510(k) Report

510(k) · Cleared

Cleared

Aequalis Press-Fit Shoulder Prosthesis

K011942510(k) SpecialCleared Jul 13, 200122-day reviewClass II21 CFR 888.3690

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Tornier · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Cleared on Jul 13, 2001 after a 22-day review. The FDA summary names no predicate by number. 111 later devices descend from it.

Decided
Jul 13, 2001
Review
22 days
Class
Class II
Product code
HSD
Recalls
None
Predicates
0

111 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2011: 4 descendants cleared2012: 1 descendant cleared2015: 2 descendants cleared2014: 4 descendants cleared2013: 3 descendants cleared2016: 2 descendants cleared2026: 13 descendants cleared2023: 10 descendants cleared2022: 14 descendants cleared2019: 8 descendants cleared2017: 4 descendants cleared2025: 12 descendants cleared2021: 10 descendants cleared2018: 5 descendants cleared2024: 10 descendants cleared2020: 9 descendants cleared200020052010201520202025
  1. This deviceK011942 Aequalis Press-Fit Shoulder ProsthesisTornier · 2001
  2. Descendant · cites it directly · 110 of its ownK102924 Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc. · 2011
  3. Descendant · 2 generations on · 108 of its ownK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  4. Descendant · 3 generations on · 97 of its ownK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  5. Descendant · 4 generations on · 96 of its ownK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
  6. Descendant · 5 generations on · 29 of its ownK140082 Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S. · 2014

Showing 5 of 111 descendants. See all descendants

Descendants cleared per year

2011: 42012: 12013: 32014: 42015: 22016: 22017: 42018: 52019: 82020: 92021: 102022: 142023: 102024: 102025: 122026: 13
2011high 14 (2022) · low 1 (2012)2026

Most influential descendants

Showing 5 of 111 · See all
  • K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc. · 2011 · cites it directly110descendants
  • K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · 2 generations on108descendants
  • K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · 3 generations on97descendants
  • K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · 4 generations on96descendants
  • K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S. · 2014 · 5 generations on29descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011942Aequalis Press-Fit Shoulder ProsthesisTornier2001—
+1K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.2011—
+2K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011—
+3K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011—
+4K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.20132
+5K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201140
201210
201330
201440
201520
201620
201740
201850
201980
202090
2021100
2022140
2023100
2024100
2025120
2026130
FIG. 1 — Lineage of K011942, 2001–2026Source: 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 HSD? 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 HSD device

  1. #1 K191433 AGILON® XO Shoulder Replacement Systemscore 13.8 · 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? (111)

See all 111

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

NumberDeviceApplicantDecidedDescendants
K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.2011110

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, K102924 (Tornier, Inc., 2011) has gone furthest, with 110 descendants of its own.

How does its category compare?

All HSD devices

HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HSD

1in 2024

2007: 42008: 32011: 22012: 22013: 42014: 12016: 32018: 12020: 22022: 12024: 1
2007high 4 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSD

145in 2016

2007: 72 days median2008: 92 days median2013: 218 days median2016: 145 days median
2007high 218 (2013) · low 72 (2007)2026

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

Recalls per year · HSD

1in 2020

2008: 22009: 22017: 32018: 12020: 1
2007high 3 (2017) · low 0 (2007)2026

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

Adverse event reports per year · HSD

757in 2025

2007: 1282008: 2592009: 1562010: 2252011: 2412012: 2542013: 2882014: 4342015: 5742016: 7842017: 9852018: 6492019: 8302020: 6582021: 5732022: 5082023: 5862024: 6932025: 757
2007high 985 (2017) · low 128 (2007)2025

MAUDE reports naming product code HSD, 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
20074720128
20083922259
20090—2156
20100—0225
20112—0241
20122—0254
201342180288
20141—0434
20150—0574
201631450784
20170—3985
20181—1649
20190—0830
20202—1658
20210—0573
20221—0508
20230—0586
20241—0693
20250—0757
20260—0—

What is it indicated for?

Primary, secondary or post-traumatic osteoarthritis, rheumatoid arthritis,

severe joint pain of osteoarticular origin compromising the patients quality

of life, joints which are defective in shape and function, a revision

intervention on a previous arthroplasty, and disorders in which arthrodesis

is not an acceptable option.

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 HSD

The HSD category page

  • K233260Univers Revers CA Head and AdapterArthrex, Inc. · 2024
  • K221232Univers Revers Humeral Cup ImplantArthrex, Inc. · 2022
  • K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH · 2020
  • K193122Biocore9 Humeral Resurfacing SystemBiocore9, LLC · 2020
  • K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc. · 2018

https://510kreport.com/device/K011942 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011942: Aequalis Press-Fit Shoulder Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011942

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