# K060177: KLS Martin Rigid Fixation  - Sterile

- Pathway: 510(k) (Traditional)
- Applicant: KLS Martin L.P.
- Decided: Apr 18, 2006 after 85 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). 42 ancestors in all.
65 later devices descend from it; 3 cite it directly.
0 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032442: KLS-Martin Mandibular/Reconstruction System II, KLS-Martin L.P. (2003) Summary page 1.
- K011590: Resorb-X Resorbable Plating System, KLS-Martin L.P. (2002)
- K971297: Centre-Drive Drill-Free Screw, KLS-Martin L.P. (1997) Summary page 1.
- K944561: Micro Osteosynthesis System (1.0), KLS-Martin L.P. (1994) Summary page 1.
- K944565: KLS-Martin Micro Osteosythesis System (1.5MM), KLS-Martin L.P. (1994) Summary page 1.

## Most influential descendants
- 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
- K222028: 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 (2022), 28 descendants of its own

## Indications for use
KLS-Martin Rigid Fixation - Sterile is intended to provide, in sterile packaging, osteosynthesis products with the following indications for use. K051236: The RESORB-X® SF Sonotrode is only intended for use for insertion of the RESORB-X® SF pins. K032442: The KLS Martin Mandibular/Reconstruction System IIis intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstruction. K971297: The KLS Martin Centre-Drive Drill-Free screws are intended for use in rigid internal fixation of the oral.-maxillo-cranio-facial bones. The bone screws are used to anchor plates which are contoured to fit the bony surface and stabilize the bone fragments. The addition of the self drilling feature is the only difference between the submitted device and the predicate device reference K944565: The KLS-Martin Micro Osteosynthesis System is used in oral-maxillo-cranio-facial surgery to stabilize fractured bone structures The bone segments are attached to the plate with screws to prevent movement of the segments. K944561: The KLS-Martin Micro Osteosynthesis System is used in cral-maxillo-cranio-facial surgery to stabilize fractured bone structures. The bone segments are attached to the plate with screws to prevent movement of the segments.

Source page: https://510kreport.com/device/K060177
Methodology: https://510kreport.com/methodology