# K014200: Optimesh

- Pathway: 510(k) (Traditional)
- Applicant: Spineology, Inc.
- Decided: Nov 26, 2003 after 705 days
- Product code: EZX (Mesh, Surgical, Metal)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010911 (2001). 1 ancestor in all.
5 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010911: Macropore OS Spinal System, Macropore Biosurgery, Inc. (2001) Summary page 4.
- (no number) MERSILENE Mesh: named in the summary without a submission number

## Most influential descendants
- K082079: Regen Collagen Scaffold (CS) (2008), 2 descendants of its own
- K170364: Collagen Meniscus Implant XL (2017), 1 descendant of its own
- K242302: RejuvaKnee™ Collagen Meniscus Implant (2024), 0 descendants of its own
- K063461: Anova Containment Device (2009), 0 descendants of its own
- K033953: Optimesh 500E Cement Restrictor (2004), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K014200
Methodology: https://510kreport.com/methodology