510(k) · Decided
DecidedOptimesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spineology, Inc. · EZX Mesh, Surgical, Metal
Cleared on Nov 26, 2003 as substantially equivalent to K010911 (Macropore Biosurgery, Inc., 2001) after a 705-day review. Its family tree reaches back 1 generation to 2001. 5 later devices descend from it.
- Decided
- Nov 26, 2003
- Review
- 705 days
- Class
- Class II
- Product code
- EZX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010911 (2001). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK010911 Macropore OS Spinal SystemMacropore Biosurgery, Inc. · 2001
- This deviceK014200 OptimeshSpineology, Inc. · 2003
- Descendant · cites it directly · 2 of its ownK082079 Regen Collagen Scaffold (CS)Regen Biologics, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK170364 Collagen Meniscus Implant XLIvy Sports Medicine, LLC · 2017
- Descendant · 3 generations on · 0 of its ownK242302 RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK063461 Anova Containment DeviceAnova Corporation · 2009
- Descendant · cites it directly · 0 of its ownK033953 Optimesh 500E Cement RestrictorSpineology, Inc. · 2004
Most influential descendants
Showing 5 of 5 · See all- K082079Regen Collagen Scaffold (CS)Regen Biologics, Inc. · 2008 · cites it directly2descendants
- K170364Collagen Meniscus Implant XLIvy Sports Medicine, LLC · 2017 · 2 generations on1descendant
- K242302RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc. · 2024 · 3 generations on0descendants
- K063461Anova Containment DeviceAnova Corporation · 2009 · cites it directly0descendants
- K033953Optimesh 500E Cement RestrictorSpineology, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010911 | Macropore OS Spinal System | Macropore Biosurgery, Inc. | 2001 | — |
| 0 (this device) | K014200 | Optimesh | Spineology, Inc. | 2003 | — |
| +1 | K082079 | Regen Collagen Scaffold (CS) | Regen Biologics, Inc. | 2008 | — |
| +2 | K170364 | Collagen Meniscus Implant XL | Ivy Sports Medicine, LLC | 2017 | — |
| +3 | K242302 | RejuvaKnee™ Collagen Meniscus Implant | Collagen Matrix, Inc. | 2024 | — |
| +1 | K063461 | Anova Containment Device | Anova Corporation | 2009 | — |
| +1 | K033953 | Optimesh 500E Cement Restrictor | Spineology, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2017 | 1 | 0 |
| 2024 | 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.
Planning a device in EZX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K010911 | Macropore OS Spinal SystemSummary page 4…3300 surgical mesh Device Product Code: KWQ, EZX Predicate Devices The subject device is substantially equivalent to the predicate device, MacroPore OS Spinal System, K010911, and related predicate device, MERSILENE Mesh. a pre- amendment device. Device Description , OptiMesh is a sterile, three-dimen… | 2001 |
| * | — | MERSILENE Mesh Named without a submission number |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All EZX devicesEZX Mesh, Surgical, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EZX
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · EZX
Too few EZX 510(k)s in any year since 2007 to give a median.
Recalls per year · EZX
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EZX
1in 2025
MAUDE reports naming product code EZX, 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 | 4 |
| 2008 | 0 | — | 0 | 8 |
| 2009 | 1 | — | 0 | 5 |
| 2010 | 0 | — | 0 | 8 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 11 |
| 2013 | 0 | — | 0 | 8 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 0 | — | 1 | 9 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 11 |
| 2019 | 0 | — | 0 | 29 |
| 2020 | 0 | — | 0 | 25 |
| 2021 | 0 | — | 0 | 35 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
OptiMesh is intended to maintain the relative position of bone graft material (such as
autograft or allograft) within a vertebral body defect (e.g. tumor) that does not impact the
stability of the vertebral body and does not include the vertebral endplates.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K014200 · printed Nov 3, 2026
Cite this page
510(k) Report. “K014200: Optimesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K014200
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026