510(k) · Cleared
ClearedExactech Equinoxe Resurfacing Humeral Head System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Cleared on Nov 26, 2013 as substantially equivalent to K010657 (Biomet Manufacturing, Inc., 2001) and 3 other predicates after a 204-day review. Its family tree reaches back 7 generations to 1980. 8 later devices descend from it.
- Decided
- Nov 26, 2013
- Review
- 204 days
- Class
- Class II
- Product code
- HSD
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K800494 (1980). 27 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
- 6 generations backK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
- 5 generations backK002998 Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000 · Recalled
- 4 generations backK010827 Copeland MB/HA Resurfacing Humeral HeadsBiomet Orthopedics, Inc. · 2001 · Recalled
- 3 generations backK031971 Global Cap Resurfacing Replacement ShoulderDePuy Orthopaedics, Inc. · 2003
- 2 generations backK033516 Depuy Global Cap HA Resurfacing Shoulder Humeral HeadsDePuy Orthopaedics, Inc. · 2003
- 1 generation backK062661 Aequalis Resurfacing HeadTornier · 2006
- This deviceK131298 Exactech Equinoxe Resurfacing Humeral Head SystemExactech, Inc. · 2013
- Descendant · cites it directly · 7 of its ownK152825 Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC · 2016
- Descendant · 2 generations on · 3 of its ownK181287 Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK182500 Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc. · 2019
- Descendant · 2 generations on · 1 of its ownK222317 Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK173812 Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc. · 2018
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC · 2016 · cites it directly7descendants
- K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc. · 2018 · 2 generations on3descendants
- K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc. · 2019 · cites it directly2descendants
- K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc. · 2022 · 2 generations on1descendant
- K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc. · 2018 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K800494 | New Jersey Hemiarthroplasty Sholder Pros | Depuy, Inc. | 1980 | — |
| −6 | K991585 | Bipolar Shoulder Prosthesis | Biomet, Inc. | 1999 | — |
| −5 | K002998 | Biomet BI-Polar Shoulder System | Biomet, Inc. | 2000 | 1 |
| −4 | K010827 | Copeland MB/HA Resurfacing Humeral Heads | Biomet Orthopedics, Inc. | 2001 | 1 |
| −3 | K031971 | Global Cap Resurfacing Replacement Shoulder | DePuy Orthopaedics, Inc. | 2003 | — |
| −2 | K033516 | Depuy Global Cap HA Resurfacing Shoulder Humeral Heads | DePuy Orthopaedics, Inc. | 2003 | — |
| −1 | K062661 | Aequalis Resurfacing Head | Tornier | 2006 | — |
| 0 (this device) | K131298 | Exactech Equinoxe Resurfacing Humeral Head System | Exactech, Inc. | 2013 | — |
| +1 | K152825 | Catalyst CSR Shoulder System | Catalyst Orthoscience, LLC | 2016 | — |
| +2 | K181287 | Catalyst CSR Shoulder System | Catalyst Orthoscience, Inc. | 2018 | — |
| +1 | K182500 | Catalyst CSR Press-Fit Humeral Components | Catalyst Orthoscience, Inc. | 2019 | — |
| +2 | K222317 | Catalyst EA Convertible Stemmed Shoulder | Catalyst Orthoscience, Inc. | 2022 | — |
| +2 | K173812 | Catalyst CSR 3 Peg Glenoids | Catalyst Orthoscience, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 HSD? 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 HSD device
- #1 K191433 AGILON® XO Shoulder Replacement Systemscore 13.8 · 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? (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 |
|---|---|---|---|
| * | K010657 | Copeland MB Resurfacing Humeral Heads | 2001 |
| * | K062661 | Aequalis Resurfacing HeadSummary page 1…h Substantial Equivalence Is Claimed * Biomet CopelandTM MB Resurfacing Humeral Heads (#KO 10657) " Tomier Aequalis® Resurfacing Head (#K06266 1) * DePuy Global CAPTM Resurfacing Replacement Shoulder (^031971) * STD Manufacturing Contoured… | 2006 |
| * | K031971 | Global Cap Resurfacing Replacement ShoulderSummary page 1…acing Humeral Heads (#KO 10657) " Tomier Aequalis® Resurfacing Head (#K06266 1) * DePuy Global CAPTM Resurfacing Replacement Shoulder (^031971) * STD Manufacturing Contoured Articular Prosthetic (CAP) Humeral Head * Resurfacing System (#… | 2003 |
| * | K023096 | Contoured Articular Prosthesis (Cap) Humeral Head Resurfacing SystemSummary page 1…esurfacing Replacement Shoulder (^031971) * STD Manufacturing Contoured Articular Prosthetic (CAP) Humeral Head * Resurfacing System (#K023096) Device Description The Equinoxe Resurfacing Humeral Head System is intended as a cementless humeral… | 2003 |
What descends from it? (8)
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)
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 33 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 4 of the 27 ancestors have a recall of any class.
- Of its descendants, K152825 (Catalyst Orthoscience, LLC, 2016) has gone furthest, with 7 descendants of its own.
- 4 other devices also cite its predicate K010657.
How does its category compare?
All HSD devicesHSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · HSD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HSD
145in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSD
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSD
757in 2025
MAUDE reports naming product code HSD, 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 | 4 | 72 | 0 | 128 |
| 2008 | 3 | 92 | 2 | 259 |
| 2009 | 0 | — | 2 | 156 |
| 2010 | 0 | — | 0 | 225 |
| 2011 | 2 | — | 0 | 241 |
| 2012 | 2 | — | 0 | 254 |
| 2013 | 4 | 218 | 0 | 288 |
| 2014 | 1 | — | 0 | 434 |
| 2015 | 0 | — | 0 | 574 |
| 2016 | 3 | 145 | 0 | 784 |
| 2017 | 0 | — | 3 | 985 |
| 2018 | 1 | — | 1 | 649 |
| 2019 | 0 | — | 0 | 830 |
| 2020 | 2 | — | 1 | 658 |
| 2021 | 0 | — | 0 | 573 |
| 2022 | 1 | — | 0 | 508 |
| 2023 | 0 | — | 0 | 586 |
| 2024 | 1 | — | 0 | 693 |
| 2025 | 0 | — | 0 | 757 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Equinoxe Resurfacing Humeral Head System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where hemi- or total arthroplasty is determined by the surgeon to be the preferred method of treatment. The Equinoxe Resurfacing Numeral Head System is intended for use in patients with the following conditions where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or…
Read the full statement (101 words)
The Equinoxe Resurfacing Humeral Head System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where hemi- or total arthroplasty is determined by the surgeon to be the preferred method of treatment. The Equinoxe Resurfacing Numeral Head System is intended for use in patients with the following conditions where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or reconstructahic.
Osteoarthritis
Avascular Necrosis
Rheumatoid Arthritis
Post-traumatic Arthritis
Correction of functional deformity
Fractures of the humeral head
The Equinoxe Resurfacing Humeral Head System is intended for uncemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131298 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131298: Exactech Equinoxe Resurfacing Humeral Head System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131298
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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