# K021928: Synthes (Usa) Resorbable Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Sep 6, 2002 after 86 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.
5 later devices descend from it; 1 cites it directly.
0 of 6 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 Fixation System: named in the summary without a submission number
- (no number) Synthes Resorbable Tack System: named in the summary without a submission number
- (no number) Synthes Resorbable Meshes and Sheets: named in the summary without a submission number

## Most influential descendants
- K132920: Spirox Inex Device (2014), 4 descendants of its own
- K223167: Spirair Nasal Septal Strap (2023), 3 descendants of its own
- K233569: SeptAlign (2024), 2 descendants of its own
- K251790: SeptAlign (2026), 1 descendant of its own
- K260620: SeptAlign (SPLN001) (2026), 0 descendants of its own

## Indications for use
Synthes Resorbable Fixation System devices (Plates, Meshes, Sheets, Screws and Tacks), are intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton. In addition, Resorbable Meshes, Sheets, Screws and 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/K021928
Methodology: https://510kreport.com/methodology