510(k) Report

510(k) · Cleared

Cleared

Synthes (Usa) Sternal Fixation System

K052683510(k) SpecialCleared Dec 5, 200568-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) · HRS Plate, Fixation, Bone

Cleared on Dec 5, 2005 after a 68-day review. The FDA summary names its predicate without a number. 11 later devices descend from it.

Decided
Dec 5, 2005
Review
68 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
0

11 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2012: 2 descendants cleared2014: 1 descendant cleared2022: 1 descendant cleared2019: 1 descendant cleared2023: 1 descendant cleared2021: 1 descendant cleared2024: 1 descendant cleared2026: 2 descendants cleared20052010201520202025
  1. This deviceK052683 Synthes (Usa) Sternal Fixation SystemSynthes (Usa) · 2005
  2. Descendant · cites it directly · 10 of its ownK101170 Acute Innovations Sternal Fixation SystemAcute Innovations, LLC · 2010
  3. Descendant · 2 generations on · 8 of its ownK113318 Acute Innovations Modular Ribloc SystemAcute Innovations, LLC · 2012 · Recalled
  4. Descendant · 3 generations on · 5 of its ownK141241 Matrixrib Endo Thoracoscopic Rib Plating SystemSynthes (USA) Products, LLC · 2014
  5. Descendant · 4 generations on · 4 of its ownK183317 AdvantageRib SystemSig Medical Corporation · 2019
  6. Descendant · 5 generations on · 3 of its ownK203474 Biomet Microfixation RibFix Advantage SystemBiomet Micofixation · 2021

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2010: 12012: 22014: 12019: 12021: 12022: 12023: 12024: 12026: 2
2010high 2 (2012) · low 0 (2011)2026

Most influential descendants

Showing 5 of 11 · See all
  • K101170Acute Innovations Sternal Fixation SystemAcute Innovations, LLC · 2010 · cites it directly10descendants
  • K113318Acute Innovations Modular Ribloc SystemAcute Innovations, LLC · 2012 · 2 generations on8descendants
  • K141241Matrixrib Endo Thoracoscopic Rib Plating SystemSynthes (USA) Products, LLC · 2014 · 3 generations on5descendants
  • K183317AdvantageRib SystemSig Medical Corporation · 2019 · 4 generations on4descendants
  • K203474Biomet Microfixation RibFix Advantage SystemBiomet Micofixation · 2021 · 5 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K052683Synthes (Usa) Sternal Fixation SystemSynthes (Usa)2005—
+1K101170Acute Innovations Sternal Fixation SystemAcute Innovations, LLC2010—
+2K113318Acute Innovations Modular Ribloc SystemAcute Innovations, LLC20121
+3K141241Matrixrib Endo Thoracoscopic Rib Plating SystemSynthes (USA) Products, LLC2014—
+4K183317AdvantageRib SystemSig Medical Corporation2019—
+5K203474Biomet Microfixation RibFix Advantage SystemBiomet Micofixation2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201220
201410
201910
202110
202210
202310
202410
202620
FIG. 1 — Lineage of K052683, 2005–2026Source: 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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*—Synthes Sternal Fixation Systems
Named without a submission number
—

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K101170Acute Innovations Sternal Fixation SystemAcute Innovations, LLC201010

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?

  • Of its descendants, K101170 (Acute Innovations, LLC, 2010) has gone furthest, with 10 descendants of its own.

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

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 Synthes Sternal Fixation System is intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.

CONTRAINDICATIONS

The Synthes Titanium 2.4mm Universal Locking Plates are contraindicated for use in acute cardiac patients.

Indications for use as stated in the FDA summary.

More from Synthes (Usa)

406 FDA decisions under this applicant name. See the company

  • K131984Synthes Synsonic Ulna NailSynthes (Usa) · 2014
  • K111667Synthes Suprapatellar Insertion InstrumentsSynthes (Usa) · 20111 recall
  • K111540Synthes 3.5MM LCP Clavicle Plate SystemSynthes (Usa) · 2011
  • K110789Synthes Sternal Zipfix SystemSynthes (Usa) · 20113 recalls
  • K103002Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa) · 20112 recalls

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/K052683 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052683: Synthes (Usa) 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/K052683

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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