510(k) · Cleared
ClearedExactech Equinoxe Stemless Shoulder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Cleared on Mar 9, 2018 as substantially equivalent to K143552 (Tornier, Inc., 2015) and 2 other predicates after a 130-day review. Its family tree reaches back 6 generations to 1991. 9 later devices descend from it.
- Decided
- Mar 9, 2018
- Review
- 130 days
- Class
- Class II
- Product code
- PKC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K911686 (1991). 34 ancestors in all, the oldest K790987 (1979). 9 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 5 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 4 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 3 generations backK060988 Total and Hemi Shoulder SystemDvo Extremity Solutions, LLC · 2006 · Recalled
- 2 generations backK103007 Affiniti Total and Hemi-Shoulder SystemTornier, Inc. · 2010
- 1 generation backK143552 Simpliciti Shoulder SystemTornier, Inc. · 2015
- This deviceK173388 Exactech Equinoxe Stemless ShoulderExactech, Inc. · 2018
- Descendant · cites it directly · 6 of its ownK182516 Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp · 2019
- Descendant · cites it directly · 3 of its ownK203108 Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021
- Descendant · 2 generations on · 1 of its ownK241873 OsseoFit Stemless Shoulder SystemZimmer, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK192097 Exactech® Equinoxe® Stemless Humeral ComponentsExactech, Inc. · 2020
- Descendant · 3 generations on · 0 of its ownK262955 OsseoFit Stemless Shoulder SystemZimmer, Inc. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp · 2019 · cites it directly6descendants
- K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021 · cites it directly3descendants
- K241873OsseoFit Stemless Shoulder SystemZimmer, Inc. · 2024 · 2 generations on1descendant
- K192097Exactech® Equinoxe® Stemless Humeral ComponentsExactech, Inc. · 2020 · cites it directly1descendant
- K262955OsseoFit Stemless Shoulder SystemZimmer, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −5 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −4 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −3 | K060988 | Total and Hemi Shoulder System | Dvo Extremity Solutions, LLC | 2006 | 13 |
| −2 | K103007 | Affiniti Total and Hemi-Shoulder System | Tornier, Inc. | 2010 | — |
| −1 | K143552 | Simpliciti Shoulder System | Tornier, Inc. | 2015 | — |
| 0 (this device) | K173388 | Exactech Equinoxe Stemless Shoulder | Exactech, Inc. | 2018 | — |
| +1 | K182516 | Comprehensive Nano Stemless Shoulder | Biomet Manufacturing Corp | 2019 | — |
| +1 | K203108 | Ignite Stemless Anatomic Shoulder System | Ignite Orthopedics, LLC | 2021 | — |
| +2 | K241873 | OsseoFit Stemless Shoulder System | Zimmer, Inc. | 2024 | — |
| +1 | K192097 | Exactech® Equinoxe® Stemless Humeral Components | Exactech, Inc. | 2020 | — |
| +3 | K262955 | OsseoFit Stemless Shoulder System | Zimmer, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1987 | 1 | 0 |
| 1991 | 2 | 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 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 PKC? 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 PKC device
- #1 K240716 AETOS Shoulder System Stemless Humeral…score 22.2 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K143552 | Simpliciti Shoulder SystemSummary page 4…60, Class II, Product Code PKC Legally Marketed Device to Which Substantial Equivalence Is Claimed: x Tornier Simpliciti Shoulder System (K143552) x Exactech Humeral Heads (K042021, K140063) Reference Devices x Exactech Equinoxe Resurfacing Humeral Head System (K13129… | 2015 |
| * | K042021 | Exactech Equinoxe Shoulder SystemSummary page 4…Code PKC Legally Marketed Device to Which Substantial Equivalence Is Claimed: x Tornier Simpliciti Shoulder System (K143552) x Exactech Humeral Heads (K042021, K140063) Reference Devices x Exactech Equinoxe Resurfacing Humeral Head System (K131298) x Exactech Novation® Crown Cup®… | 2004 |
| * | K140063 | Equinoxe Extra Short Humeral HeadSummary page 4…Code PKC Legally Marketed Device to Which Substantial Equivalence Is Claimed: x Tornier Simpliciti Shoulder System (K143552) x Exactech Humeral Heads (K042021, K140063) Reference Devices x Exactech Equinoxe Resurfacing Humeral Head System (K131298) x Exactech Novation® Crown Cup® with Inte… | 2014 |
| † | K131298 | Exactech Equinoxe Resurfacing Humeral Head System | 2013 |
| † | K102975 | Novation Crown Cup with Integrip Acetabular Shell, Cluster-Hole | 2010 |
| † | K153595 | Optetrak Logic Metaphyseal Cones | 2016 |
What descends from it? (9)
4 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 27 years and passes through 5 companies; a new generation was cleared every 4.3 years on median.
- 4 of the 34 ancestors have a recall of any class.
- Of its descendants, K182516 (Biomet Manufacturing Corp, 2019) has gone furthest, with 6 descendants of its own.
- 9 other devices also cite its predicate K143552.
How does its category compare?
All PKC devicesPKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · PKC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PKC
167in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PKC
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PKC
86in 2025
MAUDE reports naming product code PKC, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 5 |
| 2019 | 1 | — | 1 | 8 |
| 2020 | 4 | 116 | 0 | 5 |
| 2021 | 2 | — | 0 | 14 |
| 2022 | 3 | 148 | 0 | 31 |
| 2023 | 1 | — | 0 | 46 |
| 2024 | 3 | 167 | 0 | 54 |
| 2025 | 1 | — | 0 | 86 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Equinoxe Stemless Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where anatomic total shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment. Clinical indications for anatomic total shoulder arthroplasty are as follows: • Osteoarthritis, osteonecrosis or post-traumatic degenerative problems • Congenital abnormalities in the skeletally…
Read the full statement (140 words)
The Equinoxe Stemless Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where anatomic total shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment.
Clinical indications for anatomic total shoulder arthroplasty are as follows:
• Osteoarthritis, osteonecrosis or post-traumatic degenerative problems
• Congenital abnormalities in the skeletally mature
• Primary and secondary necrosis of the humeral head.
• Pathologies where arthrodesis 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)
• To restore mobility from previous procedures (e.g. previous fusion)
The Equinoxe Stemless Shoulder humeral components are indicated for press-fit, uncemented use.
The Equinoxe Stemless Shoulder System is intended to be used with the cemented Equinoxe glenoid components.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173388 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173388: Exactech Equinoxe Stemless Shoulder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173388
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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