510(k) · Cleared
Recalled · Class II · 2024Exactech Equinoxe Cage Glenoids
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 Dec 8, 2011 as substantially equivalent to K093430 (Exactech, Inc., 2010) and 2 other predicates after a 30-day review. Its family tree reaches back 7 generations to 1993. 3 later devices descend from it. It has been recalled 8 times.
- Decided
- Dec 8, 2011
- Review
- 30 days
- Class
- Class II
- Product code
- KWS
- Recalls
- 8
- Predicates
- 3
Its longest line of descent runs back 7 generations to K920362 (1993). 62 ancestors in all, the oldest K790987 (1979). 3 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK920362 3M Modular Shoulder System3M Health Care, Ltd. · 1993
- 6 generations backK002683 WMT Ultra-Fit Modular Shoulder SystemWrightmedicaltechnologyinc · 2000
- 5 generations backK032679 Aequalis Shoulder Fracture SystemTornier · 2003
- 4 generations backK043077 Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder…Tornier · 2004
- 3 generations backK060209 Aequalis Shoulder Fracture System & Aequalis Shoulder SystemTornier · 2006
- 2 generations backK081707 Aequalis Shoulder Fracture and Shoulder SystemsTornier, Inc. · 2008
- 1 generation backK093430 Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech…Exactech, Inc. · 2010 · Recalled
- This deviceK113309 Exactech Equinoxe Cage GlenoidsExactech, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK212356 Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc. · 2022 · Recalled
- Descendant · 2 generations on · 0 of its ownK254084 AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK231099 SMR Hybrid Glenoid SystemLima Corporate S.P.A. · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K920362 | 3M Modular Shoulder System | 3M Health Care, Ltd. | 1993 | — |
| −6 | K002683 | WMT Ultra-Fit Modular Shoulder System | Wrightmedicaltechnologyinc | 2000 | — |
| −5 | K032679 | Aequalis Shoulder Fracture System | Tornier | 2003 | — |
| −4 | K043077 | Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder System | Tornier | 2004 | — |
| −3 | K060209 | Aequalis Shoulder Fracture System & Aequalis Shoulder System | Tornier | 2006 | — |
| −2 | K081707 | Aequalis Shoulder Fracture and Shoulder Systems | Tornier, Inc. | 2008 | — |
| −1 | K093430 | Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage… | Exactech, Inc. | 2010 | 1 |
| 0 (this device) | K113309 | Exactech Equinoxe Cage Glenoids | Exactech, Inc. | 2011 | — |
| +1 | K212356 | Exactech® Equinoxe® Laser Cage Glenoid | Exactech, Inc. | 2022 | 1 |
| +2 | K254084 | AETOS Shoulder System - CONCELOC Glenoids | Smith & Nephew, Inc. | 2026 | — |
| +2 | K231099 | SMR Hybrid Glenoid System | Lima Corporate S.P.A. | 2023 | — |
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 | 3 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 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 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? (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 |
|---|---|---|---|
| * | K093430 | Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid…Summary page 1…Legally Marketed Devices to Which Substantial Equivalence Is Claimed: 510(k) Number Trade or Proprietary or Model Name Manufacturer K093430 Exactech Equinoxe Cage Glenoid Exactech, Inc. IV. Device Description: This submis… | 2010 |
| * | K042021 | Exactech Equinoxe Shoulder SystemSummary page 1…dd plasma coating. The proposed Equinoxe Cage Glenoids are intended to be used with the same Equinoxe shoulder system components described in 510(k) #K042021I and 510(k) #K06 1454 as cited predicates. V. Intended Use of the Device The Equinoxe Shoulder System… | 2004 |
| * | K061454 | Exactech Equinoxe Shoulder StemsSummary page 1…e proposed Equinoxe Cage Glenoids are intended to be used with the same Equinoxe shoulder system components described in 510(k) #K042021I and 510(k) #K06 1454 as cited predicates. V. Intended Use of the Device The Equinoxe Shoulder System is indicated for use… | 2006 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212356 | Exactech® Equinoxe® Laser Cage Glenoid | 2022 | 2 |
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-1415-2024 | 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-1412-2024 | 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-1413-2024 | 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-1414-2024 | 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… |
| Oct 6, 2020 | Class II | Z-0460-2021 | Packaging process control | The product may be mislabeled. |
| Oct 6, 2020 | Class II | Z-0459-2021 | Packaging process control | The product may be mislabeled. |
| Aug 31, 2017 | Class II | Z-0414-2018 | Under Investigation by firm | Potentially mislabeled. |
| Aug 31, 2017 | Class II | Z-0415-2018 | Under Investigation by firm | Potentially mislabeled. |
The 5 latest of 8 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 18 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 15 of the 62 ancestors have a recall of any class.
- Of its descendants, K212356 (Exactech, Inc., 2022) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K093430.
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. 2011, 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 glenohumeral 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…
Read the full statement (390 words)
The Equinoxe Shoulder System is indicated for use 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.
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 (P), LONG/REVISION (L), 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 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/K113309 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113309: Exactech Equinoxe Cage Glenoids.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113309
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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