# K241018: KLS Martin Orthopedic Implants - MR Conditional

- Pathway: 510(k) (Traditional)
- Applicant: KLS-Martin L.P.
- Decided: Jul 12, 2024 after 88 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K761228 (1976). 136 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 138 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032413: KLS-Martin Sternal Plating System, KLS-Martin L.P. (2003) Summary page 3.
- K040598: KLS Martin Hand Plating System, KLS-Martin L.P. (2004) Summary page 3.
- K051165: KLS Martin Sternal Talon, KLS-Martin L.P. (2006) Summary page 3.
- K070169: KLS Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile, KLS Martin L.P. (2007) Summary page 3.
- K122860: KLS Martin Recon Talon, KLS Martin L.P. (2012) Summary page 3.
- K141489: Linos Moh Hand Plating System, KLS Martin L.P. (2014) Summary page 3.
- K151983: KLS Martin LSS Plating System, KLS Martin L.P. (2016) Summary page 3.
- K153482: KLS Martin Thoracic Plating System, KLS-Martin L.P. (2016) Summary page 3.
- K161259: KLS Martin Cannulated Headless Screws, KLS Martin L.P. (2016) Summary page 3.
- K170124: Level One Hand Plating System, KLS Martin L.P. (2017) Summary page 3.
- K221938: KLS Martin Pure Pectus System, KLS Martin L.P. (2023) Summary page 3.
- K222397: KLS Martin Level One Rib Fixation System, KLS-Martin L.P. (2023) Summary page 3.
- K222624: KLS Martin LINOS Wrist System, KLS-Martin L.P. (2023) Summary page 3.

## Most influential descendants
- K250988: KLS Martin Pure Pectus System (2025), 0 descendants of its own

## Indications for use
The KLS Martin Sternal Plating System is intended for use in stabilization and fixation of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures. The KLS Martin Hand Plating System is used for stabilization and fixation of fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, wrist, fingers, feet, ankles and toes. The KLS Martin Sternal Talon is intended for use in stabilization and fixation of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures. To offer KLS Martin Sternal Talon and KLS Martin Sternal Plating in sterile packaging with the following indications for use: KO51165 KLS Martin Sternal Talon and K032413 KLS Martin Sternal Plating System are intended for use in stabilization and fixation of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures. The KLS Martin Recon Talon is intended for use in stabilization and fixation of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures. The LINOS MOH Hand Plating System is used for stabilization and fixation of fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, wrist, fingers, feet, ankles and toes. The KLS Martin LSS Plating System is to be used in conjunction with sternal closure wire for use in primary or secondary closure/repair of the sternum following sternotomy and is intended to reinforce the sternal halves and distribute wire tension. The KLS Martin Thoracic Plating System is indicated for use in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies. KLS Martin Cannulated Headless Screws are intended for the treatment of fractures, osteotomies, arthrodeses, and nonunions of small bones in the hand, wrist, foot, and ankle. The Level One Hand Plating System is used for stabilization and fixation of fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, wrist, fingers, feet, ankles and toes. The KLS Martin Pure Pectus System is indicated for use in surgical procedures to repair pectus excavatum. It is indicated for use in adult and pediatric (children and adolescents) populations. The KLS Martin Level One Rib Fixation System is indicated for use in the stabilization and rigid fixation of rib fractures in the chest wall including reconstructive procedures, trauma, or planned osteotomies in patients 18 years of age or older. The KLS Martin LINOS Wrist System is indicated for use in forearm fractures, osteotomies, and arthrodeses. It is intended for adults, and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation.

Source page: https://510kreport.com/device/K241018
Methodology: https://510kreport.com/methodology