510(k) Report

510(k) · Cleared

Cleared

Tornier Perform Advanced Glenoid

K260721510(k) TraditionalCleared Jul 22, 2026139-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

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

Cleared on Jul 22, 2026 as substantially equivalent to K160975 (Tornier, Inc., 2016) and 5 other predicates after a 139-day review. Its family tree reaches back 18 generations to 1991. 1 of the 211 devices in its family, counting itself, has a Class I recall.

Decided
Jul 22, 2026
Review
139 days
Class
Class II
Product code
KWS
Recalls
None
Predicates
6

Its longest line of descent runs back 18 generations to K911686 (1991). 210 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet. 1 of the 211 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 2020: 1 other ancestor2016: 2 other ancestors2011: 8 other ancestors2009: 4 other ancestors2019: 1 other ancestor2015: 1 other ancestor2010: 6 other ancestors2007: 7 other ancestors2006: 13 other ancestors2000: 15 other ancestors1998: 8 other ancestors1995: 11 other ancestors2018: 1 other ancestor2012: 7 other ancestors2005: 8 other ancestors2004: 8 other ancestors2003: 7 other ancestors2002: 4 other ancestors1999: 7 other ancestors1996: 10 other ancestors1993: 1 other ancestor1992: 2 other ancestors1991: 3 other ancestors1989: 1 other ancestor1987: 5 other ancestors1986: 1 other ancestor1979: 1 other ancestor2017: 1 other ancestor2014: 4 other ancestors2008: 9 other ancestors2001: 12 other ancestors1994: 10 other ancestors2013: 3 other ancestors1997: 6 other ancestors1980: 2 other ancestors1988: 1 other ancestor1990: 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) ×2: 2 generations cleared close together, K110599 (2011), K112615 (2011) K122698 · Aequalis Ascend Flex Shoulder System · Tornier S.A.S. · 2013 · recalledK132285 · Aequalis Reversed Shoulder Prosthesis · Tornier S.A.S. · 2013K151293 · Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis · Tornier S.A.S. · 2015K190521 · Aequalis Ascend Flex Shoulder System · Tornier S.A.S. · 2019K201315 · PERFORM Humeral System – Stem · Tornier, Inc. · 2020 · recalled19801990200020102020
Other ancestors, by generation 1 generation back: 5 other ancestors2 generations back: 12 other ancestors3 generations back: 27 other ancestors4 generations back: 26 other ancestors5 generations back: 21 other ancestors6 generations back: 25 other ancestors7 generations back: 24 other ancestors8 generations back: 18 other ancestors9 generations back: 14 other ancestors10 generations back: 8 other ancestors11 generations back: 11 other ancestors12 generations back: 1 other ancestor K201315 · PERFORM Humeral System – Stem · Tornier, Inc. · 2020 · recalledK190521 · Aequalis Ascend Flex Shoulder System · Tornier S.A.S. · 2019K151293 · Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis · Tornier S.A.S. · 2015K132285 · Aequalis Reversed Shoulder Prosthesis · Tornier S.A.S. · 2013K122698 · Aequalis Ascend Flex Shoulder System · Tornier S.A.S. · 2013 · recalledK112615 · Aequalis Ascend Modular Reverse Shoulder System · Tornier, Inc. · 2011K110599 · 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 · 18 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 14 generations between
  3. 3 generations backK151293 Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder…Tornier S.A.S. · 2015
  4. 2 generations backK190521 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2019
  5. 1 generation backK201315 PERFORM Humeral System – StemTornier, Inc. · 2020 · Recalled
  6. This deviceK260721 Tornier Perform Advanced GlenoidTornier, Inc. · 2026
Show all 18 generations
  1. Root · 18 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 17 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
  3. 16 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
  4. 15 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
  5. 14 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  6. 13 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  7. 12 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
  8. 11 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
  9. 10 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
  10. 9 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
  11. 8 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
  12. 7 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  13. 6 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  14. 5 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
  15. 4 generations backK132285 Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2013
  16. 3 generations backK151293 Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder…Tornier S.A.S. · 2015
  17. 2 generations backK190521 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2019
  18. 1 generation backK201315 PERFORM Humeral System – StemTornier, Inc. · 2020 · Recalled
  19. This deviceK260721 Tornier Perform Advanced GlenoidTornier, Inc. · 2026

Class I recalls in this family

  • K080642 Comprehensive Reverse Shoulder6 generations back · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−18K911686Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc.1991—
−17K984541Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc.1999—
−16K992065Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage…DePuy Orthopaedics, Inc.1999—
−15K021478Delta ShoulderDepuy, Inc.2003—
−14K030941Aequalis Reversed Shoulder ProsthesisTornier2004—
−13K041873Aequalis Reversed Shoulder ProsthesisTornier2004—
−12K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.200512
−11K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc.200610
−10K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200713
−9K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081
−8K080642Comprehensive Reverse ShoulderBiomet, Inc.2008Class I
−7K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011—
−6K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011—
−5K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.20132
−4K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.2013—
−3K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.2015—
−2K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2019—
−1K201315PERFORM Humeral System – StemTornier, Inc.20201
0 (this device)K260721Tornier Perform Advanced GlenoidTornier, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198020
198610
198750
198810
198910
199010
199130
199220
199310
1994100
1995110
1996100
199760
199880
199970
2000150
2001120
200240
200370
200480
200580
2006130
200770
200890
200940
201060
201180
201270
201330
201440
201510
201620
201710
201810
201910
202010
FIG. 1 — Lineage of K260721, 1991–2026Source: 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.

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? (6)

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
*K160975Aequalis PerFORM+ Shoulder System
Summary page 5
…r 888.3660 Product Code(s) KWS | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K160975 Tornier Perform Anatomic Augmented Glenoid (Aequalis KWS PerFORM+ Shoulder System) K111902 Tornier Perform Anatomic Glenoid KWS K…
Tornier, Inc.2016—
*K111902Aequalis Shoulder System
Summary page 5
…dicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K160975 Tornier Perform Anatomic Augmented Glenoid (Aequalis KWS PerFORM+ Shoulder System) K111902 Tornier Perform Anatomic Glenoid KWS K201315 Tornier Perform Humeral System - Stem KWT K102670 Total Shoulder System KWS K091196…
Tornier2011—
*K201315PERFORM Humeral System – Stem
Summary page 5
…ate is listed first) Product Code K160975 Tornier Perform Anatomic Augmented Glenoid (Aequalis KWS PerFORM+ Shoulder System) K111902 Tornier Perform Anatomic Glenoid KWS K201315 Tornier Perform Humeral System - Stem KWT K102670 Total Shoulder System KWS K091196 GRS Glenoid Resurfacing System KWS K202289 Re…
Tornier, Inc.20201
*K102670Total Shoulder System
Summary page 5
…Perform Anatomic Augmented Glenoid (Aequalis KWS PerFORM+ Shoulder System) K111902 Tornier Perform Anatomic Glenoid KWS K201315 Tornier Perform Humeral System - Stem KWT K102670 Total Shoulder System KWS K091196 GRS Glenoid Resurfacing System KWS K202289 ReUnion Reversible Fracture System (RFX), ReUnion Re…
Shoulder Innovations, LLC2011—
*K091196GRS Glenoid Resurfacing System
Summary page 5
…(Aequalis KWS PerFORM+ Shoulder System) K111902 Tornier Perform Anatomic Glenoid KWS K201315 Tornier Perform Humeral System - Stem KWT K102670 Total Shoulder System KWS K091196 GRS Glenoid Resurfacing System KWS K202289 ReUnion Reversible Fracture System (RFX), ReUnion Reverse KWS Shoulder Arthroplasty Sy…
Arthrosurface, Inc.2009—
*K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…
Summary page 5
…11902 Tornier Perform Anatomic Glenoid KWS K201315 Tornier Perform Humeral System - Stem KWT K102670 Total Shoulder System KWS K091196 GRS Glenoid Resurfacing System KWS K202289 ReUnion Reversible Fracture System (RFX), ReUnion Reverse KWS Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthropl…
Stryker GmbH2020—

Also cleared against K160975: 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 · 6 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 35 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
  • 57 of the 210 ancestors have a recall of any class; 1 has a Class I recall.
  • 1 other device also cites its predicate K160975.

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. 2026, 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?

Prosthetic replacement with the Tornier Perform Advanced Glenoid implants may be indicated to relieve severe pain or significant disability caused by: • Degenerative pathologies: osteoarthritis and post-traumatic arthritis • Revision surgery when other treatments or devices have failed if sufficient bone stock remains Refer to the Indications for the compatible humeral systems. Tornier Perform Advanced Glenoid is compatible with the following humeral…

Read the full statement (150 words)

Prosthetic replacement with the Tornier Perform Advanced Glenoid implants may be indicated to relieve severe pain or significant disability caused by:

• Degenerative pathologies: osteoarthritis and post-traumatic arthritis

• Revision surgery when other treatments or devices have failed if sufficient bone stock remains

Refer to the Indications for the compatible humeral systems. Tornier Perform Advanced Glenoid is compatible with the following humeral systems:

• Tornier Perform Humeral System - Stem

• Tornier Perform Humeral System - Stemless

• Tornier Perform Humeral System - Fracture

• Tornier HRS

• Tornier HRS Max

• Tornier Flex Shoulder System

• Tornier Simpliciti Shoulder System

• ReUnion Shoulder System

Tornier Perform Advanced Glenoid is intended for cemented use only.

Tornier Perform humeral components are intended for cemented and un-cemented use, except for stemless systems (Tornier Perform Humeral System - Stemless and the Tornier Simpliciti Shoulder System) which are intended for press-fit (un-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.

Also cleared against K160975

1 other device cites the same predicate.

  • K220847AETOS Shoulder SystemSmith & Nephew, Inc. · 2023

More from Tornier, Inc.

52 FDA decisions under this applicant name. See the company

  • K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc. · 2026
  • K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc. · 20251 recall
  • K230352Tornier Humeral Nail and Tornier Long Humeral NailTornier, Inc. · 2023
  • K220914Tornier Perform Humeral System – FractureTornier, Inc. · 2022
  • K220418Tornier Perform Humeral System – StemlessTornier, Inc. · 20221 recall

Recent decisions in KWS

The KWS category page

  • 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
  • K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)Stryker Corporation (Tornier, Inc.) · 2024

https://510kreport.com/device/K260721 · printed Nov 6, 2026

Cite this page

510(k) Report. “K260721: Tornier Perform Advanced Glenoid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260721

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Record history
  • FDA decision record loaded Oct 30, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026