510(k) · Cleared
ClearedMecta-C Stand Alone Extension
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 Nov 6, 2020 as substantially equivalent to K192906 (Medacta International S.A., 2020) and 1 other predicate after a 24-day review. Its family tree reaches back 18 generations to 1984. 1 of the 260 devices in its family, counting itself, has a Class I recall.
- Decided
- Nov 6, 2020
- Review
- 24 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 18 generations to K841189 (1984). 259 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet. 1 of the 260 devices in this family, counting this one, has a Class I recall.
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations between
- 3 generations backK142744 Mecta-C TiPEEKMedacta International · 2015
- 2 generations backK160605 MectaLIF Anterior Stand-AloneMedacta International · 2016
- 1 generation backK192906 Mecta-C Stand AloneMedacta International S.A. · 2020
- This deviceK203076 Mecta-C Stand Alone ExtensionMedacta International S.A. · 2020
Show all 18 generations
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 17 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 16 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 15 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 12 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 11 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 8 generations backK100175 Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010
- 7 generations backK110927 MectalifMedacta International · 2011 · Recalled
- 6 generations backK120024 Mectalif TransforaminalMedacta International S.A. · 2012
- 5 generations backK131671 MectalifMedacta International · 2013
- 4 generations backK133192 Mectalif TipeekMedacta International · 2014
- 3 generations backK142744 Mecta-C TiPEEKMedacta International · 2015
- 2 generations backK160605 MectaLIF Anterior Stand-AloneMedacta International · 2016
- 1 generation backK192906 Mecta-C Stand AloneMedacta International S.A. · 2020
- This deviceK203076 Mecta-C Stand Alone ExtensionMedacta International S.A. · 2020
Class I recalls in this family
- K073202 Ardis Spacer7 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −17 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −16 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −15 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −12 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −11 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −8 | K100175 | Clydesdale Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −7 | K110927 | Mectalif | Medacta International | 2011 | 1 |
| −6 | K120024 | Mectalif Transforaminal | Medacta International S.A. | 2012 | — |
| −5 | K131671 | Mectalif | Medacta International | 2013 | — |
| −4 | K133192 | Mectalif Tipeek | Medacta International | 2014 | — |
| −3 | K142744 | Mecta-C TiPEEK | Medacta International | 2015 | — |
| −2 | K160605 | MectaLIF Anterior Stand-Alone | Medacta International | 2016 | — |
| −1 | K192906 | Mecta-C Stand Alone | Medacta International S.A. | 2020 | — |
| 0 (this device) | 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 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 6 | 0 |
| 2000 | 4 | 0 |
| 2001 | 12 | 0 |
| 2002 | 11 | 0 |
| 2003 | 14 | 0 |
| 2004 | 25 | 0 |
| 2005 | 17 | 0 |
| 2006 | 11 | 0 |
| 2007 | 14 | 0 |
| 2008 | 35 | 1 |
| 2009 | 18 | 0 |
| 2010 | 12 | 0 |
| 2011 | 12 | 0 |
| 2012 | 9 | 0 |
| 2013 | 10 | 0 |
| 2014 | 9 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 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? (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 |
|---|---|---|---|
| * | K192906 | Mecta-C Stand AloneSummary page 4…Number: 21 CFR 888.3080 Device Classification II III. Predicate Device Primary predicate: Medacta International SA, Mecta-C Stand Alone, K192906 Additional predicate: Globus Medical Inc., Coalition MIS with Screws Coalition AGX, K173115 IV. Device Descript… | 2020 |
| * | K173115 | COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Summary page 4…ary predicate: Medacta International SA, Mecta-C Stand Alone, K192906 Additional predicate: Globus Medical Inc., Coalition MIS with Screws Coalition AGX, K173115 IV. Device Description The Mecta-C Stand Alone implants are the same of the predicate device, Mecta-C Stand Alone cleared… | 2017 |
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 · 7 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.
- 34 of the 259 ancestors have a recall of any class; 1 has a Class I recall.
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 for one level or two contiguous levels 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 autograft bone and/or allogenic bone graft composed of cancellous, cortical and/or corticocancellous bone graft and implanted via an anterior approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203076 · printed Nov 4, 2026
Cite this page
510(k) Report. “K203076: Mecta-C Stand Alone Extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K203076
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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