510(k) Report

510(k) · Cleared

Cleared

Synthes (Usa) Modification to Sternal Reconstruction System

K033816510(k) TraditionalCleared Mar 2, 200484-day reviewClass II21 CFR 888.3010

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Synthes (Usa) · JDQ Cerclage, Fixation

Cleared on Mar 2, 2004 after an 84-day review. The FDA summary names its predicate without a number. 47 later devices descend from it.

Decided
Mar 2, 2004
Review
84 days
Class
Class II
Product code
JDQ
Recalls
None
Predicates
0

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

Descendants, by year cleared 2012: 1 descendant cleared2014: 1 descendant cleared2015: 1 descendant cleared2021: 2 descendants cleared2018: 2 descendants cleared2016: 1 descendant cleared2023: 6 descendants cleared2022: 3 descendants cleared2020: 1 descendant cleared2024: 10 descendants cleared2025: 11 descendants cleared2026: 8 descendants cleared200020052010201520202025
  1. This deviceK033816 Synthes (Usa) Modification to Sternal Reconstruction SystemSynthes (Usa) · 2004
  2. Descendant · cites it directly · 46 of its ownK122293 Pioneer Sternal Cable Plate SystemPioneer Surgical Technology, Inc. · 2012
  3. Descendant · 2 generations on · 45 of its ownK133785 Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. · 2014 · Recalled
  4. Descendant · 3 generations on · 44 of its ownK150581 Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2015
  5. Descendant · 4 generations on · 43 of its ownK161876 Tritium® Sternal Cable Plate SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. · 2016
  6. Descendant · 5 generations on · 40 of its ownK193468 Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2020

Showing 5 of 47 descendants. See all descendants

Descendants cleared per year

2012: 12014: 12015: 12016: 12018: 22020: 12021: 22022: 32023: 62024: 102025: 112026: 8
2012high 11 (2025) · low 0 (2013)2026

Most influential descendants

Showing 5 of 47 · See all
  • K122293Pioneer Sternal Cable Plate SystemPioneer Surgical Technology, Inc. · 2012 · cites it directly46descendants
  • K133785Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. · 2014 · 2 generations on45descendants
  • K150581Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2015 · 3 generations on44descendants
  • K161876Tritium® Sternal Cable Plate SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. · 2016 · 4 generations on43descendants
  • K193468Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2020 · 5 generations on40descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K033816Synthes (Usa) Modification to Sternal Reconstruction SystemSynthes (Usa)2004—
+1K122293Pioneer Sternal Cable Plate SystemPioneer Surgical Technology, Inc.2012—
+2K133785Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc.20141
+3K150581Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)2015—
+4K161876Tritium® Sternal Cable Plate SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.2016—
+5K193468Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201410
201510
201610
201820
202010
202120
202230
202360
2024100
2025110
202680
FIG. 1 — Lineage of K033816, 2004–2026Source: 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 JDQ? 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 JDQ device

  1. #1 K261271 Cable-Ready® Cable Grip Systemscore 14.7 · 11 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? (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 Reconstruction System
Named without a submission number
—

What descends from it? (47)

See all 47

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

NumberDeviceApplicantDecidedDescendants
K122293Pioneer Sternal Cable Plate SystemPioneer Surgical Technology, Inc.201246

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, K122293 (Pioneer Surgical Technology, Inc., 2012) has gone furthest, with 46 descendants of its own.

How does its category compare?

All JDQ devices

JDQ Cerclage, Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDQ

2in 2025

2007: 12008: 22009: 22011: 62012: 32013: 12014: 22015: 52016: 42017: 12018: 62020: 42022: 22023: 32024: 32025: 22026 (partial year): 1
2007high 6 (2011) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDQ

130in 2024

2011: 130 days median2012: 134 days median2015: 92 days median2016: 129 days median2018: 101 days median2020: 93 days median2023: 141 days median2024: 130 days median
2007high 141 (2023) · low 92 (2015)2026

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

Recalls per year · JDQ

5in 2019

2008: 22010: 22013: 12015: 12019: 5
2007high 5 (2019) · low 0 (2007)2026

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

Adverse event reports per year · JDQ

84in 2025

2007: 52008: 252009: 192010: 282011: 302012: 1302013: 3212014: 2232015: 2052016: 2242017: 1382018: 1822019: 1582020: 1252021: 1412022: 1342023: 982024: 1152025: 84
2007high 321 (2013) · low 5 (2007)2025

MAUDE reports naming product code JDQ, 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
20071—05
20082—225
20092—019
20100—228
20116130030
201231340130
20131—1321
20142—0223
20155921205
201641290224
20171—0138
201861010182
20190—5158
20204930125
20210—0141
20222—0134
20233141098
202431300115
20252—084
20261—0—

What is it indicated for?

Synthes (USA) Sternal Reconstruction System is intended for use in sternal repair and reconstruction.

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 JDQ

The JDQ category page

  • K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc. · 2026
  • K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda. · 2025
  • K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage SuturesArthrex, Inc. · 2025
  • K232733Mbrace CableMedacta International S.A. · 2024
  • K233949ACCORD Cable SystemSmith & Nephew, Inc. · 2024

https://510kreport.com/device/K033816 · printed Nov 5, 2026

Cite this page

510(k) Report. “K033816: Synthes (Usa) Modification to Sternal Reconstruction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033816

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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