510(k) · Cleared
ClearedSMR 40MM Glenosphere
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lima Corporate S.P.A. · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Nov 7, 2014 as substantially equivalent to K110598 (Lima Corporate S.P.A., 2011) and 3 other predicates after a 94-day review. Its family tree reaches back 10 generations to 1991. 13 later devices descend from it.
- Decided
- Nov 7, 2014
- Review
- 94 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K911686 (1991). 31 ancestors in all, the oldest K800494 (1980). 13 later devices descend from it, 4 citing it directly.
- Root · 10 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 6 generations between
- 3 generations backK073676 Depuy Delta Xtend Reverse Shoulder High Mobility CupDePuy Orthopaedics, Inc. · 2008
- 2 generations backK091751 Depuy Delta Xtend Reverse Shoulder XLK CupDePuy Orthopaedics, Inc. · 2009
- 1 generation backK110598 SMR Reverse Shoulder SystemLima Corporate S.P.A. · 2011 · Recalled
- This deviceK142139 SMR 40MM GlenosphereLima Corporate S.P.A. · 2014
- Descendant · cites it directly · 12 of its ownK163397 SMR Hybrid Glenoid SystemLima Corporate S.P.A. · 2017 · Recalled
- Descendant · cites it directly · 8 of its ownK190911 Physica KR Liner and SMR Reverse Humeral LinerLimacorporate · 2019
- Descendant · 2 generations on · 7 of its ownK220792 SMR Reverse LinerLima Corporate S.P.A. · 2022
- Descendant · 3 generations on · 3 of its ownK223876 SMR Shoulder SystemLima Corporate S.P.A. · 2023
- Descendant · 3 generations on · 2 of its ownK222427 PRIMA TT GlenoidLima Corporate S.P.A. · 2022 · Recalled
Show all 10 generations
- Root · 10 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 9 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 8 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 7 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 6 generations backK062116 Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc. · 2006
- 5 generations backK062250 Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc. · 2007 · Recalled
- 4 generations backK071379 Delta Xtend Reverse Shoulder Modular StemDePuy Orthopaedics, Inc. · 2007
- 3 generations backK073676 Depuy Delta Xtend Reverse Shoulder High Mobility CupDePuy Orthopaedics, Inc. · 2008
- 2 generations backK091751 Depuy Delta Xtend Reverse Shoulder XLK CupDePuy Orthopaedics, Inc. · 2009
- 1 generation backK110598 SMR Reverse Shoulder SystemLima Corporate S.P.A. · 2011 · Recalled
- This deviceK142139 SMR 40MM GlenosphereLima Corporate S.P.A. · 2014
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A. · 2017 · cites it directly12descendants
- K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate · 2019 · cites it directly8descendants
- K220792SMR Reverse LinerLima Corporate S.P.A. · 2022 · 2 generations on7descendants
- K223876SMR Shoulder SystemLima Corporate S.P.A. · 2023 · 3 generations on3descendants
- K222427PRIMA TT GlenoidLima Corporate S.P.A. · 2022 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −9 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −8 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −7 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −6 | K062116 | Delta Cta Reverse Shoulder System Humeral Heads | DePuy Orthopaedics, Inc. | 2006 | — |
| −5 | K062250 | Delta Xtend Reverse Shoulder System | DePuy Orthopaedics, Inc. | 2007 | 8 |
| −4 | K071379 | Delta Xtend Reverse Shoulder Modular Stem | DePuy Orthopaedics, Inc. | 2007 | — |
| −3 | K073676 | Depuy Delta Xtend Reverse Shoulder High Mobility Cup | DePuy Orthopaedics, Inc. | 2008 | — |
| −2 | K091751 | Depuy Delta Xtend Reverse Shoulder XLK Cup | DePuy Orthopaedics, Inc. | 2009 | — |
| −1 | K110598 | SMR Reverse Shoulder System | Lima Corporate S.P.A. | 2011 | 1 |
| 0 (this device) | K142139 | SMR 40MM Glenosphere | Lima Corporate S.P.A. | 2014 | — |
| +1 | K163397 | SMR Hybrid Glenoid System | Lima Corporate S.P.A. | 2017 | 1 |
| +1 | K190911 | Physica KR Liner and SMR Reverse Humeral Liner | Limacorporate | 2019 | — |
| +2 | K220792 | SMR Reverse Liner | Lima Corporate S.P.A. | 2022 | — |
| +3 | K223876 | SMR Shoulder System | Lima Corporate S.P.A. | 2023 | — |
| +3 | K222427 | PRIMA TT Glenoid | Lima Corporate S.P.A. | 2022 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 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? (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 |
|---|---|---|---|
| * | K110598 | SMR Reverse Shoulder SystemSummary page 6…Glenosphere is a Co-Cr-Mo glenosphere intended to be used with the 40mm standard UHMWPE reverse liner (standard or retentive) as part of the SMR Reverse Shoulder System (K110598). The SMR Reverse Shoulder System consists of a humeral stem, a reverse humeral body, a reverse liner, a metal-back glenoid, a gl… | 2011 |
| * | K081016 | Smith & Nephew, Inc., Promos Reverse Shoulder SystemSummary page 9…ition of screws for fixation. Predicate Devices: • SMR Reverse Shoulder System (Limacorporate, K110598); • Promos Reverse Shoulder System (Plus Orthopedics, K081016); • Inverse/reverse Shoulder (Zimmer, K053274); • Delta Xtend Reverse Shoulder (DePuy, K091751). Comparable Features… | 2008 |
| * | K053274 | Anatomical Shoulder Inverse/ReverseSummary page 9…SMR Reverse Shoulder System (Limacorporate, K110598); • Promos Reverse Shoulder System (Plus Orthopedics, K081016); • Inverse/reverse Shoulder (Zimmer, K053274); • Delta Xtend Reverse Shoulder (DePuy, K091751). Comparable Features to Predicate Device(s): The SMR 40mm Glenosphere a… | 2006 |
| * | K091751 | Depuy Delta Xtend Reverse Shoulder XLK CupSummary page 9…98); • Promos Reverse Shoulder System (Plus Orthopedics, K081016); • Inverse/reverse Shoulder (Zimmer, K053274); • Delta Xtend Reverse Shoulder (DePuy, K091751). Comparable Features to Predicate Device(s): The SMR 40mm Glenosphere and Liner are similar to the predicate devices in terms… | 2009 |
What descends from it? (13)
See all 134 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 23 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 10 of the 31 ancestors have a recall of any class.
- Of its descendants, K163397 (Lima Corporate S.P.A., 2017) has gone furthest, with 12 descendants of its own.
- 11 other devices also cite its predicate K110598.
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?
The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement. The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to: non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; inflammatory degenerative joint disease such as rheumatoid arthritis; treatment of acute fractures…
Read the full statement (497 words)
The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement.
The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to:
non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
inflammatory degenerative joint disease such as rheumatoid arthritis;
treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
revision of a failed primary implant;
cuff tear arthropathy (CTA Heads only).
The Large Resection Stems (not available in the US) are indicated for oncology applications.
The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient’s joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented and uncemented use as specified in the following table.
In the Anatomic shoulder the humeral construct consists of the humeral stem, the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral construct consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented.
The Anatomic glenoid construct consists of an all polyethylene glenoid or a metal back assembled with a liner while the Reverse glenoid construct consists of the metal back, the connector and the glenosphere. On the glenoid side, the fixation of the all polyethylene glenoid or the metal back determines if the construct is cemented or uncemented.
In the US, the SMR Metal Backed Glenoid/Liner construct, used as part of the SMR Anatomic Shoulder Replacement, is intended for use with bone cement and should be used without bone screws.
Outside the US, the SMR Metal Backed Glenoid/Liner construct, used as part of the SMR Anatomic Shoulder Replacement, is intended for uncemented use with the addition of screws for fixation.
The SMR Metal Backed Glenoid/Connector/Glenosphere construct, used as part of the SMR Reverse Shoulder replacement, is intended for uncemented use with the addition of screws for fixation.
The SMR TT Metal Back is indicated for primary implant in anatomic or reverse total shoulder arthroplasty with poor glenoid bone quality or in revision case with consistent bone loss on the glenoid side. The implant is suitable for implantation with or without bone graft. These indications are not yet approved in the US.
In the US the SMR TT Metal Back Baseplate used as part of the SMR Anatomic Shoulder Replacement, is intended for use with bone cement and should be used without bone screws; while when used as part of the SMR Reverse Shoulder replacement, is intended for uncemented use with the addition of screws for fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142139 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142139: SMR 40MM Glenosphere.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142139
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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