# K032413: KLS-Martin Sternal Plating System

- Pathway: 510(k) (Traditional)
- Applicant: KLS-Martin L.P.
- Decided: Oct 10, 2003 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: 1 generation back to K011076 (2001). 1 ancestor in all.
74 later devices descend from it; 8 cite it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011076: Lorenz Sternal Closure System with Modular Screw, Walter Lorenz Surgical, Inc. (2001). Our OCR of the scanned summary read K011079, FDA’s number for K-Assay HS-CRP Controls (Kamiya Biomedical Co.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Lorenz Sternal Closure System with Modular Screws”.
- (no number) ETHICON Surgical Stainless Steel Suture U.S.P. sizes 5-7: named in the summary without a submission number

## Most influential descendants
- K051165: KLS Martin Sternal Talon (2006), 62 descendants of its own
- 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

## Indications for use
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.

Source page: https://510kreport.com/device/K032413
Methodology: https://510kreport.com/methodology