510(k) Report

510(k) · Cleared

Recalled · 2010

Encore Shoulder Primary Humeral Stem, Model 500-00, Encore Shoulder Humeral Head, Model 520-38

K080402510(k) TraditionalCleared Mar 28, 200843-day reviewClass II21 CFR 888.3660Recalls 4

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

Encore Medical L.P. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Cleared on Mar 28, 2008 after a 43-day review. The FDA summary names its predicate without a number. 78 later devices descend from it. It has been recalled 4 times.

Decided
Mar 28, 2008
Review
43 days
Class
Class II
Product code
KWS
Recalls
4
Predicates
0

78 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2013: 2 descendants cleared2011: 1 descendant cleared2014: 2 descendants cleared2016: 4 descendants cleared2020: 4 descendants cleared2017: 5 descendants cleared2015: 1 descendant cleared2021: 9 descendants cleared2019: 3 descendants cleared2022: 10 descendants cleared2025: 10 descendants cleared2024: 8 descendants cleared2023: 7 descendants cleared2026: 12 descendants cleared20052010201520202025
  1. This deviceK080402 Encore Shoulder Primary Humeral Stem, Model 500-00, Encore Shoulder…Encore Medical L.P. · 2008
  2. Descendant · cites it directly · 40 of its ownK111629 Turon RSP Socket Shell-Neutral Model 508-02-000, Turon RSP Socket…Encore Medical L.P. · 2011
  3. Descendant · cites it directly · 35 of its ownK131559 Match Point System (TM), Surgicase Connect, Match Point System (TM)…Materialise NV · 2013
  4. Descendant · cites it directly · 35 of its ownK123982 Turon Glenoid Pegged, E+, Turon Keeled Glenoid, E+Encore Medical L.P. · 2013
  5. Descendant · cites it directly · 34 of its ownK162024 AltiVate Anatomic Shoulder SystemEncore Medical L.P. · 2016 · Recalled
  6. Descendant · 2 generations on · 31 of its ownK143374 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015

Showing 5 of 78 descendants. See all descendants

Descendants cleared per year

2011: 12013: 22014: 22015: 12016: 42017: 52019: 32020: 42021: 92022: 102023: 72024: 82025: 102026: 12
2011high 12 (2026) · low 0 (2012)2026

Most influential descendants

Showing 5 of 78 · See all
  • K111629Turon RSP Socket Shell-Neutral Model 508-02-000, Turon RSP Socket Shell-Offset Model…Encore Medical L.P. · 2011 · cites it directly40descendants
  • K131559Match Point System (TM), Surgicase Connect, Match Point System (TM) GuidesMaterialise NV · 2013 · cites it directly35descendants
  • K123982Turon Glenoid Pegged, E+, Turon Keeled Glenoid, E+Encore Medical L.P. · 2013 · cites it directly35descendants
  • K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P. · 2016 · cites it directly34descendants
  • K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015 · 2 generations on31descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K080402Encore Shoulder Primary Humeral Stem, Model 500-00, Encore Shoulder Humeral…Encore Medical L.P.2008—
+1K111629Turon RSP Socket Shell-Neutral Model 508-02-000, Turon RSP Socket Shell-Offset…Encore Medical L.P.2011—
+1K131559Match Point System (TM), Surgicase Connect, Match Point System (TM) GuidesMaterialise NV2013—
+1K123982Turon Glenoid Pegged, E+, Turon Keeled Glenoid, E+Encore Medical L.P.2013—
+1K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.20166
+2K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201320
201420
201510
201640
201750
201930
202040
202190
2022100
202370
202480
2025100
2026120
FIG. 1 — Lineage of K080402, 2008–2026Source: 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 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
*—Bio-Modular Choice Shoulder System
Named without a submission number
—
*—Global Advantage
Named without a submission number
—

What descends from it? (78)

See all 78

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K111629Turon RSP Socket Shell-Neutral Model 508-02-000, Turon RSP Socket Shell-Offset Model…Encore Medical L.P.201140
K131559Match Point System (TM), Surgicase Connect, Match Point System (TM) GuidesMaterialise NV201335
K123982Turon Glenoid Pegged, E+, Turon Keeled Glenoid, E+Encore Medical L.P.201335
K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.201634
K141990Encore Humeral Shoulder StemEncore Medical L.P.201419
K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202
K130550RSP Modular Glenoid Baseplate, Glenoid Taper Adapter, Retaining ScrewEncore Medical L.P.20140

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 5, 2010Not classifiedZ-0799-2011Device DesignComplaints of fracturing were reported for affected trial products.
Nov 5, 2010Not classifiedZ-0800-2011Device DesignComplaints of fracturing were reported for affected trial products.
Nov 5, 2010Not classifiedZ-0801-2011Device DesignComplaints of fracturing were reported for affected trial products.
Nov 5, 2010Not classifiedZ-0798-2011Device DesignComplaints of fracturing were reported for trial products.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K111629 (Encore Medical L.P., 2011) has gone furthest, with 40 descendants of its own.

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. 2008, 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?

Joint replacement is indicated for patients suffering from disability due to:

* noninflammatory degenerative joint disease including osteoarthritis and avascular

necrosis of the natural humeral head and/or glenoid;

* rheumatoid arthritis;

correction of functional deformity;

humeral fracture.

This device may also be indicated in the salvage of previously failed surgical attempts. The

glenoid components are indicated for cemented use only.

Indications for use as stated in the FDA summary.

More from Encore Medical L.P.

82 FDA decisions under this applicant name. See the company

  • K263086AltiVate Reverse® Glenosphere with RAVN™ TechnologyEncore Medical L.P. · 2026
  • K252567AltiVate Reverse® ADLC GlenosphereEncore Medical L.P. · 2026
  • K252974EMPOWR KneeEncore Medical L.P. · 2025
  • K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P. · 2025
  • K252141AltiVate Reverse® GlenoidEncore Medical L.P. · 2025

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/K080402 · printed Nov 3, 2026

Cite this page

510(k) Report. “K080402: Encore Shoulder Primary Humeral Stem, Model 500-00, Encore Shoulder Humeral Head, Model 520-38.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080402

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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