510(k) Report

510(k) · Cleared

Cleared

Exactech Equinoxe Proximal Humerus Fracture Plate System

K093978510(k) TraditionalCleared May 11, 2010138-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

Exactech, Inc. · HRS Plate, Fixation, Bone

Cleared on May 11, 2010 as substantially equivalent to K011815 (Synthes (Usa), 2001) and 4 other predicates after a 138-day review. Its family tree reaches back 3 generations to 2004. 4 later devices descend from it.

Decided
May 11, 2010
Review
138 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to K042059 (2004). 5 ancestors in all, the oldest K011815 (2001). 4 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2001: 1 other ancestor2023: 1 descendant cleared2012: 1 descendant cleared2026: 1 descendant cleared2018: 1 descendant clearedK042059 · Shoulder Fixation System · Hand Innovations, Inc. · 2004K051728 · Modification to Shoulder Fixation System · Hand Innovations, LLC · 2005K060290 · Shoulder Fixation System · Hand Innovations, LLC · 2006200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 2 descendants K060290 · Shoulder Fixation System · Hand Innovations, LLC · 2006K051728 · Modification to Shoulder Fixation System · Hand Innovations, LLC · 2005K042059 · Shoulder Fixation System · Hand Innovations, Inc. · 20040
  1. Root · 3 generations backK042059 Shoulder Fixation SystemHand Innovations, Inc. · 2004
  2. 2 generations backK051728 Modification to Shoulder Fixation SystemHand Innovations, LLC · 2005
  3. 1 generation backK060290 Shoulder Fixation SystemHand Innovations, LLC · 2006
  4. This deviceK093978 Exactech Equinoxe Proximal Humerus Fracture Plate SystemExactech, Inc. · 2010
  5. Descendant · cites it directly · 2 of its ownK120108 Aptus Proximal Humerus SystemMedartis AG · 2012
  6. Descendant · 2 generations on · 1 of its ownK181425 APTUS® Proximal Humerus SystemMedartis AG · 2018
  7. Descendant · 2 generations on · 0 of its ownK253916 APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG · 2026
  8. Descendant · cites it directly · 0 of its ownK223933 Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc. · 2023

Most influential descendants

Showing 4 of 4 · See all
  • K120108Aptus Proximal Humerus SystemMedartis AG · 2012 · cites it directly2descendants
  • K181425APTUS® Proximal Humerus SystemMedartis AG · 2018 · 2 generations on1descendant
  • K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG · 2026 · 2 generations on0descendants
  • K223933Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K042059Shoulder Fixation SystemHand Innovations, Inc.2004—
−2K051728Modification to Shoulder Fixation SystemHand Innovations, LLC2005—
−1K060290Shoulder Fixation SystemHand Innovations, LLC2006—
0 (this device)K093978Exactech Equinoxe Proximal Humerus Fracture Plate SystemExactech, Inc.2010—
+1K120108Aptus Proximal Humerus SystemMedartis AG2012—
+2K181425APTUS® Proximal Humerus SystemMedartis AG2018—
+2K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG2026—
+1K223933Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201810
202310
202610
FIG. 1 — Lineage of K093978, 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 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? (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
*K011815Synthes LCP Proximal Humerus Plates
Summary page 1
…Class 11, Product Code KTW) Legally Marketed Devices to Which Substantial Equivalence Is Claimed * Synthes LCP® Proximal Humerus Plate (#K011815) * Synthes (USA) LCP® Proximal Humerus Plates, Long (#K041860) * Hand Innovations Modified Shoulder Fixation Systems (#K042059, #…
Synthes (Usa)2001—
*K041860Synthes (Usa) LCP Proximal Humerus Plates, Long
Summary page 1
…egally Marketed Devices to Which Substantial Equivalence Is Claimed * Synthes LCP® Proximal Humerus Plate (#K011815) * Synthes (USA) LCP® Proximal Humerus Plates, Long (#K041860) * Hand Innovations Modified Shoulder Fixation Systems (#K042059, #K05 1728, #K060290) Device Descrigtion The Equinoxe Proxi…
Synthes (Usa)2004—
*K042059Shoulder Fixation System
Summary page 1
…ed * Synthes LCP® Proximal Humerus Plate (#K011815) * Synthes (USA) LCP® Proximal Humerus Plates, Long (#K041860) * Hand Innovations Modified Shoulder Fixation Systems (#K042059, #K05 1728, #K060290) Device Descrigtion The Equinoxe Proximal Humerus Fracture Plate System is for use in the repair of pro…
Hand Innovations, Inc.2004—
*K051728Modification to Shoulder Fixation System
Summary page 1
…es LCP® Proximal Humerus Plate (#K011815) * Synthes (USA) LCP® Proximal Humerus Plates, Long (#K041860) * Hand Innovations Modified Shoulder Fixation Systems (#K042059, #K05 1728, #K060290) Device Descrigtion The Equinoxe Proximal Humerus Fracture Plate System is for use in the repair of proximal humer…
Hand Innovations, LLC2005—
*K060290Shoulder Fixation System
Summary page 1
…al Humerus Plate (#K011815) * Synthes (USA) LCP® Proximal Humerus Plates, Long (#K041860) * Hand Innovations Modified Shoulder Fixation Systems (#K042059, #K05 1728, #K060290) Device Descrigtion The Equinoxe Proximal Humerus Fracture Plate System is for use in the repair of proximal humerus fractures.…
Hand Innovations, LLC2006—

Also cleared against K011815: 24 other devices →

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K120108Aptus Proximal Humerus SystemMedartis AG20122
K223933Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc.20230

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 6 years and passes through 3 companies; a new generation was cleared every 10 months on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K120108 (Medartis AG, 2012) has gone furthest, with 2 descendants of its own.
  • 24 other devices also cite its predicate K011815.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Equinoxe® Shoulder Proximal Humerus Fracture Plate System is indicated for Open Reduction Internal Fixation (ORIF) procedures of the proximal humerus. Clinical indications are as follows:

Fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus.

Indications for use as stated in the FDA summary.

Also cleared against K011815

24 other devices cite the same predicate.

  • K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG · 2025
  • K233994VOLT™ Proximal Humerus 3.5 Plating SystemSynthes GmbH · 2024
  • K232394Internal Locking Plate and Screw Fixation SystemChangzhou Geasure Medical Apparatus and Instruments Co., Ltd. · 2023
  • K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal…Bonebridge AG · 2023
  • K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG · 2022
  • K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd. · 2020

More from Exactech, Inc.

207 FDA decisions under this applicant name. See the company

  • K260583Equinoxe® Shoulder SystemExactech, Inc. · 2026
  • K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc. · 2025
  • K243448Equinoxe® Shoulder SystemExactech, Inc. · 2025
  • K243275Equinoxe® Scapula Fracture SystemExactech, Inc. · 2025
  • K243839Alteon® HA Femoral StemsExactech, Inc. · 2025

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/K093978 · printed Nov 4, 2026

Cite this page

510(k) Report. “K093978: Exactech Equinoxe Proximal Humerus Fracture Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093978

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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