# K241314: KLS Martin Oral-Max Implants MR Conditional (bundled)

- Pathway: 510(k) (Traditional)
- Applicant: KLS-Martin L.P.
- Decided: Aug 16, 2024 after 98 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). 73 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943347: KLS Mini Osteosynthesis System, Patton, Boggs & Blow (1994) Summary page 4.
- K943348: KLS Chin Plate System, Patton, Boggs & Blow (1994) Summary page 4.
- K944561: Micro Osteosynthesis System (1.0), KLS-Martin L.P. (1994) Summary page 4.
- K944565: KLS-Martin Micro Osteosythesis System (1.5MM), KLS-Martin L.P. (1994) Summary page 4.
- K971297: Centre-Drive Drill-Free Screw, KLS-Martin L.P. (1997) Summary page 4.
- K990667: KLS-Martin Temporary Condylar Implant, KLS-Martin L.P. (2001) Summary page 4.
- K032442: KLS-Martin Mandibular/Reconstruction System II, KLS-Martin L.P. (2003) Summary page 4.
- K033483: KLS-Martin Ortho Anchorage System, KLS-Martin L.P. (2004) Summary page 4.
- K040891: KLS Martin Ortho Anchorage System (Plates), KLS-Martin L.P. (2004) Summary page 4.
- K060177: KLS Martin Rigid Fixation  - Sterile, KLS Martin L.P. (2006) Summary page 4.
- K042573: KLS Martin Drill-Free MMF Screw, KLS-Martin L.P. (2004) Summary page 4.
- K083432: Drill Free MMF Screw, KLS Martin L.P. (2009) Summary page 4.
- K173320: KLS Martin L1 MMF System, KLS Martin L.P. (2018) Summary page 4.

## Most influential descendants
- K260137: KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient Solutions (2026), 0 descendants of its own

## Indications for use
KLS Mini Osteosynthesis System (K943347): The KLS Mini Osteosynthesis System is indicated for 1) Fractures, 2) Osteotomies, 3) Reconstruction procedures of the craniomaxillofacial skeletal system. KLS Chin Plate System (K943348): The KLS Chin Plate System is indicated for 1) Fractures, 2) Osteotomies, 3) Reconstruction procedures of the craniomaxillofacial skeletal system. KLS-Martin Micro Osteosynthesis System (1.0MM) (K944561): The KLS-Martin Micro Osteosynthesis System (1.0MM) 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. KLS-Martin Micro Osteosynthesis System (1.5MM) (K944565): The KLS-Martin Micro Osteosynthesis System (1.5MM) 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. KLS Martin Centre-Drive Drill-Free Screw (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 referenced. KLS-Martin Temporary Condylar Implant (K990667): The KLS-Martin Temporary Condylar Implant is only intended for temporary reconstruction of the mandibular condyle in patients who have undergone resective procedures to remove malignant or benign tumors requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMF or traumatic injuries, or for treatment of temporomandibular joint disease (I MD). KLS-Martin Mandibular/Reconstruction System Il (K032442): The KLS-Martin Mandibular/Reconstruction System Il is intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstruction. KLS-Martin Ortho Anchorage System (K033483): The KLS-Martin Ortho Anchorage System is intended to be surgically placed in the mouth for use an an anchor for orthodontic procedures. KLS-Martin Ortho Anchorage System (Plates) (K040891): The KLS-Martin Ortho Anchorage System (Plates) are implants intended to be surgically placed in the mouth for use as an anchor for orthodontic procedures in patients. KLS Martin Rigid Fixation - Sterile (K060177): The 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 Il is 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 segments. 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 oral-maxillo-cranio-facial surgery to stabilize fractured bone segments. The bone segments are attached to the plate with screws to prevent movement of the segments. KLS Martin Drill-Free MMF Screw (K042573): The KLS Martin Drill-Free MMF Screws is intended for use in maxillomandibular fixation to provide stabilization of fractures of the maxilla, mandible, or both. Drill Free MMF Screw (K083432): The Drill Free MMF Screw is intended for use in maxillomandibular fixation to provide stabilization of fractures of the maxilla, mandible, or both. KLS Martin L1 MMF System (K173320): The KLS Martin L1 MMF System is intended for temporary stabilization of mandibular and maxillary fractures. It is designed to maintain proper occlusion during intraoperative bone fixation and postoperative bone healing (app. 6-8 weeks). It is indicated for the temporary treatment of maxillomandibular fixation (MMF) in adults or adolescents who have permanent teeth present (ages 12 and older).

Source page: https://510kreport.com/device/K241314
Methodology: https://510kreport.com/methodology