510(k) Report

510(k) · Cleared

Cleared

Aequalis Shoulder Fracture and Shoulder Systems

K081707510(k) SpecialCleared Jul 17, 200830-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 17, 2008 as substantially equivalent to K994392 (Tornier, 2000) and 9 other predicates after a 30-day review. Its family tree reaches back 5 generations to 1993. 25 later devices descend from it.

Decided
Jul 17, 2008
Review
30 days
Class
Class II
Product code
KWS
Recalls
None
Predicates
10

Its longest line of descent runs back 5 generations to K920362 (1993). 23 ancestors in all, the oldest K790987 (1979). 25 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2004: 1 other ancestor2001: 1 other ancestor2000: 2 other ancestors1999: 3 other ancestors1995: 1 other ancestor1996: 1 other ancestor1991: 3 other ancestors1987: 2 other ancestors1979: 1 other ancestor1998: 1 other ancestor1992: 1 other ancestor2010: 2 descendants cleared2011: 2 descendants cleared2023: 4 descendants cleared2022: 2 descendants cleared2012: 1 descendant cleared2026: 2 descendants cleared2019: 2 descendants cleared2015: 1 descendant cleared2018: 3 descendants cleared2016: 2 descendants cleared2025: 3 descendants cleared2024: 1 descendant clearedK920362 · 3M Modular Shoulder System · 3M Health Care, Ltd. · 1993K002683 · WMT Ultra-Fit Modular Shoulder System · Wrightmedicaltechnologyinc · 2000K032679 · Aequalis Shoulder Fracture System · Tornier · 2003K043077 · Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder System · Tornier · 2004K060209 · Aequalis Shoulder Fracture System & Aequalis Shoulder System · Tornier · 200619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 7 other ancestors3 generations back: 3 other ancestors4 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 3 descendants4 generations forward: 3 descendants5 generations forward: 2 descendants6 generations forward: 3 descendants7 generations forward: 5 descendants8 generations forward: 4 descendants9 generations forward: 2 descendants K060209 · Aequalis Shoulder Fracture System & Aequalis Shoulder System · Tornier · 2006K043077 · Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder System · Tornier · 2004K032679 · Aequalis Shoulder Fracture System · Tornier · 2003K002683 · WMT Ultra-Fit Modular Shoulder System · Wrightmedicaltechnologyinc · 2000K920362 · 3M Modular Shoulder System · 3M Health Care, Ltd. · 1993−50+5
  1. Root · 5 generations backK920362 3M Modular Shoulder System3M Health Care, Ltd. · 1993
  2. 4 generations backK002683 WMT Ultra-Fit Modular Shoulder SystemWrightmedicaltechnologyinc · 2000
  3. 3 generations backK032679 Aequalis Shoulder Fracture SystemTornier · 2003
  4. 2 generations backK043077 Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder…Tornier · 2004
  5. 1 generation backK060209 Aequalis Shoulder Fracture System & Aequalis Shoulder SystemTornier · 2006
  6. This deviceK081707 Aequalis Shoulder Fracture and Shoulder SystemsTornier, Inc. · 2008
  7. Descendant · cites it directly · 24 of its ownK093430 Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech…Exactech, Inc. · 2010 · Recalled
  8. Descendant · 2 generations on · 22 of its ownK103419 Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc. · 2010 · Recalled
  9. Descendant · 3 generations on · 21 of its ownK111379 Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium…Exactech, Inc. · 2011 · Recalled
  10. Descendant · 4 generations on · 20 of its ownK121220 Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small…Exactech, Inc. · 2012 · Recalled
  11. Descendant · 5 generations on · 16 of its ownK150583 Aequalis PerFORM+ Shoulder SystemTornier, Inc. · 2015

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2010: 22011: 22012: 12015: 12016: 22018: 32019: 22022: 22023: 42024: 12025: 32026: 2
2010high 4 (2023) · low 0 (2013)2026

Most influential descendants

Showing 5 of 25 · See all
  • 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
  • K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc. · 2015 · 5 generations on16descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K9203623M Modular Shoulder System3M Health Care, Ltd.1993—
−4K002683WMT Ultra-Fit Modular Shoulder SystemWrightmedicaltechnologyinc2000—
−3K032679Aequalis Shoulder Fracture SystemTornier2003—
−2K043077Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder SystemTornier2004—
−1K060209Aequalis Shoulder Fracture System & Aequalis Shoulder SystemTornier2006—
0 (this device)K081707Aequalis Shoulder Fracture and Shoulder SystemsTornier, Inc.2008—
+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
+5K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198720
199130
199210
199510
199610
199810
199930
200020
200110
200410
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201020
201120
201210
201510
201620
201830
201920
202220
202340
202410
202530
202620
FIG. 1 — Lineage of K081707, 1993–2026Source: 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? (10)

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
*K994392Aequalis Shoulder Fracture System
Summary page 1
…- constrained cemented prosthesis; Class II PRODUCT CODES: 87 KWS PREDICATE DEVICES: Aequalis Shoulder Fracture System: K994392, K1003728, K012212, K1032679 and K060209 Aequalis Shoulder System: K952928, K980244, K,012212, 1K041339, K043077 and K060209 DV…
Tornier2000—
*K003728Modification to Aequalis Shoulder Fracture System
Summary page 1
…constrained cemented prosthesis; Class II PRODUCT CODES: 87 KWS PREDICATE DEVICES: Aequalis Shoulder Fracture System: K994392, K1003728, K012212, K1032679 and K060209 Aequalis Shoulder System: K952928, K980244, K,012212, 1K041339, K043077 and K060209 DVO (now Tor…
Tornier2000—
*K012212Modification to Aequalis Shoulder System
Summary page 1
…constrained cemented prosthesis; Class II PRODUCT CODES: 87 KWS PREDICATE DEVICES: Aequalis Shoulder Fracture System: K994392, K1003728, K012212, K1032679 and K060209 Aequalis Shoulder System: K952928, K980244, K,012212, 1K041339, K043077 and K060209 DVO (now Tornier) Tot…
Tornier2001—
*K032679Aequalis Shoulder Fracture System
Summary page 1
…constrained cemented prosthesis; Class II PRODUCT CODES: 87 KWS PREDICATE DEVICES: Aequalis Shoulder Fracture System: K994392, K1003728, K012212, K1032679 and K060209 Aequalis Shoulder System: K952928, K980244, K,012212, 1K041339, K043077 and K060209 DVO (now Tornier) Total and Hem…
Tornier2003—
*K060209Aequalis Shoulder Fracture System & Aequalis Shoulder System
Summary page 1
…ned cemented prosthesis; Class II PRODUCT CODES: 87 KWS PREDICATE DEVICES: Aequalis Shoulder Fracture System: K994392, K1003728, K012212, K1032679 and K060209 Aequalis Shoulder System: K952928, K980244, K,012212, 1K041339, K043077 and K060209 DVO (now Tornier) Total and Hemi Shoulder S…
Tornier2006—
*K952928Aequalis Shoulder System for Total & Hemishoulder Applications
Summary page 1
…PRODUCT CODES: 87 KWS PREDICATE DEVICES: Aequalis Shoulder Fracture System: K994392, K1003728, K012212, K1032679 and K060209 Aequalis Shoulder System: K952928, K980244, K,012212, 1K041339, K043077 and K060209 DVO (now Tornier) Total and Hemi Shoulder System: K060988 DEVICE DESCRIPTION…
Tornier1995—
*K980244Aequalis Shoulder Prosthesis
Summary page 1
…ODES: 87 KWS PREDICATE DEVICES: Aequalis Shoulder Fracture System: K994392, K1003728, K012212, K1032679 and K060209 Aequalis Shoulder System: K952928, K980244, K,012212, 1K041339, K043077 and K060209 DVO (now Tornier) Total and Hemi Shoulder System: K060988 DEVICE DESCRIPTION: The lab…
Tornier1999—
*K041339Aequalis Shoulder System
Summary page 1
…87 KWS PREDICATE DEVICES: Aequalis Shoulder Fracture System: K994392, K1003728, K012212, K1032679 and K060209 Aequalis Shoulder System: K952928, K980244, K,012212, 1K041339, K043077 and K060209 DVO (now Tornier) Total and Hemi Shoulder System: K060988 DEVICE DESCRIPTION: The labeling for the Aequal…
Tornier2004—
*K043077Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder System
Summary page 1
…PREDICATE DEVICES: Aequalis Shoulder Fracture System: K994392, K1003728, K012212, K1032679 and K060209 Aequalis Shoulder System: K952928, K980244, K,012212, 1K041339, K043077 and K060209 DVO (now Tornier) Total and Hemi Shoulder System: K060988 DEVICE DESCRIPTION: The labeling for the Aequalis Should…
Tornier2004—
*K060988Total and Hemi Shoulder System
Summary page 1
…28, K012212, K1032679 and K060209 Aequalis Shoulder System: K952928, K980244, K,012212, 1K041339, K043077 and K060209 DVO (now Tornier) Total and Hemi Shoulder System: K060988 DEVICE DESCRIPTION: The labeling for the Aequalis Shoulder Fracture System and Aequalis Shoulder System is being modified to in…
Dvo Extremity Solutions, LLC200613

Also cleared against K994392: 9 other devices →

What descends from it? (25)

See all 25

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

NumberDeviceApplicantDecidedDescendants
K093430Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid…Exactech, Inc.201024

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?

  • The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
  • 1 of the 23 ancestors has a recall of any class.
  • Of its descendants, K093430 (Exactech, Inc., 2010) has gone furthest, with 24 descendants of its own.
  • 9 other devices also cite its predicate K994392.

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. 2008, 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?

Aequalis Shoulder System (excluding Aequalis Shoulder Fracture System): Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by: · Degenerative pathologies : arthrosis, rheumatoid arthritis, post-traumatic arthrosis. · Primary and secondary necrosis of the humeral head * Displaced 4-part upper humeral fracture * Humeral head fracture * Other pathologies where arthrodesis or resectional…

Read the full statement (118 words)

Aequalis Shoulder System (excluding Aequalis Shoulder Fracture System):

Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by:

· Degenerative pathologies : arthrosis, rheumatoid arthritis, post-traumatic arthrosis.

· Primary and secondary necrosis of the humeral head

* Displaced 4-part upper humeral fracture

* Humeral head fracture

* Other pathologies where arthrodesis or resectional arthroplasty of the humeral head

are not acceptable

: Revision surgery when other treatments or devices have failed.

Aequalis Shoulder Fracture System

Traumatic or pathologic conditions of the shoulder resulting in fracture of the

glenohumeral joint, including

o humeral head fracture and displaced 3-or 4-part proximal humeral fractures.

o Revision surgery when other treatments or devices have failed.

Indications for use as stated in the FDA summary.

Also cleared against K994392

9 other devices cite the same predicate.

  • K140071Humelock II Cemented Shoulder SystemFx Solutions · 2014
  • K112144Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis Reversed Fracture…Tornier · 2012
  • K111902Aequalis Shoulder SystemTornier · 2011
  • K082120Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008
  • K062661Aequalis Resurfacing HeadTornier · 2006
  • K060209Aequalis Shoulder Fracture System & Aequalis Shoulder SystemTornier · 2006

More from Tornier, Inc.

52 FDA decisions under this applicant name. See the company

  • K260721Tornier Perform Advanced GlenoidTornier, Inc. · 2026
  • 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

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/K081707 · printed Nov 4, 2026

Cite this page

510(k) Report. “K081707: Aequalis Shoulder Fracture and Shoulder Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081707

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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