510(k) · Cleared
ClearedEquinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Cleared on Dec 1, 2025 as substantially equivalent to K143659 (Exactech, Inc., 2015) and 3 other predicates after a 266-day review. Its family tree reaches back 9 generations to 1980.
- Decided
- Dec 1, 2025
- Review
- 266 days
- Class
- Class II
- Product code
- KWT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K800494 (1980). 60 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet.
- Root · 9 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
- 5 generations between
- 3 generations backK111746 Comprehensive Segmental Revision System (SRS)Biomet, Inc. · 2011 · Recalled
- 2 generations backK143659 Equinoxe Mega ProsthesisExactech, Inc. · 2015
- 1 generation backK162903 Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small…Exactech, Inc. · 2017
- This deviceK250713 Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless…Exactech, Inc. · 2025
Show all 9 generations
- Root · 9 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
- 8 generations backK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
- 7 generations backK002998 Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000 · Recalled
- 6 generations backK030710 Bio-Modular Shoulder SystemBiomet, Inc. · 2003 · Recalled
- 5 generations backK032895 BI-Angular Shoulder SystemBiomet, Inc. · 2003
- 4 generations backK042321 Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral HeadBiomet Manufacturing Corp · 2005
- 3 generations backK111746 Comprehensive Segmental Revision System (SRS)Biomet, Inc. · 2011 · Recalled
- 2 generations backK143659 Equinoxe Mega ProsthesisExactech, Inc. · 2015
- 1 generation backK162903 Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small…Exactech, Inc. · 2017
- This deviceK250713 Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless…Exactech, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K800494 | New Jersey Hemiarthroplasty Sholder Pros | Depuy, Inc. | 1980 | — |
| −8 | K991585 | Bipolar Shoulder Prosthesis | Biomet, Inc. | 1999 | — |
| −7 | K002998 | Biomet BI-Polar Shoulder System | Biomet, Inc. | 2000 | 1 |
| −6 | K030710 | Bio-Modular Shoulder System | Biomet, Inc. | 2003 | 1 |
| −5 | K032895 | BI-Angular Shoulder System | Biomet, Inc. | 2003 | — |
| −4 | K042321 | Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral Head | Biomet Manufacturing Corp | 2005 | — |
| −3 | K111746 | Comprehensive Segmental Revision System (SRS) | Biomet, Inc. | 2011 | 1 |
| −2 | K143659 | Equinoxe Mega Prosthesis | Exactech, Inc. | 2015 | — |
| −1 | K162903 | Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies | Exactech, Inc. | 2017 | — |
| 0 (this device) | K250713 | Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder… | Exactech, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1987 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 7 | 0 |
| 2000 | 6 | 0 |
| 2001 | 8 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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 KWT? 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 KWT device
- #1 K231657 AGILON® XO Shoulder Replacement Systemscore 17.7 · 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? (4)
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 |
|---|---|---|---|
| * | K143659 | Equinoxe Mega ProsthesisSummary page 6…de(s) KWT, KWS, PHX, HSD, PKC I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K143659 Equinoxe® Mega Prosthesis KWT K162903 Equinoxe® Humeral Reconstruction Prosthesis Extra-Small KWT Proximal Bodies K173388 Exact… | 2015 |
| * | K162903 | Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal BodiesSummary page 6…ly Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K143659 Equinoxe® Mega Prosthesis KWT K162903 Equinoxe® Humeral Reconstruction Prosthesis Extra-Small KWT Proximal Bodies K173388 Exactech Equinoxe Stemless Shoulder Implant… | 2017 |
| * | K173388 | Exactech Equinoxe Stemless ShoulderSummary page 6…imary Predicate is listed first) Product Code K143659 Equinoxe® Mega Prosthesis KWT K162903 Equinoxe® Humeral Reconstruction Prosthesis Extra-Small KWT Proximal Bodies K173388 Exactech Equinoxe Stemless Shoulder Implant System PKC K192097 Exactech Equinoxe Stemless Shoulder Implant System PKC Device Desc… | 2018 |
| * | K192097 | Exactech® Equinoxe® Stemless Humeral ComponentsSummary page 6…Mega Prosthesis KWT K162903 Equinoxe® Humeral Reconstruction Prosthesis Extra-Small KWT Proximal Bodies K173388 Exactech Equinoxe Stemless Shoulder Implant System PKC K192097 Exactech Equinoxe Stemless Shoulder Implant System PKC Device Description Summary 21 CFR 807.92(a)(4) Humeral Reconstruction Pro… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 45 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 11 of the 60 ancestors have a recall of any class.
- 2 other devices also cite its predicate K143659.
How does its category compare?
All KWT devicesKWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · KWT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWT
242in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWT
749in 2025
MAUDE reports naming product code KWT, 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 | 1 | — | 0 | 32 |
| 2008 | 0 | — | 1 | 48 |
| 2009 | 0 | — | 0 | 58 |
| 2010 | 1 | — | 7 | 71 |
| 2011 | 5 | 165 | 0 | 112 |
| 2012 | 1 | — | 2 | 83 |
| 2013 | 1 | — | 1 | 113 |
| 2014 | 1 | — | 0 | 168 |
| 2015 | 2 | — | 0 | 176 |
| 2016 | 2 | — | 1 | 445 |
| 2017 | 1 | — | 1 | 560 |
| 2018 | 2 | — | 1 | 480 |
| 2019 | 4 | 91 | 3 | 419 |
| 2020 | 1 | — | 0 | 215 |
| 2021 | 1 | — | 0 | 228 |
| 2022 | 1 | — | 0 | 273 |
| 2023 | 1 | — | 1 | 361 |
| 2024 | 1 | — | 0 | 601 |
| 2025 | 4 | 242 | 0 | 749 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Humeral Reconstruction Prosthesis The Equinoxe® Humeral Reconstruction Prosthesis System is intended for use in hemi or total shoulder arthroplasty where proximal humeral resection is deemed necessary in cases of: • Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis • Rheumatoid arthritis • Revision where other devices or treatments have failed • Correction of functional deformity • Treatment of acute or chronic…
Read the full statement (351 words)
Humeral Reconstruction Prosthesis
The Equinoxe® Humeral Reconstruction Prosthesis System is intended for use in hemi or total shoulder arthroplasty where proximal humeral resection is deemed necessary in cases of:
• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• Revision where other devices or treatments have failed
• Correction of functional deformity
• Treatment of acute or chronic fracture with humeral head involvement, which are unmanageable using other treatment
• Traumatic arthritis
• Oncology applications including bone loss due to tumor resection.
• Significant humeral resection which are unmanageable using other treatment methods
The Equinoxe® Humeral Reconstruction Prosthesis System can be used in either primary or revision arthroplasty procedures.
The Equinoxe® Humeral Reconstruction Prosthesis System is indicated for proximal humeral replacement in conjunction with reverse shoulder arthroplasty in which significant resection of the proximal humerus is necessary, the rotator cuff is irreplaceable and grossly deficient, and a functional deltoid muscle is present.
In the USA, the Equinoxe® Humeral Reconstruction Prosthesis System is not indicated for use with the Equinoxe Reverse Shoulder System components in oncology applications.
The Equinoxe® Humeral Reconstruction Prosthesis Distal Stems are for cemented use only, while the HA coated Equinoxe® Humeral Reconstruction Prosthesis Distal Stem Collars are only for uncemented, press-fit use.
Stemless Shoulder
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K250713 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250713: Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250713
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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