510(k) · Cleared
Recalled · Class II · 2025Exactech Equinoxe Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Oct 26, 2004 as substantially equivalent to K980244 (Tornier, 1999) and 17 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1991. 71 later devices descend from it. It has been recalled 10 times.
- Decided
- Oct 26, 2004
- Review
- 90 days
- Class
- Class II
- Product code
- KWS
- Recalls
- 10
- Predicates
- 18
Its longest line of descent runs back 3 generations to K911686 (1991). 27 ancestors in all, the oldest K790987 (1979). 71 later devices descend from it, 14 citing it directly.
- Root · 3 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 2 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 1 generation backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- This deviceK042021 Exactech Equinoxe Shoulder SystemExactech, Inc. · 2004
- Descendant · cites it directly · 24 of its ownK093430 Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech…Exactech, Inc. · 2010 · Recalled
- Descendant · cites it directly · 22 of its ownK103419 Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 21 of its ownK111379 Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium…Exactech, Inc. · 2011 · Recalled
- Descendant · 3 generations on · 20 of its ownK121220 Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small…Exactech, Inc. · 2012 · Recalled
- Descendant · 4 generations on · 16 of its ownK150583 Aequalis PerFORM+ Shoulder SystemTornier, Inc. · 2015
Showing 5 of 71 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 71 · See all- K093430Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid…Exactech, Inc. · 2010 · cites it directly24descendants
- K103419Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc. · 2010 · cites it directly22descendants
- K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc. · 2011 · 2 generations on21descendants
- K121220Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/RightExactech, Inc. · 2012 · 3 generations on20descendants
- K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc. · 2015 · 4 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −2 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −1 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| 0 (this device) | K042021 | Exactech Equinoxe Shoulder System | Exactech, Inc. | 2004 | — |
| +1 | K093430 | Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage… | Exactech, Inc. | 2010 | 1 |
| +1 | K103419 | Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TM | Exactech, Inc. | 2010 | 2 |
| +2 | K111379 | Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /… | Exactech, Inc. | 2011 | 2 |
| +3 | K121220 | Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/Right | Exactech, Inc. | 2012 | 2 |
| +4 | K150583 | Aequalis PerFORM+ Shoulder System | Tornier, Inc. | 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 |
|---|---|---|
| 2006 | 2 | 0 |
| 2010 | 6 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 7 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 7 | 0 |
| 2024 | 6 | 0 |
| 2025 | 8 | 0 |
| 2026 | 5 | 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 KWS? 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 KWS device
- #1 K220847 AETOS Shoulder Systemscore 21.1 · 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? (18)
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 |
|---|---|---|---|
| * | K980244 | Aequalis Shoulder ProsthesisSummary page 2…Specifically, the Equinoxe® press-fit humeral stems are substantially equivalent to the Tomier Aequalis (K980244), the Zimmer (Sulzer) Anatomica (K003801), the Plus Orthopedic PROMOS (K032126), and the Arthrex… | 1999 |
| * | K003801 | Anatomical Press-Fit Humeral StemSummary page 2…ally, the Equinoxe® press-fit humeral stems are substantially equivalent to the Tomier Aequalis (K980244), the Zimmer (Sulzer) Anatomica (K003801), the Plus Orthopedic PROMOS (K032126), and the Arthrex (K010124) press-fit… | 2001 |
| * | K032126 | Promos ShoulderSummary page 2…nt to the Tomier Aequalis (K980244), the Zimmer (Sulzer) Anatomica (K003801), the Plus Orthopedic PROMOS (K032126), and the Arthrex (K010124) press-fit humeral stems. The Equinoxe® cemented humeral (short & long… | 2004 |
| * | K010124 | Arthrex Univers 30 Shoulder ProsthesisSummary page 2…the Tomier Aequalis (K980244), the Zimmer (Sulzer) Anatomica (K003801), the Plus Orthopedic PROMOS (K032126), and the Arthrex (K010124) press-fit humeral stems. The Equinoxe® cemented humeral (short & long) stems are… | 2001 |
| * | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric HeadSummary page 2…ort & long) stems are substantially equivalent to the Plus Orthopedic PROMOS (K032126), the Depuy Global (K992065), and the Arthrex (K010124) press-fit humeral stems. The Equinoxe® fracture humeral stems are sub… | 1999 |
| * | K994392 | Aequalis Shoulder Fracture SystemSummary page 2…humeral stems. The Equinoxe® fracture humeral stems are substantially equivalent to the Tornier Fracture (K994392, K003728, K032679), and the Depuy Global FX (K1011099 & K984541) fracture humeral stems. The modu… | 2000 |
| * | K003728 | Modification to Aequalis Shoulder Fracture SystemSummary page 2…tems. The Equinoxe® fracture humeral stems are substantially equivalent to the Tornier Fracture (K994392, K003728, K032679), and the Depuy Global FX (K1011099 & K984541) fracture humeral stems. The modular eccen… | 2000 |
| * | K032679 | Aequalis Shoulder Fracture SystemSummary page 2…Equinoxe® fracture humeral stems are substantially equivalent to the Tornier Fracture (K994392, K003728, K032679), and the Depuy Global FX (K1011099 & K984541) fracture humeral stems. The modular eccentric hume… | 2003 |
| * | K011099 | Global FX Porous-Coated Humeral Stem Our reading of the summary gave K101099, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Depuy Global FX fracture humeral stems”. | 2001 |
| * | K984541 | Global FX Humeral Stem, Global Advantage Humeral HeadSummary page 2…ially equivalent to the Tornier Fracture (K994392, K003728, K032679), and the Depuy Global FX (K1011099 & K984541) fracture humeral stems. The modular eccentric humeral heads are substantially equivalent to the… | 1999 |
| * | K974044 | Global Total Shoulder Eccentric Humeral HeadSummary page 2…K984541) fracture humeral stems. The modular eccentric humeral heads are substantially equivalent to the Depuy Global (K974044 & K992065), the Stryker Howmedica Osteonics Solar (K001419), the Tomier Aequalis (K012212), and t… | 1998 |
| * | K001419 | Solar Shoulder Offset Humeral HeadSummary page 2…substantially equivalent to the Depuy Global (K974044 & K992065), the Stryker Howmedica Osteonics Solar (K001419), the Tomier Aequalis (K012212), and the Zimmer (Sulzer) Anatomica (K990137) eccentric humeral he… | 2000 |
| * | K012212 | Modification to Aequalis Shoulder SystemSummary page 2…substantially equivalent to the Depuy Global (K974044 & K992065), the Stryker Howmedica Osteonics Solar (K001419), the Tomier Aequalis (K012212), and the Zimmer (Sulzer) Anatomica (K990137) eccentric humeral heads. Finally, the… | 2001 |
| * | K990137 | Anatomica Humeral Stem/Head ComponentsSummary page 2…er Howmedica Osteonics Solar (K001419), the Tomier Aequalis (K012212), and the Zimmer (Sulzer) Anatomica (K990137) eccentric humeral heads. Finally, the Equinoxe® cemented pegged and keeled glenoids are substant… | 1999 |
| * | K994393 | Aequalis Universal Shoulder GlenoidSummary page 2…y, the Equinoxe® cemented pegged and keeled glenoids are substantially equivalent to the Torier Aequalis (K994393), the Encore Foundation (K960906), the Plus Orthopedic PROMOS (K032126), the Zimmer (Sulzer) Anat… | 2000 |
| * | K960906 | Foundation Glenoid ComponentSummary page 2…Equinoxe® cemented pegged and keeled glenoids are substantially equivalent to the Torier Aequalis (K994393), the Encore Foundation (K960906), the Plus Orthopedic PROMOS (K032126), the Zimmer (Sulzer) Anatomica (K990136),… | 1996 |
| * | K990136 | Anatomica Glenoid ComponentSummary page 2…the Torier Aequalis (K994393), the Encore Foundation (K960906), the Plus Orthopedic PROMOS (K032126), the Zimmer (Sulzer) Anatomica (K990136), and the Depuy Global (K981487) cemented glenoids.… | 1999 |
| * | K981487 | Depuy Global Shoulder GlenoidSummary page 2…06), the Plus Orthopedic PROMOS (K032126), the Zimmer (Sulzer) Anatomica (K990136), and the Depuy Global (K981487) cemented glenoids.… | 1998 |
What descends from it? (71)
See all 7114 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093430 | Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid… | 2010 | 24 |
| K103419 | Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TM | 2010 | 22 |
| K061454 | Exactech Equinoxe Shoulder Stems | 2006 | 16 |
| K093599 | Arrow Anatomical Shoulder System | 2010 | 11 |
| K140063 | Equinoxe Extra Short Humeral Head | 2014 | 10 |
| K173388 | Exactech Equinoxe Stemless Shoulder | 2018 | 9 |
| K060535 | Spacer-S Temporary Shoulder Spacer | 2006 | 8 |
| K102951 | Exactech Equinox Fixed Angle Replicator Plate (0MM,1.5MM,4.5MM), Humeral Head-Short… | 2010 | 7 |
| K150568 | ARROW Humeral stems size 6 and 16 | 2015 | 4 |
| K162726 | Exactech® Equinoxe® Preserve Stem | 2017 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 5, 2025 | Class II | Z-0535-2026 | Release of Material/Component prior to receiving test results | Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria. |
| Sep 5, 2025 | Class II | Z-0537-2026 | Release of Material/Component prior to receiving test results | Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria. |
| Sep 5, 2025 | Class II | Z-0536-2026 | Release of Material/Component prior to receiving test results | Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria. |
| Mar 6, 2024 | Class II | Z-1402-2024 | Nonconforming Material/Component | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer… |
| Mar 6, 2024 | Class II | Z-1403-2024 | Nonconforming Material/Component | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer… |
| Mar 6, 2024 | Class II | Z-1405-2024 | Nonconforming Material/Component | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer… |
| Mar 6, 2024 | Class II | Z-1404-2024 | Nonconforming Material/Component | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer… |
| Nov 9, 2020 | Class II | Z-0884-2021 | Employee error | Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package. |
| Feb 13, 2015 | Class II | Z-1459-2015 | Labeling mix-ups | Incorrectly packaged. Outer and inner labeling may incorrectly identify the size of the enclosed device. |
| Jun 15, 2012 | Class II | Z-2115-2012 | Labeling False and Misleading | Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that… |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- 2 of the 27 ancestors have a recall of any class.
- Of its descendants, K093430 (Exactech, Inc., 2010) has gone furthest, with 24 descendants of its own.
- 2 other devices also cite its predicate K980244.
How does its category compare?
All KWS devicesKWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWS
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWS
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWS
2,281in 2025
MAUDE reports naming product code KWS, 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 | 2 | — | 21 | 158 |
| 2008 | 4 | 37 | 29 | 238 |
| 2009 | 4 | 108 | 0 | 294 |
| 2010 | 7 | 33 | 10 | 393 |
| 2011 | 11 | 90 | 11 | 486 |
| 2012 | 7 | 86 | 10 | 542 |
| 2013 | 12 | 120 | 0 | 818 |
| 2014 | 7 | 89 | 1 | 1,066 |
| 2015 | 8 | 129 | 0 | 1,170 |
| 2016 | 10 | 114 | 1 | 970 |
| 2017 | 7 | 120 | 4 | 1,681 |
| 2018 | 4 | 152 | 1 | 1,545 |
| 2019 | 9 | 106 | 2 | 1,728 |
| 2020 | 3 | 98 | 5 | 1,567 |
| 2021 | 5 | 151 | 0 | 1,358 |
| 2022 | 5 | 158 | 0 | 1,268 |
| 2023 | 4 | 250 | 2 | 1,750 |
| 2024 | 2 | — | 0 | 2,122 |
| 2025 | 3 | 97 | 0 | 2,281 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Equinoxe 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 (156 words)
The Equinoxe 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/K042021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042021: Exactech Equinoxe Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042021
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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