510(k) Report

510(k) · Cleared

Cleared

Promos Shoulder

K032126510(k) TraditionalCleared Jan 8, 2004182-day reviewClass II21 CFR 888.3690

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

Plus Orthopedics · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Cleared on Jan 8, 2004 as substantially equivalent to K010124 (Arthrex, Inc., 2001) and 4 other predicates after a 182-day review. Its family tree reaches back 1 generation to 1999. 130 later devices descend from it.

Decided
Jan 8, 2004
Review
182 days
Class
Class II
Product code
HSD
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K990137 (1999). 5 ancestors in all. 130 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 3 other ancestors1999: 1 other ancestor2011: 9 descendants cleared2007: 1 descendant cleared2012: 8 descendants cleared2004: 1 descendant cleared2010: 8 descendants cleared2018: 10 descendants cleared2006: 2 descendants cleared2017: 4 descendants cleared2015: 6 descendants cleared2014: 5 descendants cleared2008: 1 descendant cleared2022: 9 descendants cleared2021: 8 descendants cleared2016: 6 descendants cleared2019: 8 descendants cleared2013: 6 descendants cleared2023: 10 descendants cleared2025: 10 descendants cleared2020: 3 descendants cleared2024: 8 descendants cleared2026: 7 descendants clearedK990137 · Anatomica Humeral Stem/Head Components · Sulzer Orthopedics, Inc. · 19991995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 5 descendants2 generations forward: 29 descendants3 generations forward: 34 descendants4 generations forward: 32 descendants5 generations forward: 15 descendants6 generations forward: 7 descendants7 generations forward: 5 descendants8 generations forward: 2 descendants9 generations forward: 1 descendant K990137 · Anatomica Humeral Stem/Head Components · Sulzer Orthopedics, Inc. · 19990+5
  1. Root · 1 generation backK990137 Anatomica Humeral Stem/Head ComponentsSulzer Orthopedics, Inc. · 1999
  2. This deviceK032126 Promos ShoulderPlus Orthopedics · 2004
  3. Descendant · cites it directly · 71 of its ownK042021 Exactech Equinoxe Shoulder SystemExactech, Inc. · 2004 · Recalled
  4. Descendant · cites it directly · 67 of its ownK063578 Promos Modular Shoulder SystemPlus Orthopedics AG · 2007 · Recalled
  5. Descendant · 2 generations on · 52 of its ownK081016 Smith & Nephew, Inc., Promos Reverse Shoulder SystemSmith & Nephew, Inc. · 2008 · Recalled
  6. Descendant · 3 generations on · 44 of its ownK110598 SMR Reverse Shoulder SystemLima Corporate S.P.A. · 2011 · Recalled
  7. Descendant · cites it directly · 38 of its ownK101263 Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR…Lima-Lto S.P.A. · 2011

Showing 5 of 130 descendants. See all descendants

Descendants cleared per year

2004: 12006: 22007: 12008: 12010: 82011: 92012: 82013: 62014: 52015: 62016: 62017: 42018: 102019: 82020: 32021: 82022: 92023: 102024: 82025: 102026: 7
2004high 10 (2018) · low 0 (2005)2026

Most influential descendants

Showing 5 of 130 · See all
  • K042021Exactech Equinoxe Shoulder SystemExactech, Inc. · 2004 · cites it directly71descendants
  • K063578Promos Modular Shoulder SystemPlus Orthopedics AG · 2007 · cites it directly67descendants
  • K081016Smith & Nephew, Inc., Promos Reverse Shoulder SystemSmith & Nephew, Inc. · 2008 · 2 generations on52descendants
  • K110598SMR Reverse Shoulder SystemLima Corporate S.P.A. · 2011 · 3 generations on44descendants
  • K101263Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR Shoulder System -…Lima-Lto S.P.A. · 2011 · cites it directly38descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K990137Anatomica Humeral Stem/Head ComponentsSulzer Orthopedics, Inc.1999—
0 (this device)K032126Promos ShoulderPlus Orthopedics2004—
+1K042021Exactech Equinoxe Shoulder SystemExactech, Inc.200410
+1K063578Promos Modular Shoulder SystemPlus Orthopedics AG20074
+2K081016Smith & Nephew, Inc., Promos Reverse Shoulder SystemSmith & Nephew, Inc.20082
+3K110598SMR Reverse Shoulder SystemLima Corporate S.P.A.20111
+1K101263Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR Shoulder…Lima-Lto S.P.A.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200130

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200620
200710
200810
201080
201190
201280
201360
201450
201560
201660
201740
2018100
201980
202030
202180
202290
2023100
202480
2025100
202670
FIG. 1 — Lineage of K032126, 1999–2026Source: 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 HSD? 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 HSD device

  1. #1 K191433 AGILON® XO Shoulder Replacement Systemscore 13.8 · 16 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? (5)

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
*K010124Arthrex Univers 30 Shoulder Prosthesis
Summary page 1
…ith bone cement only. Summarv of Technoloeical Characteristics Comparedto Predicate Device The P ROMOS S houlder is si milar to the Arthrex (Arthrex, Inc.; Naples, F L; K010124) a nd Anatomical (Sulzer Orthopedics, Inc.; Austin, TX; K990136, K990137, K003801, K003832) Shoulders in termrs of material, adju…
Arthrex, Inc.2001—
*K990136Anatomica Glenoid Component
Summary page 1
…Comparedto Predicate Device The P ROMOS S houlder is si milar to the Arthrex (Arthrex, Inc.; Naples, F L; K010124) a nd Anatomical (Sulzer Orthopedics, Inc.; Austin, TX; K990136, K990137, K003801, K003832) Shoulders in termrs of material, adjustable inclination of humeral head, and indications for use. Sum…
Sulzer Orthopedics, Inc.19992
*K990137Anatomica Humeral Stem/Head Components
Summary page 1
…o Predicate Device The P ROMOS S houlder is si milar to the Arthrex (Arthrex, Inc.; Naples, F L; K010124) a nd Anatomical (Sulzer Orthopedics, Inc.; Austin, TX; K990136, K990137, K003801, K003832) Shoulders in termrs of material, adjustable inclination of humeral head, and indications for use. SumnmarvNon-…
Sulzer Orthopedics, Inc.1999—
*K003801Anatomical Press-Fit Humeral Stem
Summary page 1
…te Device The P ROMOS S houlder is si milar to the Arthrex (Arthrex, Inc.; Naples, F L; K010124) a nd Anatomical (Sulzer Orthopedics, Inc.; Austin, TX; K990136, K990137, K003801, K003832) Shoulders in termrs of material, adjustable inclination of humeral head, and indications for use. SumnmarvNon-clinical…
Sulzer Orthopedics, Inc.20011
*K003832Sulzer Orthopedics Anatomical Shoulder Cemented Humeral Stem
Summary page 1
…The P ROMOS S houlder is si milar to the Arthrex (Arthrex, Inc.; Naples, F L; K010124) a nd Anatomical (Sulzer Orthopedics, Inc.; Austin, TX; K990136, K990137, K003801, K003832) Shoulders in termrs of material, adjustable inclination of humeral head, and indications for use. SumnmarvNon-clinical Tests The…
Sulzer Orthopedics, Inc.2001—

Also cleared against K010124: 4 other devices →

What descends from it? (130)

See all 130

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

NumberDeviceApplicantDecidedDescendants
K042021Exactech Equinoxe Shoulder SystemExactech, Inc.200471
K063578Promos Modular Shoulder SystemPlus Orthopedics AG200767
K101263Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR Shoulder System -…Lima-Lto S.P.A.201138
K100448Ascension Modular Total Shoulder SystemAscension Orthopedics, Inc.20105
K121714Smith & Nephew, Inc. Shoulder System InstrumentsSmith & Nephew, Inc.20120

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?

  • 2 of the 5 ancestors have a recall of any class.
  • Of its descendants, K042021 (Exactech, Inc., 2004) has gone furthest, with 71 descendants of its own.
  • 4 other devices also cite its predicate K010124.

How does its category compare?

All HSD devices

HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HSD

1in 2024

2007: 42008: 32011: 22012: 22013: 42014: 12016: 32018: 12020: 22022: 12024: 1
2007high 4 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSD

145in 2016

2007: 72 days median2008: 92 days median2013: 218 days median2016: 145 days median
2007high 218 (2013) · low 72 (2007)2026

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

Recalls per year · HSD

1in 2020

2008: 22009: 22017: 32018: 12020: 1
2007high 3 (2017) · low 0 (2007)2026

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

Adverse event reports per year · HSD

757in 2025

2007: 1282008: 2592009: 1562010: 2252011: 2412012: 2542013: 2882014: 4342015: 5742016: 7842017: 9852018: 6492019: 8302020: 6582021: 5732022: 5082023: 5862024: 6932025: 757
2007high 985 (2017) · low 128 (2007)2025

MAUDE reports naming product code HSD, 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
20074720128
20083922259
20090—2156
20100—0225
20112—0241
20122—0254
201342180288
20141—0434
20150—0574
201631450784
20170—3985
20181—1649
20190—0830
20202—1658
20210—0573
20221—0508
20230—0586
20241—0693
20250—0757
20260—0—

What is it indicated for?

The PROMOS® Shoulder is indicated for:

* Advanced wear of the shoulder joint due to degenerative, post-traumatic or rheumatoid arthritis

* Fracture or avascular necrosis of the humeral head

* Post-traumatic loss of joint configuration, especially in the case of functional impairment

* Humerus fracture

The humeral component is intended for cemented or cementless use.

The glenoid component is for use with bone cement only.

Indications for use as stated in the FDA summary.

Also cleared against K010124

4 other devices cite the same predicate.

  • K120044Arthrex Universii XL Glenoid-Pegged, Arthrex Univers II XL Glenoid-KeeledArthrex, Inc. · 2012
  • K083435Arthrex Univers II Shoulder Pegged GlenoidArthrex, Inc. · 2009
  • K071032Arthrex Univers II Shoulder ProsthesisArthrex, Inc. · 2007
  • K042021Exactech Equinoxe Shoulder SystemExactech, Inc. · 200410 recalls

More from Plus Orthopedics

38 FDA decisions under this applicant name. See the company

  • K033763Modification to Slim Gliding Nail SystemPlus Orthopedics · 2003
  • K032709Modular Plus Hip StemPlus Orthopedics · 2003
  • K032548IP-XS Compression Nail SystemPlus Orthopedics · 2003
  • K032215VKS/TC-Plus Revision KneePlus Orthopedics · 2003
  • K032052UC-Plus Solution Unicondylar KneePlus Orthopedics · 20031 recall

Recent decisions in HSD

The HSD category page

  • K233260Univers Revers CA Head and AdapterArthrex, Inc. · 2024
  • K221232Univers Revers Humeral Cup ImplantArthrex, Inc. · 2022
  • K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH · 2020
  • K193122Biocore9 Humeral Resurfacing SystemBiocore9, LLC · 2020
  • K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc. · 2018

https://510kreport.com/device/K032126 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032126: Promos Shoulder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032126

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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