# K030069: Synthes Poly (L-Lactide-CO-Glycolide) Resorbable Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Apr 8, 2003 after 90 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 3 cite it directly.
0 of 9 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) Lorenz LactoSorb Trauma Plating System (Biomet): named in the summary without a submission number
- (no number) Synthes Resorbable Fixation System, Poly (L/DL-lactide): named in the summary without a submission number

## Most influential descendants
- K061881: Osteotrans -MX Bioabsorbable Bone Fixation System (2007), 3 descendants of its own
- K073006: Osteotrans -MX Bioabsorbable Bone Fixation System (2008), 2 descendants of its own
- K102656: Synthes Dentoalveolar Bone Fixation System (2010), 1 descendant of its own
- K073115: Orthomesh (2008), 1 descendant of its own
- K192655: Depuy Synthes Maxillofacial Portfolio - MR Conditional (2019), 0 descendants of its own

## Recalls of this device
- May 2, 2016 · Class II · Z-1919-2016: Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.
- May 2, 2016 · Class II · Z-1920-2016: Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.
- May 2, 2016 · Class II · Z-1918-2016: Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.

## Indications for use
Synthes Poly (L-Lactide-co-Glycolide) Resorbable Fixation System devices (Plates, Meshes, Sheets, and Screws) are intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton. In addition, Resorbable Meshes, Sheets and Screws may be used in non-load bearing applications for maintaining the relative position of and/or containing bony fragments, bone grafts (autograft or allograft) or bone graft substitutes in reconstruction of the craniofacial or mandibular areas.

Source page: https://510kreport.com/device/K030069
Methodology: https://510kreport.com/methodology