generations backK133192 Mectalif TipeekMedacta International · 2014
- 2 generations backK142744 Mecta-C TiPEEKMedacta International · 2015
- 1 generation backK160605 MectaLIF Anterior Stand-AloneMedacta International · 2016
- This deviceK192906 Mecta-C Stand AloneMedacta International S.A. · 2020
Class I recalls in this family
- K073202 Ardis Spacer6 generations back · 2008
Most influential descendants
Showing 1 of 1 · See all- K203076Mecta-C Stand Alone ExtensionMedacta International S.A. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −16 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −15 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −14 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −11 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −10 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −7 | K100175 | Clydesdale Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −6 | K110927 | Mectalif | Medacta International | 2011 | 1 |
| −5 | K120024 | Mectalif Transforaminal | Medacta International S.A. | 2012 | — |
| −4 | K131671 | Mectalif | Medacta International | 2013 | — |
| −3 | K133192 | Mectalif Tipeek | Medacta International | 2014 | — |
| −2 | K142744 | Mecta-C TiPEEK | Medacta International | 2015 | — |
| −1 | K160605 | MectaLIF Anterior Stand-Alone | Medacta International | 2016 | — |
| 0 (this device) | K192906 | Mecta-C Stand Alone | Medacta International S.A. | 2020 | — |
| +1 | K203076 | Mecta-C Stand Alone Extension | Medacta International S.A. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 11 | 0 |
| 2002 | 10 | 0 |
| 2003 | 10 | 0 |
| 2004 | 21 | 0 |
| 2005 | 15 | 0 |
| 2006 | 6 | 0 |
| 2007 | 9 | 0 |
| 2008 | 24 | 1 |
| 2009 | 11 | 0 |
| 2010 | 6 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 OVE device
- #1 K241846 E3D™-C Interbody Systemscore 32.1 · 32 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (8)
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 |
|---|---|---|---|
| * | K112459 | Synthes Zero-PSummary page 4…0 Device Classification II III. Predicate Device Substantial equivalence is claimed to the following devices: Primary predicate device: Synthes Zero-P, K112459, Synthes Spine Additional predicate devices: MectaLIF Anterior, K124034, Medacta International SA MectaLIF Anterior St… | 2011 |
| * | K124034 | Mectalif AnteriorSummary page 4…alence is claimed to the following devices: Primary predicate device: Synthes Zero-P, K112459, Synthes Spine Additional predicate devices: MectaLIF Anterior, K124034, Medacta International SA MectaLIF Anterior Stand-Alone, K160605, Medacta International SA STALIF C, K120819, Centinel… | 2013 |
| * | K160605 | MectaLIF Anterior Stand-AloneSummary page 4… Synthes Zero-P, K112459, Synthes Spine Additional predicate devices: MectaLIF Anterior, K124034, Medacta International SA MectaLIF Anterior Stand-Alone, K160605, Medacta International SA STALIF C, K120819, Centinel Spine STALIF C, K072415, Centinel Spine Anchor C, K102606, S… | 2016 |
| * | K120819 | Stalif CSummary page 4…itional predicate devices: MectaLIF Anterior, K124034, Medacta International SA MectaLIF Anterior Stand-Alone, K160605, Medacta International SA STALIF C, K120819, Centinel Spine STALIF C, K072415, Centinel Spine Anchor C, K102606, Stryker Spine Mosaic-C, K133218, Spinal Eleme… | 2012 |
| * | K072415 | Stalif (TM) CSummary page 4…F Anterior, K124034, Medacta International SA MectaLIF Anterior Stand-Alone, K160605, Medacta International SA STALIF C, K120819, Centinel Spine STALIF C, K072415, Centinel Spine Anchor C, K102606, Stryker Spine Mosaic-C, K133218, Spinal Elements Mosaic-C, K071833, Spinal Elem… | 2008 |
| * | K102606 | Avs Anchor-C Cervical Cage SystemSummary page 4…nal SA MectaLIF Anterior Stand-Alone, K160605, Medacta International SA STALIF C, K120819, Centinel Spine STALIF C, K072415, Centinel Spine Anchor C, K102606, Stryker Spine Mosaic-C, K133218, Spinal Elements Mosaic-C, K071833, Spinal Elements IV. Device Description The Me… | 2011 |
| * | K133218 | Crystal ®; Mosaic ®; Vertu ®Summary page 4…one, K160605, Medacta International SA STALIF C, K120819, Centinel Spine STALIF C, K072415, Centinel Spine Anchor C, K102606, Stryker Spine Mosaic-C, K133218, Spinal Elements Mosaic-C, K071833, Spinal Elements IV. Device Description The Mecta-C Stand Alone implants are a line… | 2014 |
| * | K071833 | Mosaic DevicesSummary page 4… STALIF C, K120819, Centinel Spine STALIF C, K072415, Centinel Spine Anchor C, K102606, Stryker Spine Mosaic-C, K133218, Spinal Elements Mosaic-C, K071833, Spinal Elements IV. Device Description The Mecta-C Stand Alone implants are a line extension to Medacta’s anterior cervical… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203076 | Mecta-C Stand Alone Extension | 2020 | 0 |
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 · 6 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 36 years and passes through 11 companies; a new generation was cleared every 1.2 years on median.
- 23 of the 158 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K203076 (Medacta International S.A., 2020) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K112459.
How does its category compare?
All OVE devicesOVE Intervertebral Fusion Device With Integrated Fixation, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · OVE
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVE
105in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVE
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVE
132in 2025
MAUDE reports naming product code OVE, 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 | 1 | — | 0 | 0 |
| 2008 | 4 | 131 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 4 | 210 | 0 | 2 |
| 2011 | 8 | 139 | 0 | 19 |
| 2012 | 7 | 125 | 0 | 59 |
| 2013 | 5 | 71 | 1 | 250 |
| 2014 | 11 | 168 | 1 | 150 |
| 2015 | 12 | 113 | 1 | 173 |
| 2016 | 15 | 149 | 1 | 145 |
| 2017 | 9 | 100 | 1 | 134 |
| 2018 | 7 | 105 | 0 | 210 |
| 2019 | 7 | 87 | 0 | 169 |
| 2020 | 13 | 149 | 0 | 162 |
| 2021 | 10 | 93 | 2 | 186 |
| 2022 | 10 | 144 | 0 | 200 |
| 2023 | 16 | 97 | 0 | 148 |
| 2024 | 6 | 56 | 0 | 142 |
| 2025 | 10 | 105 | 0 | 132 |
| 2026 | 13 | 66 | 0 | — |
What is it indicated for?
The Mecta-C Stand Alone is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the spacer component of the Mecta-C Stand Alone should be packed with autogenous bone graft and implanted via an anterior approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192906 · printed Nov 4, 2026
Cite this page
510(k) Report. “K192906: Mecta-C Stand Alone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K192906
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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