510(k) Report

510(k) · Cleared

Cleared

Synthes (Usa) Sternal Fixation System - Line Extension

K081700510(k) SpecialCleared Jul 17, 200830-day reviewClass II21 CFR 888.3040

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

Synthes (Usa) · HWC Screw, Fixation, Bone

Cleared on Jul 17, 2008 after a 30-day review. The FDA summary names its predicate without a number. 27 later devices descend from it.

Decided
Jul 17, 2008
Review
30 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
0

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

Descendants, by year cleared 2014: 1 descendant cleared2016: 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 cleared20052010201520202025
  1. This deviceK081700 Synthes (Usa) Sternal Fixation System - Line ExtensionSynthes (Usa) · 2008
  2. Descendant · cites it directly · 26 of its ownK133616 Matrixrib Fixation SystemSynthes (USA) Products, LLC · 2014
  3. Descendant · 2 generations on · 23 of its ownK142823 Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation · 2015
  4. Descendant · 3 generations on · 13 of its ownK151173 Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2015
  5. Descendant · 3 generations on · 11 of its ownK152253 Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2016
  6. Descendant · 3 generations on · 9 of its ownK153482 KLS Martin Thoracic Plating SystemKLS-Martin L.P. · 2016

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2014: 12015: 22016: 42018: 12019: 22022: 22023: 32024: 42025: 32026: 5
2014high 5 (2026) · low 0 (2017)2026

Most influential descendants

Showing 5 of 27 · See all
  • K133616Matrixrib Fixation SystemSynthes (USA) Products, LLC · 2014 · cites it directly26descendants
  • K142823Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation · 2015 · 2 generations on23descendants
  • K151173Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2015 · 3 generations on13descendants
  • K152253Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2016 · 3 generations on11descendants
  • K153482KLS Martin Thoracic Plating SystemKLS-Martin L.P. · 2016 · 3 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K081700Synthes (Usa) Sternal Fixation System - Line ExtensionSynthes (Usa)2008—
+1K133616Matrixrib Fixation SystemSynthes (USA) Products, LLC2014—
+2K142823Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation2015—
+3K151173Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation2015—
+3K152253Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation2016—
+3K153482KLS Martin Thoracic Plating SystemKLS-Martin L.P.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201520
201640
201810
201920
202220
202330
202440
202530
202650
FIG. 1 — Lineage of K081700, 2008–2026Source: 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 HWC? 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 HWC device

  1. #1 K203011 Monster Screw Systemscore 22.2 · 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? (2)

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 (USA) Sternal Fixation System
Named without a submission number
—
*—Synthes (USA) Sterile Sternal Fixation System
Named without a submission number
—

What descends from it? (27)

See all 27

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

NumberDeviceApplicantDecidedDescendants
K133616Matrixrib Fixation SystemSynthes (USA) Products, LLC201426

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, K133616 (Synthes (USA) Products, LLC, 2014) has gone furthest, with 26 descendants of its own.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · HWC

15in 2025

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

What is it indicated for?

The Synthes (USA) 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.

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 HWC

The HWC category page

  • K261961Ntegrate Threaded Nail SystemNvision Biomedical Technologies · 2026
  • K263116OsteoCentric Technologies Cannulated and Soild Fasteners with NutsOsteoCentric Technologies · 2026
  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
  • K254280F.A.S.T ScrewSteps Ortho · 2026

https://510kreport.com/device/K081700 · printed Nov 6, 2026

Cite this page

510(k) Report. “K081700: Synthes (Usa) Sternal Fixation System - Line Extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081700

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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