510(k) Report

510(k) · Cleared

Cleared

Total Shoulder System

K110905510(k) SpecialCleared May 24, 201154-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

Shoulder Innovations, LLC · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Cleared on May 24, 2011 as substantially equivalent to K102670 (Shoulder Innovations, LLC, 2011) and 1 other predicate after a 54-day review. Its family tree reaches back 4 generations to 1994.

Decided
May 24, 2011
Review
54 days
Class
Class II
Product code
KWS
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K943462 (1994). 22 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2011: 1 other ancestor1998: 2 other ancestors1991: 1 other ancestor1997: 1 other ancestor1996: 5 other ancestors1995: 2 other ancestors1993: 1 other ancestor1992: 1 other ancestor1989: 1 other ancestor1987: 1 other ancestor1986: 1 other ancestor1979: 1 other ancestorK943462 · Darwin Knee System · Johnson & Johnson Professionals, Inc. · 1994 · recalled×2: 2 generations cleared close together, K033272 (2004), K040166 (2004) K052472 · Depuy Global Shoulder Crosslink Glenoid · DePuy Orthopaedics, Inc. · 20051980199020002010
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 3 other ancestors3 generations back: 14 other ancestors K052472 · Depuy Global Shoulder Crosslink Glenoid · DePuy Orthopaedics, Inc. · 2005K040166 · Depuy Sigma XLK Tibial Inserts · DePuy Orthopaedics, Inc. · 2004K033272 · Depuy Sigma Tibial Inserts · DePuy Orthopaedics, Inc. · 2004 · recalledK943462 · Darwin Knee System · Johnson & Johnson Professionals, Inc. · 1994 · recalled0
  1. Root · 4 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
  2. 3 generations backK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
  3. 2 generations backK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
  4. 1 generation backK052472 Depuy Global Shoulder Crosslink GlenoidDePuy Orthopaedics, Inc. · 2005
  5. This deviceK110905 Total Shoulder SystemShoulder Innovations, LLC · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K943462Darwin Knee SystemJohnson & Johnson Professionals, Inc.19948
−3K033272Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc.200451
−2K040166Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc.2004—
−1K052472Depuy Global Shoulder Crosslink GlenoidDePuy Orthopaedics, Inc.2005—
0 (this device)K110905Total Shoulder SystemShoulder Innovations, LLC2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198610
198710
198910
199110
199210
199310
199520
199650
199710
199820
201110
FIG. 1 — Lineage of K110905, 1994–2011Source: 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 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. #1 K220847 AETOS Shoulder Systemscore 21.1 · 16 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? (2)

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
*K102670Total Shoulder System
Summary page 1
…(hemi-shoulder) metallic uncemented prosthesis. Product Code: HSID Substantially Equivalent Device: K102670: Shoulder Innovation Total Shoulder System K052472: DePuy Global Shoulder Glenoid 4) Shoulder k…
Shoulder Innovations, LLC2011—
*K052472Depuy Global Shoulder Crosslink Glenoid
Summary page 1
…d prosthesis. Product Code: HSID Substantially Equivalent Device: K102670: Shoulder Innovation Total Shoulder System K052472: DePuy Global Shoulder Glenoid 4) Shoulder k-, Innovations Toa hudrSs,0rPage…
DePuy Orthopaedics, Inc.2005—

Also cleared against K102670: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 17 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
  • 7 of the 22 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K102670.

How does its category compare?

All KWS devices

KWS Prosthesis, Shoulder, Semi-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 · KWS

3in 2025

2007: 22008: 42009: 42010: 72011: 112012: 72013: 122014: 72015: 82016: 102017: 72018: 42019: 92020: 32021: 52022: 52023: 42024: 22025: 32026 (partial year): 2
2007high 12 (2013) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWS

97in 2025

2008: 37 days median2009: 108 days median2010: 33 days median2011: 90 days median2012: 86 days median2013: 120 days median2014: 89 days median2015: 129 days median2016: 114 days median2017: 120 days median2018: 152 days median2019: 106 days median2020: 98 days median2021: 151 days median2022: 158 days median2023: 250 days median2025: 97 days median
2007high 250 (2023) · low 33 (2010)2026

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

Recalls per year · KWS

2in 2023

2007: 212008: 292010: 102011: 112012: 102014: 12016: 12017: 42018: 12019: 22020: 52023: 22026 (partial year): 1
2007high 29 (2008) · low 0 (2009)2026

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

Adverse event reports per year · KWS

2,281in 2025

2007: 1582008: 2382009: 2942010: 3932011: 4862012: 5422013: 8182014: 1,0662015: 1,1702016: 9702017: 1,6812018: 1,5452019: 1,7282020: 1,5672021: 1,3582022: 1,2682023: 1,7502024: 2,1222025: 2,281
2007high 2,281 (2025) · low 158 (2007)2025

MAUDE reports naming product code KWS, 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
20072—21158
200843729238
200941080294
201073310393
2011119011486
201278610542
2013121200818
201478911,066
2015812901,170
2016101141970
2017712041,681
2018415211,545
2019910621,728
202039851,567
2021515101,358
2022515801,268
2023425021,750
20242—02,122
202539702,281
20262—1—

What is it indicated for?

The Shoulder Innovations Total Shoulder System is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following: 1. significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; 2. united humeral head fractures of long duration; 3. irreducible 3- and 4-part proximal humeral fractures; 4. avascular necrosis of the humeral head. The assembled humeral component may be used…

Read the full statement (111 words)

The Shoulder Innovations Total Shoulder System is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following:

1. significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;

2. united humeral head fractures of long duration;

3. irreducible 3- and 4-part proximal humeral fractures;

4. avascular necrosis of the humeral head.

The assembled humeral component may be used alone for hemniarthroplasty or combined with the glenoid component for total shoulder arthroplasty.

The Total Shoulder System components are intended for single use only. The glenoid component is intended for cemented fixation only; the humneral stem may be implanted by press-fit or cement fixation.

Indications for use as stated in the FDA summary.

Also cleared against K102670

2 other devices cite the same predicate.

  • K260721Tornier Perform Advanced GlenoidTornier, Inc. · 2026
  • K111596Total Shoulder SystemShoulder Innovations, LLC · 2011

More from Shoulder Innovations, LLC

3 FDA decisions under this applicant name. See the company

  • K111596Total Shoulder SystemShoulder Innovations, LLC · 2011
  • K102670Total Shoulder SystemShoulder Innovations, LLC · 2011

Recent decisions in KWS

The KWS category page

  • K260721Tornier Perform Advanced GlenoidTornier, Inc. · 2026
  • K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026
  • K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc. · 2025
  • K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc. · 2025
  • K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A. · 2025

https://510kreport.com/device/K110905 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110905: Total Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110905

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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