# K011590: Resorb-X Resorbable Plating System

- Pathway: 510(k) (Traditional)
- Applicant: KLS-Martin L.P.
- Decided: Mar 20, 2002 after 301 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: 5 generations back to K904436 (1990). 26 ancestors in all.
73 later devices descend from it; 3 cite it directly.
0 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955729: Lactosorb Trauma Plating System, Poly-Medics,Inc. (1996) Summary page 1.
- K960988: Lactosorb Trauma Plating System, Poly-Medics,Inc. (1996) Summary page 1.
- K971870: Lactosorb Trauma Plating System, Biomet, Inc. (1997) Summary page 1.
- K974309: Lactosorb Panels, Biomet, Inc. (1998) Summary page 1.
- K992158: Lactosorb Sheets, Biomet, Inc. (1999) Summary page 1.
- K972913: Macropore Protective Sheet (Protego System), Pacific Materials and Interfaces (1998) Summary page 1.
- K974554: Synthes Resorbable Fixation System, Synthes (Usa) (1998) Summary page 1.
- K982139: Biosorbfx 1.5/2.0 Bioabsorbable Fixation System, Bionx Implants, Inc. (1998) Summary page 1.
- K982531: Howmedica Leibinger Resorbable Fixation System, Howmedica Corp. (1998) Summary page 1.
- K993061: Stryker Leibinger Resorbable Fixation System, Stryker Instruments (1999) Summary page 1.

## Most influential descendants
- 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
- K151983: KLS Martin LSS Plating System (2016), 45 descendants of its own
- K202889: Able Medical Devices Valkyrie Thoracic Fixation System (2021), 39 descendants of its own
- K220782: IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System, IdentiTi™ Cervical Standalone Interbody System, IdentiTi™ NanoTec™ Cervical Standalone Interbody System (2022), 36 descendants of its own

## Indications for use
The KLS-Martin Resorb-X System 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 KLS-Martin Resorb-X System 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.

Source page: https://510kreport.com/device/K011590
Methodology: https://510kreport.com/methodology