510(k) · Cleared
ClearedMecta-C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Dec 19, 2011 as substantially equivalent to K101363 (Musculoskeletal Clinical Regulatory Advisers, 2010) and 6 other predicates after an 80-day review. Its family tree reaches back 13 generations to 2001. 1 of the 106 devices in its family, counting itself, has a Class I recall. 14 later devices descend from it.
- Decided
- Dec 19, 2011
- Review
- 80 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 13 generations to K003155 (2001). 91 ancestors in all, the oldest K841189 (1984). 14 later devices descend from it, 3 citing it directly. 1 of the 106 devices in this family, counting this one, has a Class I recall.
- Root · 13 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 9 generations between
- 3 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 2 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 1 generation backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- This deviceK112862 Mecta-CMedacta International · 2011
- Descendant · cites it directly · 12 of its ownK142744 Mecta-C TiPEEKMedacta International · 2015
- Descendant · 2 generations on · 10 of its ownK160605 MectaLIF Anterior Stand-AloneMedacta International · 2016
- Descendant · 3 generations on · 4 of its ownK170455 MectaLIF Anterior Stand AloneMedacta International S.A. · 2017
- Descendant · 3 generations on · 2 of its ownK221545 MectaLIF Anterior ExtensionMedacta International S.A. · 2022 · Recalled
- Descendant · 4 generations on · 1 of its ownK232123 MectaLIF Anterior Lag ExtensionMedacta International S.A. · 2023
Show all 13 generations
- Root · 13 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 12 generations backK012254 VBROsteotech, Inc. · 2001
- 11 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 10 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 9 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 8 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 7 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 6 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 5 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 4 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 3 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 2 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 1 generation backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- This deviceK112862 Mecta-CMedacta International · 2011
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer3 generations back · 2008
Most influential descendants
Showing 5 of 14 · See all- K142744Mecta-C TiPEEKMedacta International · 2015 · cites it directly12descendants
- K160605MectaLIF Anterior Stand-AloneMedacta International · 2016 · 2 generations on10descendants
- K170455MectaLIF Anterior Stand AloneMedacta International S.A. · 2017 · 3 generations on4descendants
- K221545MectaLIF Anterior ExtensionMedacta International S.A. · 2022 · 3 generations on2descendants
- K232123MectaLIF Anterior Lag ExtensionMedacta International S.A. · 2023 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −12 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −11 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −10 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −9 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −8 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −7 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −6 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −5 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −4 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −3 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| −2 | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | Aesculap Implant Systems, Inc. | 2009 | — |
| −1 | K100889 | Endoskeleton TC | Titan Spine, LLC | 2010 | — |
| 0 (this device) | K112862 | Mecta-C | Medacta International | 2011 | — |
| +1 | K142744 | Mecta-C TiPEEK | Medacta International | 2015 | — |
| +2 | K160605 | MectaLIF Anterior Stand-Alone | Medacta International | 2016 | — |
| +3 | K170455 | MectaLIF Anterior Stand Alone | Medacta International S.A. | 2017 | — |
| +3 | K221545 | MectaLIF Anterior Extension | Medacta International S.A. | 2022 | 6 |
| +4 | K232123 | MectaLIF Anterior Lag Extension | Medacta International S.A. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1996 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 6 | 0 |
| 2003 | 9 | 0 |
| 2004 | 13 | 0 |
| 2005 | 6 | 0 |
| 2006 | 1 | 0 |
| 2007 | 8 | 0 |
| 2008 | 13 | 1 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (7)
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 |
|---|---|---|---|
| * | K101363 | VU Cpod Intervertebral Bodu Fusion DeviceSummary page 1…21 OFR 888.3060 Class 11 Device Product Codes: ODP Predicate Devices: K101363 Theken Spine Vu cPOD P980048 Centerpulse Spine-Tech BAK-C K081917 Depuy Spine Bengal Cage… | 2010 |
| * | P980048 | Bak/Cervical (Bak/C) Interbody Fusion SystemSummary page 1…Class 11 Device Product Codes: ODP Predicate Devices: K101363 Theken Spine Vu cPOD P980048 Centerpulse Spine-Tech BAK-C K081917 Depuy Spine Bengal Cage K110927 Medacta MectaLiF… | 2001 |
| * | K081917 | Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsSummary page 1…Device Product Codes: ODP Predicate Devices: K101363 Theken Spine Vu cPOD P980048 Centerpulse Spine-Tech BAK-C K081917 Depuy Spine Bengal Cage K110927 Medacta MectaLiF K083311 Aesculap CeSpace… | 2009 |
| * | K110927 | MectalifSummary page 1…icate Devices: K101363 Theken Spine Vu cPOD P980048 Centerpulse Spine-Tech BAK-C K081917 Depuy Spine Bengal Cage K110927 Medacta MectaLiF K083311 Aesculap CeSpace K073177 Pioneer Intervertebral Body Fusion System… | 2011 |
| * | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion SystemSummary page 1…P980048 Centerpulse Spine-Tech BAK-C K081917 Depuy Spine Bengal Cage K110927 Medacta MectaLiF K083311 Aesculap CeSpace K073177 Pioneer Intervertebral Body Fusion System K1 00889 - Titan Spine E… | 2009 |
| * | K073177 | Pioneer Intervertebral Fusion Device SystemSummary page 1…-Tech BAK-C K081917 Depuy Spine Bengal Cage K110927 Medacta MectaLiF K083311 Aesculap CeSpace K073177 Pioneer Intervertebral Body Fusion System K1 00889 - Titan Spine Endoskeleton TO Mecta-O 510(k)… | 2008 |
| * | K100889 | Endoskeleton TCSummary page 1…K110927 Medacta MectaLiF K083311 Aesculap CeSpace K073177 Pioneer Intervertebral Body Fusion System K1 00889 - Titan Spine Endoskeleton TO Mecta-O 510(k) Section 5 -Page 2 of 4 === Pa… | 2010 |
What descends from it? (14)
See all 143 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 3 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 10 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 13 of the 91 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K142744 (Medacta International, 2015) has gone furthest, with 12 descendants of its own.
- 4 other devices also cite its predicate K101363.
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. 2011, 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 02-Ti, 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 02-Ti, 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/K112862 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112862: Mecta-C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112862
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