# K252573: KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE

- Pathway: 510(k) (Traditional)
- Applicant: KLS-Martin L.P.
- Decided: Nov 10, 2025 after 88 days
- Product code: GXN (Plate, Cranioplasty, Preformed, Non-Alterable)
- Device class: 2
- Regulation: 21 CFR 882.5330
- 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). 53 ancestors in all.
No later device cites it as a predicate yet.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944565: KLS-Martin Micro Osteosythesis System (1.5MM), KLS-Martin L.P. (1994) Summary page 6.
- K971297: Centre-Drive Drill-Free Screw, KLS-Martin L.P. (1997) Summary page 6.
- K060177: KLS Martin Rigid Fixation  - Sterile, KLS Martin L.P. (2006) Summary page 6.
- K062570: Patient Contoured Mesh (PCM), KLS-Martin L.P. (2006) Summary page 6.
- K072707: Patient Contoured Mesh-Peek (PCM-P), KLS-Martin L.P. (2007) Summary page 6.
- K151382: Patient Contoured Implant-PEEK (PCI-PEEK), KLS Martin L.P. (2015) Summary page 6.

## Indications for use
KLS-Martin Micro Osteosynthesis System (1.5MM): 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: 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 Rigid Fixation - Sterile: The KLS Martin Rigid Fixation - Sterile is intended to provide, in sterile packaging, osteosynthesis products with the following indications for use: -The RESORB-X® SF Sonotrode is only intended for use for insertion of the RESORB-X® SF pins. -The KLS Martin Mandibular/Reconstruction System II is intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstruction. -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 -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. -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. Individual Patient Solutions - Ti (IPS-Ti)*: Individual Patient Solutions - Ti (IPS-Ti) is intended to replace bony voids in the mandibular, maxillofacial or craniofacial skeleton. Individual Patient Solutions - PEEK (IPS-PEEK)*: Individual Patient Solutions - PEEK (IPS-PEEK) is intended to replace bony voids in the cranial and/or craniofacial skeleton. Individual Patient Solutions - (IPS-PEEK)**: The Individual Patient Solutions - (IPS-PEEK) is intended to replace bony voids in the cranial skeleton.

Source page: https://510kreport.com/device/K252573
Methodology: https://510kreport.com/methodology