510(k) · Cleared
Recalled · Class II · 2024Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid Contd.
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 Sep 2, 2010 as substantially equivalent to K981487 (DePuy Orthopaedics, Inc., 1998) and 6 other predicates after a 303-day review. Its family tree reaches back 6 generations to 1993. 24 later devices descend from it. It has been recalled once.
- Decided
- Sep 2, 2010
- Review
- 303 days
- Class
- Class II
- Product code
- KWS
- Recalls
- 1
- Predicates
- 7
Its longest line of descent runs back 6 generations to K920362 (1993). 60 ancestors in all, the oldest K790987 (1979). 24 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK920362 3M Modular Shoulder System3M Health Care, Ltd. · 1993
- 5 generations backK002683 WMT Ultra-Fit Modular Shoulder SystemWrightmedicaltechnologyinc · 2000
- 4 generations backK032679 Aequalis Shoulder Fracture SystemTornier · 2003
- 3 generations backK043077 Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder…Tornier · 2004
- 2 generations backK060209 Aequalis Shoulder Fracture System & Aequalis Shoulder SystemTornier · 2006
- 1 generation backK081707 Aequalis Shoulder Fracture and Shoulder SystemsTornier, Inc. · 2008
- This deviceK093430 Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech…Exactech, Inc. · 2010
- 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
- Descendant · 5 generations on · 7 of its ownK160975 Aequalis PerFORM+ Shoulder SystemTornier, Inc. · 2016
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- 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
- K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc. · 2016 · 5 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K920362 | 3M Modular Shoulder System | 3M Health Care, Ltd. | 1993 | — |
| −5 | K002683 | WMT Ultra-Fit Modular Shoulder System | Wrightmedicaltechnologyinc | 2000 | — |
| −4 | K032679 | Aequalis Shoulder Fracture System | Tornier | 2003 | — |
| −3 | K043077 | Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder System | Tornier | 2004 | — |
| −2 | K060209 | Aequalis Shoulder Fracture System & Aequalis Shoulder System | Tornier | 2006 | — |
| −1 | K081707 | Aequalis Shoulder Fracture and Shoulder Systems | Tornier, Inc. | 2008 | — |
| 0 (this device) | K093430 | Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage… | Exactech, Inc. | 2010 | — |
| +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 | — |
| +5 | K160975 | Aequalis PerFORM+ Shoulder System | Tornier, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1987 | 2 | 0 |
| 1991 | 3 | 0 |
| 1992 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 8 | 0 |
| 2000 | 5 | 0 |
| 2001 | 7 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 6 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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 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? (7)
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 |
|---|---|---|---|
| * | K981487 | Depuy Global Shoulder GlenoidSummary page 1…(WS) III. Legally Marketed Devices to Which Substantial Equivalence Is Claimed Exactech Equinoxe Cage Glenoid * Depuy Anchor Peg Glenoid #1(981487 a Torrnier Affiniti Glenoid#1(081707 * Smith and Nephexv Cofield Glenoid: #1(955767 and #1(0705… | 1998 |
| * | K081707 | Aequalis Shoulder Fracture and Shoulder SystemsSummary page 1…tantial Equivalence Is Claimed Exactech Equinoxe Cage Glenoid * Depuy Anchor Peg Glenoid #1(981487 a Torrnier Affiniti Glenoid#1(081707 * Smith and Nephexv Cofield Glenoid: #1(955767 and #1(070565. * Biomet Modular Hybrid Glenoid:… | 2008 |
| * | K955767 | Cofied Modular Shoulder SystemSummary page 1…noid * Depuy Anchor Peg Glenoid #1(981487 a Torrnier Affiniti Glenoid#1(081707 * Smith and Nephexv Cofield Glenoid: #1(955767 and #1(070565. * Biomet Modular Hybrid Glenoid: #1(060694 Exactech Equinoxe XL Keeled and XL Pegged Glen… | 1996 |
| * | K070565 | Cofield Total Shoulder SystemSummary page 1…* Depuy Anchor Peg Glenoid #1(981487 a Torrnier Affiniti Glenoid#1(081707 * Smith and Nephexv Cofield Glenoid: #1(955767 and #1(070565. * Biomet Modular Hybrid Glenoid: #1(060694 Exactech Equinoxe XL Keeled and XL Pegged Glenoid… | 2007 |
| * | K060694 | Modular Hybrid GlenoidSummary page 1…a Torrnier Affiniti Glenoid#1(081707 * Smith and Nephexv Cofield Glenoid: #1(955767 and #1(070565. * Biomet Modular Hybrid Glenoid: #1(060694 Exactech Equinoxe XL Keeled and XL Pegged Glenoid * Exactech Equinoxe Glenoids: #1(042021… | 2006 |
| * | K042021 | Exactech Equinoxe Shoulder SystemSummary page 2…head from the Equinoxe total-shoulder system. The subject devices are a modification of the previously cleared Eqluinoxe cemented keeled and pegged glenoids (#1K042021). All components ate supplied sterile. Additionally, this "Traditional" 510(k) proposes several modifications to our previo… | 2004 |
| * | K994393 | Aequalis Universal Shoulder GlenoidSummary page 1…(060694 Exactech Equinoxe XL Keeled and XL Pegged Glenoid * Exactech Equinoxe Glenoids: #1(042021 * Tornier Aequalis Glenoids: #1(994393 • Depuy Global Glenoids: #1(981487 IV. Device Description The Equinoxe Shoulder System comprises b… | 2000 |
What descends from it? (24)
See all 242 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 14 of the 60 ancestors have a recall of any class.
- Of its descendants, K103419 (Exactech, Inc., 2010) has gone furthest, with 22 descendants of its own.
- 11 other devices also cite its predicate K981487.
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. 2010, this device’s year, is highlighted.
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 for use in skeletally mature individuals with degenerative diseases or fractures of the glenohiumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment. * The cemented primary humeral stem, long/revision stem, fracture stems and all Equinoxe glenoids are intended for cemented fixation. * The press-fit humeral stems are intended for press-fit applications…
Read the full statement (396 words)
The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohiumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.
* The cemented primary humeral stem, long/revision stem, fracture stems and all Equinoxe glenoids are intended for cemented fixation.
* The press-fit humeral stems are intended for press-fit applications but may be used with bone cement at the discretion the surgeon.
* The reverse humeral components are intended to be used in cemented applications or in revision cases when the humeral component is well-fixed/stable, as deemed by the orthopaedic surgeon.
* Humeral Heads are intended for use in cemented and press-fit applications.
Clinical indications for the PRIMARY (F'), LONG/REVISION (L/R) and FRACTURE (F) humeral components are as follows:
Indications:
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 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)
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)
The Equinoxe Reverse Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe Reverse Shoulder is also indicated for a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.
The Equinoxe Platform Fracture Stem is indicated for use in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4-part fractures of the proximal humerus (hemi-arthroplasty), or acute fracture of the proximal humerus with failure of the glenohumeral joint (primary total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is also indicated for acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is indicated for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093430 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093430: Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid Contd..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093430
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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