# K051236: Resorb-X SF

- Pathway: 510(k) (Traditional)
- Applicant: KLS-Martin L.P.
- Decided: Aug 22, 2005 after 101 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: 6 generations back to K904436 (1990). 27 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011590: Resorb-X Resorbable Plating System, KLS-Martin L.P. (2002) Summary page 1.

## Most influential descendants
- K080862: Sonicweld RX (Resorb-X) (2008), 4 descendants of its own
- K112064: Resorb X-G (2012), 2 descendants of its own
- K141385: Depuy Synthes Injectable Polymer System (Ips) (2015), 0 descendants of its own
- K133304: RXG Distraction System (2014), 0 descendants of its own
- K121606: Resorb-X G (2013), 0 descendants of its own

## Indications for use
The RESORB-X® SF is intended for fractures of the craniofacial skeleton including, but not limited to, comminuted fractures of the naso-ethomoidal and infraorbital areas, comminuted fractures of the frontal sinus wall, and midface fractures; and reconstructive procedures of the midface or craniofacial skeleton. The RESORB-X® SF pins are designed only to be inserted with the RESORB-X® SF Sonotrode device. The RESORB-X® SF is NOT intended for use in the mandible or full load-bearing situations, nor in areas of active infection or for patients with conditions including blood supply limitations, insufficient quantity or quality of bone, or latent infections. The RESORB-X® SF Sonotrode is NOT intended for any other use and is only intended for use for insertion of the RESORB-X® SF pins.

Source page: https://510kreport.com/device/K051236
Methodology: https://510kreport.com/methodology