510(k) · Cleared
ClearedExactech Equinoxe Shoulder Stems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Cleared on Jun 12, 2006 as substantially equivalent to K042021 (Exactech, Inc., 2004) after an 18-day review. Its family tree reaches back 4 generations to 1991. 16 later devices descend from it.
- Decided
- Jun 12, 2006
- Review
- 18 days
- Class
- Class II
- Product code
- HSD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K911686 (1991). 28 ancestors in all, the oldest K790987 (1979). 16 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 3 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 2 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 1 generation backK042021 Exactech Equinoxe Shoulder SystemExactech, Inc. · 2004 · Recalled
- This deviceK061454 Exactech Equinoxe Shoulder StemsExactech, Inc. · 2006
- Descendant · cites it directly · 11 of its ownK093599 Arrow Anatomical Shoulder SystemFournitures Hospitalieres Industrie · 2010
- Descendant · 2 generations on · 10 of its ownK112193 Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie · 2012
- Descendant · 3 generations on · 5 of its ownK142778 ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie · 2015
- Descendant · 2 generations on · 4 of its ownK162068 ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie · 2017
- Descendant · cites it directly · 4 of its ownK150568 ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie · 2015
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K093599Arrow Anatomical Shoulder SystemFournitures Hospitalieres Industrie · 2010 · cites it directly11descendants
- K112193Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie · 2012 · 2 generations on10descendants
- K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie · 2015 · 3 generations on5descendants
- K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie · 2017 · 2 generations on4descendants
- K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie · 2015 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −3 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −2 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −1 | K042021 | Exactech Equinoxe Shoulder System | Exactech, Inc. | 2004 | 10 |
| 0 (this device) | K061454 | Exactech Equinoxe Shoulder Stems | Exactech, Inc. | 2006 | — |
| +1 | K093599 | Arrow Anatomical Shoulder System | Fournitures Hospitalieres Industrie | 2010 | — |
| +2 | K112193 | Arrow Reverse Shoulder System | Fournitures Hospitalieres Industrie | 2012 | — |
| +3 | K142778 | ARROW Reverse Shoulder long keel and short keel glenoid base | Fournitures Hospitalieres Industrie | 2015 | — |
| +2 | K162068 | ARROW Anatomical Porous glenoid | Fournitures Hospitalieres Industrie | 2017 | — |
| +1 | K150568 | ARROW Humeral stems size 6 and 16 | Fournitures Hospitalieres Industrie | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 5 | 0 |
| 2001 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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 HSD? 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 HSD device
- #1 K191433 AGILON® XO Shoulder Replacement Systemscore 13.8 · 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042021 | Exactech Equinoxe Shoulder SystemSummary page 2…x200mm) Information on devices to which substantial equivalence is claimed: 510(k) Number Trade or Proprietary or Model Name Manufacturer #K042021 Equinoxe Press-Fit Primary Humeral Stems Exactech, Inc. (Size 7x100mm, 9xl05mm,… | 2004 |
What descends from it? (16)
See all 163 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 15 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- 3 of the 28 ancestors have a recall of any class.
- Of its descendants, K093599 (Fournitures Hospitalieres Industrie, 2010) has gone furthest, with 11 descendants of its own.
- 13 other devices also cite its predicate K042021.
How does its category compare?
All HSD devicesHSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HSD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HSD
145in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSD
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSD
757in 2025
MAUDE reports naming product code HSD, 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 | 4 | 72 | 0 | 128 |
| 2008 | 3 | 92 | 2 | 259 |
| 2009 | 0 | — | 2 | 156 |
| 2010 | 0 | — | 0 | 225 |
| 2011 | 2 | — | 0 | 241 |
| 2012 | 2 | — | 0 | 254 |
| 2013 | 4 | 218 | 0 | 288 |
| 2014 | 1 | — | 0 | 434 |
| 2015 | 0 | — | 0 | 574 |
| 2016 | 3 | 145 | 0 | 784 |
| 2017 | 0 | — | 3 | 985 |
| 2018 | 1 | — | 1 | 649 |
| 2019 | 0 | — | 0 | 830 |
| 2020 | 2 | — | 1 | 658 |
| 2021 | 0 | — | 0 | 573 |
| 2022 | 1 | — | 0 | 508 |
| 2023 | 0 | — | 0 | 586 |
| 2024 | 1 | — | 0 | 693 |
| 2025 | 0 | — | 0 | 757 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Equinoxe TM Shoulder System is indicated to relieve pain and restore function in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment. Clinical indications for the PRIMARY (P), LONG/REVISION (L/R) and FRACTURE (F) humeral components are as follows: rheumatoid arthritis, osteoarthritis, osteonecrosis or…
Read the full statement (158 words)
The Equinoxe TM Shoulder System is indicated to relieve pain and restore function in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.
Clinical indications for the PRIMARY (P), LONG/REVISION (L/R) and FRACTURE (F) humeral components are as follows:
rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic degenerative problems
congenital abnormalities in the skeletally mature
primary and secondary necrosis of the humeral head.
humeral head fracture with displacement of the tuberosities
pathologies where arthodesis or resectional arthroplasty of the humeral head are not acceptable
revisions of humeral prostheses when other treatments or devices have failed (where adequate fixation can be achieved)
displaced three-part and four-part upper humeral fractures
spiral and other fractures of the mid-humerus (in combination with glenohumeral degenerative diseases)
revision of failed previous reconstructions when distal anchorage is required
to restore mobility from previous procedures (e.g. previous fusion)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061454 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061454: Exactech Equinoxe Shoulder Stems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061454
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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