510(k) · Cleared
Recalled · Class II · 2012Anatomical Shoulder Fracture System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer GmbH · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Oct 31, 2006 as substantially equivalent to K060209 (Tornier, 2006) and 3 other predicates after a 105-day review. Its family tree reaches back 7 generations to 1991. 10 later devices descend from it. It has been recalled 3 times.
- Decided
- Oct 31, 2006
- Review
- 105 days
- Class
- Class II
- Product code
- KWS
- Recalls
- 3
- Predicates
- 4
Its longest line of descent runs back 7 generations to K911686 (1991). 39 ancestors in all, the oldest K790987 (1979). 10 later devices descend from it, 5 citing it directly.
- Root · 7 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 6 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 5 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 4 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 3 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 2 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 1 generation backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- This deviceK062029 Anatomical Shoulder Fracture SystemZimmer GmbH · 2006
- Descendant · cites it directly · 5 of its ownK142403 Anatomical Shoulder System/Anatomical Shoulder Domelock…Zimmer GmbH · 2014 · Recalled
- Descendant · 2 generations on · 3 of its ownK161620 Anatomical Shoulder Domelock Dome centricZimmer GmbH · 2016
- Descendant · cites it directly · 3 of its ownK160085 Anatomical Shoulder System, Anatomical Shoulder Domelock System…Zimmer GmbH · 2016
- Descendant · cites it directly · 3 of its ownK103404 ANA0TOMICAL Shoulder TM Combined SystemZimmer GmbH · 2011 · Recalled
- Descendant · cites it directly · 2 of its ownK170711 ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical…Zimmer GmbH · 2017
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K142403Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder…Zimmer GmbH · 2014 · cites it directly5descendants
- K161620Anatomical Shoulder Domelock Dome centricZimmer GmbH · 2016 · 2 generations on3descendants
- K160085Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder…Zimmer GmbH · 2016 · cites it directly3descendants
- K103404ANA0TOMICAL Shoulder TM Combined SystemZimmer GmbH · 2011 · cites it directly3descendants
- K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemZimmer GmbH · 2017 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −6 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −5 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −4 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −3 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −2 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −1 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| 0 (this device) | K062029 | Anatomical Shoulder Fracture System | Zimmer GmbH | 2006 | — |
| +1 | K142403 | Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical… | Zimmer GmbH | 2014 | 1 |
| +2 | K161620 | Anatomical Shoulder Domelock Dome centric | Zimmer GmbH | 2016 | — |
| +1 | K160085 | Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical… | Zimmer GmbH | 2016 | — |
| +1 | K103404 | ANA0TOMICAL Shoulder TM Combined System | Zimmer GmbH | 2011 | 1 |
| +1 | K170711 | ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder… | Zimmer GmbH | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 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 KWS? 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 KWS device
- #1 K220847 AETOS Shoulder Systemscore 21.1 · 16 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 |
|---|---|---|---|
| * | K060209 | Aequalis Shoulder Fracture System & Aequalis Shoulder SystemSummary page 1…FR § 888.3690 Predicate Devices: Aequalis Shoulder Fracture System & Aequalis Shoulder, manufactured by Tornier S.A., K060209, cleared March 2, 2006 Global Fx Humeral Stem and Global Ad… | 2006 |
| * | K984541 | Global FX Humeral Stem, Global Advantage Humeral HeadSummary page 1…Global Fx Humeral Stem and Global Advantage Humeral Head, manufactured by Depuy Orthopedics, Inc., K984541, cleared January 14, 1999. Zimmer Trabecular MetalTM Rever… | 1999 |
| * | K052906 | Zimmer Trabecular Metal Reverse Shoulder SystemSummary page 1…1999. Zimmer Trabecular MetalTM Reverse Shoulder System, manufactured by Zimmer, Inc., K052906, cleared December 19, 2005. Anatomical Shoulder, manufactur… | 2005 |
| * | K030259 | Amatomical Shoulder with Removable HeadSummary page 1…ecember 19, 2005. Anatomical Shoulder, manufactured Zimmer GmbH (Formerly Centerpulse Orthopedics), K030259, cleared April 24, 2003. Device Description: The Anatomical Shoulder Fracture… | 2003 |
What descends from it? (10)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142403 | Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder… | 2014 | 5 |
| K160085 | Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder… | 2016 | 3 |
| K103404 | ANA0TOMICAL Shoulder TM Combined System | 2011 | 3 |
| K170711 | ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System | 2017 | 2 |
| K092900 | Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture Stem | 2010 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 4, 2012 | Class II | Z-0224-2013 | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product… |
| Sep 4, 2012 | Class II | Z-0227-2013 | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product… |
| Sep 4, 2012 | Class II | Z-0233-2013 | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 9 of the 39 ancestors have a recall of any class.
- Of its descendants, K142403 (Zimmer GmbH, 2014) has gone furthest, with 5 descendants of its own.
- 11 other devices also cite its predicate K060209.
How does its category compare?
All KWS devicesKWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWS
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWS
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWS
2,281in 2025
MAUDE reports naming product code KWS, 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 | 2 | — | 21 | 158 |
| 2008 | 4 | 37 | 29 | 238 |
| 2009 | 4 | 108 | 0 | 294 |
| 2010 | 7 | 33 | 10 | 393 |
| 2011 | 11 | 90 | 11 | 486 |
| 2012 | 7 | 86 | 10 | 542 |
| 2013 | 12 | 120 | 0 | 818 |
| 2014 | 7 | 89 | 1 | 1,066 |
| 2015 | 8 | 129 | 0 | 1,170 |
| 2016 | 10 | 114 | 1 | 970 |
| 2017 | 7 | 120 | 4 | 1,681 |
| 2018 | 4 | 152 | 1 | 1,545 |
| 2019 | 9 | 106 | 2 | 1,728 |
| 2020 | 3 | 98 | 5 | 1,567 |
| 2021 | 5 | 151 | 0 | 1,358 |
| 2022 | 5 | 158 | 0 | 1,268 |
| 2023 | 4 | 250 | 2 | 1,750 |
| 2024 | 2 | — | 0 | 2,122 |
| 2025 | 3 | 97 | 0 | 2,281 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Anatomical ShoulderTM 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; *…
Read the full statement (132 words)
The Anatomical ShoulderTM 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 fragments of the proximal humerus;
* Posttraumatic necrosis of the humeral head;
* Posttraumatic arthrosis after humeral head fracture.
The Anatomical Shoulder Fracture stem is intended for cemented or cementless use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062029 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062029: Anatomical Shoulder Fracture System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062029
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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