# K974554: Synthes Resorbable Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Feb 24, 1998 after 82 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
Longest line of descent: 1 generation back to K955729 (1996). 3 ancestors in all.
89 later devices descend from it; 5 cite it directly.
0 of 93 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953806: Synthes (Usa) Midfacial System, Synthes (Usa) (1996) Summary page 1.
- K955729: Lactosorb Trauma Plating System, Poly-Medics,Inc. (1996). Our OCR of the scanned summary read K255729, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Lorenz LactoSorb Trauma Plating System”.
- K960988: Lactosorb Trauma Plating System, Poly-Medics,Inc. (1996) Summary page 1.

## Cited in the summary but kept off the family tree
- K512932: Synthes Maxillofacial Titanium Micro Set. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K982139: Biosorbfx 1.5/2.0 Bioabsorbable Fixation System (1998), 86 descendants of its own
- K993061: Stryker Leibinger Resorbable Fixation System (1999), 79 descendants of its own
- K011590: Resorb-X Resorbable Plating System (2002), 73 descendants of its own
- K060177: KLS Martin Rigid Fixation  - Sterile (2006), 65 descendants of its own
- K070169: KLS Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile (2007), 61 descendants of its own

## Indications for use
Synthes Resorbable Fixation System is intended for fractures of the craniofaciai skeleton, including, but not limited to, comminuted fractures of the nasoethmoidal and infraorbitul arcas, comminuted fractures of the frontal sinus wall, and midfacial fractures; and recvusttuctive procedures of the midface or craniofacial skeleton. Do not use in the mandible. Synthes Resarbable Fixation System is not intended for: 1) areas with active infection; 2) patient conditions including: blnnd supply limitations, insufficient quantity of yuality of bonc, or latent infections. ‘I'hic device is not designed for use in the mandible or fur use in full load bearing procedures

Source page: https://510kreport.com/device/K974554
Methodology: https://510kreport.com/methodology