510(k) Report

510(k) · Cleared

Cleared

Kirschner (R) Modular II-C (TM) Total Shoulder System

K940537510(k) TraditionalCleared Aug 29, 1995568-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

Kirschner Medical Corp. · KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Cleared on Aug 29, 1995 after a 568-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 282 devices in its family, counting itself, has a Class I recall. 281 later devices descend from it.

Decided
Aug 29, 1995
Review
568 days
Class
Class II
Product code
KWT
Recalls
None
Predicates
0

281 later devices descend from it, 3 citing it directly. 1 of the 282 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1996: 1 descendant cleared1998: 1 descendant cleared1997: 1 descendant cleared2006: 4 descendants cleared2002: 1 descendant cleared2000: 1 descendant cleared2003: 1 descendant cleared2004: 3 descendants cleared2011: 15 descendants cleared2017: 16 descendants cleared2010: 6 descendants cleared2014: 14 descendants cleared2005: 2 descendants cleared2013: 16 descendants cleared2019: 17 descendants cleared2020: 21 descendants cleared2021: 24 descendants cleared2018: 14 descendants cleared2022: 20 descendants cleared2025: 18 descendants cleared2012: 12 descendants cleared2026: 19 descendants cleared2024: 14 descendants cleared2007: 2 descendants cleared2008: 3 descendants cleared, 1 with a Class I recall12016: 10 descendants cleared2015: 8 descendants cleared2023: 17 descendants cleared1995200020052010201520202025
  1. This deviceK940537 Kirschner (R) Modular II-C (TM) Total Shoulder SystemKirschner Medical Corp. · 1995
  2. Descendant · cites it directly · 235 of its ownK982981 New Zimmer Shoulder SystemZimmer, Inc. · 1998 · Recalled
  3. Descendant · 2 generations on · 218 of its ownK041549 Zimmer Trabecular Metal Humeral StemZimmer, Inc. · 2004 · Recalled
  4. Descendant · 3 generations on · 216 of its ownK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
  5. Descendant · 4 generations on · 207 of its ownK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
  6. Descendant · 4 generations on · 190 of its ownK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled

Showing 5 of 281 descendants. See all descendants

Descendants cleared per year

1996: 11997: 11998: 12000: 12002: 12003: 12004: 32005: 22006: 42007: 22008: 32010: 62011: 152012: 122013: 162014: 142015: 82016: 102017: 162018: 142019: 172020: 212021: 242022: 202023: 172024: 142025: 182026: 19
1996high 24 (2021) · low 0 (1999)2026

Class I recalls in this family

  • K080642 Comprehensive Reverse Shoulder4 generations on · 2008

Most influential descendants

Showing 5 of 281 · See all
  • K982981New Zimmer Shoulder SystemZimmer, Inc. · 1998 · cites it directly235descendants
  • K041549Zimmer Trabecular Metal Humeral StemZimmer, Inc. · 2004 · 2 generations on218descendants
  • K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · 3 generations on216descendants
  • K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · 4 generations on207descendants
  • K063569Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · 4 generations on190descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K940537Kirschner (R) Modular II-C (TM) Total Shoulder SystemKirschner Medical Corp.1995—
+1K982981New Zimmer Shoulder SystemZimmer, Inc.19981
+2K041549Zimmer Trabecular Metal Humeral StemZimmer, Inc.20048
+3K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.200512
+4K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc.200610
+4K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200713

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199710
199810
200010
200210
200310
200430
200520
200640
200720
200831
201060
2011150
2012120
2013160
2014140
201580
2016100
2017160
2018140
2019170
2020210
2021240
2022200
2023170
2024140
2025180
2026190
FIG. 1 — Lineage of K940537, 1995–2026Source: 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), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (281)

See all 281

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

NumberDeviceApplicantDecidedDescendants
K982981New Zimmer Shoulder SystemZimmer, Inc.1998235
K961260Kirschner Sholders with Titanium Plasma SprayBiomet, Inc.1997176
K961571Cocr BI-Angular Humeral ComponentBiomet, Inc.1996147

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 · 4 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K982981 (Zimmer, Inc., 1998) has gone furthest, with 235 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 Kirschner Medical Corp.

76 FDA decisions under this applicant name. See the company

  • K936274Kirschner Performance Posterior Stabilized Total Knee SystemKirschner Medical Corp. · 1995
  • K942891Summit Total Hip SystemKirschner Medical Corp. · 1994
  • K941486Integrity Total Hip System, Non-PorousKirschner Medical Corp. · 1994
  • K933843Line Extension for Kirschner Performance Total Knee System, Porous CoatedKirschner Medical Corp. · 1994
  • K935951Kirschner C-2 Osteocap Total Hip SystemKirschner Medical Corp. · 1994

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/K940537 · printed Nov 6, 2026

Cite this page

510(k) Report. “K940537: Kirschner (R) Modular II-C (TM) 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/K940537

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
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026