# K021511: Cytoflex Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Unicare Biomedical, Inc.
- Decided: Aug 6, 2002 after 89 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Precision Titanium Foil: named in the summary without a submission number
- (no number) Osteomed MSS: named in the summary without a submission number
- (no number) Micro-Titanium Augmentation Mesh: named in the summary without a submission number
- (no number) Ti Mini Bone Plate and Screws: named in the summary without a submission number
- (no number) Reconstructive Surgery System: named in the summary without a submission number
- (no number) Osteogenics Cytoplast GBR: named in the summary without a submission number
- (no number) Imtec BioBarrier membrane: named in the summary without a submission number
- (no number) Gore-tex Regenerative Material: named in the summary without a submission number

## Most influential descendants
- K141764: Tristar Bone Graft Fixation System (2014), 3 descendants of its own
- K170697: GBR system (2018), 2 descendants of its own
- K222367: Save GBR (2023), 0 descendants of its own
- K182759: BoniPlus Dental G-Mesh System (2020), 0 descendants of its own

## Indications for use
For use to ensure three-dimensional reconstruction of alveolar bone defects and to facilitate augmentation with adequate fixation of the augmentation material.

Source page: https://510kreport.com/device/K021511
Methodology: https://510kreport.com/methodology