# K983528: Micro Dynamic Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Dec 23, 1998 after 76 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.
13 later devices descend from it; 2 cite it directly.
0 of 14 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) TiMesh™ System (TiMesh Inc. & Sofamor Danek USA): named in the summary without a submission number
- (no number) 1.5/2.0 Combination Titanium Osteosynthesis System (Walter Lorenz): named in the summary without a submission number
- (no number) Osteomed’s TRAM™: named in the summary without a submission number

## Most influential descendants
- K112557: Stryker Universal Neuro 3 System (2012), 9 descendants of its own
- K120352: Stryker Quikflap Sterile Procedure Pack (2012), 4 descendants of its own
- K113109: Stryker Resorbable Fixation System (2011), 3 descendants of its own
- K213777: Stryker Resorbable Fixation System (2022), 2 descendants of its own
- K151387: Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade (2015), 2 descendants of its own

## Indications for use
Micro Dynamic Mesh is intended to stabilize fractures, grafts and elective osteotomies for the reconstruction of the bones of the craniomaxillofacial skeleton, and the oral cavity (including the mandible and maxilla).

Source page: https://510kreport.com/device/K983528
Methodology: https://510kreport.com/methodology