510(k) · Cleared

Recalled · Class II · 2023

RSP Glenoid Baseplate Porous Coated

K112069510(k) TraditionalCleared Nov 15, 2011118-day reviewClass II21 CFR 888.3660Recalls 1

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

Encore Medical L.P. · PHX Shoulder Prosthesis, Reverse Configuration

Cleared on Nov 15, 2011 as substantially equivalent to K041066 (Encore Medical L.P., 2005) and 3 other predicates after a 118-day review. Its family tree reaches back 3 generations to 2005. 74 later devices descend from it. It has been recalled once.

Decided: Nov 15, 2011
Review: 118 days
Class: Class II
Product code: PHX
Recalls: 1
Predicates: 4

Its longest line of descent runs back 3 generations to K041066 (2005). 7 ancestors in all, the oldest K974093 (1998). 74 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 3 generations backK041066 Encore Reverse Shoulder ProsthesisEncore Medical L.P. · 2005 · Recalled
2 generations backK051075 Encore Reverse Shoulder ProsthesisEncore Medical L.P. · 2005 · Recalled
1 generation backK092873 Reverse Shoulder ProsthesisDjo Surgical · 2009
This deviceK112069 RSP Glenoid Baseplate Porous CoatedEncore Medical L.P. · 2011
Descendant · cites it directly · 55 of its ownK140904 RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P. · 2014
Descendant · 2 generations on · 34 of its ownK162024 AltiVate Anatomic Shoulder SystemEncore Medical L.P. · 2016 · Recalled
Descendant · cites it directly · 20 of its ownK151293 Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder…Tornier S.A.S. · 2015
Descendant · 2 generations on · 19 of its ownK141990 Encore Humeral Shoulder StemEncore Medical L.P. · 2014 · Recalled
Descendant · 3 generations on · 18 of its ownK172351 AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer…Encore Medical L.P. · 2017 · Recalled

Showing 5 of 74 descendants. See all descendants

Descendants cleared per year

2013high 11 (2026) · low 1 (2013)2026

Most influential descendants

Showing 5 of 74 · See all

K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P. · 2014 · cites it directly55descendants
K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P. · 2016 · 2 generations on34descendants
K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2015 · cites it directly20descendants
K141990Encore Humeral Shoulder StemEncore Medical L.P. · 2014 · 2 generations on19descendants
K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P. · 2017 · 3 generations on18descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K041066	Encore Reverse Shoulder Prosthesis	Encore Medical L.P.	2005	4
−2	K051075	Encore Reverse Shoulder Prosthesis	Encore Medical L.P.	2005	5
−1	K092873	Reverse Shoulder Prosthesis	Djo Surgical	2009	—
0 (this device)	K112069	RSP Glenoid Baseplate Porous Coated	Encore Medical L.P.	2011	—
+1	K140904	RSP Monoblock Stem with P2 Coating, Size 6	Encore Medical L.P.	2014	—
+2	K162024	AltiVate Anatomic Shoulder System	Encore Medical L.P.	2016	6
+1	K151293	Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis	Tornier S.A.S.	2015	—
+2	K141990	Encore Humeral Shoulder Stem	Encore Medical L.P.	2014	3
+3	K172351	AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate…	Encore Medical L.P.	2017	3

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	3	0
2008	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2014	2	0
2015	1	0
2016	2	0
2017	3	0
2018	2	0
2019	5	0
2020	7	0
2021	8	0
2022	9	0
2023	6	0
2024	8	0
2025	9	0
2026	11	0

FIG. 1 — Lineage of K112069, 2005–2026Source: 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

Get a 510(k) Report

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
*	K041066	Encore Reverse Shoulder Prosthesis Summary page 4 …: (512) 834-6313 9800 Metric Blvd Email: [email protected] Austin, TX 78758 ‘ ‘ 510(k) Number, Clearance Date, — AA"__,Product B Classification Product Code K041066 — March 24, 2005 . K051075 — May 27, 2005 N Reverse® Shoulder Prosthesis K092873 — October 27, 2009 KWS Class Il Product Code ___…	Encore Medical L.P.	2005	4
*	K051075	Encore Reverse Shoulder Prosthesis Summary page 4 …c Blvd Email: [email protected] Austin, TX 78758 ‘ ‘ 510(k) Number, Clearance Date, — AA"__,Product B Classification Product Code K041066 — March 24, 2005 . K051075 — May 27, 2005 N Reverse® Shoulder Prosthesis K092873 — October 27, 2009 KWS Class Il Product Code ___Repulation and Classificati…	Encore Medical L.P.	2005	5
*	K092873	Reverse Shoulder Prosthesis Summary page 4 …X 78758 ‘ ‘ 510(k) Number, Clearance Date, — AA"__,Product B Classification Product Code K041066 — March 24, 2005 . K051075 — May 27, 2005 N Reverse® Shoulder Prosthesis K092873 — October 27, 2009 KWS Class Il Product Code ___Repulation and Classification Name KWwWS Shoulder joint metal/polymer semi-constr…	Djo Surgical	2009	—
*	K072888	Revelation and Linear Hip Stems and FMP Acetabular Shells (Spiked, Hemispherical and… Summary page 4 …ion. The humeral stem is intended for cemented use only. Predicate Device: s Reverse Shoulder Prosthesis — K041066, K051075, K092873 e DJO Surgical Acetabular Shells — K072888 : Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same indications, sterilizati…	Encore Medical L.P.	2008	—

Also cleared against K041066: 24 other devices →

What descends from it? (74)

See all 74

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

Number	Device	Applicant	Decided	Descendants
K140904	RSP Monoblock Stem with P2 Coating, Size 6	Encore Medical L.P.	2014	55
K151293	Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis	Tornier S.A.S.	2015	20
K130895	Reunion Rsa Shoulder System	Howmedica Osteonics Corp.	2013	14
K233481	AltiVate Reverse® Glenoid	Encore Medical L.P.	2024	4
K201905	SMR 140° Reverse Humeral Body	Lima Corporate S.P.A.	2020	0
K183042	SMR Lateralized Connectors with screws	Lima Corporate S.P.A.	2019	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 6, 2023	Class II	Z-0532-2024	Component design/selection	Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw Driver

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
2 of the 7 ancestors have a recall of any class.
Of its descendants, K140904 (Encore Medical L.P., 2014) has gone furthest, with 55 descendants of its own.
24 other devices also cite its predicate K041066.

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. 2011, 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 Reverse Shoulder is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint.

The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.

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/K112069 · printed Nov 5, 2026

Cite this page

510(k) Report. “K112069: RSP Glenoid Baseplate Porous Coated.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K112069

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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