510(k) Report

510(k) · Cleared

Cleared

TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst)

K213827510(k) TraditionalCleared Mar 11, 202293-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

Smith & Nephew, Inc. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Cleared on Mar 11, 2022 as substantially equivalent to K142413 (Ascension Orthopedics, 2014) and 10 other predicates after a 93-day review. Its family tree reaches back 17 generations to 1991. 1 of the 122 devices in its family, counting itself, has a Class I recall.

Decided
Mar 11, 2022
Review
93 days
Class
Class II
Product code
KWS
Recalls
None
Predicates
11

Its longest line of descent runs back 17 generations to K911686 (1991). 121 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet. 1 of the 122 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 2019: 1 other ancestor2015: 1 other ancestor2014: 1 other ancestor2012: 2 other ancestors2010: 2 other ancestors2006: 10 other ancestors2004: 5 other ancestors2003: 7 other ancestors2007: 6 other ancestors2005: 7 other ancestors2001: 9 other ancestors1999: 7 other ancestors1998: 4 other ancestors1996: 5 other ancestors2011: 3 other ancestors2008: 5 other ancestors2000: 6 other ancestors1995: 3 other ancestors2009: 1 other ancestor1994: 1 other ancestor1992: 2 other ancestors1987: 5 other ancestors1980: 2 other ancestors2002: 1 other ancestor1997: 1 other ancestor1991: 2 other ancestors1979: 1 other ancestor1993: 1 other ancestor1988: 1 other ancestor1989: 1 other ancestor1986: 1 other ancestorK911686 · Global Total Shoulder, Uncement Humeral Hemi-Shoul · Depuy, Inc. · 1991×2: 2 generations cleared close together, K984541 (1999), K992065 (1999) ×3: 3 generations cleared close together, K021478 (2003), K030941 (2004), K041873 (2004) ×2: 2 generations cleared close together, K052906 (2005), K060704 (2006) K063569 · Equinoxe Reverse Shoulder System · Exactech, Inc. · 2007 · recalled×2: 2 generations cleared close together, K073688 (2008), K080642 (2008) K110599 · Aequalis Ascend Modular Reverse Shoulder System · Tornier, Inc. · 2011K120739 · Aequalis Adjustable Modular Reverse Shoulder System · Tornier, Inc. · 2012K130050 · Titan Reverse Shoulder System · Ascension Orthopedic · 2013K161189 · Integra TITAN Reverse Shoulder System · Integra LifeSciences Corporation · 2016×2: 2 generations cleared close together, K173717 (2018), K181999 (2018) 19801990200020102020
Other ancestors, by generation 1 generation back: 8 other ancestors2 generations back: 8 other ancestors3 generations back: 17 other ancestors4 generations back: 18 other ancestors5 generations back: 25 other ancestors6 generations back: 15 other ancestors7 generations back: 8 other ancestors8 generations back: 5 other ancestors K181999 · Integra TITAN Reverse Shoulder System · Integra LifeSciences Corporation · 2018K173717 · Integra TITAN Reverse Shoulder System · Integra LifeSciences Corporation · 2018K161189 · Integra TITAN Reverse Shoulder System · Integra LifeSciences Corporation · 2016K130050 · Titan Reverse Shoulder System · Ascension Orthopedic · 2013K120739 · Aequalis Adjustable Modular Reverse Shoulder System · Tornier, Inc. · 2012K110599 · Aequalis Ascend Modular Reverse Shoulder System · Tornier, Inc. · 2011K080642 · Comprehensive Reverse Shoulder · Biomet, Inc. · 2008 · Class I recallK073688 · Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw · Exactech, Inc. · 2008 · recalledK063569 · Equinoxe Reverse Shoulder System · Exactech, Inc. · 2007 · recalledK060704 · Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM · Zimmer, Inc. · 2006 · recalledK052906 · Zimmer Trabecular Metal Reverse Shoulder System · Zimmer, Inc. · 2005 · recalledK041873 · 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. · 1991−15−10−50
  1. Root · 17 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 13 generations between
  3. 3 generations backK161189 Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation · 2016
  4. 2 generations backK173717 Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation · 2018
  5. 1 generation backK181999 Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation · 2018
  6. This deviceK213827 TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System…Smith & Nephew, Inc. · 2022
Show all 17 generations
  1. Root · 17 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 16 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
  3. 15 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
  4. 14 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
  5. 13 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  6. 12 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  7. 11 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
  8. 10 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
  9. 9 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
  10. 8 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
  11. 7 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
  12. 6 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  13. 5 generations backK120739 Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc. · 2012
  14. 4 generations backK130050 Titan Reverse Shoulder SystemAscension Orthopedic · 2013
  15. 3 generations backK161189 Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation · 2016
  16. 2 generations backK173717 Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation · 2018
  17. 1 generation backK181999 Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation · 2018
  18. This deviceK213827 TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System…Smith & Nephew, Inc. · 2022

Class I recalls in this family

  • K080642 Comprehensive Reverse Shoulder4 generations back · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−17K911686Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc.1991—
−16K984541Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc.1999—
−15K992065Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage…DePuy Orthopaedics, Inc.1999—
−14K021478Delta ShoulderDepuy, Inc.2003—
−13K030941Aequalis Reversed Shoulder ProsthesisTornier2004—
−12K041873Aequalis Reversed Shoulder ProsthesisTornier2004—
−11K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.200512
−10K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc.200610
−9K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200713
−8K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081
−7K080642Comprehensive Reverse ShoulderBiomet, Inc.2008Class I
−6K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011—
−5K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.2012—
−4K130050Titan Reverse Shoulder SystemAscension Orthopedic2013—
−3K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation2016—
−2K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation2018—
−1K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation2018—
0 (this device)K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN…Smith & Nephew, Inc.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198020
198610
198750
198810
198910
199120
199220
199310
199410
199530
199650
199710
199840
199970
200060
200190
200210
200370
200450
200570
2006100
200760
200850
200910
201020
201130
201220
201410
201510
201910
FIG. 1 — Lineage of K213827, 1991–2022Source: 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.

1 device in this family has a Class I recall. 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? (11)

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
*K142413TITAN Modular Total Shoulder System
Summary page 8
…I, Elbow joint radial (hemi-elbow) polymer prosthesis (21 CFR 888.3170) Classification Class II Primary Predicate: 1. K142413 – TSS (Line Extension) Additional Predicates: 1. K100448 – TSS (Original)…
Ascension Orthopedics2014—
*K100448Ascension Modular Total Shoulder System
Summary page 8
…I Primary Predicate: 1. K142413 – TSS (Line Extension) Additional Predicates: 1. K100448 – TSS (Original) K112438 – TSS (Line Extension) Predicate Device K152047 – TSS (Line Extension…
Ascension Orthopedics, Inc.20101
*K112438Titan Modular Total Shoulder System
Summary page 8
…1. K142413 – TSS (Line Extension) Additional Predicates: 1. K100448 – TSS (Original) K112438 – TSS (Line Extension) Predicate Device K152047 – TSS (Line Extension) 2. K161189 – RSS (Indicati…
Ascension Orthopedic2012—
*K152047INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid
Summary page 8
…Additional Predicates: 1. K100448 – TSS (Original) K112438 – TSS (Line Extension) Predicate Device K152047 – TSS (Line Extension) 2. K161189 – RSS (Indication Add) K173717 – RSS (Design C…
Ascension Orthopedics2015—
*K161189Integra TITAN Reverse Shoulder System
Summary page 8
…1. K100448 – TSS (Original) K112438 – TSS (Line Extension) Predicate Device K152047 – TSS (Line Extension) 2. K161189 – RSS (Indication Add) K173717 – RSS (Design Change) K181999 – RSS (Line Exte…
Integra LifeSciences Corporation2016—
*K173717Integra TITAN Reverse Shoulder System
Summary page 8
…112438 – TSS (Line Extension) Predicate Device K152047 – TSS (Line Extension) 2. K161189 – RSS (Indication Add) K173717 – RSS (Design Change) K181999 – RSS (Line Extension) K190588 – RSS (Line Exte…
Integra LifeSciences Corporation2018—
*K181999Integra TITAN Reverse Shoulder System
Summary page 8
…K152047 – TSS (Line Extension) 2. K161189 – RSS (Indication Add) K173717 – RSS (Design Change) K181999 – RSS (Line Extension) K190588 – RSS (Line Extension) 3. K062861 – HRA…
Integra LifeSciences Corporation2018—
*K190588Integra TITAN Reverse Shoulder System
Summary page 8
…K161189 – RSS (Indication Add) K173717 – RSS (Design Change) K181999 – RSS (Line Extension) K190588 – RSS (Line Extension) 3. K062861 – HRA 4. K032686 – MRH 5.…
Integra LifeSciences Corporation2019—
*K062861Ascension Humeral Resurfacing Arthroplasty System
Summary page 8
…K173717 – RSS (Design Change) K181999 – RSS (Line Extension) K190588 – RSS (Line Extension) 3. K062861 – HRA 4. K032686 – MRH 5. K032806 – Katalyst The purpose of t…
Ascension Orthopedics, Inc.20061
*K032686Ascension Modular Radial Head
Summary page 8
…K181999 – RSS (Line Extension) K190588 – RSS (Line Extension) 3. K062861 – HRA 4. K032686 – MRH 5. K032806 – Katalyst The purpose of this submission is the addition of MR Con…
Ascension Orthopedics, Inc.2003—
*K032806Katalyst Radial Head Implant
Summary page 8
…nsion) K190588 – RSS (Line Extension) 3. K062861 – HRA 4. K032686 – MRH 5. K032806 – Katalyst The purpose of this submission is the addition of MR Conditional information to the labeling of…
Kinetikos Medical, Inc.2004—

Also cleared against K142413: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 31 years and passes through 10 companies; a new generation was cleared every 1.0 years on median.
  • 34 of the 121 ancestors have a recall of any class; 1 has a Class I recall.
  • 1 other device also cites its predicate K142413.

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. 2022, 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 TITAN Modular Total Shoulder System is indicated for use as a hemi or total shoulder replacement for: * Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. * Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory. *…

Read the full statement (461 words)

The TITAN Modular Total Shoulder System is indicated for use as a hemi or total shoulder replacement for:

* Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis.

* Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.

* Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component).

Shoulder Hemiarthroplasty is also indicated for:

* Ununited humeral head fractures.

* Avascular necrosis of the humeral head.

* Rotator cuff arthropathy.

* Deformity and/or limited motion.

The humeral component is intended for cemented or uncemented use. The glenoid component is intended for cemented use only.

The TITAN Reverse Shoulder System is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff joint. The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The Titan Reverse Shoulder System is indicated for primary, fractures including proximal humeral, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is indicated for cemented or uncemented use and the humeral body component is intended for cementless use.

The Ascension HRA System is intended for resurfacing of the humeral head due to:

- Patients disabled by either non-inflammatory or inflammatory arthritis (i.e. rheumatoid arthritis, osteoarthritis and avascular necrosis)

- Mild or moderate humeral head deformity and/or limited motion

- Post-traumatic arthritis

- Malunions of the humeral head

- Acute fractures of the humeral head

- Patients with an intact or reparable rotator cuff

Contraindications:

- Infection, sepsis, and osteomyelitis

- Osteoporosis

- Metabolic disorders which may impair bone formation

- Osteomalacia

- Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram

- Revision procedures where other devices or treatments have failed

The Ascension Modular Radial Head is intended for:

* Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnarjoint with:

- joint destruction or subluxation visible on x-ray

- resistance to conservative treatment

* Primary replacement after fracture of the radial head

* Symptomatic sequelae after radial head resection

* Revision following failed radial head arthroplasty

The Katalyst Radial Head system is generally indicated for use in radial head replacement arthroplasty.

Use of the implant is contraindicated in those cases where complete avascular necrosis has rendered bone stock inadequate.

Indications for use as stated in the FDA summary.

Also cleared against K142413

1 other device cites the same predicate.

  • K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026

More from Smith & Nephew, Inc.

692 FDA decisions under this applicant name. See the company

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  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
  • K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981)…Smith & Nephew, Inc. · 2026
  • DEN250037TESSA Spatial Surgery System; INTELLIO Tablet (72205455)Smith & Nephew, Inc. · 2026
  • K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, 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/K213827 · printed Nov 4, 2026

Cite this page

510(k) Report. “K213827: TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213827

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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