510(k) Report

510(k) · Cleared

Cleared

Select Shoulder Concentric Humeral Head Components

K962224510(k) TraditionalCleared Aug 28, 199679-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

Intermedics Orthopedics · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Cleared on Aug 28, 1996 after a 79-day review. The FDA summary names its predicate without a number. 77 later devices descend from it.

Decided
Aug 28, 1996
Review
79 days
Class
Class II
Product code
KWS
Recalls
None
Predicates
0

77 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2000: 1 descendant cleared2011: 4 descendants cleared2013: 5 descendants cleared2010: 1 descendant cleared2021: 8 descendants cleared2016: 2 descendants cleared2012: 1 descendant cleared2019: 5 descendants cleared2015: 2 descendants cleared2026: 7 descendants cleared2014: 2 descendants cleared2018: 1 descendant cleared2017: 4 descendants cleared2020: 6 descendants cleared2023: 10 descendants cleared2024: 5 descendants cleared2022: 7 descendants cleared2025: 6 descendants cleared1995200020052010201520202025
  1. This deviceK962224 Select Shoulder Concentric Humeral Head ComponentsIntermedics Orthopedics · 1996
  2. Descendant · cites it directly · 76 of its ownK992525 Acumed Modular Shoulder SystemAcu Med, Inc. · 2000 · Recalled
  3. Descendant · 2 generations on · 38 of its ownK101263 Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR…Lima-Lto S.P.A. · 2011
  4. Descendant · 2 generations on · 37 of its ownK100858 Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder…Lima-Lto S.P.A. · 2010 · Recalled
  5. Descendant · 2 generations on · 34 of its ownK111097 Humelock Cemented Shoulder ProsthesisFx Solutions · 2011 · Recalled
  6. Descendant · 3 generations on · 34 of its ownK110847 SMR Shoulder System - Cta Humeral HeadsLima Corporate S.P.A. · 2011

Showing 5 of 77 descendants. See all descendants

Descendants cleared per year

2000: 12010: 12011: 42012: 12013: 52014: 22015: 22016: 22017: 42018: 12019: 52020: 62021: 82022: 72023: 102024: 52025: 62026: 7
2000high 10 (2023) · low 0 (2001)2026

Most influential descendants

Showing 5 of 77 · See all
  • K992525Acumed Modular Shoulder SystemAcu Med, Inc. · 2000 · cites it directly76descendants
  • K101263Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR Shoulder System -…Lima-Lto S.P.A. · 2011 · 2 generations on38descendants
  • K100858Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral…Lima-Lto S.P.A. · 2010 · 2 generations on37descendants
  • K111097Humelock Cemented Shoulder ProsthesisFx Solutions · 2011 · 2 generations on34descendants
  • K110847SMR Shoulder System - Cta Humeral HeadsLima Corporate S.P.A. · 2011 · 3 generations on34descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K962224Select Shoulder Concentric Humeral Head ComponentsIntermedics Orthopedics1996—
+1K992525Acumed Modular Shoulder SystemAcu Med, Inc.20001
+2K101263Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR Shoulder…Lima-Lto S.P.A.2011—
+2K100858Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System -…Lima-Lto S.P.A.20102
+2K111097Humelock Cemented Shoulder ProsthesisFx Solutions20112
+3K110847SMR Shoulder System - Cta Humeral HeadsLima Corporate S.P.A.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
201010
201140
201210
201350
201420
201520
201620
201740
201810
201950
202060
202180
202270
2023100
202450
202560
202670
FIG. 1 — Lineage of K962224, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (6)

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
*—Depuy Global Total Shoulder System
Named without a submission number
—
*—Biomet Bio-Modular Total Shoulder
Named without a submission number
—
*—Zimmer Fenlin Total Shoulder
Named without a submission number
—
*—Kirschner/Biomet Modular Shoulder System
Named without a submission number
—
*—3M/Orthomet Modular Neer II Shoulder System
Named without a submission number
—
*—Encore Foundation Shoulder System
Named without a submission number
—

What descends from it? (77)

See all 77

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

NumberDeviceApplicantDecidedDescendants
K992525Acumed Modular Shoulder SystemAcu Med, Inc.200076

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?

  • Of its descendants, K992525 (Acu Med, Inc., 2000) has gone furthest, with 76 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.

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—

More from Intermedics Orthopedics

108 FDA decisions under this applicant name. See the company

  • K970300Natural-Hip System Porous Stem with HA/CstiIntermedics Orthopedics · 1997
  • K970498Natural-Knee II Revision Femoral Spacer LugsIntermedics Orthopedics · 1997
  • K970166Natural-Hip System Cocr Revision StemIntermedics Orthopedics · 1997
  • K970567Select Shoulder Curved-Back Pegged All Poly GlenoidsIntermedics Orthopedics · 1997
  • K964357Natural-Hip System Cocr StemIntermedics Orthopedics · 1997

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/K962224 · printed Nov 6, 2026

Cite this page

510(k) Report. “K962224: Select Shoulder Concentric Humeral Head Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962224

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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