510(k) · Cleared

Cleared

Comprehensive Segmental Revision System (SRS)

K173411510(k) TraditionalCleared Feb 8, 201899-day reviewClass II21 CFR 888.3660

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

Biomet Manufacturing Corp · PHX Shoulder Prosthesis, Reverse Configuration

Cleared on Feb 8, 2018 as substantially equivalent to K143659 (Exactech, Inc., 2015) and 3 other predicates after a 99-day review. Its family tree reaches back 8 generations to 1980. 2 later devices descend from it.

Decided: Feb 8, 2018
Review: 99 days
Class: Class II
Product code: PHX
Recalls: None
Predicates: 4

Its longest line of descent runs back 8 generations to K800494 (1980). 41 ancestors in all. 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 8 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
7 generations backK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
6 generations backK002998 Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000 · Recalled
5 generations backK030710 Bio-Modular Shoulder SystemBiomet, Inc. · 2003 · Recalled
4 generations backK032895 BI-Angular Shoulder SystemBiomet, Inc. · 2003
3 generations backK042321 Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral HeadBiomet Manufacturing Corp · 2005
2 generations backK111746 Comprehensive Segmental Revision System (SRS)Biomet, Inc. · 2011 · Recalled
1 generation backK143659 Equinoxe Mega ProsthesisExactech, Inc. · 2015
This deviceK173411 Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp · 2018
Descendant · cites it directly · 1 of its ownK223631 Comprehensive Segmental Revision System (SRS)Biomet Orthopedics · 2023
Descendant · 2 generations on · 0 of its ownK251686 Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc. · 2025 · Recalled

Most influential descendants

Showing 2 of 2 · See all

K223631Comprehensive Segmental Revision System (SRS)Biomet Orthopedics · 2023 · cites it directly1descendant
K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc. · 2025 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−8	K800494	New Jersey Hemiarthroplasty Sholder Pros	Depuy, Inc.	1980	—
−7	K991585	Bipolar Shoulder Prosthesis	Biomet, Inc.	1999	—
−6	K002998	Biomet BI-Polar Shoulder System	Biomet, Inc.	2000	1
−5	K030710	Bio-Modular Shoulder System	Biomet, Inc.	2003	1
−4	K032895	BI-Angular Shoulder System	Biomet, Inc.	2003	—
−3	K042321	Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral Head	Biomet Manufacturing Corp	2005	—
−2	K111746	Comprehensive Segmental Revision System (SRS)	Biomet, Inc.	2011	1
−1	K143659	Equinoxe Mega Prosthesis	Exactech, Inc.	2015	—
0 (this device)	K173411	Comprehensive Segmental Revision System (SRS)	Biomet Manufacturing Corp	2018	—
+1	K223631	Comprehensive Segmental Revision System (SRS)	Biomet Orthopedics	2023	—
+2	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
2023	1	0
2025	1	0

FIG. 1 — Lineage of K173411, 1980–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 PHX? 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 PHX device

#1 K212737 INHANCE™ Reverse Shoulder Systemscore 28.4 · 15 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (4)

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	Applicant	Decided	Recalls
*	K143659	Equinoxe Mega Prosthesis Summary page 5 …al/polymer constrained cemented prosthesis (21 CFR 888.3150) Predicate Device: Equinoxe Mega Prosthesis (Exactech) K143659 Secondary (Reference) Predicate: Comprehensive Segmental Revision System (SRS) (Biomet) K111746,…	Exactech, Inc.	2015	—
*	K111746	Comprehensive Segmental Revision System (SRS) Summary page 5 …Equinoxe Mega Prosthesis (Exactech) K143659 Secondary (Reference) Predicate: Comprehensive Segmental Revision System (SRS) (Biomet) K111746, K112905 & K153398 Compatible Components Provided for reference: Comprehensive Reverse Shoulder System (Biomet) K08064…	Biomet, Inc.	2011	1
*	K112905	Compress (R) Segmental Humeral Replacement System Summary page 5 …noxe Mega Prosthesis (Exactech) K143659 Secondary (Reference) Predicate: Comprehensive Segmental Revision System (SRS) (Biomet) K111746, K112905 & K153398 Compatible Components Provided for reference: Comprehensive Reverse Shoulder System (Biomet) K080642,…	Biomet Orthopedics, LLC	2012	2
*	K153398	Comprehensive SRS/Nexel Elbow Summary page 5 …Prosthesis (Exactech) K143659 Secondary (Reference) Predicate: Comprehensive Segmental Revision System (SRS) (Biomet) K111746, K112905 & K153398 Compatible Components Provided for reference: Comprehensive Reverse Shoulder System (Biomet) K080642,…	Biomet Manufacturing Corp	2016	—
†	K080642	Comprehensive Reverse Shoulder	Biomet, Inc.	2008	Class I
†	K113069	Comprehensive Reverse Shoulder Humeral Tray	Biomet Manufacturing Corp	2012	—
†	K113121	Comprehensive Reverse Shoulder	Biomet Manufacturing, Inc.	2011	—
†	K120121	Comprehensive Reverse Shoulder-Mini Baseplate	Biomet, Inc.	2012	4
†	K131353	Comprehensive Reverse Shoulder - Titanium Glenosphere	Biomet Manufacturing Corp	2013	—
†	K152754	Comprehensive Vault Reconstruction System (VRS)	Biomet Manufacturing Corp	2016	1
†	K052906	Zimmer Trabecular Metal Reverse Shoulder System	Zimmer, Inc.	2005	12
†	K060704	Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM	Zimmer, Inc.	2006	10
†	K121543	Zimmer Trabecular Metal Reverse Shoulder System, Base Plates & Humeral Stems	Zimmer, Inc.	2012	—
†	K122692	Zimmer Trabecular Metal Reverse Shoulder System, Non-Porous Humeral Stems	Zimmer, Inc.	2012	—
†	K130661	Zimmer Trabecular Metal Reverse Shoulder System	Zimmer, Inc.	2013	2
†	K133378	Zimmer Trabecular Metal Reverse Shoulder System	Zimmer, Inc.	2014	—

Also cleared against K143659: 2 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K223631	Comprehensive Segmental Revision System (SRS)	Biomet Orthopedics	2023	1

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 38 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
13 of the 41 ancestors have a recall of any class.
Of its descendants, K223631 (Biomet Orthopedics, 2023) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K143659.

How does its category compare?

All PHX devices

PHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · PHX

9in 2025

2007high 21 (2021) · low 1 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PHX

72in 2025

2007high 206 (2015) · low 72 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · PHX

3in 2025

2007high 8 (2021) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · PHX

2,848in 2025

2007high 2,848 (2025) · low 0 (2007)2025

MAUDE reports naming product code PHX, 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	5	97	0	0
2008	6	79	0	0
2009	1	—	0	0
2010	8	124	0	0
2011	12	94	0	0
2012	12	114	0	0
2013	8	143	0	0
2014	12	110	0	0
2015	4	206	2	14
2016	4	132	0	5
2017	11	141	0	25
2018	14	127	1	323
2019	9	144	3	504
2020	13	143	3	986
2021	21	143	8	1,404
2022	9	198	0	1,342
2023	9	154	7	1,401
2024	9	139	1	2,142
2025	9	72	3	2,848
2026	18	130	7	—

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 (239 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.

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. Reverse application is limited to proximal humeral replacement in the United States.

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.

https://510kreport.com/device/K173411 · printed Nov 6, 2026

Cite this page

510(k) Report. “K173411: 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/K173411

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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