510(k) · Cleared
Recalled · Class II · 2016Aequalis FX2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tornier S.A.S. · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Nov 18, 2014 as substantially equivalent to K122698 (Tornier S.A.S., 2013) and 4 other predicates after a 180-day review. Its family tree reaches back 14 generations to 1991. 1 of the 105 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled once.
- Decided
- Nov 18, 2014
- Review
- 180 days
- Class
- Class II
- Product code
- PHX
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 14 generations to K911686 (1991). 103 ancestors in all, the oldest K790987 (1979). 1 later device descends from it, 1 citing it directly. 1 of the 105 devices in this family, counting this one, has a Class I recall.
- Root · 14 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 10 generations between
- 3 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 2 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 1 generation backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- This deviceK141345 Aequalis FX2Tornier S.A.S. · 2014
- Descendant · cites it directly · 0 of its ownK152966 Aequalis Fx2Tornier S.A.S. · 2016 · Recalled
Show all 14 generations
- Root · 14 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 13 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 12 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 11 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 10 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 9 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 8 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 7 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 6 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 5 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 4 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 3 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 2 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 1 generation backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- This deviceK141345 Aequalis FX2Tornier S.A.S. · 2014
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder2 generations back · 2008
Most influential descendants
Showing 1 of 1 · See all- K152966Aequalis Fx2Tornier S.A.S. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −13 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −12 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −11 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −10 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −9 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −8 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −7 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −6 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −5 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −4 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −3 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −2 | K112615 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −1 | K122698 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2013 | 2 |
| 0 (this device) | K141345 | Aequalis FX2 | Tornier S.A.S. | 2014 | — |
| +1 | K152966 | Aequalis Fx2 | Tornier S.A.S. | 2016 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 5 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2000 | 6 | 0 |
| 2001 | 7 | 0 |
| 2002 | 1 | 0 |
| 2003 | 6 | 0 |
| 2004 | 3 | 0 |
| 2005 | 6 | 0 |
| 2006 | 10 | 0 |
| 2007 | 5 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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.
1 device in this family has a Class I recall. 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 PHX device
- #1 K212737 INHANCE™ Reverse Shoulder Systemscore 28.4 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K122698 | Aequalis Ascend Flex Shoulder SystemSummary page 4…ass II Classification panel: Orthopedic Product code: KWS, PHX, HSD 5) Equivalent / Predicate device : Aequalis Ascend Flex Shoulder System, TORNIER SAS, K122698 TORNIER S.A.S. Tél. : 33 (0)4 76 61 35 00 S.A.S. au capital de 35 043 008 € 161, rue… | 2013 |
| * | K060209 | Aequalis Shoulder Fracture System & Aequalis Shoulder SystemSummary page 5…K141345 Page 2 of 5 TORNIER Aequalis Shoulder Fracture System, TORNIER SAS, K060209, K131231 Aequalis Reversed Fracture Shoulder Prosthesis, TORNIER SAS, K082120, K131231 Comprehensive Reverse Shoulder System, BIO… | 2006 |
| * | K131231 | Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Summary page 5…K141345 Page 2 of 5 TORNIER Aequalis Shoulder Fracture System, TORNIER SAS, K060209, K131231 Aequalis Reversed Fracture Shoulder Prosthesis, TORNIER SAS, K082120, K131231 Comprehensive Reverse Shoulder System, BIOMET, K113… | 2013 |
| * | K082120 | Aequalis Reversed Fracture Shoulder ProthesisSummary page 5…5 TORNIER Aequalis Shoulder Fracture System, TORNIER SAS, K060209, K131231 Aequalis Reversed Fracture Shoulder Prosthesis, TORNIER SAS, K082120, K131231 Comprehensive Reverse Shoulder System, BIOMET, K113069 6) Device description : The Aequalis Fx2 is a non-constrained p… | 2008 |
| * | K113069 | Comprehensive Reverse Shoulder Humeral TraySummary page 5…acture System, TORNIER SAS, K060209, K131231 Aequalis Reversed Fracture Shoulder Prosthesis, TORNIER SAS, K082120, K131231 Comprehensive Reverse Shoulder System, BIOMET, K113069 6) Device description : The Aequalis Fx2 is a non-constrained prosthesis intended for the total or partial replacement of the g… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152966 | Aequalis Fx2 | 2016 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 19, 2016 | Class II | Z-0699-2017 | Component design/selection | Tornier is conducting a recall on Aequalis Fx2 ( implant parts and instrument trays) due to reports of dislocations of the poly insert and the stem. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 8 companies; a new generation was cleared every 1.0 years on median.
- 25 of the 103 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K152966 (Tornier S.A.S., 2016) has gone furthest, with 0 descendants of its own.
- 15 other devices also cite its predicate K122698.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · PHX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PHX
72in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PHX
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PHX
2,848in 2025
MAUDE reports naming product code PHX, 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 | 5 | 97 | 0 | 0 |
| 2008 | 6 | 79 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 8 | 124 | 0 | 0 |
| 2011 | 12 | 94 | 0 | 0 |
| 2012 | 12 | 114 | 0 | 0 |
| 2013 | 8 | 143 | 0 | 0 |
| 2014 | 12 | 110 | 0 | 0 |
| 2015 | 4 | 206 | 2 | 14 |
| 2016 | 4 | 132 | 0 | 5 |
| 2017 | 11 | 141 | 0 | 25 |
| 2018 | 14 | 127 | 1 | 323 |
| 2019 | 9 | 144 | 3 | 504 |
| 2020 | 13 | 143 | 3 | 986 |
| 2021 | 21 | 143 | 8 | 1,404 |
| 2022 | 9 | 198 | 0 | 1,342 |
| 2023 | 9 | 154 | 7 | 1,401 |
| 2024 | 9 | 139 | 1 | 2,142 |
| 2025 | 9 | 72 | 3 | 2,848 |
| 2026 | 18 | 130 | 7 | — |
What is it indicated for?
IN ANATOMIC: The Aequalis Fx2 humeral stem combined with the Flex Shoulder System humeral head may be used by themselves, as a hemiarthroplasty. if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid. as a total replacement. The Aequalis Fx2 is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain. The…
Read the full statement (282 words)
IN ANATOMIC:
The Aequalis Fx2 humeral stem combined with the Flex Shoulder System humeral head may be used by themselves, as a hemiarthroplasty. if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid. as a total replacement.
The Aequalis Fx2 is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain. The Aequalis Fx2 is indicated for use as a replacement of shoulder joints disabled by:
- Rheumatoid arthritis with pain
- Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
- Correction of functional deformity
- Fractures of the proximal humerus
- Traumatic arthritis
- Revision of other devices if sufficient bone stock remains
IN REVERSE:
The Aequalis Fx2 is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by:
- Rheumatoid arthritis
- Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
- Correction of functional deformity
- Fractures of the proximal humerus
- Traumatic arthritis
- Revision of the devices if sufficient bone stock remains.
The reversed insert is permitted to be used in the transformation from anatomic to reverse Aequalis Fx2 without the removal of the humeral stem, and if it is well fixed. during a revision surgery, for patient with a functional deltoid muscle.
Notes:
- all components are single use.
- the humeral stem is for cemented use only.
- the all-poly glenoid components are intended for cemented use only.
- the glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation.
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/K141345 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141345: Aequalis FX2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141345
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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