510(k) Report

510(k) · Cleared

Cleared

Biomodular Shoulder Humeral Head W/ Ionguard

K915596510(k) TraditionalCleared Mar 11, 199289-day reviewClass II21 CFR 888.3650

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

Biomet, Inc. · KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Cleared on Mar 11, 1992 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 255 devices in its family, counting itself, has a Class I recall. 254 later devices descend from it.

Decided
Mar 11, 1992
Review
89 days
Class
Class II
Product code
KWT
Recalls
None
Predicates
0

254 later devices descend from it, 2 citing it directly. 1 of the 255 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2014: 9 descendants cleared2003: 2 descendants cleared2013: 9 descendants cleared2017: 13 descendants cleared2007: 4 descendants cleared2019: 18 descendants cleared2011: 9 descendants cleared2005: 3 descendants cleared2004: 1 descendant cleared2006: 4 descendants cleared2015: 6 descendants cleared2012: 12 descendants cleared2008: 2 descendants cleared, 1 with a Class I recall12020: 18 descendants cleared2021: 24 descendants cleared2018: 15 descendants cleared2022: 20 descendants cleared2025: 19 descendants cleared2010: 5 descendants cleared2009: 1 descendant cleared2016: 10 descendants cleared2023: 17 descendants cleared2024: 14 descendants cleared2026: 19 descendants cleared1990200020102020
  1. This deviceK915596 Biomodular Shoulder Humeral Head W/ IonguardBiomet, Inc. · 1992
  2. Descendant · cites it directly · 253 of its ownK030710 Bio-Modular Shoulder SystemBiomet, Inc. · 2003 · Recalled
  3. Descendant · 2 generations on · 176 of its ownK043100 Bio-Modular Shoulder System with Hydroxyapatite (HA) Coated Glenoid…Biomet, Inc. · 2005 · Recalled
  4. Descendant · 2 generations on · 175 of its ownK072804 Comprehensive RS Shoulder SystemBiomet Manufacturing Corp · 2007
  5. Descendant · 3 generations on · 172 of its ownK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
  6. Descendant · 2 generations on · 138 of its ownK060692 Comprehensive Primary Shoulder StemsBiomet Manufacturing Corp · 2006 · Recalled

Showing 5 of 254 descendants. See all descendants

Descendants cleared per year

2003: 22004: 12005: 32006: 42007: 42008: 22009: 12010: 52011: 92012: 122013: 92014: 92015: 62016: 102017: 132018: 152019: 182020: 182021: 242022: 202023: 172024: 142025: 192026: 19
2003high 24 (2021) · low 1 (2004)2026

Class I recalls in this family

  • K080642 Comprehensive Reverse Shoulder3 generations on · 2008

Most influential descendants

Showing 5 of 254 · See all
  • K030710Bio-Modular Shoulder SystemBiomet, Inc. · 2003 · cites it directly253descendants
  • K043100Bio-Modular Shoulder System with Hydroxyapatite (HA) Coated Glenoid ComponentsBiomet, Inc. · 2005 · 2 generations on176descendants
  • K072804Comprehensive RS Shoulder SystemBiomet Manufacturing Corp · 2007 · 2 generations on175descendants
  • K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · 3 generations on172descendants
  • K060692Comprehensive Primary Shoulder StemsBiomet Manufacturing Corp · 2006 · 2 generations on138descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K915596Biomodular Shoulder Humeral Head W/ IonguardBiomet, Inc.1992—
+1K030710Bio-Modular Shoulder SystemBiomet, Inc.20031
+2K043100Bio-Modular Shoulder System with Hydroxyapatite (HA) Coated Glenoid ComponentsBiomet, Inc.20051
+2K072804Comprehensive RS Shoulder SystemBiomet Manufacturing Corp2007—
+3K080642Comprehensive Reverse ShoulderBiomet, Inc.2008Class I
+2K060692Comprehensive Primary Shoulder StemsBiomet Manufacturing Corp20066

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200320
200410
200530
200640
200740
200821
200910
201050
201190
2012120
201390
201490
201560
2016100
2017130
2018150
2019180
2020180
2021240
2022200
2023170
2024140
2025190
2026190
FIG. 1 — Lineage of K915596, 1992–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (254)

See all 254

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

NumberDeviceApplicantDecidedDescendants
K030710Bio-Modular Shoulder SystemBiomet, Inc.2003253
K140390Titanium Versa-Dial Humeral Head ProsthesisBiomet Manufacturing Corp20141

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K030710 (Biomet, Inc., 2003) has gone furthest, with 253 descendants of its own.

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.

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—

More from Biomet, Inc.

449 FDA decisions under this applicant name. See the company

  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K251270Taperloc® Complete Hip StemBiomet, Inc. · 2026
  • K241014Biomet Kirschner Wires (K-Wires)Biomet, Inc. · 2024
  • K222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc. · 2022
  • K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc. · 2022

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/K915596 · printed Nov 6, 2026

Cite this page

510(k) Report. “K915596: Biomodular Shoulder Humeral Head W/ Ionguard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K915596

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026