510(k) Report

510(k) · Cleared

Cleared

Acute Innovations Sternal Fixation System

K101170510(k) TraditionalCleared Sep 17, 2010144-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

Acute Innovations, LLC · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Sep 17, 2010 as substantially equivalent to K931246 (Acu Med, Inc., 1994) and 4 other predicates after a 144-day review. Its family tree reaches back 2 generations to 2001. 10 later devices descend from it.

Decided
Sep 17, 2010
Review
144 days
Class
Class II
Product code
KTT
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K011076 (2001). 5 ancestors in all, the oldest K931246 (1994). 10 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2003: 1 other ancestor1994: 1 other ancestor2012: 2 descendants cleared2014: 1 descendant cleared2022: 1 descendant cleared2019: 1 descendant cleared2023: 1 descendant cleared2021: 1 descendant cleared2024: 1 descendant cleared2026: 2 descendants clearedK011076 · Lorenz Sternal Closure System with Modular Screw · Walter Lorenz Surgical, Inc. · 2001K032413 · KLS-Martin Sternal Plating System · KLS-Martin L.P. · 20031990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant5 generations forward: 3 descendants K032413 · KLS-Martin Sternal Plating System · KLS-Martin L.P. · 2003K011076 · Lorenz Sternal Closure System with Modular Screw · Walter Lorenz Surgical, Inc. · 20010+5
  1. Root · 2 generations backK011076 Lorenz Sternal Closure System with Modular ScrewWalter Lorenz Surgical, Inc. · 2001
  2. 1 generation backK032413 KLS-Martin Sternal Plating SystemKLS-Martin L.P. · 2003
  3. This deviceK101170 Acute Innovations Sternal Fixation SystemAcute Innovations, LLC · 2010
  4. Descendant · cites it directly · 8 of its ownK113318 Acute Innovations Modular Ribloc SystemAcute Innovations, LLC · 2012 · Recalled
  5. Descendant · 2 generations on · 5 of its ownK141241 Matrixrib Endo Thoracoscopic Rib Plating SystemSynthes (USA) Products, LLC · 2014
  6. Descendant · 3 generations on · 4 of its ownK183317 AdvantageRib SystemSig Medical Corporation · 2019
  7. Descendant · 4 generations on · 3 of its ownK203474 Biomet Microfixation RibFix Advantage SystemBiomet Micofixation · 2021
  8. Descendant · 2 generations on · 1 of its ownK221412 ARIX Rib SystemJeil Medical Corporation · 2022

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2012: 22014: 12019: 12021: 12022: 12023: 12024: 12026: 2
2012high 2 (2012) · low 0 (2013)2026

Most influential descendants

Showing 5 of 10 · See all
  • K113318Acute Innovations Modular Ribloc SystemAcute Innovations, LLC · 2012 · cites it directly8descendants
  • K141241Matrixrib Endo Thoracoscopic Rib Plating SystemSynthes (USA) Products, LLC · 2014 · 2 generations on5descendants
  • K183317AdvantageRib SystemSig Medical Corporation · 2019 · 3 generations on4descendants
  • K203474Biomet Microfixation RibFix Advantage SystemBiomet Micofixation · 2021 · 4 generations on3descendants
  • K221412ARIX Rib SystemJeil Medical Corporation · 2022 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K011076Lorenz Sternal Closure System with Modular ScrewWalter Lorenz Surgical, Inc.2001—
−1K032413KLS-Martin Sternal Plating SystemKLS-Martin L.P.2003—
0 (this device)K101170Acute Innovations Sternal Fixation SystemAcute Innovations, LLC2010—
+1K113318Acute Innovations Modular Ribloc SystemAcute Innovations, LLC20121
+2K141241Matrixrib Endo Thoracoscopic Rib Plating SystemSynthes (USA) Products, LLC2014—
+3K183317AdvantageRib SystemSig Medical Corporation2019—
+4K203474Biomet Microfixation RibFix Advantage SystemBiomet Micofixation2021—
+2K221412ARIX Rib SystemJeil Medical Corporation2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
200310
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201220
201410
201910
202110
202210
202310
202410
202620
FIG. 1 — Lineage of K101170, 2001–2026Source: 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 KTT? 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 KTT device

  1. #1 K242861 TrueLok Elevatescore 21.3 · 14 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K931246Cerclage Wire Crimp Sleeve
Summary page 2
…This 510(k) demonstrates the substantial equivalence of the ACUTE Innovations® Sternal Fixation System to the following predicate devices: Acumred Cerclage Crimp Sleeve (K931246); KLS-Martin Sternal Plating System (K032413); Lorenz Sternal Closure System with Modular Screw (KOI 1076); Synthes Sternal Recon…
Acu Med, Inc.1994—
*K032413KLS-Martin Sternal Plating System
Summary page 2
…valence of the ACUTE Innovations® Sternal Fixation System to the following predicate devices: Acumred Cerclage Crimp Sleeve (K931246); KLS-Martin Sternal Plating System (K032413); Lorenz Sternal Closure System with Modular Screw (KOI 1076); Synthes Sternal Reconstruction System (K052683, K03 1508). The ge…
KLS-Martin L.P.2003—
*K011076Lorenz Sternal Closure System with Modular ScrewWalter Lorenz Surgical, Inc.2001—
*K052683Synthes (Usa) Sternal Fixation System
Summary page 2
…Crimp Sleeve (K931246); KLS-Martin Sternal Plating System (K032413); Lorenz Sternal Closure System with Modular Screw (KOI 1076); Synthes Sternal Reconstruction System (K052683, K03 1508). The geometry of the subject plates matches that of the sternum and predicate sternal plates. The cerclage-based devi…
Synthes (Usa)2005—
*K031508Synthes (Usa) Sternal Reconstruction System
Summary page 2
…eeve (K931246); KLS-Martin Sternal Plating System (K032413); Lorenz Sternal Closure System with Modular Screw (KOI 1076); Synthes Sternal Reconstruction System (K052683, K03 1508). The geometry of the subject plates matches that of the sternum and predicate sternal plates. The cerclage-based device has the…
Synthes (Usa)2003—

Also cleared against K931246: 1 other device →

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K113318Acute Innovations Modular Ribloc SystemAcute Innovations, LLC20128
K120016Pioneer Sternal Assist Implant SystemPioneer Surgical Technology, Inc.20120

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 3 companies; a new generation was cleared every 6.9 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K113318 (Acute Innovations, LLC, 2012) has gone furthest, with 8 descendants of its own.
  • 1 other device also cites its predicate K931246.

How does its category compare?

All KTT devices

KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · KTT

10in 2025

2007: 92008: 112009: 112010: 122011: 102012: 92013: 72014: 142015: 122016: 102017: 112018: 62019: 82020: 92021: 102022: 32023: 72024: 52025: 102026 (partial year): 5
2007high 14 (2014) · low 3 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KTT

88in 2025

2007: 55 days median2008: 73 days median2009: 94 days median2010: 148 days median2011: 157 days median2012: 140 days median2013: 87 days median2014: 129 days median2015: 60 days median2016: 142 days median2017: 184 days median2018: 149 days median2019: 110 days median2020: 200 days median2021: 83 days median2022: 25 days median2023: 29 days median2024: 90 days median2025: 88 days median2026 (partial year): 68 days median
2007high 200 (2020) · low 25 (2022)2026

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

Recalls per year · KTT

2in 2021

2007: 22008: 12009: 22010: 12012: 42013: 72017: 12018: 142019: 32021: 22026 (partial year): 11
2007high 14 (2018) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KTT

673in 2025

2007: 452008: 662009: 452010: 1212011: 1962012: 5272013: 8982014: 4452015: 4012016: 4002017: 4852018: 5972019: 8002020: 9422021: 9612022: 6272023: 5542024: 5232025: 673
2007high 961 (2021) · low 45 (2007)2025

MAUDE reports naming product code KTT, 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
2007955245
20081173166
20091194245
2010121481121
2011101570196
201291404527
20137877898
2014141290445
201512600401
2016101420400
2017111841485
2018614914597
201981103800
202092000942
202110832961
20223250627
20237290554
20245900523
202510880673
202656811—

What is it indicated for?

The ACUTE Innovations® Sternal Fixation System is intended for use in the stabilization and fixation of fractures of the anterior chest wall, including sternal fixation following sternotomy and sternal reconstructive surgical procedures.

Indications for use as stated in the FDA summary.

Also cleared against K931246

1 other device cites the same predicate.

  • K960651Cerclage Wire Crimp BlockAcu-Med, Inc. · 1996

More from Acute Innovations, LLC

5 FDA decisions under this applicant name. See the company

  • K120163Acute Innovations Biobridge Resorbable Plating SystemAcute Innovations, LLC · 2012
  • K113318Acute Innovations Modular Ribloc SystemAcute Innovations, LLC · 20121 recall
  • K081588RE-Zorb Plating SystemAcute Innovations, LLC · 2008
  • K061206Acute Bone ScrewAcute Innovations, LLC · 2006

Recent decisions in KTT

The KTT category page

  • K263083Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC · 2026
  • K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC · 2026
  • K260900DYNEX® External Fixation SystemsVilex, LLC · 2026
  • K260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc. · 2026
  • K253291Excelsior SystemBlue Ocean Global · 2026

https://510kreport.com/device/K101170 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101170: Acute Innovations Sternal 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/K101170

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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