510(k) · Cleared
ClearedExactech Equinoxe PHx Fracture System; Exactech EPIC Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · HRS Plate, Fixation, Bone
Cleared on Sep 25, 2023 as substantially equivalent to K093978 (Exactech, Inc., 2010) and 4 other predicates after a 269-day review. Its family tree reaches back 5 generations to 1985.
- Decided
- Sep 25, 2023
- Review
- 269 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K850886 (1985). 51 ancestors in all, the oldest K781762 (1978). No later device cites it as a predicate yet.
- Root · 5 generations backK850886 Compression Hip Screw SystemPfizer, Inc. · 1985 · Recalled
- 4 generations backK955306 Omega+ Compression Screw SystemHowmedica Corp. · 1996 · Recalled
- 3 generations backK984331 Odi Ultimate Compression Hip ScrewOrthopedic Designs, Inc. · 1999
- 2 generations backK033286 Odi Talon Long Proximal Femoral Nail SystemOrthopedic Designs, Inc. (Odi) · 2004
- 1 generation backK111352 Talon Distalfix Proximal Femoral NailOrthopedic Designs North America, Inc. · 2011
- This deviceK223933 Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K850886 | Compression Hip Screw System | Pfizer, Inc. | 1985 | 1 |
| −4 | K955306 | Omega+ Compression Screw System | Howmedica Corp. | 1996 | 1 |
| −3 | K984331 | Odi Ultimate Compression Hip Screw | Orthopedic Designs, Inc. | 1999 | — |
| −2 | K033286 | Odi Talon Long Proximal Femoral Nail System | Orthopedic Designs, Inc. (Odi) | 2004 | — |
| −1 | K111352 | Talon Distalfix Proximal Femoral Nail | Orthopedic Designs North America, Inc. | 2011 | — |
| 0 (this device) | K223933 | Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws | Exactech, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
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 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K093978 | Exactech Equinoxe Proximal Humerus Fracture Plate SystemSummary page 4…ich Substantial Equivalence Is Claimed: Predicate 510(k) Trade or Proprietary Model Name Manufacturer Designation Number Primary K093978 Exactech® Equinoxe® Proximal Humerus Exactech, Inc Fracture Plate System Additiona… | 2010 |
| * | K153340 | Epic Extremity Plate SystemSummary page 3…osteotomies, and non-unions of the proximal humerus. Exactech® EPIC Screws: The 3.5mm diameter Exactech® EPIC Screws of the Epic Extremity Plate System (cleared under K153340) are also intended for use with the Exactech® Equinoxe® PHx® Fracture System for Open Reduction Internal Fixation procedures of t… | 2016 |
| * | K111352 | Talon Distalfix Proximal Femoral NailSummary page 4…tech, Inc Fracture Plate System Additional K153340 Epic Extremity Plate System Exactech, Inc Additional K111352 Talon™ DistalFix™ Proximal Femoral Orthopedic Designs Nail… | 2011 |
| * | K051412 | Humeral Head Plate with Angular StabilitySummary page 4…Nail North America, Inc. (ODi) Additional K051412 Humeral Head Plate with Angular Implants for Trauma Stability… | 2005 |
| * | K133668 | Aft Greater Tuberosity Fracture Plate, Left, Aft Greater Tuberosity Fracture Plate…Summary page 4…Humeral Head Plate with Angular Implants for Trauma Stability Surgery (ITS) Additional K133668 AFT™ GTF System Shoulder Options Page 1 of 3 ==… | 2014 |
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 38 years and passes through 6 companies; a new generation was cleared every 7.6 years on median.
- 13 of the 51 ancestors have a recall of any class.
- 1 other device also cites its predicate K093978.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The Exactech® Equinoxe® PHx® Fracture System is indicated for Open Reduction Internal Fixation (ORIF) procedures of the proximal humerus. Specific clinical indications for ORIF are as follows: fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus.
The 3.5mm diameter Exactech® EPIC Screws of the Epic Extremity Plate System (cleared under K153340) are also intended for use with the Exactech® Equinoxe® PHx® Fracture System for Open Reduction Internal Fixation procedures of the proximal humerus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223933 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223933: Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223933
Report an extraction error
Are you the manufacturer?
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