510(k) Report

510(k) · Cleared

Cleared

ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System

K170711510(k) TraditionalCleared Jun 1, 201785-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

Zimmer GmbH · PHX Shoulder Prosthesis, Reverse Configuration

Cleared on Jun 1, 2017 as substantially equivalent to K142403 (Zimmer GmbH, 2014) and 12 other predicates after an 85-day review. Its family tree reaches back 12 generations to 1991. 1 of the 73 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.

Decided
Jun 1, 2017
Review
85 days
Class
Class II
Product code
PHX
Recalls
None
Predicates
13

Its longest line of descent runs back 12 generations to K911686 (1991). 70 ancestors in all, the oldest K790987 (1979). 2 later devices descend from it, 1 citing it directly. 1 of the 73 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2016: 2 other ancestors2014: 1 other ancestor2012: 1 other ancestor2011: 1 other ancestor2006: 4 other ancestors2005: 7 other ancestors2003: 3 other ancestors1999: 5 other ancestors2007: 1 other ancestor2004: 3 other ancestors2002: 1 other ancestor2001: 3 other ancestors1998: 3 other ancestors2000: 5 other ancestors1996: 4 other ancestors1995: 2 other ancestors1993: 1 other ancestor1992: 2 other ancestors1989: 1 other ancestor1987: 3 other ancestors1986: 1 other ancestor1979: 1 other ancestor1994: 1 other ancestor1980: 2 other ancestors2020: 1 descendant cleared2026: 1 descendant clearedK911686 · Global Total Shoulder, Uncement Humeral Hemi-Shoul · Depuy, Inc. · 1991×2: 2 generations cleared close together, K984541 (1999), K992065 (1999) ×3: 3 generations cleared close together, K021478 (2003), K030941 (2004), K041873 (2004) ×2: 2 generations cleared close together, K052906 (2005), K060704 (2006) K063569 · Equinoxe Reverse Shoulder System · Exactech, Inc. · 2007 · recalled×2: 2 generations cleared close together, K073688 (2008), K080642 (2008) K113121 · Comprehensive Reverse Shoulder · Biomet Manufacturing, Inc. · 201119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 10 other ancestors2 generations back: 10 other ancestors3 generations back: 25 other ancestors4 generations back: 13 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K113121 · Comprehensive Reverse Shoulder · Biomet Manufacturing, Inc. · 2011K080642 · Comprehensive Reverse Shoulder · Biomet, Inc. · 2008 · Class I recallK073688 · Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw · Exactech, Inc. · 2008 · recalledK063569 · Equinoxe Reverse Shoulder System · Exactech, Inc. · 2007 · recalledK060704 · Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM · Zimmer, Inc. · 2006 · recalledK052906 · Zimmer Trabecular Metal Reverse Shoulder System · Zimmer, Inc. · 2005 · recalledK041873 · Aequalis Reversed Shoulder Prosthesis · Tornier · 2004K030941 · Aequalis Reversed Shoulder Prosthesis · Tornier · 2004K021478 · Delta Shoulder · Depuy, Inc. · 2003K992065 · Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head · DePuy Orthopaedics, Inc. · 1999K984541 · Global FX Humeral Stem, Global Advantage Humeral Head · DePuy Orthopaedics, Inc. · 1999K911686 · Global Total Shoulder, Uncement Humeral Hemi-Shoul · Depuy, Inc. · 1991−10−50
  1. Root · 12 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 8 generations between
  3. 3 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
  4. 2 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
  5. 1 generation backK113121 Comprehensive Reverse ShoulderBiomet Manufacturing, Inc. · 2011
  6. This deviceK170711 ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical…Zimmer GmbH · 2017
  7. Descendant · cites it directly · 1 of its ownK193099 Anatomical Shoulder SystemZimmer GmbH · 2020
  8. Descendant · 2 generations on · 0 of its ownK260556 Veritas Shoulder SystemRestor3D · 2026
Show all 12 generations
  1. Root · 12 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 11 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
  3. 10 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
  4. 9 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
  5. 8 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  6. 7 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  7. 6 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
  8. 5 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
  9. 4 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
  10. 3 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
  11. 2 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
  12. 1 generation backK113121 Comprehensive Reverse ShoulderBiomet Manufacturing, Inc. · 2011
  13. This deviceK170711 ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical…Zimmer GmbH · 2017

Class I recalls in this family

  • K080642 Comprehensive Reverse Shoulderdirect predicate · 2008

Most influential descendants

Showing 2 of 2 · See all
  • K193099Anatomical Shoulder SystemZimmer GmbH · 2020 · cites it directly1descendant
  • K260556Veritas Shoulder SystemRestor3D · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K911686Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc.1991—
−11K984541Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc.1999—
−10K992065Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage…DePuy Orthopaedics, Inc.1999—
−9K021478Delta ShoulderDepuy, Inc.2003—
−8K030941Aequalis Reversed Shoulder ProsthesisTornier2004—
−7K041873Aequalis Reversed Shoulder ProsthesisTornier2004—
−6K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.200512
−5K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc.200610
−4K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200713
−3K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081
−2K080642Comprehensive Reverse ShoulderBiomet, Inc.2008Class I
−1K113121Comprehensive Reverse ShoulderBiomet Manufacturing, Inc.2011—
0 (this device)K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder…Zimmer GmbH2017—
+1K193099Anatomical Shoulder SystemZimmer GmbH2020—
+2K260556Veritas Shoulder SystemRestor3D2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198020
198610
198730
198910
199220
199310
199410
199520
199640
199830
199950
200050
200130
200210
200330
200430
200570
200640
200710
201110
201210
201410
201620

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
202610
FIG. 1 — Lineage of K170711, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K212737 INHANCE™ Reverse Shoulder Systemscore 28.4 · 15 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (13)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K142403Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder…
Summary page 6
…K170711 p. 2/6 Anatomical Shoulder System manufactured by Zimmer GmbH, K142403, cleared November 24, 2014 Comprehensive Reverse Shou…
Zimmer GmbH20141
*K080642Comprehensive Reverse Shoulder
Summary page 6
…2014 Comprehensive Reverse Shoulder, manufactured by Biomet Inc, K080642, cleared September 7, 2008, K113069, cleared January 11, 2012 and K113121,…
Biomet, Inc.2008Class I
*K113069Comprehensive Reverse Shoulder Humeral Tray
Summary page 6
…mprehensive Reverse Shoulder, manufactured by Biomet Inc, K080642, cleared September 7, 2008, K113069, cleared January 11, 2012 and K113121, cleared December 16, 2011.…
Biomet Manufacturing Corp2012—
*K113121Comprehensive Reverse Shoulder
Summary page 6
…ured by Biomet Inc, K080642, cleared September 7, 2008, K113069, cleared January 11, 2012 and K113121, cleared December 16, 2011. The following predicate…
Biomet Manufacturing, Inc.2011—
*K990136Anatomica Glenoid Component
Summary page 6
…conditional”: Anatomical Shoulder System, manufactured by Zimmer GmbH, K990136, cleared March, 01, 1999; K030259, cleared April, 24, 2003; K051623, cleared…
Sulzer Orthopedics, Inc.19992
*K030259Amatomical Shoulder with Removable Head
Summary page 6
…Anatomical Shoulder System, manufactured by Zimmer GmbH, K990136, cleared March, 01, 1999; K030259, cleared April, 24, 2003; K051623, cleared July, 19, 2005, K053274, January, 25, 2006;…
Centerplus Orthopedics, Inc.20033
*K051623Anatomical Shoulder Keeled Glenoid
Summary page 6
…ufactured by Zimmer GmbH, K990136, cleared March, 01, 1999; K030259, cleared April, 24, 2003; K051623, cleared July, 19, 2005, K053274, January, 25, 2006;…
Zimmer GmbH20051
*K053274Anatomical Shoulder Inverse/Reverse
Summary page 6
…, cleared March, 01, 1999; K030259, cleared April, 24, 2003; K051623, cleared July, 19, 2005, K053274, January, 25, 2006; K052906, cleared December, 19, 2005; K062029,…
Zimmer GmbH20063
*K052906Zimmer Trabecular Metal Reverse Shoulder System
Summary page 6
…030259, cleared April, 24, 2003; K051623, cleared July, 19, 2005, K053274, January, 25, 2006; K052906, cleared December, 19, 2005; K062029, cleared October, 31, 2006; K142403 cleared…
Zimmer, Inc.200512
*K062029Anatomical Shoulder Fracture System
Summary page 6
…623, cleared July, 19, 2005, K053274, January, 25, 2006; K052906, cleared December, 19, 2005; K062029, cleared October, 31, 2006; K142403 cleared November…
Zimmer GmbH20063
*K160085Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder…
Summary page 6
…ed December, 19, 2005; K062029, cleared October, 31, 2006; K142403 cleared November 24, 2014, K160085, cleared March, 8, 2016 and K161620, cleared November, 1, 2016.…
Zimmer GmbH2016—
*K161620Anatomical Shoulder Domelock Dome centric
Summary page 6
…red October, 31, 2006; K142403 cleared November 24, 2014, K160085, cleared March, 8, 2016 and K161620, cleared November, 1, 2016. Anatomical Shoulder Combined System,…
Zimmer GmbH2016—
*K103404ANA0TOMICAL Shoulder TM Combined System
Summary page 6
…cleared November, 1, 2016. Anatomical Shoulder Combined System, manufactured by Zimmer GmbH, K103404, cleared May, 15th, 2011. Device Description: The ASHCOM Shoulder AC-Con…
Zimmer GmbH20111

Also cleared against K142403: 2 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K193099Anatomical Shoulder SystemZimmer GmbH20201

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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 26 years and passes through 8 companies; a new generation was cleared every 1.0 years on median.
  • 24 of the 70 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K193099 (Zimmer GmbH, 2020) has gone furthest, with 1 descendant of its own.
  • 2 other devices also cite its predicate K142403.

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. 2017, this device’s year, is highlighted.

FDA decisions per year · PHX

9in 2025

2007: 52008: 62009: 12010: 82011: 122012: 122013: 82014: 122015: 42016: 42017: 112018: 142019: 92020: 132021: 212022: 92023: 92024: 92025: 92026 (partial year): 18
2007high 21 (2021) · low 1 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PHX

72in 2025

2007: 97 days median2008: 79 days median2010: 124 days median2011: 94 days median2012: 114 days median2013: 143 days median2014: 110 days median2015: 206 days median2016: 132 days median2017: 141 days median2018: 127 days median2019: 144 days median2020: 143 days median2021: 143 days median2022: 198 days median2023: 154 days median2024: 139 days median2025: 72 days median2026 (partial year): 130 days median
2007high 206 (2015) · low 72 (2025)2026

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

Recalls per year · PHX

3in 2025

2015: 22018: 12019: 32020: 32021: 82023: 72024: 12025: 32026 (partial year): 7
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

2015: 142016: 52017: 252018: 3232019: 5042020: 9862021: 1,4042022: 1,3422023: 1,4012024: 2,1422025: 2,848
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200759700
200867900
20091—00
2010812400
2011129400
20121211400
2013814300
20141211000
20154206214
2016413205
201711141025
2018141271323
201991443504
2020131433986
20212114381,404
2022919801,342
2023915471,401
2024913912,142
202597232,848
2026181307—

What is it indicated for?

Anatomical Shoulder System and ASHCOM Shoulder System 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. • Avascular necrosis. • Conditions consequent to earlier operations. • Omarthrosis. • Rheumatoid arthritis. •…

Read the full statement (583 words)

Anatomical Shoulder System and ASHCOM Shoulder System

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.

• Avascular necrosis.

• Conditions consequent to earlier operations.

• Omarthrosis.

• Rheumatoid arthritis.

• Revision of shoulder prosthesis.

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 Anatomical Shoulder Pegged and Keeled 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 Inverse/Reverse System and 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 Anatomical Shoulder Pegged and Keeled 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 (including revision shoulder arthroplasty).

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 Revision 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.

Also cleared against K142403

2 other devices cite the same predicate.

  • K161620Anatomical Shoulder Domelock Dome centricZimmer GmbH · 2016
  • K160085Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture SystemZimmer GmbH · 2016

More from Zimmer GmbH

43 FDA decisions under this applicant name. See the company

  • K211047CoCr HeadZimmer GmbH · 2023
  • K200814Affixus (R) Natural Nail (R) System Humeral NailZimmer GmbH · 2020
  • K200112Zimmer Hip Joint ReplacementZimmer GmbH · 20202 recalls
  • K193099Anatomical Shoulder SystemZimmer GmbH · 2020
  • K193050Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral StemZimmer GmbH · 2019

Recent decisions in PHX

The PHX category page

  • K263421Veritas Shoulder Systemrestor3d, inc. · 2026
  • K263086AltiVate Reverse® Glenosphere with RAVN™ TechnologyEncore Medical L.P. · 2026
  • K260556Veritas Shoulder SystemRestor3D · 2026
  • K261683Augment Off-Axis Instrument SystemZimmer, Inc. · 2026
  • K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder SystemStryker Corporation (Tornier, Inc.) · 2026

https://510kreport.com/device/K170711 · printed Nov 6, 2026

Cite this page

510(k) Report. “K170711: ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170711

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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