510(k) · Cleared

Cleared

Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis Reversed Fracture Shoulder Prosthesis

K112144510(k) SpecialCleared Mar 13, 2012231-day reviewClass II21 CFR 888.3660

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Tornier · PHX Shoulder Prosthesis, Reverse Configuration

Cleared on Mar 13, 2012 as substantially equivalent to K952928 (Tornier, 1995) and 16 other predicates after a 231-day review. Its family tree reaches back 9 generations to 1991. 23 later devices descend from it.

Decided: Mar 13, 2012
Review: 231 days
Class: Class II
Product code: PHX
Recalls: None
Predicates: 17

Its longest line of descent runs back 9 generations to K911686 (1991). 38 ancestors in all, the oldest K800494 (1980). 23 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 9 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
5 generations between
3 generations backK050316 Aequalis Reversed Shoulder ProsthesisTornier · 2005
2 generations backK061439 Aequalis Reversed ProsthesisTornier · 2006
1 generation backK071948 Aequalis Reversed AdapterTornier · 2007
This deviceK112144 Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder…Tornier · 2012
Descendant · cites it directly · 13 of its ownK161863 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…Stryker GmbH · 2016
Descendant · cites it directly · 12 of its ownK170452 Medacta Shoulder SystemMedacta International S.A. · 2017
Descendant · 2 generations on · 10 of its ownK172210 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…Stryker Trauma AG · 2017
Descendant · 3 generations on · 9 of its ownK181742 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…Stryker GmbH · 2018
Descendant · 4 generations on · 8 of its ownK183039 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…Stryker GmbH · 2019

Show all 9 generations

Root · 9 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
8 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
7 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
6 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
5 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
4 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
3 generations backK050316 Aequalis Reversed Shoulder ProsthesisTornier · 2005
2 generations backK061439 Aequalis Reversed ProsthesisTornier · 2006
1 generation backK071948 Aequalis Reversed AdapterTornier · 2007
This deviceK112144 Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder…Tornier · 2012

Showing 5 of 23 descendants. See all descendants

Descendants cleared per year

2016high 4 (2021) · low 0 (2022)2026

Most influential descendants

Showing 5 of 23 · See all

K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH · 2016 · cites it directly13descendants
K170452Medacta Shoulder SystemMedacta International S.A. · 2017 · cites it directly12descendants
K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG · 2017 · 2 generations on10descendants
K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH · 2018 · 3 generations on9descendants
K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH · 2019 · 4 generations on8descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−9	K911686	Global Total Shoulder, Uncement Humeral Hemi-Shoul	Depuy, Inc.	1991	—
−8	K984541	Global FX Humeral Stem, Global Advantage Humeral Head	DePuy Orthopaedics, Inc.	1999	—
−7	K992065	Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage…	DePuy Orthopaedics, Inc.	1999	—
−6	K021478	Delta Shoulder	Depuy, Inc.	2003	—
−5	K030941	Aequalis Reversed Shoulder Prosthesis	Tornier	2004	—
−4	K041873	Aequalis Reversed Shoulder Prosthesis	Tornier	2004	—
−3	K050316	Aequalis Reversed Shoulder Prosthesis	Tornier	2005	—
−2	K061439	Aequalis Reversed Prosthesis	Tornier	2006	—
−1	K071948	Aequalis Reversed Adapter	Tornier	2007	—
0 (this device)	K112144	Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis…	Tornier	2012	—
+1	K161863	ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…	Stryker GmbH	2016	—
+1	K170452	Medacta Shoulder System	Medacta International S.A.	2017	—
+2	K172210	ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…	Stryker Trauma AG	2017	—
+3	K181742	ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…	Stryker GmbH	2018	—
+4	K183039	ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…	Stryker GmbH	2019	—

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	4	0
2001	3	0
2003	2	0
2004	2	0
2005	1	0
2006	3	0
2007	2	0
2008	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0
2017	2	0
2018	3	0
2019	2	0
2020	3	0
2021	4	0
2024	1	0
2025	3	0
2026	4	0

FIG. 1 — Lineage of K112144, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (17)

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	Applicant	Decided	Recalls
*	K952928	Aequalis Shoulder System for Total & Hemishoulder Applications Summary page 6 …Classification panel: Orthopedic - Product code: KWS 6) Equivalent/ Predicate device For the Aequalis Fracture shoner System: . Aequalis Shoulder System, TORNIER SA, K952928, K041339, K043077, K060209 Aequalis Fracture Shoulder System, TORNIER SA, K994392, K003728, K032679, K 043077, K060209 For the A…	Tornier	1995	—
*	K041339	Aequalis Shoulder System Summary page 6 …cation panel: Orthopedic - Product code: KWS 6) Equivalent/ Predicate device For the Aequalis Fracture shoner System: . Aequalis Shoulder System, TORNIER SA, K952928, K041339, K043077, K060209 Aequalis Fracture Shoulder System, TORNIER SA, K994392, K003728, K032679, K 043077, K060209 For the Aequalis R…	Tornier	2004	—
*	K043077	Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder System Summary page 6 …nel: Orthopedic - Product code: KWS 6) Equivalent/ Predicate device For the Aequalis Fracture shoner System: . Aequalis Shoulder System, TORNIER SA, K952928, K041339, K043077, K060209 Aequalis Fracture Shoulder System, TORNIER SA, K994392, K003728, K032679, K 043077, K060209 For the Aequalis Reversed S…	Tornier	2004	—
*	K060209	Aequalis Shoulder Fracture System & Aequalis Shoulder System Summary page 6 …hopedic - Product code: KWS 6) Equivalent/ Predicate device For the Aequalis Fracture shoner System: . Aequalis Shoulder System, TORNIER SA, K952928, K041339, K043077, K060209 Aequalis Fracture Shoulder System, TORNIER SA, K994392, K003728, K032679, K 043077, K060209 For the Aequalis Reversed Shoulder P…	Tornier	2006	—
*	K012212	Modification to Aequalis Shoulder System Summary page 6 …eversed Shoulder Prosthesis: Aequalis Reversed Shoulder Prosthesis, TORNIER SA, K030941, K041873, K050316, K061439,.K08105 Aequalis Shoulder System, TORNIER SA, K952928, K012212, K041339, K060209 . ' For the Aequalis Reversed Fracture Shoulder Prosthesis: Aequalis Reversed Shoulder Prosthesis, TORNIER SA…	Tornier	2001	—
*	K994392	Aequalis Shoulder Fracture System Summary page 6 …evice For the Aequalis Fracture shoner System: . Aequalis Shoulder System, TORNIER SA, K952928, K041339, K043077, K060209 Aequalis Fracture Shoulder System, TORNIER SA, K994392, K003728, K032679, K 043077, K060209 For the Aequalis Reversed Shoulder Prosthesis: Aequalis Reversed Shoulder Prosthesis, TORNI…	Tornier	2000	—
*	K003728	Modification to Aequalis Shoulder Fracture System Summary page 6 …r the Aequalis Fracture shoner System: . Aequalis Shoulder System, TORNIER SA, K952928, K041339, K043077, K060209 Aequalis Fracture Shoulder System, TORNIER SA, K994392, K003728, K032679, K 043077, K060209 For the Aequalis Reversed Shoulder Prosthesis: Aequalis Reversed Shoulder Prosthesis, TORNIER SA, K0…	Tornier	2000	—
*	K032679	Aequalis Shoulder Fracture System Summary page 6 …ualis Fracture shoner System: . Aequalis Shoulder System, TORNIER SA, K952928, K041339, K043077, K060209 Aequalis Fracture Shoulder System, TORNIER SA, K994392, K003728, K032679, K 043077, K060209 For the Aequalis Reversed Shoulder Prosthesis: Aequalis Reversed Shoulder Prosthesis, TORNIER SA, K030941, K0…	Tornier	2003	—
*	K030941	Aequalis Reversed Shoulder Prosthesis Summary page 6 …ulder System, TORNIER SA, K994392, K003728, K032679, K 043077, K060209 For the Aequalis Reversed Shoulder Prosthesis: Aequalis Reversed Shoulder Prosthesis, TORNIER SA, K030941, K041873, K050316, K061439,.K08105 Aequalis Shoulder System, TORNIER SA, K952928, K012212, K041339, K060209 . ' For the Aequalis…	Tornier	2004	—
*	K041873	Aequalis Reversed Shoulder Prosthesis Summary page 6 …tem, TORNIER SA, K994392, K003728, K032679, K 043077, K060209 For the Aequalis Reversed Shoulder Prosthesis: Aequalis Reversed Shoulder Prosthesis, TORNIER SA, K030941, K041873, K050316, K061439,.K08105 Aequalis Shoulder System, TORNIER SA, K952928, K012212, K041339, K060209 . ' For the Aequalis Reversed…	Tornier	2004	—
*	K050316	Aequalis Reversed Shoulder Prosthesis Summary page 6 …IER SA, K994392, K003728, K032679, K 043077, K060209 For the Aequalis Reversed Shoulder Prosthesis: Aequalis Reversed Shoulder Prosthesis, TORNIER SA, K030941, K041873, K050316, K061439,.K08105 Aequalis Shoulder System, TORNIER SA, K952928, K012212, K041339, K060209 . ' For the Aequalis Reversed Fracture…	Tornier	2005	—
*	K061439	Aequalis Reversed Prosthesis Summary page 6 …994392, K003728, K032679, K 043077, K060209 For the Aequalis Reversed Shoulder Prosthesis: Aequalis Reversed Shoulder Prosthesis, TORNIER SA, K030941, K041873, K050316, K061439,.K08105 Aequalis Shoulder System, TORNIER SA, K952928, K012212, K041339, K060209 . ' For the Aequalis Reversed Fracture Shoulder…	Tornier	2006	—
*	K081059	Aequalis Reversed Shoulder Prosthesis Summary page 6 …12, K041339, K060209 . ' For the Aequalis Reversed Fracture Shoulder Prosthesis: Aequalis Reversed Shoulder Prosthesis, TORNIER SA, K030941, K041873, K050316, K061439, K081059 Aequalis Fracture Shoulder System, TORNIER SA, K994392, K003728, K 032679, K043077, K060209. Delta Xtend Reverse Shoulder System,…	Tornier	2008	—
*	K062250	Delta Xtend Reverse Shoulder System Summary page 6 …41873, K050316, K061439, K081059 Aequalis Fracture Shoulder System, TORNIER SA, K994392, K003728, K 032679, K043077, K060209. Delta Xtend Reverse Shoulder System, DEPUY, K062250, K071379. Delta Shoulder, DEPUY, K021478 Aequalis Reversed Adapter, TORNIER SA, K071948 Section 5 - Page 2/ page 6 TORNIER S.…	DePuy Orthopaedics, Inc.	2007	8
*	K071379	Delta Xtend Reverse Shoulder Modular Stem Summary page 6 …50316, K061439, K081059 Aequalis Fracture Shoulder System, TORNIER SA, K994392, K003728, K 032679, K043077, K060209. Delta Xtend Reverse Shoulder System, DEPUY, K062250, K071379. Delta Shoulder, DEPUY, K021478 Aequalis Reversed Adapter, TORNIER SA, K071948 Section 5 - Page 2/ page 6 TORNIER S.A.S. Tel.…	DePuy Orthopaedics, Inc.	2007	—
*	K021478	Delta Shoulder Summary page 6 …Fracture Shoulder System, TORNIER SA, K994392, K003728, K 032679, K043077, K060209. Delta Xtend Reverse Shoulder System, DEPUY, K062250, K071379. Delta Shoulder, DEPUY, K021478 Aequalis Reversed Adapter, TORNIER SA, K071948 Section 5 - Page 2/ page 6 TORNIER S.A.S. Tel.: 33 (0)4 76613500 S.A.S. au capi…	Depuy, Inc.	2003	—
*	K071948	Aequalis Reversed Adapter Summary page 6 …003728, K 032679, K043077, K060209. Delta Xtend Reverse Shoulder System, DEPUY, K062250, K071379. Delta Shoulder, DEPUY, K021478 Aequalis Reversed Adapter, TORNIER SA, K071948 Section 5 - Page 2/ page 6 TORNIER S.A.S. Tel.: 33 (0)4 76613500 S.A.S. au capital de 288 G00 € 161, rue Lavoisier - Montbonno…	Tornier	2007	—

Also cleared against K952928: 18 other devices →

What descends from it? (23)

See all 23

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K161863	ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…	Stryker GmbH	2016	13
K170452	Medacta Shoulder System	Medacta International S.A.	2017	12
K193175	Lateralized Glenosphere	Medacta Inernational SA	2020	1

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 21 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
6 of the 38 ancestors have a recall of any class.
Of its descendants, K161863 (Stryker GmbH, 2016) has gone furthest, with 13 descendants of its own.
18 other devices also cite its predicate K952928.

How does its category compare?

All PHX devices

PHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · PHX

9in 2025

2007high 21 (2021) · low 1 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PHX

72in 2025

2007high 206 (2015) · low 72 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · PHX

3in 2025

2007high 8 (2021) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · PHX

2,848in 2025

2007high 2,848 (2025) · low 0 (2007)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?

Aequalis Shoulder Range (except Aequalis for Fracture): Prosthetic replacenient with this device may be indicated to relieve severe pain or significant disability caused by: - Degenerative pathologies: arthrosis, rheumatoid arthritis, post-traumatic arthrosis. Primary and secondary necrosis of the humeral head - Displaced 4-part upper humeral fracture - Humeral head fracture . - Other pathologies where arthrodesis or resectional arthroplasty of the…

Read the full statement (630 words)

Aequalis Shoulder Range (except Aequalis for Fracture):

Prosthetic replacenient with this device may be indicated to relieve severe pain or significant disability caused by:

- Degenerative pathologies: arthrosis, rheumatoid arthritis, post-traumatic arthrosis.

Primary and secondary necrosis of the humeral head

- Displaced 4-part upper humeral fracture

- Humeral head fracture .

- Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are " not acceptable -

- Revision sargery when other treatments or devices have failed.

Aequalis monobloc stem is for use with cemented applications and is labeled as such.

Aequalis Press-Fit stem is for uncemented applications and is labeled as such.

Glenoid component is for use with cemented applications ad is labeled as such.

Aequalis for Fracture:

Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint, including humeral head fracture and displaced 3-or 4-part proximal humeral fractures.

Revision surgery when other treatments or devices have failed.

Aequalis fracture stem is for cemented use.

Aequalis Reversed Shoulder Prosthesis:

The Aequalis Reversed Shoulder Prosthesis is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated to massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairablé rotator cuff-tear. Only the humeral components are for cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.

When during the primary surgery the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemi-prosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis.

When, in case of revision of a Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to implant a base-plate and a sphere of Aequalis Reversed range again, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.

Aecqualis Reversed Fracture Shoulder Prosthesis:

The Aequalis Reversed Fracture Shoulder Prosthesis is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain or significant disability following arthropathy associated to a grossly deficient rotator cuff joint:

- in case of traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint, including humeral head fracture and displaced 3-or 4-part proximal humeral fractures, or

- in case of bone defect in proximal humerus.

The Aequalis Reversed Fracture Shoulder Prosthesis is also indicated for prosthetic revisions with a grossly deficient rotator cuff joint when other treatments or devices have failed.

When during the primary surgery the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemiprosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the dequalis Reversed Fracture Shoulder Prosthesis into a non reversed hemi-prosthesis.

When, in case of revision of a Aequalis Reversed Fracture Shoulder Prosthesis, the glenoid bone stock appears to be insufficient to implant a base plate and a sphere of Aequalis Reversed range again, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed Fracture Shoulder Prosthesis into a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.

The Aequalis Reversed Fracture Shoulder humeral stem is used in association with the glenoid components of the Aequalis Reversed Shoulder Prosthesis.

The Aequalis Reversed Fracture Shoulder humeral stem is for cemented use only.

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/K112144 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112144: Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis Reversed Fracture Shoulder Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112144

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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