510(k) Report

510(k) · Cleared

Cleared

Matrixrib Fixation System

K133616510(k) TraditionalCleared May 2, 2014158-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

Synthes (USA) Products, LLC · HRS Plate, Fixation, Bone

Cleared on May 2, 2014 as substantially equivalent to K081623 (Synthes (Usa), 2008) and 6 other predicates after a 158-day review. Its family tree reaches back 4 generations to 1997. 26 later devices descend from it.

Decided
May 2, 2014
Review
158 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
7

Its longest line of descent runs back 4 generations to K972420 (1997). 13 ancestors in all, the oldest K942340 (1994). 26 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 1 other ancestor2010: 1 other ancestor2008: 2 other ancestors2005: 1 other ancestor2001: 1 other ancestor2006: 1 other ancestor2003: 1 other ancestor1994: 1 other ancestor2016: 4 descendants cleared2015: 2 descendants cleared2018: 1 descendant cleared2019: 2 descendants cleared2024: 4 descendants cleared2022: 2 descendants cleared2023: 3 descendants cleared2026: 5 descendants cleared2025: 3 descendants clearedK972420 · Lorenz Pectus Support Bar · Walter Lorenz Surgical, Inc. · 1997K981789 · Lorenz Pectus Support Bar Stabilizer · Walter Lorenz Surgical, Inc. · 1998K061384 · Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar Stabilizer, Titanium · Walter Lorenz Surgical, Inc. · 2006K073556 · Medxpert P.E.S. (Pectus Exacvatum System), Medxpert Stratos · Medxpert GmbH · 20081990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 2 other ancestors3 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 7 descendants3 generations forward: 5 descendants4 generations forward: 7 descendants5 generations forward: 5 descendants K073556 · Medxpert P.E.S. (Pectus Exacvatum System), Medxpert Stratos · Medxpert GmbH · 2008K061384 · Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar Stabilizer, Titanium · Walter Lorenz Surgical, Inc. · 2006K981789 · Lorenz Pectus Support Bar Stabilizer · Walter Lorenz Surgical, Inc. · 1998K972420 · Lorenz Pectus Support Bar · Walter Lorenz Surgical, Inc. · 19970+5
  1. Root · 4 generations backK972420 Lorenz Pectus Support BarWalter Lorenz Surgical, Inc. · 1997
  2. 3 generations backK981789 Lorenz Pectus Support Bar StabilizerWalter Lorenz Surgical, Inc. · 1998
  3. 2 generations backK061384 Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar…Walter Lorenz Surgical, Inc. · 2006
  4. 1 generation backK073556 Medxpert P.E.S. (Pectus Exacvatum System), Medxpert StratosMedxpert GmbH · 2008
  5. This deviceK133616 Matrixrib Fixation SystemSynthes (USA) Products, LLC · 2014
  6. Descendant · cites it directly · 23 of its ownK142823 Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation · 2015
  7. Descendant · 2 generations on · 13 of its ownK151173 Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2015
  8. Descendant · 2 generations on · 11 of its ownK152253 Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2016
  9. Descendant · 2 generations on · 9 of its ownK153482 KLS Martin Thoracic Plating SystemKLS-Martin L.P. · 2016
  10. Descendant · 3 generations on · 8 of its ownK162974 Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2016

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2015: 22016: 42018: 12019: 22022: 22023: 32024: 42025: 32026: 5
2015high 5 (2026) · low 0 (2017)2026

Most influential descendants

Showing 5 of 26 · See all
  • K142823Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation · 2015 · cites it directly23descendants
  • K151173Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2015 · 2 generations on13descendants
  • K152253Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2016 · 2 generations on11descendants
  • K153482KLS Martin Thoracic Plating SystemKLS-Martin L.P. · 2016 · 2 generations on9descendants
  • K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2016 · 3 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K972420Lorenz Pectus Support BarWalter Lorenz Surgical, Inc.1997—
−3K981789Lorenz Pectus Support Bar StabilizerWalter Lorenz Surgical, Inc.1998—
−2K061384Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar Stabilizer…Walter Lorenz Surgical, Inc.2006—
−1K073556Medxpert P.E.S. (Pectus Exacvatum System), Medxpert StratosMedxpert GmbH2008—
0 (this device)K133616Matrixrib Fixation SystemSynthes (USA) Products, LLC2014—
+1K142823Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation2015—
+2K151173Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation2015—
+2K152253Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation2016—
+2K153482KLS Martin Thoracic Plating SystemKLS-Martin L.P.2016—
+3K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
200110
200310
200510
200610
200820
201010
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201520
201640
201810
201920
202220
202330
202440
202530
202650
FIG. 1 — Lineage of K133616, 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? (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
*K081623Synthes Rib Fixation System
Summary page 1
…B Fixation System contains the above Class 2 implants and also includes Class 1 instruments and accessories. Predicate Devices * Synthes MatrixRlB Fixation System (K081623) * Synthes Sternal Fixation System (1112689, K093772, K081700, K050041, K(01 0943) *MedXpert STRATOS (K073556) Ind…
Synthes (Usa)2008—
*K112689Synthes Sternal Fixation System
Summary page 1
…ants and also includes Class 1 instruments and accessories. Predicate Devices * Synthes MatrixRlB Fixation System (K081623) * Synthes Sternal Fixation System (1112689, K093772, K081700, K050041, K(01 0943) *MedXpert STRATOS (K073556) Indications for Use The MatrixRlB Fixation System…
Synthes, Inc.2011—
*K093772Synthes Sternal Fixation System
Summary page 1
…also includes Class 1 instruments and accessories. Predicate Devices * Synthes MatrixRlB Fixation System (K081623) * Synthes Sternal Fixation System (1112689, K093772, K081700, K050041, K(01 0943) *MedXpert STRATOS (K073556) Indications for Use The MatrixRlB Fixation System is indica…
Synthes2010—
*K081700Synthes (Usa) Sternal Fixation System - Line Extension
Summary page 1
…ludes Class 1 instruments and accessories. Predicate Devices * Synthes MatrixRlB Fixation System (K081623) * Synthes Sternal Fixation System (1112689, K093772, K081700, K050041, K(01 0943) *MedXpert STRATOS (K073556) Indications for Use The MatrixRlB Fixation System is indicated for u…
Synthes (Usa)2008—
*K050041Synthes (Usa) Sterile Sternal Fixation System
Summary page 1
…ss 1 instruments and accessories. Predicate Devices * Synthes MatrixRlB Fixation System (K081623) * Synthes Sternal Fixation System (1112689, K093772, K081700, K050041, K(01 0943) *MedXpert STRATOS (K073556) Indications for Use The MatrixRlB Fixation System is indicated for use in ske…
Synthes (Usa)2005—
*K010943Synthes Sternal Fixation SystemSynthes (Usa)2001—
*K073556Medxpert P.E.S. (Pectus Exacvatum System), Medxpert Stratos
Summary page 1
…ces * Synthes MatrixRlB Fixation System (K081623) * Synthes Sternal Fixation System (1112689, K093772, K081700, K050041, K(01 0943) *MedXpert STRATOS (K073556) Indications for Use The MatrixRlB Fixation System is indicated for use in skeletally mature patients with normal or osteoporot…
Medxpert GmbH2008—

Also cleared against K081623: 1 other device →

What descends from it? (26)

See all 26

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

NumberDeviceApplicantDecidedDescendants
K142823Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation201523
K161590MatrixRIB Fixation SystemSynthes (USA) Products, LLC20163

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 17 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
  • 1 of the 13 ancestors has a recall of any class.
  • Of its descendants, K142823 (Biomet Microfixation, 2015) has gone furthest, with 23 descendants of its own.
  • 1 other device also cites its predicate K081623.

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 MatrixRlB Fixation System is indicated for use in skeletally mature patients with normal or osteoporotic bone for the fixation, stabilization, and reconstruction of:

* fractures, fusions, osteotomies, and/or resections of the ribs and sternum, including spanning gaps and/or defects

* Pectus Excavatum, Pectus Carinatumn, and other chest wall deformities

Indications for use as stated in the FDA summary.

Also cleared against K081623

1 other device cites the same predicate.

  • K141241Matrixrib Endo Thoracoscopic Rib Plating SystemSynthes (USA) Products, LLC · 2014

More from Synthes (USA) Products, LLC

45 FDA decisions under this applicant name. See the company

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  • K210205DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating SystemSynthes (USA) Products, 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/K133616 · printed Nov 6, 2026

Cite this page

510(k) Report. “K133616: Matrixrib Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133616

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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