510(k) · Cleared
ClearedComprehensive Segmental Revision System (SRS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Orthopedics · KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Cleared on Jul 12, 2023 as substantially equivalent to K173411 (Biomet Manufacturing Corp, 2018) after a 219-day review. Its family tree reaches back 9 generations to 1980. 1 later device descends from it.
- Decided
- Jul 12, 2023
- Review
- 219 days
- Class
- Class II
- Product code
- KWT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K800494 (1980). 42 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
- 5 generations between
- 3 generations backK111746 Comprehensive Segmental Revision System (SRS)Biomet, Inc. · 2011 · Recalled
- 2 generations backK143659 Equinoxe Mega ProsthesisExactech, Inc. · 2015
- 1 generation backK173411 Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp · 2018
- This deviceK223631 Comprehensive Segmental Revision System (SRS)Biomet Orthopedics · 2023
- Descendant · cites it directly · 0 of its ownK251686 Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc. · 2025 · Recalled
Show all 9 generations
- Root · 9 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
- 8 generations backK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
- 7 generations backK002998 Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000 · Recalled
- 6 generations backK030710 Bio-Modular Shoulder SystemBiomet, Inc. · 2003 · Recalled
- 5 generations backK032895 BI-Angular Shoulder SystemBiomet, Inc. · 2003
- 4 generations backK042321 Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral HeadBiomet Manufacturing Corp · 2005
- 3 generations backK111746 Comprehensive Segmental Revision System (SRS)Biomet, Inc. · 2011 · Recalled
- 2 generations backK143659 Equinoxe Mega ProsthesisExactech, Inc. · 2015
- 1 generation backK173411 Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp · 2018
- This deviceK223631 Comprehensive Segmental Revision System (SRS)Biomet Orthopedics · 2023
Most influential descendants
Showing 1 of 1 · See all- K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K800494 | New Jersey Hemiarthroplasty Sholder Pros | Depuy, Inc. | 1980 | — |
| −8 | K991585 | Bipolar Shoulder Prosthesis | Biomet, Inc. | 1999 | — |
| −7 | K002998 | Biomet BI-Polar Shoulder System | Biomet, Inc. | 2000 | 1 |
| −6 | K030710 | Bio-Modular Shoulder System | Biomet, Inc. | 2003 | 1 |
| −5 | K032895 | BI-Angular Shoulder System | Biomet, Inc. | 2003 | — |
| −4 | K042321 | Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral Head | Biomet Manufacturing Corp | 2005 | — |
| −3 | K111746 | Comprehensive Segmental Revision System (SRS) | Biomet, Inc. | 2011 | 1 |
| −2 | K143659 | Equinoxe Mega Prosthesis | Exactech, Inc. | 2015 | — |
| −1 | K173411 | Comprehensive Segmental Revision System (SRS) | Biomet Manufacturing Corp | 2018 | — |
| 0 (this device) | K223631 | Comprehensive Segmental Revision System (SRS) | Biomet Orthopedics | 2023 | — |
| +1 | K251686 | Tornier Humeral Reconstruction System Max (Tornier HRS Max) | Tornier, Inc. | 2025 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
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 K231657 AGILON® XO Shoulder Replacement Systemscore 17.7 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K173411 | Comprehensive Segmental Revision System (SRS)Summary page 5…ow joint metal/polymer constrained cemented prosthesis (21 CFR 888.3150) Predicate Device(s): K173411 Comprehensive Segmental Revision Biomet Manufacturing Corp System (SRS) R… | 2018 |
| † | K111746 | Comprehensive Segmental Revision System (SRS) | 2011 |
| † | K172502 | Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate… | 2018 |
| † | K182516 | Comprehensive Nano Stemless Shoulder | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251686 | Tornier Humeral Reconstruction System Max (Tornier HRS Max) | 2025 | 0 |
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?
- The line of descent spans 43 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 13 of the 42 ancestors have a recall of any class.
- Of its descendants, K251686 (Tornier, Inc., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KWT devicesKWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · KWT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWT
242in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWT
749in 2025
MAUDE reports naming product code KWT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 32 |
| 2008 | 0 | — | 1 | 48 |
| 2009 | 0 | — | 0 | 58 |
| 2010 | 1 | — | 7 | 71 |
| 2011 | 5 | 165 | 0 | 112 |
| 2012 | 1 | — | 2 | 83 |
| 2013 | 1 | — | 1 | 113 |
| 2014 | 1 | — | 0 | 168 |
| 2015 | 2 | — | 0 | 176 |
| 2016 | 2 | — | 1 | 445 |
| 2017 | 1 | — | 1 | 560 |
| 2018 | 2 | — | 1 | 480 |
| 2019 | 4 | 91 | 3 | 419 |
| 2020 | 1 | — | 0 | 215 |
| 2021 | 1 | — | 0 | 228 |
| 2022 | 1 | — | 0 | 273 |
| 2023 | 1 | — | 1 | 361 |
| 2024 | 1 | — | 0 | 601 |
| 2025 | 4 | 242 | 0 | 749 |
| 2026 | 1 | — | 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. Revision where other devices or treatments have failed. 3. Correction of functional deformity. 4. 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…
Read the full statement (247 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. Revision where other devices or treatments have failed.
3. Correction of functional deformity.
4. 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.
Biomet Comprehensive Segmental Revision System is indicated for use in a reverse application in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. For the US and Canada only: reverse application is limited to proximal humeral replacement.
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. Tissue Attachment Augments are not available in all markets.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223631 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223631: Comprehensive Segmental Revision System (SRS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223631
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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