510(k) · Cleared
ClearedAequalis Reversed Adapter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tornier · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Oct 18, 2007 as substantially equivalent to K053274 (Zimmer GmbH, 2006) and 4 other predicates after a 97-day review. Its family tree reaches back 8 generations to 1991. 178 later devices descend from it.
- Decided
- Oct 18, 2007
- Review
- 97 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K911686 (1991). 32 ancestors in all, the oldest K800494 (1980). 178 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 7 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 6 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 5 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 4 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 3 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 2 generations backK050316 Aequalis Reversed Shoulder ProsthesisTornier · 2005
- 1 generation backK061439 Aequalis Reversed ProsthesisTornier · 2006
- This deviceK071948 Aequalis Reversed AdapterTornier · 2007
- Descendant · cites it directly · 164 of its ownK082120 Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008
- Descendant · 2 generations on · 147 of its ownK100142 Aequalis Reversed Shoulder ProsthesisTornier · 2010
- Descendant · 2 generations on · 108 of its ownK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- Descendant · 3 generations on · 97 of its ownK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- Descendant · 4 generations on · 96 of its ownK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
Showing 5 of 178 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 178 · See all- K082120Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008 · cites it directly164descendants
- K100142Aequalis Reversed Shoulder ProsthesisTornier · 2010 · 2 generations on147descendants
- K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · 2 generations on108descendants
- K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · 3 generations on97descendants
- K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · 4 generations on96descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −7 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −6 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −5 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −4 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −3 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −2 | K050316 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2005 | — |
| −1 | K061439 | Aequalis Reversed Prosthesis | Tornier | 2006 | — |
| 0 (this device) | K071948 | Aequalis Reversed Adapter | Tornier | 2007 | — |
| +1 | K082120 | Aequalis Reversed Fracture Shoulder Prothesis | Tornier | 2008 | — |
| +2 | K100142 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2010 | — |
| +2 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| +3 | K112615 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| +4 | K122698 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2013 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 6 | 0 |
| 2014 | 10 | 0 |
| 2015 | 4 | 0 |
| 2016 | 5 | 0 |
| 2017 | 12 | 0 |
| 2018 | 12 | 0 |
| 2019 | 14 | 0 |
| 2020 | 16 | 0 |
| 2021 | 18 | 0 |
| 2022 | 18 | 0 |
| 2023 | 14 | 0 |
| 2024 | 10 | 0 |
| 2025 | 14 | 0 |
| 2026 | 14 | 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 PHX? 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 |
|---|---|---|---|
| * | K053274 | Anatomical Shoulder Inverse/ReverseSummary page 4…fication Device class: Class II Classification panel: Orthopedic Product code: KWS 5) Equivalent / Predicate device Anatomical Shoulder™ [nverse/Reverse, Zimmer, Inc, K053274 Aequalis Reversed Prosthesis, Tornier, K061439, K050316, K041873, K030941 6) Device description The Aequalis Reversed Adapter o… | 2006 |
| * | K061439 | Aequalis Reversed ProsthesisSummary page 4…panel: Orthopedic Product code: KWS 5) Equivalent / Predicate device Anatomical Shoulder™ [nverse/Reverse, Zimmer, Inc, K053274 Aequalis Reversed Prosthesis, Tornier, K061439, K050316, K041873, K030941 6) Device description The Aequalis Reversed Adapter offers the surgeons the possibility to convert a… | 2006 |
| * | K050316 | Aequalis Reversed Shoulder ProsthesisSummary page 4…Orthopedic Product code: KWS 5) Equivalent / Predicate device Anatomical Shoulder™ [nverse/Reverse, Zimmer, Inc, K053274 Aequalis Reversed Prosthesis, Tornier, K061439, K050316, K041873, K030941 6) Device description The Aequalis Reversed Adapter offers the surgeons the possibility to convert a current… | 2005 |
| * | K041873 | Aequalis Reversed Shoulder ProsthesisSummary page 4…c Product code: KWS 5) Equivalent / Predicate device Anatomical Shoulder™ [nverse/Reverse, Zimmer, Inc, K053274 Aequalis Reversed Prosthesis, Tornier, K061439, K050316, K041873, K030941 6) Device description The Aequalis Reversed Adapter offers the surgeons the possibility to convert a current implanted… | 2004 |
| * | K030941 | Aequalis Reversed Shoulder ProsthesisSummary page 4…code: KWS 5) Equivalent / Predicate device Anatomical Shoulder™ [nverse/Reverse, Zimmer, Inc, K053274 Aequalis Reversed Prosthesis, Tornier, K061439, K050316, K041873, K030941 6) Device description The Aequalis Reversed Adapter offers the surgeons the possibility to convert a current implanted standard… | 2004 |
What descends from it? (178)
See all 1783 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 16 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 32 ancestors have a recall of any class.
- Of its descendants, K082120 (Tornier, 2008) has gone furthest, with 164 descendants of its own.
- 12 other devices also cite its predicate K053274.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
The Aequalis Reversed Adapter is indicated for use as a component of a total shoulder replacement and is designed to allow the transformation of Aequalis Anatomical (monobloc or press-fit) or Aequalis Fracture stems into components of a reverse shoulder prosthesis without removal during revision surgery. The Aequalis Reversed Adapter is for use only when the implanted humeral stem is well fixed along its entire length and when the patient has a…
Read the full statement (174 words)
The Aequalis Reversed Adapter is indicated for use as a component of a total shoulder replacement and is designed to allow the transformation of Aequalis Anatomical (monobloc or press-fit) or Aequalis Fracture stems into components of a reverse shoulder prosthesis without removal during revision surgery. The Aequalis Reversed Adapter is for use only when the implanted humeral stem is well fixed along its entire length and when the patient has a functional deltoid muscle and when the arthropathy is associated with a massive and non repairable rotator cuff-tear.
The Aequalis Reversed Adapter is intended for uncemented use only.
The Aequalis Reversed Adapter is intended to be used with the Aequalis Reversed glenoid which is anchored to the bone with 4 screws and which is for uncemented fixation.
The Aequalis Reversed Adapter is intended to be used with a cemented (Aequalis monobloc or Aequalis Fracture) or uncemented (Aequalis press-fit) stem. The humeral component is not to be revised in the conversion to a reverse shoulder prosthesis and must be well fixed along its entire length.
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/K071948 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071948: Aequalis Reversed Adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071948
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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