510(k) Report

510(k) · Cleared

Cleared

Equinoxe® Scapula Fracture System

K243275510(k) TraditionalCleared Jun 26, 2025253-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 Jun 26, 2025 as substantially equivalent to K051083 (Acumed, LLC, 2005) after a 253-day review. Its family tree reaches back 4 generations to 2000.

Decided
Jun 26, 2025
Review
253 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K000684 (2000). 9 ancestors in all, the oldest K890939 (1989). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestor2000: 1 other ancestor1995: 1 other ancestor1991: 1 other ancestor1989: 1 other ancestorK000684 · Small Fragment Dynamic Compression Locking (DCL) System · Synthes (Usa) · 2000 · recalled×2: 2 generations cleared close together, K011335 (2001), K012655 (2001) K051083 · Acumed Scapula Congruent Bone Plate System · Acumed, LLC · 20051990200020102020
Other ancestors, by generation 3 generations back: 5 other ancestors K051083 · Acumed Scapula Congruent Bone Plate System · Acumed, LLC · 2005K012655 · Congruent Bone Plate System · Acu Med, Inc. · 2001 · recalledK011335 · Synths One-Third Tubular DCL Plate · Synthes (Usa) · 2001 · recalledK000684 · Small Fragment Dynamic Compression Locking (DCL) System · Synthes (Usa) · 2000 · recalled0
  1. Root · 4 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
  2. 3 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
  3. 2 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
  4. 1 generation backK051083 Acumed Scapula Congruent Bone Plate SystemAcumed, LLC · 2005
  5. This deviceK243275 Equinoxe® Scapula Fracture SystemExactech, Inc. · 2025
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K000684Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa)20001
−3K011335Synths One-Third Tubular DCL PlateSynthes (Usa)20012
−2K012655Congruent Bone Plate SystemAcu Med, Inc.200116
−1K051083Acumed Scapula Congruent Bone Plate SystemAcumed, LLC2005—
0 (this device)K243275Equinoxe® Scapula Fracture SystemExactech, Inc.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199110
199510
200010
200110
FIG. 1 — Lineage of K243275, 2000–2025Source: 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? (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
*K051083Acumed Scapula Congruent Bone Plate System
Summary page 5
…21 CFR 807.92(a)(3) Predicate# Predicate Trade Name (Primary Predicate is listed first) Product Code I K051083 1 1 Acumed Scapula Congruent Bone Plate System 1 1 HRS Device D…
Acumed, LLC2005—

Also cleared against K051083: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 25 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
  • 4 of the 9 ancestors have a recall of any class.
  • 1 other device also cites its predicate K051083.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?

Equinoxe® Scapula Fracture System The Exactech@ Equinoxe® Scapula Fracture System is indicated for Open Reduction Internal Fixation (ORIF) procedures of the scapula. Specific clinical indications for ORIF are as follows: Levy Type 1, IIA, and llB fractures, fracture dislocations, osteotomies, and non-unions of the acromion and scapular spine. The 3.5mm diameter and 2.7mm diameter Exactech@ EPIC Screws of the Epic Extremity Plate System (cleared under…

Read the full statement (120 words)

Equinoxe® Scapula Fracture System

The Exactech@ Equinoxe® Scapula Fracture System is indicated for Open Reduction Internal Fixation (ORIF) procedures of the scapula. Specific clinical indications for ORIF are as follows: Levy Type 1, IIA, and llB fractures, fracture dislocations, osteotomies, and non-unions of the acromion and scapular spine.

The 3.5mm diameter and 2.7mm diameter Exactech@ EPIC Screws of the Epic Extremity Plate System (cleared under K153340) are also intended for use with the Exactech@ Equinoxe@ Scapula Fracture System for Open Reduction Internal Fixation procedures of the scapula.

The Straight Plates of the EPIC Fracture Plate System (cleared under K172441) are also intended for use with the Exactech® Equinoxe@ Scapula Fracture System for Open Reduction Internal Fixation procedures of the scapula.

Indications for use as stated in the FDA summary.

Also cleared against K051083

1 other device cites the same predicate.

  • K240181Clavicle and Scapula SystemAuxein Medical Pvt., Ltd. · 2024

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
  • K243839Alteon® HA Femoral StemsExactech, Inc. · 2025
  • K240393Exactech® TRULIANT® Knee SystemExactech, Inc. · 2024

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/K243275 · printed Nov 6, 2026

Cite this page

510(k) Report. “K243275: Equinoxe® Scapula Fracture System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243275

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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