510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

Comprehensive Segmental Revision System (SRS)

K111746510(k) TraditionalCleared Dec 15, 2011177-day reviewClass II21 CFR 888.3650Recalls 1

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 Dec 15, 2011 as substantially equivalent to K043505 (Biomet, Inc., 2005) and 7 other predicates after a 177-day review. Its family tree reaches back 6 generations to 1980. 7 later devices descend from it. It has been recalled once.

Decided
Dec 15, 2011
Review
177 days
Class
Class II
Product code
KWT
Recalls
1
Predicates
8

Its longest line of descent runs back 6 generations to K800494 (1980). 27 ancestors in all. 7 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 2 other ancestors2003: 1 other ancestor2002: 2 other ancestors1994: 2 other ancestors2001: 3 other ancestors2000: 1 other ancestor1999: 2 other ancestors1998: 2 other ancestors1992: 2 other ancestors1991: 1 other ancestor1987: 1 other ancestor1995: 1 other ancestor1980: 1 other ancestor2015: 1 descendant cleared2016: 1 descendant cleared2018: 1 descendant cleared2025: 2 descendants cleared2017: 1 descendant cleared2023: 1 descendant clearedK800494 · New Jersey Hemiarthroplasty Sholder Pros · Depuy, Inc. · 1980K991585 · Bipolar Shoulder Prosthesis · Biomet, Inc. · 1999K002998 · Biomet BI-Polar Shoulder System · Biomet, Inc. · 2000 · recalled×2: 2 generations cleared close together, K030710 (2003), K032895 (2003) K042321 · Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral Head · Biomet Manufacturing Corp · 200519801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 12 other ancestors3 generations back: 2 other ancestors4 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant K042321 · Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral Head · Biomet Manufacturing Corp · 2005K032895 · BI-Angular Shoulder System · Biomet, Inc. · 2003K030710 · Bio-Modular Shoulder System · Biomet, Inc. · 2003 · recalledK002998 · Biomet BI-Polar Shoulder System · Biomet, Inc. · 2000 · recalledK991585 · Bipolar Shoulder Prosthesis · Biomet, Inc. · 1999K800494 · New Jersey Hemiarthroplasty Sholder Pros · Depuy, Inc. · 1980−50
  1. Root · 6 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
  2. 5 generations backK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
  3. 4 generations backK002998 Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000 · Recalled
  4. 3 generations backK030710 Bio-Modular Shoulder SystemBiomet, Inc. · 2003 · Recalled
  5. 2 generations backK032895 BI-Angular Shoulder SystemBiomet, Inc. · 2003
  6. 1 generation backK042321 Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral HeadBiomet Manufacturing Corp · 2005
  7. This deviceK111746 Comprehensive Segmental Revision System (SRS)Biomet, Inc. · 2011
  8. Descendant · cites it directly · 5 of its ownK143659 Equinoxe Mega ProsthesisExactech, Inc. · 2015
  9. Descendant · cites it directly · 3 of its ownK153398 Comprehensive SRS/Nexel ElbowBiomet Manufacturing Corp · 2016
  10. Descendant · cites it directly · 2 of its ownK173411 Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp · 2018
  11. Descendant · 2 generations on · 1 of its ownK223631 Comprehensive Segmental Revision System (SRS)Biomet Orthopedics · 2023
  12. Descendant · 2 generations on · 1 of its ownK162903 Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small…Exactech, Inc. · 2017

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2015: 12016: 12017: 12018: 12023: 12025: 2
2015high 2 (2025) · low 0 (2019)2026

Most influential descendants

Showing 5 of 7 · See all
  • K143659Equinoxe Mega ProsthesisExactech, Inc. · 2015 · cites it directly5descendants
  • K153398Comprehensive SRS/Nexel ElbowBiomet Manufacturing Corp · 2016 · cites it directly3descendants
  • K173411Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp · 2018 · cites it directly2descendants
  • K223631Comprehensive Segmental Revision System (SRS)Biomet Orthopedics · 2023 · 2 generations on1descendant
  • K162903Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal BodiesExactech, Inc. · 2017 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K800494New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc.1980—
−5K991585Bipolar Shoulder ProsthesisBiomet, Inc.1999—
−4K002998Biomet BI-Polar Shoulder SystemBiomet, Inc.20001
−3K030710Bio-Modular Shoulder SystemBiomet, Inc.20031
−2K032895BI-Angular Shoulder SystemBiomet, Inc.2003—
−1K042321Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral HeadBiomet Manufacturing Corp2005—
0 (this device)K111746Comprehensive Segmental Revision System (SRS)Biomet, Inc.2011—
+1K143659Equinoxe Mega ProsthesisExactech, Inc.2015—
+1K153398Comprehensive SRS/Nexel ElbowBiomet Manufacturing Corp2016—
+1K173411Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp2018—
+2K223631Comprehensive Segmental Revision System (SRS)Biomet Orthopedics2023—
+2K162903Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal BodiesExactech, Inc.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198710
199110
199220
199420
199510
199820
199920
200010
200130
200220
200310
200520

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201610
201710
201810
202310
202520
FIG. 1 — Lineage of K111746, 1980–2025Source: 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 KWT? 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? (8)

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
*K043505Discovery-Mosaic Total Humerus System
Summary page 2
…Pr~oxinial Numeral, distal humeral K925613, K(020045, K(033280, \ . or totalkhumeral replacement K043505 Proximal Bodies Resection Levels - 42-71mm K(020045 _______________…
Biomet, Inc.2005—
*K042321Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral Head
Summary page 2
…Diameters - 40-54mm K(030710 ________________________Extended Articular Surace _ K042321, 1(30710 Distal Humeral Bodies Resection Height - 50, 60, 70mm 1(033280, K043505…
Biomet Manufacturing Corp2005—
*K033280Discovery Elbow-Mosaic Distal Humeral Replacement System
Summary page 1
…uvalece k04221-MoaictNon-Modular Proximal Body and EAS Offset /,.Modular Humera~Ha N - K033280 -Disco/very® Elbow - Mosaic® Proximal Humeral / ~,- N Replacement System…
Biomet, Inc.20031
*K0200453-Piece Proximal Humeral Replacement System
Summary page 2
…- Comprehensiv'Je SRS Predicate Materials/' ~ .T-GAI-4V K020045 / ' \ Co-Cr-Mo K020045 Prindipal of Operation…
Biomet Orthopedics, Inc.2002—
*K022079Short and Long Soft Tissue Attachment
Summary page 2
…- 30-120mm 1(020045 1(033280 1(043505 Tissue Attachment Augments K(022079 Humeral Heads Diameters - 40-54mm K(030710 _____________…
Biomet, Inc.2002—
*K925613Proximal Humeral Replacement System
Summary page 2
…\ Co-Cr-Mo K020045 Prindipal of Operation Pr~oxinial Numeral, distal humeral K925613, K(020045, K(033280, \ . or totalkhumeral replacement K043505 Pro…
Biomet, Inc.1994—
*K030710Bio-Modular Shoulder System
Summary page 1
…. k2 e13 - Proximal Humeral Replacement System 1< K K * K030710 - Bio-Modular® Shoulder System Reason for 510(k) submission Upate o xitn product line Device ~ ~…
Biomet, Inc.20031
*K051975Porous Coated Discovery Elbow
Summary page 2
…Resection Height - 50, 60, 70mm 1(033280, K043505 Modular Flange K(051975 K1t 240 2 510(k) Summa é) /? Comprehensive% Segmental Revision System (SRS) Page 3 of 3 PERFORMANCE DATA Summa…
Biomet, Inc.20052

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K143659Equinoxe Mega ProsthesisExactech, Inc.20155
K153398Comprehensive SRS/Nexel ElbowBiomet Manufacturing Corp20163
K173411Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp20182

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

Recalls of this device

DateClassRecallRoot causeReason
Feb 28, 2018Class IIZ-1173-2018Under Investigation by firmDuring assembly, an SRS Humeral Distal Body implant failed to engage correctly at the point of reduction with a Discovery Elbow System Humeral Condyle. A mismatch between the screw holes in the Humeral Body & Elbow Condyle affects…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 31 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
  • 6 of the 27 ancestors have a recall of any class.
  • Of its descendants, K143659 (Exactech, Inc., 2015) has gone furthest, with 5 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. 2011, this device’s year, is highlighted.

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—

What is it indicated for?

The Comprehensive® Segmental Revision System is intended for use in cases of: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Revision where other devices or treatments have failed. 4. Correction of functional deformity. 5. Oncology applications including bone loss due to tumor resection. When used in a proximal or total humeral replacement, the Comprehensive® Segmental Revision…

Read the full statement (169 words)

The Comprehensive® Segmental Revision System is intended for use in cases of:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.

2. Rheumatoid arthritis.

3. Revision where other devices or treatments have failed.

4. Correction of functional deformity.

5. Oncology applications including bone loss due to tumor resection.

When used in a proximal or total humeral replacement, the Comprehensive® Segmental Revision System is also intended for:

Treatment of acute or chronic fractures with humeral head (shoulder) involvement, which are unmanageable using other treatment methods.

When used as a distal or total humeral replacement, the Comprehensive® Segmental Revision System is also intended for:

Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement, which are unmanageable using other treatment methods.

The Comprehensive® Segmental Revision System is intended for use with or without bone cement in the proximal shoulder.

The Comprehensive® Segmental Revision System is intended for use with bone cement in distal humeral and total humeral applications.

Tissue Attachment Augments provide the option for tissue stabilization and attachment.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

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/K111746 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111746: Comprehensive Segmental Revision System (SRS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111746

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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