510(k) Report

510(k) · Cleared

Recalled · Class II · 2012

ANA0TOMICAL Shoulder TM Combined System

K103404510(k) TraditionalCleared Mar 15, 2011116-day reviewClass II21 CFR 888.3650Recalls 1

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

Zimmer GmbH · KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Cleared on Mar 15, 2011 as substantially equivalent to K030259 (Centerplus Orthopedics, Inc., 2003) and 3 other predicates after a 116-day review. Its family tree reaches back 8 generations to 1991. 3 later devices descend from it. It has been recalled once.

Decided
Mar 15, 2011
Review
116 days
Class
Class II
Product code
KWT
Recalls
1
Predicates
4

Its longest line of descent runs back 8 generations to K911686 (1991). 41 ancestors in all, the oldest K790987 (1979). 3 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 2 other ancestors2002: 1 other ancestor1998: 2 other ancestors2006: 1 other ancestor2001: 2 other ancestors1999: 3 other ancestors1996: 4 other ancestors1995: 2 other ancestors1993: 1 other ancestor1992: 1 other ancestor1989: 1 other ancestor1987: 2 other ancestors1986: 1 other ancestor1979: 1 other ancestor2005: 1 other ancestor2004: 3 other ancestors2000: 3 other ancestors1980: 2 other ancestors2017: 1 descendant cleared2020: 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) K052906 · Zimmer Trabecular Metal Reverse Shoulder System · Zimmer, Inc. · 2005 · recalledK062029 · Anatomical Shoulder Fracture System · Zimmer GmbH · 2006 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 15 other ancestors3 generations back: 8 other ancestors4 generations back: 4 other ancestors5 generations back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant K062029 · Anatomical Shoulder Fracture System · Zimmer GmbH · 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. · 1991−50
  1. Root · 8 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 7 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
  3. 6 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
  4. 5 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
  5. 4 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  6. 3 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  7. 2 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
  8. 1 generation backK062029 Anatomical Shoulder Fracture SystemZimmer GmbH · 2006 · Recalled
  9. This deviceK103404 ANA0TOMICAL Shoulder TM Combined SystemZimmer GmbH · 2011
  10. Descendant · cites it directly · 2 of its ownK170711 ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical…Zimmer GmbH · 2017
  11. Descendant · 2 generations on · 1 of its ownK193099 Anatomical Shoulder SystemZimmer GmbH · 2020
  12. Descendant · 3 generations on · 0 of its ownK260556 Veritas Shoulder SystemRestor3D · 2026

Most influential descendants

Showing 3 of 3 · See all
  • K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemZimmer GmbH · 2017 · cites it directly2descendants
  • K193099Anatomical Shoulder SystemZimmer GmbH · 2020 · 2 generations on1descendant
  • K260556Veritas Shoulder SystemRestor3D · 2026 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K911686Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc.1991—
−7K984541Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc.1999—
−6K992065Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage…DePuy Orthopaedics, Inc.1999—
−5K021478Delta ShoulderDepuy, Inc.2003—
−4K030941Aequalis Reversed Shoulder ProsthesisTornier2004—
−3K041873Aequalis Reversed Shoulder ProsthesisTornier2004—
−2K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.200512
−1K062029Anatomical Shoulder Fracture SystemZimmer GmbH20063
0 (this device)K103404ANA0TOMICAL Shoulder TM Combined SystemZimmer GmbH2011—
+1K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder…Zimmer GmbH2017—
+2K193099Anatomical Shoulder SystemZimmer GmbH2020—
+3K260556Veritas Shoulder SystemRestor3D2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198020
198610
198720
198910
199210
199310
199520
199640
199820
199930
200030
200120
200210
200320
200430
200510
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
202010
202610
FIG. 1 — Lineage of K103404, 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.

Planning a device in KWT? 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 KWT device

  1. #1 K231657 AGILON® XO Shoulder Replacement Systemscore 17.7 · 17 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K030259Amatomical Shoulder with Removable Head
Summary page 1
…cemented prosthesis. Predicate Device: Anatomical Shoulder with Removable Head, manufactured by Zimmer GmbH, K030259, cleared 04/24/2003 Anatomical Shoulder Fracture Sy…
Centerplus Orthopedics, Inc.20033
*K062029Anatomical Shoulder Fracture System
Summary page 1
…04/24/2003 Anatomical Shoulder Fracture System, manufactured by Zimmer Gm-bH, K062029, cleared October 31, 2006) Bigliani/Flatow®The Comp…
Zimmer GmbH20063
*K982981New Zimmer Shoulder SystemZimmer, Inc.19981
*K022377The Trabecular Metal Glenoid-Bigliani/Flatow the Complete Shoulder Solution, Model 4306
Summary page 1
…, Inc., K98298l1, cleared 12/17/1998; Trabecular Metal Glenoid, manufactured by Zimmer TMT, K022377, cleared 12/10/2002…
Implex Corp.20028

Also cleared against K030259: 8 other devices →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemZimmer GmbH20172

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 12, 2012Class IIZ-1895-2012Mixed-up of materials/componentsBigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm. Catalog number 47-4301-031-00 was actually packaged and labeled as catalog number 47-4307-031-00, lot 62071190.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
  • 11 of the 41 ancestors have a recall of any class.
  • Of its descendants, K170711 (Zimmer GmbH, 2017) has gone furthest, with 2 descendants of its own.
  • 8 other devices also cite its predicate K030259.

How does its category compare?

All KWT devices

KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · KWT

4in 2025

2007: 12010: 12011: 52012: 12013: 12014: 12015: 22016: 22017: 12018: 22019: 42020: 12021: 12022: 12023: 12024: 12025: 42026 (partial year): 1
2007high 5 (2011) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWT

242in 2025

2011: 165 days median2019: 91 days median2025: 242 days median
2007high 242 (2025) · low 91 (2019)2026

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

Recalls per year · KWT

1in 2023

2008: 12010: 72012: 22013: 12016: 12017: 12018: 12019: 32023: 1
2007high 7 (2010) · low 0 (2007)2026

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

Adverse event reports per year · KWT

749in 2025

2007: 322008: 482009: 582010: 712011: 1122012: 832013: 1132014: 1682015: 1762016: 4452017: 5602018: 4802019: 4192020: 2152021: 2282022: 2732023: 3612024: 6012025: 749
2007high 749 (2025) · low 32 (2007)2025

MAUDE reports naming product code KWT, 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
20071—032
20080—148
20090—058
20101—771
201151650112
20121—283
20131—1113
20141—0168
20152—0176
20162—1445
20171—1560
20182—1480
20194913419
20201—0215
20211—0228
20221—0273
20231—1361
20241—0601
202542420749
20261—0—

What is it indicated for?

Advanced destruction of the shoulder joint resulting from: * Omarthrosis. * Rheumatoid arthritis * Post-traumatic arthritis * Avascular necrosis of the humeral head * Cuff-tear arthropathy (BF 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…

Read the full statement (163 words)

Advanced destruction of the shoulder joint resulting from:

* Omarthrosis.

* Rheumatoid arthritis

* Post-traumatic arthritis

* Avascular necrosis of the humeral head

* Cuff-tear arthropathy (BF 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 K030259

8 other devices cite the same predicate.

  • K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemZimmer GmbH · 2017
  • K160085Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture SystemZimmer GmbH · 2016
  • K142403Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture SystemZimmer GmbH · 20141 recall
  • K101263Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR Shoulder System - Finned Humeral Bodies,Lima-Lto S.P.A. · 2011
  • K100858Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral Bodies,Lima-Lto S.P.A. · 20102 recalls
  • K062029Anatomical Shoulder Fracture SystemZimmer GmbH · 20063 recalls

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 KWT

The KWT category page

  • K262173N22 Offset Humeral HeadShoulder Innovations, Inc. · 2026
  • K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc. · 2025
  • K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc. · 20251 recall
  • K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH · 2025
  • K241817InSet Total Shoulder SystemShoulder Innovations, Inc. · 2025

https://510kreport.com/device/K103404 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103404: ANA0TOMICAL Shoulder TM 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/K103404

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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