# K050204: Synthes Rapid Resorbable Tack System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Mar 4, 2005 after 35 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 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) Synthes Resorbable Tack System: named in the summary without a submission number
- (no number) Synthes Rapid Resorbable Fixation System (aka Synthes Poly (L-Lactide-co-Glycolide) Resorbable Fixation System: named in the summary without a submission number

## Most influential descendants
- K073115: Orthomesh (2008), 1 descendant of its own
- K180821: TruMatch Graft Cage - Long Bone (2018), 0 descendants of its own
- K141385: Depuy Synthes Injectable Polymer System (Ips) (2015), 0 descendants of its own

## Indications for use
Synthes Rapid Resorbable Tack System is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton. In addition, Rapid Resorbable Tacks 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/K050204
Methodology: https://510kreport.com/methodology