510(k) · Cleared
ClearedAnatomical Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer GmbH · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Jan 29, 2020 as substantially equivalent to K170711 (Zimmer GmbH, 2017) after an 83-day review. Its family tree reaches back 13 generations to 1991. 1 of the 73 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Jan 29, 2020
- Review
- 83 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K911686 (1991). 71 ancestors in all, the oldest K790987 (1979). 1 later device descends from it, 1 citing it directly. 1 of the 73 devices in this family, counting this one, has a Class I recall.
- Root · 13 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 9 generations between
- 3 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 2 generations backK113121 Comprehensive Reverse ShoulderBiomet Manufacturing, Inc. · 2011
- 1 generation backK170711 ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical…Zimmer GmbH · 2017
- This deviceK193099 Anatomical Shoulder SystemZimmer GmbH · 2020
- Descendant · cites it directly · 0 of its ownK260556 Veritas Shoulder SystemRestor3D · 2026
Show all 13 generations
- Root · 13 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 12 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 11 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 10 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 9 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 8 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 7 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 6 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 5 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 4 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 3 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 2 generations backK113121 Comprehensive Reverse ShoulderBiomet Manufacturing, Inc. · 2011
- 1 generation backK170711 ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical…Zimmer GmbH · 2017
- This deviceK193099 Anatomical Shoulder SystemZimmer GmbH · 2020
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder2 generations back · 2008
Most influential descendants
Showing 1 of 1 · See all- K260556Veritas Shoulder SystemRestor3D · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −12 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −11 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −10 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −9 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −8 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −7 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −6 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −5 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −4 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −3 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −2 | K113121 | Comprehensive Reverse Shoulder | Biomet Manufacturing, Inc. | 2011 | — |
| −1 | K170711 | ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder… | Zimmer GmbH | 2017 | — |
| 0 (this device) | K193099 | Anatomical Shoulder System | Zimmer GmbH | 2020 | — |
| +1 | K260556 | Veritas Shoulder System | Restor3D | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 3 | 0 |
| 1989 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2000 | 5 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 7 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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? (1)
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 |
|---|---|---|---|
| * | K170711 | ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemSummary page 5…houlder™ System, and Anatomical Shoulder™ Combined System, manufactured by Zimmer GmbH, K170711, cleared June 1, 2017. Device Description: Anatomical Shoulder™ System… | 2017 |
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 |
|---|---|---|---|
| K260556 | Veritas Shoulder System | 2026 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 29 years and passes through 8 companies; a new generation was cleared every 1.0 years on median.
- 24 of the 71 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K260556 (Restor3D, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Hemi- or Total Arthroplasty Application of the Anatomical Shoulder Humeral Stems and Domelock System The Anatomical Shoulder Humeral Stems and Domelock System are indicated for: • Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis if bone stock is adequate. • Avascular necrosis. • Conditions consequent to earlier operations. • Optional use in revision: in some medical conditions (e.g. early…
Read the full statement (595 words)
Hemi- or Total Arthroplasty Application of the Anatomical Shoulder Humeral Stems and Domelock System
The Anatomical Shoulder Humeral Stems and Domelock System are indicated for:
• Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis if bone stock is adequate.
• Avascular necrosis.
• Conditions consequent to earlier operations.
• Optional use in revision: in some medical conditions (e.g. early revision when adequate bone stock exits), the surgeon may opt to use primary implants in a revision procedure).
The Humeral Stems Cemented are intended for cemented use and the Humeral Stems Uncemented are intended for uncemented use. When used in a total shoulder application, the Anaverse Anatomical Shoulder Pegged Glenoids Cemented and the Biomet all-polyethylene Keeled Glenoid are intended for cemented use only. The Biomet Modular Hybrid Glenoid is intended to be implanted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.
Reverse Application of the Anatomical Shoulder System and ASHCOM Shoulder System
• The Anatomical Shoulder Reverse System and the ASHCOM Shoulder system are indicated for primary, fracture or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
• 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 Humeral Stems Cemented are intended for cemented use and the Humeral Stems Uncemented are intended for uncemented use. When used with the Anatomical Shoulder Glenoid Fixation, it is intended for uncemented use and requires two screws for fixation.
Fracture Application of the Anatomical Shoulder Fracture System
The Anatomical Shoulder Fracture System is intended for use in prosthetic replacement of the proximal humerus and the glenoid articular surface of the scapula during total, hemi- and fracture shoulder arthroplasty in treatment of the following:
• Complex 3- and 4-part fractures of the proximal humerus with subluxation of the head fragment.
• Complex 3- and 4-part fractures of the proximal humerus with loosening of the spongiosa in the head fragment.
• Complex 3- and 4-part fractures of the proximal humerus with additional cross split of the head fragment.
• Fracture instability after osteosynthesis of 3- and 4-part fracture fragments of the proximal humerus.
• Posttraumatic necrosis of the humeral head.
• Posttraumatic arthrosis after humeral head fracture.
The Humeral Fracture Stems are intended for either cemented or uncemented use. When used in a total shoulder application, the Anaverse Anatomical Shoulder Pegged Glenoids Cemented are intended for cemented use only.
Anatomical Shoulder Combined System
Advanced destruction of the shoulder joint resulting from:
• Omarthrosis
• Rheumatoid arthritis
• Post-traumatic arthritis
• Avascular necrosis of the humeral head
• Cuff-tear arthropathy (Bigliani/Flatow Heads with heights of 27mm or greater)
• Conditions following earlier operations
The Anatomical Shoulder Combined System is intended for cemented or cementless use.
When used with the following humeral stems the Anatomical Shoulder Combined System is intended for cemented use.
• Anatomical Shoulder Standard Cemented Humeral Stem
• Anatomical Shoulder Long Stem
When used with the following humeral stem the Anatomical Shoulder Combined System is intended for cementless use:
• Anatomical Shoulder Standard Uncemented Stem.
When used with the following humeral stems the Anatomical Shoulder Combined System is intended for cemented or cementless use:
• Anatomical Shoulder Fracture Stem.
• Anatomical Shoulder Fracture Long Stem.
When used with the following glenoids the Anatomical Shoulder Combined System is intended for cemented use:
• Bigliani/Flatow Glenoid (pegged and keeled).
• Trabecular Metal™ Glenoid.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193099 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193099: Anatomical Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193099
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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