510(k) · Cleared
Recalled · Class II · 2023Exactech® Equinoxe® Laser Cage Glenoid
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 Mar 4, 2022 as substantially equivalent to K113309 (Exactech, Inc., 2011) and 2 other predicates after a 218-day review. Its family tree reaches back 10 generations to 1993. 2 later devices descend from it. It has been recalled once.
- Decided
- Mar 4, 2022
- Review
- 218 days
- Class
- Class II
- Product code
- KWS
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 10 generations to K920362 (1993). 66 ancestors in all, the oldest K790987 (1979). 2 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK920362 3M Modular Shoulder System3M Health Care, Ltd. · 1993
- 6 generations between
- 3 generations backK103419 Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc. · 2010 · Recalled
- 2 generations backK111379 Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium…Exactech, Inc. · 2011 · Recalled
- 1 generation backK121220 Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small…Exactech, Inc. · 2012 · Recalled
- This deviceK212356 Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK254084 AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK231099 SMR Hybrid Glenoid SystemLima Corporate S.P.A. · 2023
Show all 10 generations
- Root · 10 generations backK920362 3M Modular Shoulder System3M Health Care, Ltd. · 1993
- 9 generations backK002683 WMT Ultra-Fit Modular Shoulder SystemWrightmedicaltechnologyinc · 2000
- 8 generations backK032679 Aequalis Shoulder Fracture SystemTornier · 2003
- 7 generations backK043077 Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder…Tornier · 2004
- 6 generations backK060209 Aequalis Shoulder Fracture System & Aequalis Shoulder SystemTornier · 2006
- 5 generations backK081707 Aequalis Shoulder Fracture and Shoulder SystemsTornier, Inc. · 2008
- 4 generations backK093430 Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech…Exactech, Inc. · 2010 · Recalled
- 3 generations backK103419 Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc. · 2010 · Recalled
- 2 generations backK111379 Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium…Exactech, Inc. · 2011 · Recalled
- 1 generation backK121220 Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small…Exactech, Inc. · 2012 · Recalled
- This deviceK212356 Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc. · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K920362 | 3M Modular Shoulder System | 3M Health Care, Ltd. | 1993 | — |
| −9 | K002683 | WMT Ultra-Fit Modular Shoulder System | Wrightmedicaltechnologyinc | 2000 | — |
| −8 | K032679 | Aequalis Shoulder Fracture System | Tornier | 2003 | — |
| −7 | K043077 | Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder System | Tornier | 2004 | — |
| −6 | K060209 | Aequalis Shoulder Fracture System & Aequalis Shoulder System | Tornier | 2006 | — |
| −5 | K081707 | Aequalis Shoulder Fracture and Shoulder Systems | Tornier, Inc. | 2008 | — |
| −4 | K093430 | Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage… | Exactech, Inc. | 2010 | 1 |
| −3 | 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 |
| −1 | K121220 | Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/Right | Exactech, Inc. | 2012 | 2 |
| 0 (this device) | K212356 | Exactech® Equinoxe® Laser Cage Glenoid | Exactech, Inc. | 2022 | — |
| +1 | K254084 | AETOS Shoulder System - CONCELOC Glenoids | Smith & Nephew, Inc. | 2026 | — |
| +1 | 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 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K113309 | Exactech Equinoxe Cage GlenoidsSummary page 7…DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED Primary Predicate: 510k Number Trade or Proprietary or Model Name Manufacturer K113309 Equinoxe® Cage Glenoid Exactech, Inc. Additional Predicates: 510k Number Trade or P… | 2011 |
| * | K121220 | Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/RightSummary page 7…uinoxe® Cage Glenoid Exactech, Inc. Additional Predicates: 510k Number Trade or Proprietary or Model Name Manufacturer K121220 Equinoxe 12° Posterior Augment Pegged Glenoid Exactech, Inc. K111379 Equinoxe 16° Posterior Augment Pegged… | 2012 |
| * | K111379 | Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Summary page 7…Number Trade or Proprietary or Model Name Manufacturer K121220 Equinoxe 12° Posterior Augment Pegged Glenoid Exactech, Inc. K111379 Equinoxe 16° Posterior Augment Pegged Glenoid Exactech, Inc. REFERENCE DEVICE 510k Number Trade or Propri… | 2011 |
| † | K192097 | Exactech® Equinoxe® Stemless Humeral Components | 2020 |
What descends from it? (2)
2 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 |
|---|---|---|---|---|
| Nov 21, 2023 | Class II | Z-0580-2024 | Packaging change control | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 19 of the 66 ancestors have a recall of any class.
- Of its descendants, K254084 (Smith & Nephew, Inc., 2026) has gone furthest, with 0 descendants of its own.
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. 2022, 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…
Read the full statement (414 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:
P L F 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/K212356 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212356: Exactech® Equinoxe® Laser Cage Glenoid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212356
Report an extraction error
Are you the manufacturer?
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