510(k) Report

510(k) · Cleared

Cleared

KLS Martin Orthopedic Implants - MR Conditional

K241018510(k) TraditionalCleared Jul 12, 202488-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 Jul 12, 2024 as substantially equivalent to K032413 (KLS-Martin L.P., 2003) and 12 other predicates after an 88-day review. Its family tree reaches back 14 generations to 1976. 1 later device descends from it.

Decided
Jul 12, 2024
Review
88 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
13

Its longest line of descent runs back 14 generations to K761228 (1976). 136 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2023: 2 other ancestors2017: 1 other ancestor2016: 2 other ancestors2014: 2 other ancestors2012: 1 other ancestor2007: 2 other ancestors2006: 6 other ancestors2004: 5 other ancestors2003: 7 other ancestors2015: 1 other ancestor2011: 4 other ancestors2010: 1 other ancestor2005: 3 other ancestors2001: 5 other ancestors2000: 4 other ancestors1999: 6 other ancestors1997: 6 other ancestors1996: 14 other ancestors1994: 10 other ancestors1993: 4 other ancestors2008: 4 other ancestors2002: 4 other ancestors1998: 14 other ancestors1995: 5 other ancestors2009: 1 other ancestor1990: 2 other ancestors1989: 1 other ancestor1992: 1 other ancestor1991: 1 other ancestor1988: 1 other ancestor1986: 2 other ancestors2025: 1 descendant clearedK761228 · Luhr Mandibular Compression-Screw System · Howmedica Corp. · 1976K963739 · Leibinger - Luhr Small Orthopedic Bone Screws · Howmedica Leibinger, Inc. · 1997×2: 2 generations cleared close together, K970912 (1997), K974785 (1998) K013954 · Lorenz Self Drilling Screws · Walter Lorenz Surgical, Inc. · 2002×2: 2 generations cleared close together, K032228 (2003), K033740 (2003) K063506 · Lorenz Sternal Closure System · Walter Lorenz Surgical, Inc. · 2006×2: 2 generations cleared close together, K110574 (2011), K111908 (2011) K121302 · Biomet Microfixation Sternal Closure System · Biomet Microfixation · 2012K142823 · Biomet Microfixation Thoracic Fixation System · Biomet Microfixation · 2015K153482 · KLS Martin Thoracic Plating System · KLS-Martin L.P. · 2016K221938 · KLS Martin Pure Pectus System · KLS Martin L.P. · 202319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 11 other ancestors2 generations back: 21 other ancestors3 generations back: 24 other ancestors4 generations back: 31 other ancestors5 generations back: 13 other ancestors6 generations back: 11 other ancestors7 generations back: 5 other ancestors8 generations back: 6 other ancestors 1 generation forward: 1 descendant K221938 · KLS Martin Pure Pectus System · KLS Martin L.P. · 2023K153482 · KLS Martin Thoracic Plating System · KLS-Martin L.P. · 2016K142823 · Biomet Microfixation Thoracic Fixation System · Biomet Microfixation · 2015K121302 · Biomet Microfixation Sternal Closure System · Biomet Microfixation · 2012K111908 · Biomet Microfixation Sternal Closure System · Biomet Microfixation, Inc. · 2011K110574 · Biomet Microfixation Sternalock Blu Sternal Closure System · Biomet Microfixation, Inc. · 2011 · recalledK063506 · Lorenz Sternal Closure System · Walter Lorenz Surgical, Inc. · 2006K033740 · Lorenz Sternal Closure System · Walter Lorenz Surgical, Inc. · 2003K032228 · Lorenz 2.4 Self Drilling Screws · Walter Lorenz Surgical, Inc. · 2003K013954 · Lorenz Self Drilling Screws · Walter Lorenz Surgical, Inc. · 2002K974785 · Auto-Drive Bone Screw · Osteomed Corp. · 1998K970912 · Leibinger Self-Drilling Screw · Howmedica Leibinger, Inc. · 1997K963739 · Leibinger - Luhr Small Orthopedic Bone Screws · Howmedica Leibinger, Inc. · 1997K761228 · Luhr Mandibular Compression-Screw System · Howmedica Corp. · 1976−10−50
  1. Root · 14 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
  2. 10 generations between
  3. 3 generations backK142823 Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation · 2015
  4. 2 generations backK153482 KLS Martin Thoracic Plating SystemKLS-Martin L.P. · 2016
  5. 1 generation backK221938 KLS Martin Pure Pectus SystemKLS Martin L.P. · 2023
  6. This deviceK241018 KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P. · 2024
  7. Descendant · cites it directly · 0 of its ownK250988 KLS Martin Pure Pectus SystemKLS-Martin L.P. · 2025
Show all 14 generations
  1. Root · 14 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
  2. 13 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
  3. 12 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
  4. 11 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
  5. 10 generations backK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002
  6. 9 generations backK032228 Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2003
  7. 8 generations backK033740 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2003
  8. 7 generations backK063506 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2006
  9. 6 generations backK110574 Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc. · 2011 · Recalled
  10. 5 generations backK111908 Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc. · 2011
  11. 4 generations backK121302 Biomet Microfixation Sternal Closure SystemBiomet Microfixation · 2012
  12. 3 generations backK142823 Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation · 2015
  13. 2 generations backK153482 KLS Martin Thoracic Plating SystemKLS-Martin L.P. · 2016
  14. 1 generation backK221938 KLS Martin Pure Pectus SystemKLS Martin L.P. · 2023
  15. This deviceK241018 KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P. · 2024

Most influential descendants

Showing 1 of 1 · See all
  • K250988KLS Martin Pure Pectus SystemKLS-Martin L.P. · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−14K761228Luhr Mandibular Compression-Screw SystemHowmedica Corp.1976—
−13K963739Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc.1997—
−12K970912Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc.1997—
−11K974785Auto-Drive Bone ScrewOsteomed Corp.1998—
−10K013954Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc.2002—
−9K032228Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc.2003—
−8K033740Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc.2003—
−7K063506Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc.2006—
−6K110574Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc.20111
−5K111908Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc.2011—
−4K121302Biomet Microfixation Sternal Closure SystemBiomet Microfixation2012—
−3K142823Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation2015—
−2K153482KLS Martin Thoracic Plating SystemKLS-Martin L.P.2016—
−1K221938KLS Martin Pure Pectus SystemKLS Martin L.P.2023—
0 (this device)K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.2024—
+1K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198620
198810
198910
199020
199110
199210
199340
1994100
199550
1996140
199760
1998140
199960
200040
200150
200240
200370
200450
200530
200660
200720
200840
200910
201010
201140
201210
201420
201510
201620
201710
202320

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202510
FIG. 1 — Lineage of K241018, 1976–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (13)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K032413KLS-Martin Sternal Plating System
Summary page 3
…tion Date: 07/31/2026 Indications for Use See PRA Statement below. Submission Number (if known) K241018 Device Name KLS Martin Orthopedic Implants - MR Conditional; K032413: KLS Martin Sternal Plating System; K040598: KLS Martin Hand Plating System; K051165: KLS Martin Sternal Talon; K070169: KLS Ma…
KLS-Martin L.P.2003—
*K040598KLS Martin Hand Plating System
Summary page 3
…ee PRA Statement below. Submission Number (if known) K241018 Device Name KLS Martin Orthopedic Implants - MR Conditional; K032413: KLS Martin Sternal Plating System; K040598: KLS Martin Hand Plating System; K051165: KLS Martin Sternal Talon; K070169: KLS Martin Sternal Talon & KLS Martin Sternal Plat…
KLS-Martin L.P.2004—
*K051165KLS Martin Sternal Talon
Summary page 3
…(if known) K241018 Device Name KLS Martin Orthopedic Implants - MR Conditional; K032413: KLS Martin Sternal Plating System; K040598: KLS Martin Hand Plating System; K051165: KLS Martin Sternal Talon; K070169: KLS Martin Sternal Talon & KLS Martin Sternal Plating System - Sterile; K122860: Recon Talon…
KLS-Martin L.P.2006—
*K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile
Summary page 3
…LS Martin Orthopedic Implants - MR Conditional; K032413: KLS Martin Sternal Plating System; K040598: KLS Martin Hand Plating System; K051165: KLS Martin Sternal Talon; K070169: KLS Martin Sternal Talon & KLS Martin Sternal Plating System - Sterile; K122860: Recon Talon ; K141489: LINOS MOH Hand Plating…
KLS Martin L.P.2007—
*K122860KLS Martin Recon Talon
Summary page 3
…ng System; K040598: KLS Martin Hand Plating System; K051165: KLS Martin Sternal Talon; K070169: KLS Martin Sternal Talon & KLS Martin Sternal Plating System - Sterile; K122860: Recon Talon ; K141489: LINOS MOH Hand Plating System ; K151983: KLS Martin LSS Plating System ; K153482: KLS Martin Thoracic P…
KLS Martin L.P.2012—
*K141489Linos Moh Hand Plating System
Summary page 3
…Martin Hand Plating System; K051165: KLS Martin Sternal Talon; K070169: KLS Martin Sternal Talon & KLS Martin Sternal Plating System - Sterile; K122860: Recon Talon ; K141489: LINOS MOH Hand Plating System ; K151983: KLS Martin LSS Plating System ; K153482: KLS Martin Thoracic Plating System ; K161259:…
KLS Martin L.P.2014—
*K151983KLS Martin LSS Plating System
Summary page 3
…Martin Sternal Talon; K070169: KLS Martin Sternal Talon & KLS Martin Sternal Plating System - Sterile; K122860: Recon Talon ; K141489: LINOS MOH Hand Plating System ; K151983: KLS Martin LSS Plating System ; K153482: KLS Martin Thoracic Plating System ; K161259: KLS Martin Cannulated Headless Screws; K…
KLS Martin L.P.2016—
*K153482KLS Martin Thoracic Plating System
Summary page 3
…n Sternal Talon & KLS Martin Sternal Plating System - Sterile; K122860: Recon Talon ; K141489: LINOS MOH Hand Plating System ; K151983: KLS Martin LSS Plating System ; K153482: KLS Martin Thoracic Plating System ; K161259: KLS Martin Cannulated Headless Screws; K170124: Level One Hand Plating System ; K…
KLS-Martin L.P.2016—
*K161259KLS Martin Cannulated Headless Screws
Summary page 3
…ystem - Sterile; K122860: Recon Talon ; K141489: LINOS MOH Hand Plating System ; K151983: KLS Martin LSS Plating System ; K153482: KLS Martin Thoracic Plating System ; K161259: KLS Martin Cannulated Headless Screws; K170124: Level One Hand Plating System ; K221938: KLS Martin Pure Pectus System ; K2223…
KLS Martin L.P.2016—
*K170124Level One Hand Plating System
Summary page 3
…: LINOS MOH Hand Plating System ; K151983: KLS Martin LSS Plating System ; K153482: KLS Martin Thoracic Plating System ; K161259: KLS Martin Cannulated Headless Screws; K170124: Level One Hand Plating System ; K221938: KLS Martin Pure Pectus System ; K222397: KLS Martin Level One Rib Fixation System ; K…
KLS Martin L.P.2017—
*K221938KLS Martin Pure Pectus System
Summary page 3
…KLS Martin LSS Plating System ; K153482: KLS Martin Thoracic Plating System ; K161259: KLS Martin Cannulated Headless Screws; K170124: Level One Hand Plating System ; K221938: KLS Martin Pure Pectus System ; K222397: KLS Martin Level One Rib Fixation System ; K222624: KLS Martin LINOS Wrist System Ind…
KLS Martin L.P.2023—
*K222397KLS Martin Level One Rib Fixation System
Summary page 3
…KLS Martin Thoracic Plating System ; K161259: KLS Martin Cannulated Headless Screws; K170124: Level One Hand Plating System ; K221938: KLS Martin Pure Pectus System ; K222397: KLS Martin Level One Rib Fixation System ; K222624: KLS Martin LINOS Wrist System Indications for Use (Describe) KLS Martin St…
KLS-Martin L.P.2023—
*K222624KLS Martin LINOS Wrist System
Summary page 3
…artin Cannulated Headless Screws; K170124: Level One Hand Plating System ; K221938: KLS Martin Pure Pectus System ; K222397: KLS Martin Level One Rib Fixation System ; K222624: KLS Martin LINOS Wrist System Indications for Use (Describe) KLS Martin Sternal Plating System (K032413): The KLS Martin Ster…
KLS-Martin L.P.2023—

Also cleared against K032413: 7 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250

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?

  • The line of descent spans 48 years and passes through 8 companies; a new generation was cleared every 1.4 years on median.
  • 15 of the 136 ancestors have a recall of any class.
  • Of its descendants, K250988 (KLS-Martin L.P., 2025) has gone furthest, with 0 descendants of its own.
  • 7 other devices also cite its predicate K032413.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · HRS

54in 2025

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

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

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
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

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

What is it indicated for?

The 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. 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. The KLS Martin Sternal Talon is…

Read the full statement (448 words)

The 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.

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.

The KLS Martin Sternal Talon is intended for use in stabilization and fixation of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.

To offer KLS Martin Sternal Talon and KLS Martin Sternal Plating in sterile packaging with the following indications for use: KO51165 KLS Martin Sternal Talon and K032413 KLS Martin Sternal Plating System are intended for use in stabilization and fixation of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.

The KLS Martin Recon Talon is intended for use in stabilization and fixation of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.

The LINOS MOH 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.

The KLS Martin LSS Plating System is to be used in conjunction with sternal closure wire for use in primary or secondary closure/repair of the sternum following sternotomy and is intended to reinforce the sternal halves and distribute wire tension.

The KLS Martin Thoracic Plating System is indicated for use in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies.

KLS Martin Cannulated Headless Screws are intended for the treatment of fractures, osteotomies, arthrodeses, and nonunions of small bones in the hand, wrist, foot, and ankle.

The Level One 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.

The KLS Martin Pure Pectus System is indicated for use in surgical procedures to repair pectus excavatum. It is indicated for use in adult and pediatric (children and adolescents) populations.

The KLS Martin Level One Rib Fixation System is indicated for use in the stabilization and rigid fixation of rib fractures in the chest wall including reconstructive procedures, trauma, or planned osteotomies in patients 18 years of age or older.

The KLS Martin LINOS Wrist System is indicated for use in forearm fractures, osteotomies, and arthrodeses. It is intended for adults, and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation.

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

Also cleared against K032413

7 other devices cite the same predicate.

  • K151983KLS Martin LSS Plating SystemKLS Martin L.P. · 2016
  • K153482KLS Martin Thoracic Plating SystemKLS-Martin L.P. · 2016
  • K101170Acute Innovations Sternal Fixation SystemAcute Innovations, LLC · 2010
  • K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007
  • K051165KLS Martin Sternal TalonKLS-Martin L.P. · 2006
  • K053624Medicon Stern-a-Fix Sternal Closure SystemMedicon EG · 2006

More from KLS-Martin L.P.

59 FDA decisions under this applicant name. See the company

  • K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual…KLS-Martin L.P. · 2026
  • K253660KLS Martin Pure Pectus SystemKLS-Martin L.P. · 2026
  • K250988KLS Martin Pure Pectus SystemKLS-Martin L.P. · 2025
  • K250865KLS Martin IPS Forearm SystemKLS-Martin L.P. · 2025
  • K252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM)…KLS-Martin L.P. · 2025

Recent decisions in HRS

The HRS category page

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K263407Tempo Plating SystemPace Surgical · 2026
  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
  • K261611TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2026
  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K241018 · printed Nov 6, 2026

Cite this page

510(k) Report. “K241018: KLS Martin Orthopedic Implants - MR Conditional.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241018

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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