510(k) Report

510(k) · Cleared

Cleared

Matrixrib Endo Thoracoscopic Rib Plating System

K141241510(k) TraditionalCleared Aug 7, 201486-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 Aug 7, 2014 as substantially equivalent to K081623 (Synthes (Usa), 2008) and 2 other predicates after an 86-day review. Its family tree reaches back 5 generations to 2000. 5 later devices descend from it.

Decided
Aug 7, 2014
Review
86 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
3

Its longest line of descent runs back 5 generations to K000684 (2000). 26 ancestors in all, the oldest K890939 (1989). 5 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 1 other ancestor2008: 2 other ancestors2010: 2 other ancestors2006: 2 other ancestors2005: 1 other ancestor2003: 3 other ancestors2001: 2 other ancestors1998: 1 other ancestor1997: 1 other ancestor1994: 2 other ancestors2000: 1 other ancestor1995: 1 other ancestor1991: 1 other ancestor1989: 1 other ancestor2019: 1 descendant cleared2021: 1 descendant cleared2024: 1 descendant cleared2026: 2 descendants clearedK000684 · Small Fragment Dynamic Compression Locking (DCL) System · Synthes (Usa) · 2000 · recalled×2: 2 generations cleared close together, K011335 (2001), K012655 (2001) K051410 · Acumed Rib Congrient Bone Plate System · Acumed, LLC · 2005 · recalledK113318 · Acute Innovations Modular Ribloc System · Acute Innovations, LLC · 2012 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors3 generations back: 10 other ancestors4 generations back: 6 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 3 descendants K113318 · Acute Innovations Modular Ribloc System · Acute Innovations, LLC · 2012 · recalledK051410 · Acumed Rib Congrient Bone Plate System · Acumed, LLC · 2005 · recalledK012655 · Congruent Bone Plate System · Acu Med, Inc. · 2001 · recalledK011335 · Synths One-Third Tubular DCL Plate · Synthes (Usa) · 2001 · recalledK000684 · Small Fragment Dynamic Compression Locking (DCL) System · Synthes (Usa) · 2000 · recalled−50
  1. Root · 5 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
  2. 4 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
  3. 3 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
  4. 2 generations backK051410 Acumed Rib Congrient Bone Plate SystemAcumed, LLC · 2005 · Recalled
  5. 1 generation backK113318 Acute Innovations Modular Ribloc SystemAcute Innovations, LLC · 2012 · Recalled
  6. This deviceK141241 Matrixrib Endo Thoracoscopic Rib Plating SystemSynthes (USA) Products, LLC · 2014
  7. Descendant · cites it directly · 4 of its ownK183317 AdvantageRib SystemSig Medical Corporation · 2019
  8. Descendant · 2 generations on · 3 of its ownK203474 Biomet Microfixation RibFix Advantage SystemBiomet Micofixation · 2021
  9. Descendant · 3 generations on · 0 of its ownK261892 ProRib Fixation SystemCosta Surgical, Inc. · 2026
  10. Descendant · 3 generations on · 0 of its ownK260411 PC Fix SystemChest Wall Innovations, Inc. · 2026
  11. Descendant · 3 generations on · 0 of its ownK241282 RibFix Titan™ Fixation SystemRiverpoint Medical · 2024

Most influential descendants

Showing 5 of 5 · See all
  • K183317AdvantageRib SystemSig Medical Corporation · 2019 · cites it directly4descendants
  • K203474Biomet Microfixation RibFix Advantage SystemBiomet Micofixation · 2021 · 2 generations on3descendants
  • K261892ProRib Fixation SystemCosta Surgical, Inc. · 2026 · 3 generations on0descendants
  • K260411PC Fix SystemChest Wall Innovations, Inc. · 2026 · 3 generations on0descendants
  • K241282RibFix Titan™ Fixation SystemRiverpoint Medical · 2024 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K000684Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa)20001
−4K011335Synths One-Third Tubular DCL PlateSynthes (Usa)20012
−3K012655Congruent Bone Plate SystemAcu Med, Inc.200116
−2K051410Acumed Rib Congrient Bone Plate SystemAcumed, LLC20051
−1K113318Acute Innovations Modular Ribloc SystemAcute Innovations, LLC20121
0 (this device)K141241Matrixrib Endo Thoracoscopic Rib Plating SystemSynthes (USA) Products, LLC2014—
+1K183317AdvantageRib SystemSig Medical Corporation2019—
+2K203474Biomet Microfixation RibFix Advantage SystemBiomet Micofixation2021—
+3K261892ProRib Fixation SystemCosta Surgical, Inc.2026—
+3K260411PC Fix SystemChest Wall Innovations, Inc.2026—
+3K241282RibFix Titan™ Fixation SystemRiverpoint Medical2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199110
199420
199510
199710
199810
200010
200120
200330
200510
200620
200820
201020
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
202110
202410
202620
FIG. 1 — Lineage of K141241, 2000–2026Source: 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), 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? (3)

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 4
…do Thoracoscopic Rib Plating System contains Class 2 implants as well as Class 1 instruments and accessories. Predicate Devices: x Synthes MatrixRIB Fixation System (K081623) x Acute Innovations Modular RibLoc System (K113318) x Synthes Sternal Fixation System (K112689) Indications for Use: The…
Synthes (Usa)2008—
*K113318Acute Innovations Modular Ribloc System
Summary page 4
…plants as well as Class 1 instruments and accessories. Predicate Devices: x Synthes MatrixRIB Fixation System (K081623) x Acute Innovations Modular RibLoc System (K113318) x Synthes Sternal Fixation System (K112689) Indications for Use: The MatrixRIB Endo Thoracoscopic Rib Plating System is indi…
Acute Innovations, LLC20121
*K112689Synthes Sternal Fixation System
Summary page 4
…sories. Predicate Devices: x Synthes MatrixRIB Fixation System (K081623) x Acute Innovations Modular RibLoc System (K113318) x Synthes Sternal Fixation System (K112689) Indications for Use: The MatrixRIB Endo Thoracoscopic Rib Plating System is indicated for the fixation, stabilization, and fusi…
Synthes, Inc.2011—

Also cleared against K081623: 1 other device →

What descends from it? (5)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K183317AdvantageRib SystemSig Medical Corporation20194

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 14 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
  • 7 of the 26 ancestors have a recall of any class.
  • Of its descendants, K183317 (Sig Medical Corporation, 2019) has gone furthest, with 4 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 MatrixRIB Endo Thoracoscopic Rib Plating System is indicated for the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K141241: Matrixrib Endo Thoracoscopic Rib Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141241

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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