510(k) Report

510(k) · Cleared

Cleared

KLS Martin Sternal Talon

K051165510(k) TraditionalCleared Sep 7, 2006490-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 Sep 7, 2006 as substantially equivalent to K931271 (ETHICON, Inc., 1994) and 7 other predicates after a 490-day review. Its family tree reaches back 7 generations to 1976. 62 later devices descend from it.

Decided
Sep 7, 2006
Review
490 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
8

Its longest line of descent runs back 7 generations to K761228 (1976). 30 ancestors in all. 62 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2003: 1 other ancestor2001: 2 other ancestors2000: 1 other ancestor1999: 1 other ancestor1994: 5 other ancestors1993: 2 other ancestors1998: 1 other ancestor1997: 2 other ancestors1996: 3 other ancestors1991: 1 other ancestor1988: 1 other ancestor1986: 2 other ancestors2007: 1 descendant cleared2012: 1 descendant cleared2014: 3 descendants cleared2024: 12 descendants cleared2016: 2 descendants cleared2011: 1 descendant cleared2021: 3 descendants cleared2025: 14 descendants cleared2013: 1 descendant cleared2023: 8 descendants cleared2022: 3 descendants cleared2026: 11 descendants cleared2015: 2 descendants 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) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 4 other ancestors4 generations back: 2 other ancestors5 generations back: 2 other ancestors6 generations back: 2 other ancestors7 generations back: 6 other ancestors 1 generation forward: 4 descendants2 generations forward: 5 descendants3 generations forward: 5 descendants4 generations forward: 7 descendants5 generations forward: 8 descendants6 generations forward: 14 descendants7 generations forward: 17 descendants8 generations forward: 2 descendants K033740 · 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. · 1976−50+5
  1. Root · 7 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
  2. 6 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
  3. 5 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
  4. 4 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
  5. 3 generations backK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002
  6. 2 generations backK032228 Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2003
  7. 1 generation backK033740 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2003
  8. This deviceK051165 KLS Martin Sternal TalonKLS-Martin L.P. · 2006
  9. Descendant · cites it directly · 61 of its ownK070169 KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007
  10. Descendant · 2 generations on · 45 of its ownK151983 KLS Martin LSS Plating SystemKLS Martin L.P. · 2016
  11. Descendant · 3 generations on · 39 of its ownK202889 Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · 2021
  12. Descendant · 4 generations on · 36 of its ownK220782 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine, Inc. · 2022
  13. Descendant · 5 generations on · 28 of its ownK222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine · 2022

Showing 5 of 62 descendants. See all descendants

Descendants cleared per year

2007: 12011: 12012: 12013: 12014: 32015: 22016: 22021: 32022: 32023: 82024: 122025: 142026: 11
2007high 14 (2025) · low 0 (2008)2026

Most influential descendants

Showing 5 of 62 · See all
  • 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 · 2 generations on45descendants
  • K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · 2021 · 3 generations on39descendants
  • K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc. · 2022 · 4 generations on36descendants
  • K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine · 2022 · 5 generations on28descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K761228Luhr Mandibular Compression-Screw SystemHowmedica Corp.1976—
−6K963739Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc.1997—
−5K970912Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc.1997—
−4K974785Auto-Drive Bone ScrewOsteomed Corp.1998—
−3K013954Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc.2002—
−2K032228Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc.2003—
−1K033740Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc.2003—
0 (this device)K051165KLS Martin Sternal TalonKLS-Martin L.P.2006—
+1K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P.2007—
+2K151983KLS Martin LSS Plating SystemKLS Martin L.P.2016—
+3K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices2021—
+4K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System…Alphatec Spine, Inc.2022—
+5K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System…Alphatec Spine2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198620
198810
199110
199320
199450
199630
199720
199810
199910
200010
200120
200310
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201110
201210
201310
201430
201520
201620
202130
202230
202380
2024120
2025140
2026110
FIG. 1 — Lineage of K051165, 1976–2026Source: 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? (8)

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
*K931271Ethi-Pack* Surgical Stainless Steel Suture
Summary page 1
…d Accessories (21 CFR 888.3030) Regulatory Class: II Predicate Devices: Ethi-Pack Surgical Stainless Steel Suture (K931271) Pioneer Silicoat Sternal Cable (K993286) PectoFix DSF System (K000694)…
ETHICON, Inc.1994—
*K993286Pioneer Silicoat Sternal Cable
Summary page 1
…y Class: II Predicate Devices: Ethi-Pack Surgical Stainless Steel Suture (K931271) Pioneer Silicoat Sternal Cable (K993286) PectoFix DSF System (K000694) Synthes Sternal Fixation System…
Pioneer Surgical Technology1999—
*K000694Pectofix Dynamic Sternal Fixation System (DSF)
Summary page 1
…ical Stainless Steel Suture (K931271) Pioneer Silicoat Sternal Cable (K993286) PectoFix DSF System (K000694) Synthes Sternal Fixation System (KOl10943) Synthes (USA) S…
Pectofix, Inc.2000—
*K010943Synthes Sternal Fixation System
Summary page 3
…K931271), Pioneer Silicoat Sternal Cable (K993286), PectoFix DSF System (K000694), Synthes Sternal Fixation System (K010943), Synthes (USA) Sterile Sternal Fixation System (K050041), Sternal Band (K9…
Synthes (Usa)2001—
*K050041Synthes (Usa) Sterile Sternal Fixation System
Summary page 1
…Synthes Sternal Fixation System (KOl10943) Synthes (USA) Sterile Sternal Fixation System (K050041) Sternal Band (K930015) Lorenz Sternal Closure System (K033740)…
Synthes (Usa)2005—
*K930015Sternal Band
Summary page 1
…(KOl10943) Synthes (USA) Sterile Sternal Fixation System (K050041) Sternal Band (K930015) Lorenz Sternal Closure System (K033740) KILS Martin Sternal Plating System (K032…
Stony Brook Surgical Innovations, Inc.1993—
*K033740Lorenz Sternal Closure System
Summary page 1
…A) Sterile Sternal Fixation System (K050041) Sternal Band (K930015) Lorenz Sternal Closure System (K033740) KILS Martin Sternal Plating System (K03241 3) c-i Intended Use…
Walter Lorenz Surgical, Inc.2003—
*K032413KLS-Martin Sternal Plating System
Summary page 1
…Sternal Band (K930015) Lorenz Sternal Closure System (K033740) KILS Martin Sternal Plating System (K03241 3) c-i Intended Use: The IKLS-Martin Sternal Talon is intended for…
KLS-Martin L.P.2003—

Also cleared against K931271: 18 other devices →

What descends from it? (62)

See all 62

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

NumberDeviceApplicantDecidedDescendants
K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P.200761
K122860KLS Martin Recon TalonKLS Martin L.P.201210
K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241
K142484Sternal Closure SystemJace Medical, LLC20141

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 30 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
  • 1 of the 30 ancestors has a recall of any class.
  • Of its descendants, K070169 (KLS Martin L.P., 2007) has gone furthest, with 61 descendants of its own.
  • 18 other devices also cite its predicate K931271.

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

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 Talon 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 as stated in the FDA summary.

Also cleared against K931271

18 other devices cite the same predicate.

  • K173579Thorecon™ Fixation SystemA & E Medical Corporation · 2018
  • K151983KLS Martin LSS Plating SystemKLS Martin L.P. · 2016
  • K142484Sternal Closure SystemJace Medical, LLC · 2014
  • K141007Demesteel (Stainless Steel) Non-Absorbable SutureDemetech Corp. · 2014
  • K120016Pioneer Sternal Assist Implant SystemPioneer Surgical Technology, Inc. · 2012
  • K120177Spinal Elements Cerclage SystemSpinal Elements, Inc. · 2012

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/K051165 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051165: KLS Martin Sternal Talon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051165

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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