510(k) · Cleared

Cleared

KLS-Martin Sternal Plating System

K032413510(k) TraditionalCleared Oct 10, 200366-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

KLS-Martin L.P. · HRS Plate, Fixation, Bone

Cleared on Oct 10, 2003 as substantially equivalent to K011076 (Walter Lorenz Surgical, Inc., 2001) after a 66-day review. Its family tree reaches back 1 generation to 2001. 74 later devices descend from it.

Decided: Oct 10, 2003
Review: 66 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K011076 (2001). 74 later devices descend from it, 8 citing it directly.

By dateBy generation

Root · 1 generation backK011076 Lorenz Sternal Closure System with Modular ScrewWalter Lorenz Surgical, Inc. · 2001
This deviceK032413 KLS-Martin Sternal Plating SystemKLS-Martin L.P. · 2003
Descendant · cites it directly · 62 of its ownK051165 KLS Martin Sternal TalonKLS-Martin L.P. · 2006
Descendant · cites it directly · 61 of its ownK070169 KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007
Descendant · cites it directly · 45 of its ownK151983 KLS Martin LSS Plating SystemKLS Martin L.P. · 2016
Descendant · 2 generations on · 39 of its ownK202889 Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · 2021
Descendant · 3 generations on · 36 of its ownK220782 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine, Inc. · 2022

Showing 5 of 74 descendants. See all descendants

Descendants cleared per year

2005high 14 (2025) · low 0 (2008)2026

Most influential descendants

Showing 5 of 74 · See all

K051165KLS Martin Sternal TalonKLS-Martin L.P. · 2006 · cites it directly62descendants
K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007 · cites it directly61descendants
K151983KLS Martin LSS Plating SystemKLS Martin L.P. · 2016 · cites it directly45descendants
K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · 2021 · 2 generations on39descendants
K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc. · 2022 · 3 generations on36descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011076	Lorenz Sternal Closure System with Modular Screw	Walter Lorenz Surgical, Inc.	2001	—
0 (this device)	K032413	KLS-Martin Sternal Plating System	KLS-Martin L.P.	2003	—
+1	K051165	KLS Martin Sternal Talon	KLS-Martin L.P.	2006	—
+1	K070169	KLS Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile	KLS Martin L.P.	2007	—
+1	K151983	KLS Martin LSS Plating System	KLS Martin L.P.	2016	—
+2	K202889	Able Medical Devices Valkyrie Thoracic Fixation System	Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices	2021	—
+3	K220782	IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System…	Alphatec Spine, Inc.	2022	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	2	0
2007	1	0
2010	1	0
2011	1	0
2012	3	0
2013	1	0
2014	4	0
2015	2	0
2016	2	0
2019	1	0
2021	4	0
2022	4	0
2023	8	0
2024	13	0
2025	14	0
2026	12	0

FIG. 1 — Lineage of K032413, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HRS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new HRS device

#1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K011076	Lorenz Sternal Closure System with Modular Screw 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”.	Walter Lorenz Surgical, Inc.	2001	—
*	—	ETHICON Surgical Stainless Steel Suture U.S.P. sizes 5-7 Named without a submission number			—

Also cleared against K011076: 8 other devices →

What descends from it? (74)

See all 74

8 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K051165	KLS Martin Sternal Talon	KLS-Martin L.P.	2006	62
K070169	KLS Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile	KLS Martin L.P.	2007	61
K151983	KLS Martin LSS Plating System	KLS Martin L.P.	2016	45
K101170	Acute Innovations Sternal Fixation System	Acute Innovations, LLC	2010	10
K153482	KLS Martin Thoracic Plating System	KLS-Martin L.P.	2016	9
K051410	Acumed Rib Congrient Bone Plate System	Acumed, LLC	2005	9
K241018	KLS Martin Orthopedic Implants - MR Conditional	KLS-Martin L.P.	2024	1
K053624	Medicon Stern-a-Fix Sternal Closure System	Medicon EG	2006	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K051165 (KLS-Martin L.P., 2006) has gone furthest, with 62 descendants of its own.
8 other devices also cite its predicate K011076.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRS

54in 2025

2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007high 144 (2022) · low 57 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRS

1in 2025

2007high 25 (2019) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRS

2,306in 2025

2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	35	63	2	339
2008	35	87	11	311
2009	47	85	3	435
2010	49	100	16	491
2011	43	88	5	773
2012	59	106	4	1,663
2013	56	89	11	2,643
2014	76	57	0	2,413
2015	56	97	7	3,095
2016	44	109	5	2,276
2017	57	122	3	2,220
2018	40	116	2	2,663
2019	46	89	25	3,359
2020	48	88	1	2,790
2021	40	87	9	2,442
2022	47	144	3	1,700
2023	40	120	1	2,049
2024	54	96	0	1,849
2025	54	90	1	2,306
2026	51	82	3	—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K032413 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032413: KLS-Martin Sternal Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032413

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026