510(k) Report

510(k) · Cleared

Cleared

Arthrex Shoulder System

K171841510(k) TraditionalCleared Mar 29, 2018282-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

Arthrex, Inc. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Cleared on Mar 29, 2018 as substantially equivalent to K020345 (Arthrex, Inc., 2002) and 13 other predicates after a 282-day review. Its family tree reaches back 14 generations to 1991. 1 later device descends from it.

Decided
Mar 29, 2018
Review
282 days
Class
Class II
Product code
KWS
Recalls
None
Predicates
14

Its longest line of descent runs back 14 generations to K911686 (1991). 73 ancestors in all, the oldest K800494 (1980). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2018: 1 other ancestor2016: 2 other ancestors2015: 1 other ancestor2013: 2 other ancestors2012: 1 other ancestor2010: 1 other ancestor2009: 2 other ancestors2007: 3 other ancestors2002: 2 other ancestors2006: 4 other ancestors2001: 5 other ancestors2008: 2 other ancestors2005: 1 other ancestor2003: 3 other ancestors1997: 1 other ancestor2004: 2 other ancestors2000: 5 other ancestors1999: 4 other ancestors1998: 2 other ancestors1996: 2 other ancestors1995: 2 other ancestors1994: 1 other ancestor1992: 2 other ancestors1988: 1 other ancestor1987: 4 other ancestors1980: 2 other ancestors1993: 1 other ancestor2023: 1 descendant clearedK911686 · Global Total Shoulder, Uncement Humeral Hemi-Shoul · Depuy, Inc. · 1991K984541 · Global FX Humeral Stem, Global Advantage Humeral Head · DePuy Orthopaedics, Inc. · 1999K992065 · Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head · DePuy Orthopaedics, Inc. · 1999K021478 · Delta Shoulder · Depuy, Inc. · 2003×2: 2 generations cleared close together, K030941 (2004), K041873 (2004) K050316 · Aequalis Reversed Shoulder Prosthesis · Tornier · 2005K061439 · Aequalis Reversed Prosthesis · Tornier · 2006K071948 · Aequalis Reversed Adapter · Tornier · 2007K082120 · Aequalis Reversed Fracture Shoulder Prothesis · Tornier · 2008K100142 · Aequalis Reversed Shoulder Prosthesis · Tornier · 2010K130129 · Univers Revers Shoulder Prosthesis System · Arthrex, Inc. · 2013K142863 · Univers Rivers Shoulder Prosthesis System · Arthrex, Inc. · 2014K161782 · Arthrex Univers Revers Shoulder Prosthesis System · Arthrex, Inc. · 201619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 11 other ancestors2 generations back: 3 other ancestors3 generations back: 9 other ancestors4 generations back: 30 other ancestors5 generations back: 5 other ancestors6 generations back: 1 other ancestor 1 generation forward: 1 descendant K161782 · Arthrex Univers Revers Shoulder Prosthesis System · Arthrex, Inc. · 2016K142863 · Univers Rivers Shoulder Prosthesis System · Arthrex, Inc. · 2014K130129 · Univers Revers Shoulder Prosthesis System · Arthrex, Inc. · 2013K100142 · Aequalis Reversed Shoulder Prosthesis · Tornier · 2010K082120 · Aequalis Reversed Fracture Shoulder Prothesis · Tornier · 2008K071948 · Aequalis Reversed Adapter · Tornier · 2007K061439 · Aequalis Reversed Prosthesis · Tornier · 2006K050316 · Aequalis Reversed Shoulder Prosthesis · Tornier · 2005K041873 · Aequalis Reversed Shoulder Prosthesis · Tornier · 2004K030941 · Aequalis Reversed Shoulder Prosthesis · Tornier · 2004K021478 · Delta Shoulder · Depuy, Inc. · 2003K992065 · Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head · DePuy Orthopaedics, Inc. · 1999K984541 · Global FX Humeral Stem, Global Advantage Humeral Head · DePuy Orthopaedics, Inc. · 1999K911686 · Global Total Shoulder, Uncement Humeral Hemi-Shoul · Depuy, Inc. · 1991−10−50
  1. Root · 14 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 10 generations between
  3. 3 generations backK130129 Univers Revers Shoulder Prosthesis SystemArthrex, Inc. · 2013
  4. 2 generations backK142863 Univers Rivers Shoulder Prosthesis SystemArthrex, Inc. · 2014
  5. 1 generation backK161782 Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc. · 2016
  6. This deviceK171841 Arthrex Shoulder SystemArthrex, Inc. · 2018
  7. Descendant · cites it directly · 0 of its ownK230366 Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc. · 2023
Show all 14 generations
  1. Root · 14 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 13 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
  3. 12 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
  4. 11 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
  5. 10 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  6. 9 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  7. 8 generations backK050316 Aequalis Reversed Shoulder ProsthesisTornier · 2005
  8. 7 generations backK061439 Aequalis Reversed ProsthesisTornier · 2006
  9. 6 generations backK071948 Aequalis Reversed AdapterTornier · 2007
  10. 5 generations backK082120 Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008
  11. 4 generations backK100142 Aequalis Reversed Shoulder ProsthesisTornier · 2010
  12. 3 generations backK130129 Univers Revers Shoulder Prosthesis SystemArthrex, Inc. · 2013
  13. 2 generations backK142863 Univers Rivers Shoulder Prosthesis SystemArthrex, Inc. · 2014
  14. 1 generation backK161782 Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc. · 2016
  15. This deviceK171841 Arthrex Shoulder SystemArthrex, Inc. · 2018

Most influential descendants

Showing 1 of 1 · See all
  • K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−14K911686Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc.1991—
−13K984541Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc.1999—
−12K992065Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage…DePuy Orthopaedics, Inc.1999—
−11K021478Delta ShoulderDepuy, Inc.2003—
−10K030941Aequalis Reversed Shoulder ProsthesisTornier2004—
−9K041873Aequalis Reversed Shoulder ProsthesisTornier2004—
−8K050316Aequalis Reversed Shoulder ProsthesisTornier2005—
−7K061439Aequalis Reversed ProsthesisTornier2006—
−6K071948Aequalis Reversed AdapterTornier2007—
−5K082120Aequalis Reversed Fracture Shoulder ProthesisTornier2008—
−4K100142Aequalis Reversed Shoulder ProsthesisTornier2010—
−3K130129Univers Revers Shoulder Prosthesis SystemArthrex, Inc.2013—
−2K142863Univers Rivers Shoulder Prosthesis SystemArthrex, Inc.2014—
−1K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.2016—
0 (this device)K171841Arthrex Shoulder SystemArthrex, Inc.2018—
+1K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198020
198740
198810
199220
199310
199410
199520
199620
199710
199820
199940
200050
200150
200220
200330
200420
200510
200640
200730
200820
200920
201010
201210
201320
201510
201620
201810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
FIG. 1 — Lineage of K171841, 1991–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 KWS? 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 KWS device

  1. #1 K220847 AETOS Shoulder Systemscore 21.1 · 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? (14)

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
*K020345Arthrex Univers Fracture Prosthesis
Summary page 8
…21 CFR 888.3690: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class II Predicate Device K020345: Arthrex Univers Shoulder Fracture Prosthesis K071032: Arthrex Univers II Shoulder Prosthesis…
Arthrex, Inc.2002—
*K071032Arthrex Univers II Shoulder Prosthesis
Summary page 8
…ic uncemented prosthesis Regulatory Class II Predicate Device K020345: Arthrex Univers Shoulder Fracture Prosthesis K071032: Arthrex Univers II Shoulder Prosthesis K083435: Arthrex Univers II Pegged Glenoid K1…
Arthrex, Inc.2007—
*K083435Arthrex Univers II Shoulder Pegged Glenoid
Summary page 8
…I Predicate Device K020345: Arthrex Univers Shoulder Fracture Prosthesis K071032: Arthrex Univers II Shoulder Prosthesis K083435: Arthrex Univers II Pegged Glenoid K103466: Arthrex Univers II #5 Stem K120044: Arthr…
Arthrex, Inc.2009—
*K103466Arthrex Univers II Shoulder Prosthesis
Summary page 8
…e Prosthesis K071032: Arthrex Univers II Shoulder Prosthesis K083435: Arthrex Univers II Pegged Glenoid K103466: Arthrex Univers II #5 Stem K120044: Arthrex Univers II Shoulder Prosthesis – XL Glenoids…
Arthrex, Inc.2010—
*K120044Arthrex Universii XL Glenoid-Pegged, Arthrex Univers II XL Glenoid-Keeled
Summary page 8
…s II Shoulder Prosthesis K083435: Arthrex Univers II Pegged Glenoid K103466: Arthrex Univers II #5 Stem K120044: Arthrex Univers II Shoulder Prosthesis – XL Glenoids K130129: Arthrex Univers Revers…
Arthrex, Inc.2012—
*K130129Univers Revers Shoulder Prosthesis System
Summary page 8
…enoid K103466: Arthrex Univers II #5 Stem K120044: Arthrex Univers II Shoulder Prosthesis – XL Glenoids K130129: Arthrex Univers Revers K130675: Arthrex Univers CA Heads K131633: Arthrex Univers Ap…
Arthrex, Inc.2013—
*K130675Arthrex Univers II CA Heads
Summary page 8
…I #5 Stem K120044: Arthrex Univers II Shoulder Prosthesis – XL Glenoids K130129: Arthrex Univers Revers K130675: Arthrex Univers CA Heads K131633: Arthrex Univers Apex K142863: Arthrex Univers Reve…
Arthrex, Inc.2013—
*K131633Arthrex Univers Apex
Summary page 8
…II Shoulder Prosthesis – XL Glenoids K130129: Arthrex Univers Revers K130675: Arthrex Univers CA Heads K131633: Arthrex Univers Apex K142863: Arthrex Univers Revers Fracture K151527: Arthrex Unive…
Arthrex, Inc.2013—
*K142863Univers Rivers Shoulder Prosthesis System
Summary page 8
…K130129: Arthrex Univers Revers K130675: Arthrex Univers CA Heads K131633: Arthrex Univers Apex K142863: Arthrex Univers Revers Fracture K151527: Arthrex Univers Revers CA Heads K153115: Ar…
Arthrex, Inc.2014—
*K151527Arthrex Univers Revers CA Heads and Adapters
Summary page 8
…130675: Arthrex Univers CA Heads K131633: Arthrex Univers Apex K142863: Arthrex Univers Revers Fracture K151527: Arthrex Univers Revers CA Heads K153115: Arthrex Univers Apex Size 5 Stem K161108: A…
Arthrex, Inc.2016—
*K153115Arthrex Univers Apex, Size 5 Stem
Summary page 8
…Arthrex Univers Apex K142863: Arthrex Univers Revers Fracture K151527: Arthrex Univers Revers CA Heads K153115: Arthrex Univers Apex Size 5 Stem K161108: Arthrex VaultLock Glenoid K161782: Arthrex…
Arthrex, Inc.2015—
*K161108Arthrex VaultLock Glenoid
Summary page 8
…vers Revers Fracture K151527: Arthrex Univers Revers CA Heads K153115: Arthrex Univers Apex Size 5 Stem K161108: Arthrex VaultLock Glenoid K161782: Arthrex Univers Revers Shoulder Prosthesis System…
Arthrex, Inc.2016—
*K161782Arthrex Univers Revers Shoulder Prosthesis System
Summary page 8
…ex Univers Revers CA Heads K153115: Arthrex Univers Apex Size 5 Stem K161108: Arthrex VaultLock Glenoid K161782: Arthrex Univers Revers Shoulder Prosthesis System K173271: Arthrex Revers Coated Baseplate Purpose of…
Arthrex, Inc.2016—
*K172371Arthrex UNIVERS REVERS COATED BASEPLATE
Our reading of the summary gave K173271, FDA’s number for Aesculap Slim Clip Applier Forceps (Aesculap, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Arthrex Revers Coated Baseplate”.
Arthrex, Inc.2018—

Also cleared against K020345: 1 other device →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.20230

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 27 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
  • 10 of the 73 ancestors have a recall of any class.
  • Of its descendants, K230366 (Arthrex, Inc., 2023) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K020345.

How does its category compare?

All KWS devices

KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · KWS

3in 2025

2007: 22008: 42009: 42010: 72011: 112012: 72013: 122014: 72015: 82016: 102017: 72018: 42019: 92020: 32021: 52022: 52023: 42024: 22025: 32026 (partial year): 2
2007high 12 (2013) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWS

97in 2025

2008: 37 days median2009: 108 days median2010: 33 days median2011: 90 days median2012: 86 days median2013: 120 days median2014: 89 days median2015: 129 days median2016: 114 days median2017: 120 days median2018: 152 days median2019: 106 days median2020: 98 days median2021: 151 days median2022: 158 days median2023: 250 days median2025: 97 days median
2007high 250 (2023) · low 33 (2010)2026

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

Recalls per year · KWS

2in 2023

2007: 212008: 292010: 102011: 112012: 102014: 12016: 12017: 42018: 12019: 22020: 52023: 22026 (partial year): 1
2007high 29 (2008) · low 0 (2009)2026

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

Adverse event reports per year · KWS

2,281in 2025

2007: 1582008: 2382009: 2942010: 3932011: 4862012: 5422013: 8182014: 1,0662015: 1,1702016: 9702017: 1,6812018: 1,5452019: 1,7282020: 1,5672021: 1,3582022: 1,2682023: 1,7502024: 2,1222025: 2,281
2007high 2,281 (2025) · low 158 (2007)2025

MAUDE reports naming product code KWS, 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
20072—21158
200843729238
200941080294
201073310393
2011119011486
201278610542
2013121200818
201478911,066
2015812901,170
2016101141970
2017712041,681
2018415211,545
2019910621,728
202039851,567
2021515101,358
2022515801,268
2023425021,750
20242—02,122
202539702,281
20262—1—

What is it indicated for?

The Arthrex UNIVERS REVERS COATED BASEPLATE is designed to be used as the glenoid component of the existing Univers Revers Shoulder Prosthesis System. The Arthrex UNIVERS REVERS COATED BASEPLATE is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. The patient’s joint must be anatomically and structurally suited to receive the…

Read the full statement (551 words)

The Arthrex UNIVERS REVERS COATED BASEPLATE is designed to be used as the glenoid component of the existing Univers Revers Shoulder Prosthesis System.

The Arthrex UNIVERS REVERS COATED BASEPLATE is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. 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 Arthrex UNIVERS REVERS COATED BASEPLATE is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

The Arthrex UNIVERS REVERS COATED BASEPLATE is coated and is intended for cementless use with the addition of screws for fixation.

The Univers Revers Shoulder Prosthesis System is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. 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 Univers Revers Shoulder Prosthesis is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

(Humeral) Stems are intended for cemented or cementless applications for use with the Arthrex Humeral Suture Cups. The glenoid baseplate is CaP coated and is intended for cementless use with the addition of screws for fixation.

The Arthrex Univers Revers CA Heads and Adapters are indicated for salvage of a failed reverse total shoulder, with an irreparable rotator cuff tear and a well-fixed humeral stem, to an anatomic hemi-shoulder replacement; or conversion of a primary reverse total shoulder, for the relief of pain secondary to severe rotator cuff arthropathy and an irreparable rotator cuff tear, to anatomic hemi-shoulder replacement when insufficient glenoid bone stock is encountered intraoperatively after the humeral stem has been implanted.

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 Arthrex Univers Shoulder Fracture Prosthesis is indicated for severe pain or significant disability resulting from degenerative, rheumatoid, or traumatic disease or injury of the glenohumeral joint. This included traumatic or pathological conditions of the shoulder resulting in fracture of the glenohumeral joint, including impression fractures, comminuted fracture, humeral head fracture, displaced 3-or4-fragment proximal head fractures, avascular necrosis of the humeral head, and fractures of the anatomical neck.

The Arthrex Univers Shoulder Fracture Prosthesis is designed for cemented or non-cemented use. This device may be used for hemi or total shoulder repair, utilizing the appropriate Arthrex Univers Glenoid component, which is to be cemented in place.

The Arthrex UNIVERS II and UNIVERS APEX Shoulder Prosthesis is indicated in replacement(s) when conditions including severe pain or significant disability resulting from degenerative, theumatoid, traumatic disease, or injury of the glenohumeral joint; non-union humeral head fractures of long duration; irreducible 2- and 4-part proximal humeral fractures; avascular necrosis of the humeral head, or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.

The glenoid components are intended for cemented fixation in the joint and must only be used with appropriate bone cement.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K020345

1 other device cites the same predicate.

  • K181555Arthrex Fracture Adapter Hemi Shoulder ProsthesisArthrex, Inc. · 2018

More from Arthrex, Inc.

355 FDA decisions under this applicant name. See the company

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  • K262618Arthrex Spine Compression FT ScrewArthrex, Inc. · 2026
  • K262451Arthrex DynaNite StaplesArthrex, Inc. · 2026
  • K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K260624Arthrex Radial Head Replacement SystemArthrex, Inc. · 2026

Recent decisions in KWS

The KWS category page

  • K260721Tornier Perform Advanced GlenoidTornier, Inc. · 2026
  • K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026
  • K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc. · 2025
  • K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc. · 2025
  • K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A. · 2025

https://510kreport.com/device/K171841 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171841: Arthrex Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171841

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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