510(k) Report

510(k) · Cleared

Cleared

Sternal Closure System

K142484510(k) TraditionalCleared Oct 31, 201457-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

Jace Medical, LLC · HRS Plate, Fixation, Bone

Cleared on Oct 31, 2014 as substantially equivalent to K110574 (Biomet Microfixation, Inc., 2011) and 6 other predicates after a 57-day review. Its family tree reaches back 11 generations to 1976. 1 later device descends from it.

Decided
Oct 31, 2014
Review
57 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
7

Its longest line of descent runs back 11 generations to K761228 (1976). 89 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2006: 3 other ancestors1995: 5 other ancestors1994: 9 other ancestors2011: 1 other ancestor2010: 1 other ancestor2005: 1 other ancestor2003: 5 other ancestors2001: 4 other ancestors2000: 3 other ancestors1999: 5 other ancestors1993: 4 other ancestors2004: 1 other ancestor2002: 2 other ancestors1998: 11 other ancestors1997: 5 other ancestors1996: 10 other ancestors1990: 2 other ancestors1992: 1 other ancestor1991: 1 other ancestor1988: 1 other ancestor1986: 2 other ancestors2021: 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 · 201219801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 11 other ancestors3 generations back: 13 other ancestors4 generations back: 21 other ancestors5 generations back: 9 other ancestors6 generations back: 11 other ancestors7 generations back: 9 other ancestors 1 generation forward: 1 descendant K121302 · 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 · 11 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
  2. 7 generations between
  3. 3 generations backK110574 Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc. · 2011 · Recalled
  4. 2 generations backK111908 Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc. · 2011
  5. 1 generation backK121302 Biomet Microfixation Sternal Closure SystemBiomet Microfixation · 2012
  6. This deviceK142484 Sternal Closure SystemJace Medical, LLC · 2014
  7. Descendant · cites it directly · 0 of its ownK210290 JACE Medical Thoracic Plating SystemJace Medical, LLC · 2021
Show all 11 generations
  1. Root · 11 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
  2. 10 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
  3. 9 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
  4. 8 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
  5. 7 generations backK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002
  6. 6 generations backK032228 Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2003
  7. 5 generations backK033740 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2003
  8. 4 generations backK063506 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2006
  9. 3 generations backK110574 Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc. · 2011 · Recalled
  10. 2 generations backK111908 Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc. · 2011
  11. 1 generation backK121302 Biomet Microfixation Sternal Closure SystemBiomet Microfixation · 2012
  12. This deviceK142484 Sternal Closure SystemJace Medical, LLC · 2014

Most influential descendants

Showing 1 of 1 · See all
  • K210290JACE Medical Thoracic Plating SystemJace Medical, LLC · 2021 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K761228Luhr Mandibular Compression-Screw SystemHowmedica Corp.1976—
−10K963739Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc.1997—
−9K970912Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc.1997—
−8K974785Auto-Drive Bone ScrewOsteomed Corp.1998—
−7K013954Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc.2002—
−6K032228Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc.2003—
−5K033740Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc.2003—
−4K063506Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc.2006—
−3K110574Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc.20111
−2K111908Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc.2011—
−1K121302Biomet Microfixation Sternal Closure SystemBiomet Microfixation2012—
0 (this device)K142484Sternal Closure SystemJace Medical, LLC2014—
+1K210290JACE Medical Thoracic Plating SystemJace Medical, LLC2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198620
198810
199020
199110
199210
199340
199490
199550
1996100
199750
1998110
199950
200030
200140
200220
200350
200410
200510
200630
200710
201010
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202110
FIG. 1 — Lineage of K142484, 1976–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (7)

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
*K110574Biomet Microfixation Sternalock Blu Sternal Closure System
Summary page 4
…titanium alloy as described by ASTM F136. Predicate Devices: Biomet Microfixation Sternal Closure System (Biomet Microfixation: K110574, K111908, K121302) Ethicon Stainless Steel Suture Wire (Ethicon Inc.: K931271,…
Biomet Microfixation, Inc.20111
*K111908Biomet Microfixation Sternal Closure System
Summary page 4
…titanium alloy as described by ASTM F136. Predicate Devices: Biomet Microfixation Sternal Closure System (Biomet Microfixation: K110574, K111908, K121302) Ethicon Stainless Steel Suture Wire (Ethicon Inc.: K931271, K946173)…
Biomet Microfixation, Inc.2011—
*K121302Biomet Microfixation Sternal Closure System
Summary page 4
…m alloy as described by ASTM F136. Predicate Devices: Biomet Microfixation Sternal Closure System (Biomet Microfixation: K110574, K111908, K121302) Ethicon Stainless Steel Suture Wire (Ethicon Inc.: K931271, K946173)…
Biomet Microfixation2012—
*K931271Ethi-Pack* Surgical Stainless Steel Suture
Summary page 4
…nal Closure System (Biomet Microfixation: K110574, K111908, K121302) Ethicon Stainless Steel Suture Wire (Ethicon Inc.: K931271, K946173) Sternal Talon (KLS Martin, LP: K051165, K070169) Performance Data:…
ETHICON, Inc.1994—
*K946173Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene, Poly…
Summary page 4
…xation: K110574, K111908, K121302) Ethicon Stainless Steel Suture Wire (Ethicon Inc.: K931271, K946173) Sternal Talon (KLS Martin, LP: K051165, K070169) Performance Data: Mechanical testing of the wor…
ETHICON, Inc.199510
*K051165KLS Martin Sternal Talon
Summary page 4
…Ethicon Stainless Steel Suture Wire (Ethicon Inc.: K931271, K946173) Sternal Talon (KLS Martin, LP: K051165, K070169) Performance Data: Mechanical testing of the worst case Sternal Closure System construct…
KLS-Martin L.P.2006—
*K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile
Summary page 4
…Ethicon Stainless Steel Suture Wire (Ethicon Inc.: K931271, K946173) Sternal Talon (KLS Martin, LP: K051165, K070169) Performance Data: Mechanical testing of the worst case Sternal Closure System constructs was per…
KLS Martin L.P.2007—

Also cleared against K110574: 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
K210290JACE Medical Thoracic Plating SystemJace Medical, LLC20210

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 38 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
  • 7 of the 89 ancestors have a recall of any class.
  • Of its descendants, K210290 (Jace Medical, LLC, 2021) has gone furthest, with 0 descendants of its own.
  • 7 other devices also cite its predicate K110574.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Sternal Closure System is intended for use in the stabilization and fixation of fractures of the sternum, including sternal fixation following sternotomy and sternal reconstructive surgical procedures.

Indications for use as stated in the FDA summary.

Also cleared against K110574

7 other devices cite the same predicate.

  • K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · 2021
  • K181806ARIX Sternal SystemJeil Medical Corporation · 2018
  • K150581Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2015
  • K133785Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. · 20141 recall
  • K122293Pioneer Sternal Cable Plate SystemPioneer Surgical Technology, Inc. · 2012
  • K121302Biomet Microfixation Sternal Closure SystemBiomet Microfixation · 2012

More from Jace Medical, LLC

2 FDA decisions under this applicant name. See the company

  • K210290JACE Medical Thoracic Plating SystemJace Medical, LLC · 2021

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/K142484 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142484: Sternal Closure System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142484

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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