510(k) · Cleared

Cleared

Lorenz Pectus Support Bar Stabilizer

K981789510(k) TraditionalCleared Jul 13, 199854-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 13, 1998 as substantially equivalent to K972420 (Walter Lorenz Surgical, Inc., 1997) after a 54-day review. Its family tree reaches back 1 generation to 1997. 42 later devices descend from it.

Decided: Jul 13, 1998
Review: 54 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K972420 (1997). 42 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK972420 Lorenz Pectus Support BarWalter Lorenz Surgical, Inc. · 1997
This deviceK981789 Lorenz Pectus Support Bar StabilizerWalter Lorenz Surgical, Inc. · 1998
Descendant · cites it directly · 41 of its ownK061384 Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar…Walter Lorenz Surgical, Inc. · 2006
Descendant · cites it directly · 32 of its ownK073556 Medxpert P.E.S. (Pectus Exacvatum System), Medxpert StratosMedxpert GmbH · 2008
Descendant · 2 generations on · 26 of its ownK133616 Matrixrib Fixation SystemSynthes (USA) Products, LLC · 2014
Descendant · 3 generations on · 23 of its ownK142823 Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation · 2015
Descendant · 4 generations on · 13 of its ownK151173 Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2015

Showing 5 of 42 descendants. See all descendants

Descendants cleared per year

2006high 7 (2026) · low 0 (2009)2026

Most influential descendants

Showing 5 of 42 · See all

K061384Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar Stabilizer, TitaniumWalter Lorenz Surgical, Inc. · 2006 · cites it directly41descendants
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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K972420	Lorenz Pectus Support Bar	Walter Lorenz Surgical, Inc.	1997	—
0 (this device)	K981789	Lorenz Pectus Support Bar Stabilizer	Walter Lorenz Surgical, Inc.	1998	—
+1	K061384	Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar Stabilizer…	Walter Lorenz Surgical, Inc.	2006	—
+1	K073556	Medxpert P.E.S. (Pectus Exacvatum System), Medxpert Stratos	Medxpert GmbH	2008	—
+2	K133616	Matrixrib Fixation System	Synthes (USA) Products, LLC	2014	—
+3	K142823	Biomet Microfixation Thoracic Fixation System	Biomet Microfixation	2015	—
+4	K151173	Biomet Microfixation RibFix Blu Thoracic Fixation System	Biomet Microfixation	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	1	0
2008	1	0
2012	1	0
2014	2	0
2015	2	0
2016	4	0
2018	1	0
2019	3	0
2020	1	0
2021	1	0
2022	4	0
2023	3	0
2024	5	0
2025	5	0
2026	7	0

FIG. 1 — Lineage of K981789, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K972420	Lorenz Pectus Support Bar Summary page 1 …Summary of Safety and Effectiveness Device Modification Name: Lorenz Pectus Support Bar Stabilizer Name of previously cleared 510(k): Lorenz Pectus Support Bar - 510(k) K972420 Classification Name and Reference: Plate, Fixation, Bone 87 HRS (CFR 888.3030) Intended use: For use during surgical procedure…	Walter Lorenz Surgical, Inc.	1997	—

Also cleared against K972420: 4 other devices →

What descends from it? (42)

See all 42

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

Number	Device	Applicant	Decided	Descendants
K061384	Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar Stabilizer, Titanium	Walter Lorenz Surgical, Inc.	2006	41
K073556	Medxpert P.E.S. (Pectus Exacvatum System), Medxpert Stratos	Medxpert GmbH	2008	32
K071577	Biomet Microfixation Lactosorb Pectus Stabilizer	Biomet Microfixation, Inc.	2007	0

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?

Its one ancestor has no recall.
Of its descendants, K061384 (Walter Lorenz Surgical, Inc., 2006) has gone furthest, with 41 descendants of its own.
4 other devices also cite its predicate K972420.

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

2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007high 144 (2022) · low 57 (2014)2026

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

Recalls per year · HRS

1in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	35	63	2	339
2008	35	87	11	311
2009	47	85	3	435
2010	49	100	16	491
2011	43	88	5	773
2012	59	106	4	1,663
2013	56	89	11	2,643
2014	76	57	0	2,413
2015	56	97	7	3,095
2016	44	109	5	2,276
2017	57	122	3	2,220
2018	40	116	2	2,663
2019	46	89	25	3,359
2020	48	88	1	2,790
2021	40	87	9	2,442
2022	47	144	3	1,700
2023	40	120	1	2,049
2024	54	96	0	1,849
2025	54	90	1	2,306
2026	51	82	3	—

What is it indicated for?

For use during surgical procedures to repair Pectus Excavatum and other sternal deformities with Lorenz Pectus Support Bar 510(k) number K972420 when additional stabilization is necessary.

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

https://510kreport.com/device/K981789 · printed Nov 4, 2026

Cite this page

510(k) Report. “K981789: Lorenz Pectus Support Bar Stabilizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981789

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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