# K121606: Resorb-X G

- Pathway: 510(k) (Traditional)
- Applicant: KLS-Martin L.P.
- Decided: Jan 17, 2013 after 230 days
- Product code: GWO (Plate, Cranioplasty, Preformed, Alterable)
- Device class: 2
- Regulation: 21 CFR 882.5320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K904436 (1990). 67 ancestors in all.
No later device cites it as a predicate yet.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073006: Osteotrans -MX Bioabsorbable Bone Fixation System, Takiron Co., Ltd. (2008) Summary page 1.
- K112064: Resorb X-G, KLS-Martin L.P. (2012) Summary page 1.
- K062789: Synthes (Usa) Rapid Resorbable Fixation System, Synthes (Usa) (2007) Summary page 1.
- K992355: Lactosorb Trauma Plating System, Biomet, Inc. (1999) Summary page 1.
- K080862: Sonicweld RX (Resorb-X), KLS-Martin L.P. (2008) Summary page 1.

## Indications for use
Resorb-X G is intended for use in non-load bearing fracture repair and reconstructive procedures in pediatric and adult populations. In addition, resorbable meshes, plates 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 cranial reconstruction.

Source page: https://510kreport.com/device/K121606
Methodology: https://510kreport.com/methodology