510(k) Report

510(k) · Cleared

Cleared

Lorenz Sternal Closure System with Modular Screw

K011076510(k) TraditionalCleared Jul 16, 200198-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

Walter Lorenz Surgical, Inc. · HRS Plate, Fixation, Bone

Cleared on Jul 16, 2001 after a 98-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 110 later devices descend from it.

Decided
Jul 16, 2001
Review
98 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
0

110 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 2012: 5 descendants cleared2003: 2 descendants cleared2010: 1 descendant cleared2006: 3 descendants cleared2011: 4 descendants cleared2007: 1 descendant cleared2016: 7 descendants cleared2005: 1 descendant cleared2024: 16 descendants cleared2020: 2 descendants cleared2018: 4 descendants cleared2025: 15 descendants cleared2014: 5 descendants cleared2022: 7 descendants cleared2019: 4 descendants cleared2021: 4 descendants cleared2015: 6 descendants cleared2023: 8 descendants cleared2013: 1 descendant cleared2026: 14 descendants cleared200020052010201520202025
  1. This deviceK011076 Lorenz Sternal Closure System with Modular ScrewWalter Lorenz Surgical, Inc. · 2001
  2. Descendant · cites it directly · 100 of its ownK033740 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2003
  3. Descendant · cites it directly · 87 of its ownK063506 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2006
  4. Descendant · 2 generations on · 84 of its ownK110574 Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc. · 2011 · Recalled
  5. Descendant · cites it directly · 78 of its ownK111908 Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc. · 2011
  6. Descendant · cites it directly · 75 of its ownK121302 Biomet Microfixation Sternal Closure SystemBiomet Microfixation · 2012

Showing 5 of 110 descendants. See all descendants

Descendants cleared per year

2003: 22005: 12006: 32007: 12010: 12011: 42012: 52013: 12014: 52015: 62016: 72018: 42019: 42020: 22021: 42022: 72023: 82024: 162025: 152026: 14
2003high 16 (2024) · low 0 (2004)2026

Most influential descendants

Showing 5 of 110 · See all
  • K033740Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2003 · cites it directly100descendants
  • K063506Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2006 · cites it directly87descendants
  • K110574Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc. · 2011 · 2 generations on84descendants
  • K111908Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc. · 2011 · cites it directly78descendants
  • K121302Biomet Microfixation Sternal Closure SystemBiomet Microfixation · 2012 · cites it directly75descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011076Lorenz Sternal Closure System with Modular ScrewWalter Lorenz Surgical, Inc.2001—
+1K033740Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc.2003—
+1K063506Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc.2006—
+2K110574Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc.20111
+1K111908Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc.2011—
+1K121302Biomet Microfixation Sternal Closure SystemBiomet Microfixation2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200320
200510
200630
200710
201010
201140
201250
201310
201450
201560
201670
201840
201940
202020
202140
202270
202380
2024160
2025150
2026140
FIG. 1 — Lineage of K011076, 2001–2026Source: 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), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (110)

See all 110

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

NumberDeviceApplicantDecidedDescendants
K033740Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc.2003100
K063506Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc.200687
K111908Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc.201178
K121302Biomet Microfixation Sternal Closure SystemBiomet Microfixation201275
K032413KLS-Martin Sternal Plating SystemKLS-Martin L.P.200374
K122293Pioneer Sternal Cable Plate SystemPioneer Surgical Technology, Inc.201246
K101170Acute Innovations Sternal Fixation SystemAcute Innovations, LLC201010
K110039Biomet Sports Medicine Sternal Closure SystemBiomet Sports Medicine20111
K053624Medicon Stern-a-Fix Sternal Closure SystemMedicon EG20060

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?

  • Of its descendants, K033740 (Walter Lorenz Surgical, Inc., 2003) has gone furthest, with 100 descendants of its own.

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—

More from Walter Lorenz Surgical, Inc.

56 FDA decisions under this applicant name. See the company

  • K063386Lorenz Orthodontic Anchorage SystemWalter Lorenz Surgical, Inc. · 2007
  • K063052Lorenz Titanium Fracture / Reconstruction Devices and Pre-Bent PlatesWalter Lorenz Surgical, Inc. · 2007
  • K063506Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2006
  • K062842Twist DrillWalter Lorenz Surgical, Inc. · 20061 recall
  • K061384Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar Stabilizer, TitaniumWalter Lorenz Surgical, Inc. · 2006

Recent decisions in HRS

The HRS category page

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  • 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/K011076 · printed Nov 5, 2026

Cite this page

510(k) Report. “K011076: Lorenz Sternal Closure System with Modular Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011076

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026