510(k) Report

510(k) · Cleared

Cleared

Aequalis Shoulder Fracture System

K994392510(k) TraditionalCleared Mar 10, 200073-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 Mar 10, 2000 after a 73-day review. The FDA summary names no predicate by number. 290 later devices descend from it.

Decided
Mar 10, 2000
Review
73 days
Class
Class II
Product code
KWS
Recalls
None
Predicates
0

290 later devices descend from it, 10 citing it directly.

Descendants, by year cleared 2004: 2 descendants cleared2006: 7 descendants cleared2008: 3 descendants cleared2014: 14 descendants cleared2003: 1 descendant cleared2012: 9 descendants cleared2011: 12 descendants cleared2010: 7 descendants cleared2018: 20 descendants cleared2017: 15 descendants cleared2015: 9 descendants cleared2013: 8 descendants cleared2026: 23 descendants cleared2020: 19 descendants cleared2016: 13 descendants cleared2019: 21 descendants cleared2007: 2 descendants cleared2021: 23 descendants cleared2025: 23 descendants cleared2023: 17 descendants cleared2022: 23 descendants cleared2024: 19 descendants cleared200020052010201520202025
  1. This deviceK994392 Aequalis Shoulder Fracture SystemTornier · 2000
  2. Descendant · cites it directly · 287 of its ownK032679 Aequalis Shoulder Fracture SystemTornier · 2003
  3. Descendant · cites it directly · 258 of its ownK043077 Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder…Tornier · 2004
  4. Descendant · cites it directly · 257 of its ownK060209 Aequalis Shoulder Fracture System & Aequalis Shoulder SystemTornier · 2006
  5. Descendant · 2 generations on · 199 of its ownK061439 Aequalis Reversed ProsthesisTornier · 2006
  6. Descendant · 2 generations on · 179 of its ownK081059 Aequalis Reversed Shoulder ProsthesisTornier · 2008

Showing 5 of 290 descendants. See all descendants

Descendants cleared per year

2003: 12004: 22006: 72007: 22008: 32010: 72011: 122012: 92013: 82014: 142015: 92016: 132017: 152018: 202019: 212020: 192021: 232022: 232023: 172024: 192025: 232026: 23
2003high 23 (2021) · low 0 (2005)2026

Most influential descendants

Showing 5 of 290 · See all
  • K032679Aequalis Shoulder Fracture SystemTornier · 2003 · cites it directly287descendants
  • K043077Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder SystemTornier · 2004 · cites it directly258descendants
  • K060209Aequalis Shoulder Fracture System & Aequalis Shoulder SystemTornier · 2006 · cites it directly257descendants
  • K061439Aequalis Reversed ProsthesisTornier · 2006 · 2 generations on199descendants
  • K081059Aequalis Reversed Shoulder ProsthesisTornier · 2008 · 2 generations on179descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K994392Aequalis Shoulder Fracture SystemTornier2000—
+1K032679Aequalis Shoulder Fracture SystemTornier2003—
+1K043077Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder SystemTornier2004—
+1K060209Aequalis Shoulder Fracture System & Aequalis Shoulder SystemTornier2006—
+2K061439Aequalis Reversed ProsthesisTornier2006—
+2K081059Aequalis Reversed Shoulder ProsthesisTornier2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200420
200670
200720
200830
201070
2011120
201290
201380
2014140
201590
2016130
2017150
2018200
2019210
2020190
2021230
2022230
2023170
2024190
2025230
2026230
FIG. 1 — Lineage of K994392, 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? (290)

See all 290

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

NumberDeviceApplicantDecidedDescendants
K032679Aequalis Shoulder Fracture SystemTornier2003287
K043077Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder SystemTornier2004258
K060209Aequalis Shoulder Fracture System & Aequalis Shoulder SystemTornier2006257
K082120Aequalis Reversed Fracture Shoulder ProthesisTornier2008164
K042021Exactech Equinoxe Shoulder SystemExactech, Inc.200471
K111902Aequalis Shoulder SystemTornier201149
K140071Humelock II Cemented Shoulder SystemFx Solutions201431
K081707Aequalis Shoulder Fracture and Shoulder SystemsTornier, Inc.200825
K112144Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier201223
K062661Aequalis Resurfacing HeadTornier200616

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, K032679 (Tornier, 2003) has gone furthest, with 287 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?

Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint. Including humeral head fracture and displaced 3 or 4 part proximal humeral fractures.

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/K994392 · printed Nov 4, 2026

Cite this page

510(k) Report. “K994392: Aequalis Shoulder Fracture System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994392

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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