510(k) · Cleared

Cleared

Medxpert P.E.S. (Pectus Exacvatum System), Medxpert Stratos

K073556510(k) TraditionalCleared Jun 24, 2008188-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

Medxpert GmbH · HRS Plate, Fixation, Bone

Cleared on Jun 24, 2008 as substantially equivalent to K972420 (Walter Lorenz Surgical, Inc., 1997) and 4 other predicates after a 188-day review. Its family tree reaches back 3 generations to 1997. 32 later devices descend from it.

Decided: Jun 24, 2008
Review: 188 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 5

Its longest line of descent runs back 3 generations to K972420 (1997). 6 ancestors in all, the oldest K942340 (1994). 32 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 3 generations backK972420 Lorenz Pectus Support BarWalter Lorenz Surgical, Inc. · 1997
2 generations backK981789 Lorenz Pectus Support Bar StabilizerWalter Lorenz Surgical, Inc. · 1998
1 generation backK061384 Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar…Walter Lorenz Surgical, Inc. · 2006
This deviceK073556 Medxpert P.E.S. (Pectus Exacvatum System), Medxpert StratosMedxpert GmbH · 2008
Descendant · cites it directly · 26 of its ownK133616 Matrixrib Fixation SystemSynthes (USA) Products, LLC · 2014
Descendant · 2 generations on · 23 of its ownK142823 Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation · 2015
Descendant · 3 generations on · 13 of its ownK151173 Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2015
Descendant · 3 generations on · 11 of its ownK152253 Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2016
Descendant · 3 generations on · 9 of its ownK153482 KLS Martin Thoracic Plating SystemKLS-Martin L.P. · 2016

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

2012high 6 (2026) · low 0 (2013)2026

Most influential descendants

Showing 5 of 32 · See all

K133616Matrixrib Fixation SystemSynthes (USA) Products, LLC · 2014 · cites it directly26descendants
K142823Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation · 2015 · 2 generations on23descendants
K151173Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2015 · 3 generations on13descendants
K152253Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2016 · 3 generations on11descendants
K153482KLS Martin Thoracic Plating SystemKLS-Martin L.P. · 2016 · 3 generations on9descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K972420	Lorenz Pectus Support Bar	Walter Lorenz Surgical, Inc.	1997	—
−2	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	—
0 (this device)	K073556	Medxpert P.E.S. (Pectus Exacvatum System), Medxpert Stratos	Medxpert GmbH	2008	—
+1	K133616	Matrixrib Fixation System	Synthes (USA) Products, LLC	2014	—
+2	K142823	Biomet Microfixation Thoracic Fixation System	Biomet Microfixation	2015	—
+3	K151173	Biomet Microfixation RibFix Blu Thoracic Fixation System	Biomet Microfixation	2015	—
+3	K152253	Biomet Microfixation RibFix Blu Thoracic Fixation System	Biomet Microfixation	2016	—
+3	K153482	KLS Martin Thoracic Plating System	KLS-Martin L.P.	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
2003	1	0
2006	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2014	2	0
2015	2	0
2016	4	0
2018	1	0
2019	3	0
2021	1	0
2022	2	0
2023	3	0
2024	4	0
2025	3	0
2026	6	0

FIG. 1 — Lineage of K073556, 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? (5)

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 2 …MEDXPERT 510(k) Application 3. Substantial Equivalence MedXpert's P.E.S &STRATOS TM implant systems are substantial equivalent to the Lorenz Pec- tus Support Bar (K972420), Lorenz Pectus Support Bar Stabilizer (K981789) and Lorenz Pectus Support Bar System (K061384) of Walter Lorenz Surgical, Inc.,…	Walter Lorenz Surgical, Inc.	1997	—
*	K981789	Lorenz Pectus Support Bar Stabilizer Summary page 2 …l Equivalence MedXpert's P.E.S &STRATOS TM implant systems are substantial equivalent to the Lorenz Pec- tus Support Bar (K972420), Lorenz Pectus Support Bar Stabilizer (K981789) and Lorenz Pectus Support Bar System (K061384) of Walter Lorenz Surgical, Inc., Acute Bone Screw (K061206) of Acute Innovations…	Walter Lorenz Surgical, Inc.	1998	—
*	K061384	Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar Stabilizer, Titanium Summary page 2 …ant systems are substantial equivalent to the Lorenz Pec- tus Support Bar (K972420), Lorenz Pectus Support Bar Stabilizer (K981789) and Lorenz Pectus Support Bar System (K061384) of Walter Lorenz Surgical, Inc., Acute Bone Screw (K061206) of Acute Innovations LLC, and MacroPore OS Reconstruction System (K0…	Walter Lorenz Surgical, Inc.	2006	—
*	K061206	Acute Bone Screw Summary page 2 …s Support Bar (K972420), Lorenz Pectus Support Bar Stabilizer (K981789) and Lorenz Pectus Support Bar System (K061384) of Walter Lorenz Surgical, Inc., Acute Bone Screw (K061206) of Acute Innovations LLC, and MacroPore OS Reconstruction System (K024169) of MacroPore Biosurgery, Inc. 4. Description of the…	Acute Innovations, LLC	2006	—
*	K024169	Macropore OS Reconstruction Summary page 2 …Lorenz Pectus Support Bar System (K061384) of Walter Lorenz Surgical, Inc., Acute Bone Screw (K061206) of Acute Innovations LLC, and MacroPore OS Reconstruction System (K024169) of MacroPore Biosurgery, Inc. 4. Description of the Device MedXpert's P.E.S. implant system is consisting out of straight bars…	Macropore Biosurgery, Inc.	2003	—

Also cleared against K972420: 4 other devices →

What descends from it? (32)

See all 32

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

Number	Device	Applicant	Decided	Descendants
K133616	Matrixrib Fixation System	Synthes (USA) Products, LLC	2014	26
K113318	Acute Innovations Modular Ribloc System	Acute Innovations, LLC	2012	8
K253660	KLS Martin Pure Pectus System	KLS-Martin L.P.	2026	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?

The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
1 of the 6 ancestors has a recall of any class.
Of its descendants, K133616 (Synthes (USA) Products, LLC, 2014) has gone furthest, with 26 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. 2008, this device’s year, is highlighted.

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?

MedXpert's P.E.S. implant system is intended for use in surgical procedures to repair Pectus Excavatum and other sternal deformities.

MedXpert's STRATOSTM implant system is intended to stabilize and provide fixation for fractures, fusions, and osteotomies of the ribs, and reconstructions of chest wall and sternum.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K073556 · printed Nov 4, 2026

Cite this page

510(k) Report. “K073556: Medxpert P.E.S. (Pectus Exacvatum System), Medxpert Stratos.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073556

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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