510(k) Report

510(k) · Cleared

Cleared

Aequalis Universal Shoulder Glenoid

K994393510(k) TraditionalCleared Jun 22, 2000177-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 · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Cleared on Jun 22, 2000 after a 177-day review. The FDA summary names no predicate by number. 81 later devices descend from it.

Decided
Jun 22, 2000
Review
177 days
Class
Class II
Product code
KWS
Recalls
None
Predicates
0

81 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2010: 6 descendants cleared2004: 1 descendant cleared2017: 3 descendants cleared2011: 4 descendants cleared2018: 8 descendants cleared2006: 2 descendants cleared2015: 4 descendants cleared2014: 2 descendants cleared2012: 3 descendants cleared2026: 8 descendants cleared2021: 4 descendants cleared2020: 2 descendants cleared2013: 1 descendant cleared2025: 9 descendants cleared2023: 7 descendants cleared2022: 4 descendants cleared2019: 3 descendants cleared2024: 7 descendants cleared2016: 3 descendants cleared200020052010201520202025
  1. This deviceK994393 Aequalis Universal Shoulder GlenoidTornier · 2000
  2. Descendant · cites it directly · 71 of its ownK042021 Exactech Equinoxe Shoulder SystemExactech, Inc. · 2004 · Recalled
  3. Descendant · cites it directly · 24 of its ownK093430 Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech…Exactech, Inc. · 2010 · Recalled
  4. Descendant · 2 generations on · 22 of its ownK103419 Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc. · 2010 · Recalled
  5. Descendant · 3 generations on · 21 of its ownK111379 Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium…Exactech, Inc. · 2011 · Recalled
  6. Descendant · 4 generations on · 20 of its ownK121220 Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small…Exactech, Inc. · 2012 · Recalled

Showing 5 of 81 descendants. See all descendants

Descendants cleared per year

2004: 12006: 22010: 62011: 42012: 32013: 12014: 22015: 42016: 32017: 32018: 82019: 32020: 22021: 42022: 42023: 72024: 72025: 92026: 8
2004high 9 (2025) · low 0 (2005)2026

Most influential descendants

Showing 5 of 81 · See all
  • K042021Exactech Equinoxe Shoulder SystemExactech, Inc. · 2004 · cites it directly71descendants
  • K093430Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid…Exactech, Inc. · 2010 · cites it directly24descendants
  • K103419Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc. · 2010 · 2 generations on22descendants
  • K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc. · 2011 · 3 generations on21descendants
  • K121220Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/RightExactech, Inc. · 2012 · 4 generations on20descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K994393Aequalis Universal Shoulder GlenoidTornier2000—
+1K042021Exactech Equinoxe Shoulder SystemExactech, Inc.200410
+1K093430Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage…Exactech, Inc.20101
+2K103419Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc.20102
+3K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc.20112
+4K121220Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/RightExactech, Inc.20122

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200620
201060
201140
201230
201310
201420
201540
201630
201730
201880
201930
202020
202140
202240
202370
202470
202590
202680
FIG. 1 — Lineage of K994393, 2000–2026Source: 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 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?

The FDA summary names no predicate by number.

What descends from it? (81)

See all 81

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

NumberDeviceApplicantDecidedDescendants
K042021Exactech Equinoxe Shoulder SystemExactech, Inc.200471
K093430Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid…Exactech, Inc.201024
K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.20178

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?

  • Of its descendants, K042021 (Exactech, Inc., 2004) has gone furthest, with 71 descendants of its own.

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.

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 this device may be indicated to relieve severe pain

or significant disability in degenerative, rheumatoid, or traumatic disease of the

glenohumeral joint; non-union humeral head fracture; displaced 3 and 4 part

proximal humeral fractures; avascular necrosis of the humeral head; or

other difficult management problems where arthrodesis or resectional

arthroplasty are not acceptable.

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

More from Tornier

44 FDA decisions under this applicant name. See the company

  • K112144Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis Reversed Fracture…Tornier · 2012
  • K111970Kneetec PFJ&HLS Kneetec Patellar ComponentTornier · 2012
  • K111902Aequalis Shoulder SystemTornier · 2011
  • K094013HLS Kneetec SystemTornier · 2011
  • K100142Aequalis Reversed Shoulder ProsthesisTornier · 2010

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/K994393 · printed Nov 4, 2026

Cite this page

510(k) Report. “K994393: Aequalis Universal Shoulder Glenoid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994393

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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