# K080862: Sonicweld RX (Resorb-X)

- Pathway: 510(k) (Traditional)
- Applicant: KLS-Martin L.P.
- Decided: Jul 21, 2008 after 116 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: 7 generations back to K904436 (1990). 29 ancestors in all.
4 later devices descend from it; 3 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 2.
- K051236: Resorb-X SF, KLS-Martin L.P. (2005) Summary page 1.
- K062789: Synthes (Usa) Rapid Resorbable Fixation System, Synthes (Usa) (2007) Summary page 1.

## Most influential descendants
- 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 KLS Martin SonicWeld RX (Resorb-X) is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations. In addition, resorbable meshes, plates, screws and pins 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. The device is not intended for load bearing indications unless used in conjunction with traditional rigid fixation. The KLS Martin SonicWeld RX (Resorb-X) is not intended for areas with active or latent infection or for patient conditions including limited blood supply or insufficient quantity or quality of bone. These devices are not intended for use in the spine. The SonicWeld Rx pins are designed only to be inserted with the SonicWeld Rx Sonotrode device.

Source page: https://510kreport.com/device/K080862
Methodology: https://510kreport.com/methodology