# K040598: KLS Martin Hand Plating System

- Pathway: 510(k) (Traditional)
- Applicant: KLS-Martin L.P.
- Decided: May 13, 2004 after 66 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: 4 generations back to K954385 (1996). 17 ancestors in all.
360 later devices descend from it; 5 cite it directly.
0 of 378 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961497: Profyle Titanium Hand and Small Fragment System, Howmedica, Inc. (1996) Summary page 1.
- K992961: Lorenz Small Fragment System, Walter Lorenz Surgical, Inc. (1999) Summary page 1.
- K011118: Normed Extremity Titanium Hand and Small Fragment System, Osteomedics (2001). Our reading of the summary gave K001118, FDA’s number for Modification to Lipoprotein (a) SPQ Iii Antibody Reagent Set (DiaSorin, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Normed Extremity Titanium Hand and Small Fragment System”. Summary page 2.
- K032442: KLS-Martin Mandibular/Reconstruction System II, KLS-Martin L.P. (2003) Summary page 1.
- K944565: KLS-Martin Micro Osteosythesis System (1.5MM), KLS-Martin L.P. (1994) Summary page 1.
- K944561: Micro Osteosynthesis System (1.0), KLS-Martin L.P. (1994) Summary page 1.

## Most influential descendants
- K050868: Maxlock (2005), 343 descendants of its own
- K073624: Modular Foot System (2008), 342 descendants of its own
- K100618: Maxlock Extreme Extremity Plating System with Variable Angle Technology (2010), 339 descendants of its own
- K100776: Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System (2010), 228 descendants of its own
- K102156: Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws (2010), 119 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K040598
Methodology: https://510kreport.com/methodology