510(k) · Cleared
ClearedComprehensive SRS/Nexel Elbow
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · JDC Prosthesis, Elbow, Constrained, Cemented
Cleared on Feb 3, 2016 as substantially equivalent to K111746 (Biomet, Inc., 2011) after a 71-day review. Its family tree reaches back 7 generations to 1980. 3 later devices descend from it.
- Decided
- Feb 3, 2016
- Review
- 71 days
- Class
- Class II
- Product code
- JDC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K800494 (1980). 28 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
- 6 generations backK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
- 5 generations backK002998 Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000 · Recalled
- 4 generations backK030710 Bio-Modular Shoulder SystemBiomet, Inc. · 2003 · Recalled
- 3 generations backK032895 BI-Angular Shoulder SystemBiomet, Inc. · 2003
- 2 generations backK042321 Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral HeadBiomet Manufacturing Corp · 2005
- 1 generation backK111746 Comprehensive Segmental Revision System (SRS)Biomet, Inc. · 2011 · Recalled
- This deviceK153398 Comprehensive SRS/Nexel ElbowBiomet Manufacturing Corp · 2016
- Descendant · cites it directly · 2 of its ownK173411 Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp · 2018
- Descendant · 2 generations on · 1 of its ownK223631 Comprehensive Segmental Revision System (SRS)Biomet Orthopedics · 2023
- Descendant · 3 generations on · 0 of its ownK251686 Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc. · 2025 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K173411Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp · 2018 · cites it directly2descendants
- K223631Comprehensive Segmental Revision System (SRS)Biomet Orthopedics · 2023 · 2 generations on1descendant
- K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K800494 | New Jersey Hemiarthroplasty Sholder Pros | Depuy, Inc. | 1980 | — |
| −6 | K991585 | Bipolar Shoulder Prosthesis | Biomet, Inc. | 1999 | — |
| −5 | K002998 | Biomet BI-Polar Shoulder System | Biomet, Inc. | 2000 | 1 |
| −4 | K030710 | Bio-Modular Shoulder System | Biomet, Inc. | 2003 | 1 |
| −3 | K032895 | BI-Angular Shoulder System | Biomet, Inc. | 2003 | — |
| −2 | K042321 | Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral Head | Biomet Manufacturing Corp | 2005 | — |
| −1 | K111746 | Comprehensive Segmental Revision System (SRS) | Biomet, Inc. | 2011 | 1 |
| 0 (this device) | K153398 | Comprehensive SRS/Nexel Elbow | Biomet Manufacturing Corp | 2016 | — |
| +1 | K173411 | Comprehensive Segmental Revision System (SRS) | Biomet Manufacturing Corp | 2018 | — |
| +2 | K223631 | Comprehensive Segmental Revision System (SRS) | Biomet Orthopedics | 2023 | — |
| +3 | 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 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 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 JDC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K111746 | Comprehensive Segmental Revision System (SRS)Summary page 4…(21 CFR 888.3150) Legally marketed devices to which substantial equivalence is claimed: x Comprehensive Segmental Revision System (SRS) - K111746 Additional reference predicate: x Zimmer Nexel Total Elbow – K123862 Device Description The components of the Comprehensive S… | 2011 |
| † | K123862 | Zimmer Nexel Total Elbow | 2013 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173411 | Comprehensive Segmental Revision System (SRS) | 2018 | 2 |
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 36 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 7 of the 28 ancestors have a recall of any class.
- Of its descendants, K173411 (Biomet Manufacturing Corp, 2018) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K111746.
How does its category compare?
All JDC devicesJDC Prosthesis, Elbow, Constrained, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · JDC
2in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · JDC
Too few JDC 510(k)s in any year since 2007 to give a median.
Recalls per year · JDC
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDC
212in 2025
MAUDE reports naming product code JDC, 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 | 0 | — | 0 | 33 |
| 2008 | 0 | — | 2 | 47 |
| 2009 | 1 | — | 6 | 45 |
| 2010 | 0 | — | 0 | 86 |
| 2011 | 0 | — | 2 | 62 |
| 2012 | 0 | — | 2 | 79 |
| 2013 | 1 | — | 0 | 74 |
| 2014 | 0 | — | 0 | 79 |
| 2015 | 1 | — | 0 | 239 |
| 2016 | 1 | — | 0 | 176 |
| 2017 | 0 | — | 0 | 401 |
| 2018 | 0 | — | 0 | 248 |
| 2019 | 2 | — | 2 | 190 |
| 2020 | 0 | — | 0 | 179 |
| 2021 | 0 | — | 0 | 157 |
| 2022 | 0 | — | 0 | 129 |
| 2023 | 0 | — | 0 | 189 |
| 2024 | 0 | — | 0 | 175 |
| 2025 | 0 | — | 0 | 212 |
| 2026 | 0 | — | 1 | — |
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 as stated in the FDA summary.
https://510kreport.com/device/K153398 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153398: Comprehensive SRS/Nexel Elbow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153398
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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