510(k) Report

510(k) · Cleared

Cleared

Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar Stabilizer, Titanium

K061384510(k) SpecialCleared Jun 6, 200619-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 Jun 6, 2006 as substantially equivalent to K981789 (Walter Lorenz Surgical, Inc., 1998) and 1 other predicate after a 19-day review. Its family tree reaches back 2 generations to 1997. 41 later devices descend from it.

Decided
Jun 6, 2006
Review
19 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K972420 (1997). 41 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2020: 1 descendant cleared2022: 4 descendants cleared2008: 1 descendant cleared2012: 1 descendant cleared2026: 7 descendants cleared2014: 2 descendants cleared2025: 5 descendants cleared2024: 5 descendants cleared2016: 4 descendants cleared2015: 2 descendants cleared2019: 3 descendants cleared2018: 1 descendant cleared2023: 3 descendants cleared2021: 1 descendant clearedK972420 · Lorenz Pectus Support Bar · Walter Lorenz Surgical, Inc. · 1997K981789 · Lorenz Pectus Support Bar Stabilizer · Walter Lorenz Surgical, Inc. · 19981995200020052010201520202025
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 8 descendants3 generations forward: 6 descendants4 generations forward: 9 descendants5 generations forward: 5 descendants6 generations forward: 6 descendants7 generations forward: 2 descendants K981789 · Lorenz Pectus Support Bar Stabilizer · Walter Lorenz Surgical, Inc. · 1998K972420 · Lorenz Pectus Support Bar · Walter Lorenz Surgical, Inc. · 19970+5
  1. Root · 2 generations backK972420 Lorenz Pectus Support BarWalter Lorenz Surgical, Inc. · 1997
  2. 1 generation backK981789 Lorenz Pectus Support Bar StabilizerWalter Lorenz Surgical, Inc. · 1998
  3. This deviceK061384 Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar…Walter Lorenz Surgical, Inc. · 2006
  4. Descendant · cites it directly · 32 of its ownK073556 Medxpert P.E.S. (Pectus Exacvatum System), Medxpert StratosMedxpert GmbH · 2008
  5. Descendant · 2 generations on · 26 of its ownK133616 Matrixrib Fixation SystemSynthes (USA) Products, LLC · 2014
  6. Descendant · 3 generations on · 23 of its ownK142823 Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation · 2015
  7. Descendant · 4 generations on · 13 of its ownK151173 Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2015
  8. Descendant · 4 generations on · 11 of its ownK152253 Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2016

Showing 5 of 41 descendants. See all descendants

Descendants cleared per year

2007: 12008: 12012: 12014: 22015: 22016: 42018: 12019: 32020: 12021: 12022: 42023: 32024: 52025: 52026: 7
2007high 7 (2026) · low 0 (2009)2026

Most influential descendants

Showing 5 of 41 · See all
  • K073556Medxpert P.E.S. (Pectus Exacvatum System), Medxpert StratosMedxpert GmbH · 2008 · cites it directly32descendants
  • K133616Matrixrib Fixation SystemSynthes (USA) Products, LLC · 2014 · 2 generations on26descendants
  • K142823Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation · 2015 · 3 generations on23descendants
  • K151173Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2015 · 4 generations on13descendants
  • K152253Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2016 · 4 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K972420Lorenz Pectus Support BarWalter Lorenz Surgical, Inc.1997—
−1K981789Lorenz Pectus Support Bar StabilizerWalter Lorenz Surgical, Inc.1998—
0 (this device)K061384Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar Stabilizer…Walter Lorenz Surgical, Inc.2006—
+1K073556Medxpert P.E.S. (Pectus Exacvatum System), Medxpert StratosMedxpert GmbH2008—
+2K133616Matrixrib Fixation SystemSynthes (USA) Products, LLC2014—
+3K142823Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation2015—
+4K151173Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation2015—
+4K152253Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
201210
201420
201520
201640
201810
201930
202010
202110
202240
202330
202450
202550
202670
FIG. 1 — Lineage of K061384, 1997–2026Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K981789Lorenz Pectus Support Bar Stabilizer
Summary page 1
…Titanium and the Pectus Titanium Support Bar Stabilizer is believed to be substantially equivalent in application and function to: Lorenz Pectus Support Bar Stabilizer (K981789) Lorenz Pectus Support Bar (K972420) Statement of Comparison of Technological Features Both the predicate and the new (contained…
Walter Lorenz Surgical, Inc.1998—
*K972420Lorenz Pectus Support Bar
Summary page 1
…port Bar Stabilizer is believed to be substantially equivalent in application and function to: Lorenz Pectus Support Bar Stabilizer (K981789) Lorenz Pectus Support Bar (K972420) Statement of Comparison of Technological Features Both the predicate and the new (contained within this submission) devices con…
Walter Lorenz Surgical, Inc.1997—

Also cleared against K981789: 2 other devices →

What descends from it? (41)

See all 41

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

NumberDeviceApplicantDecidedDescendants
K073556Medxpert P.E.S. (Pectus Exacvatum System), Medxpert StratosMedxpert GmbH200832
K212841Pectus Blu Support Bar SystemBiomet Micofixation20225
K191057Park's Pectus SystemTdm Co., Ltd.20205
K213712Pectus Support Bar SystemBiomet Microfixation20221
K071577Biomet Microfixation Lactosorb Pectus StabilizerBiomet Microfixation, Inc.20070

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 9 years and passes through 1 company; a new generation was cleared every 7.9 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K073556 (Medxpert GmbH, 2008) has gone furthest, with 32 descendants of its own.
  • 2 other devices also cite its predicate K981789.

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?

This device is intended for use in surgical procedures to repair Pectus Excavatum and other chest wall deformities.

Indications for use as stated in the FDA summary.

Also cleared against K981789

2 other devices cite the same predicate.

  • K073556Medxpert P.E.S. (Pectus Exacvatum System), Medxpert StratosMedxpert GmbH · 2008
  • K071577Biomet Microfixation Lactosorb Pectus StabilizerBiomet Microfixation, Inc. · 20071 recall

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
  • K042516OtomimixWalter Lorenz Surgical, Inc. · 2004

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/K061384 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061384: Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar Stabilizer, Titanium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061384

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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