510(k) · Cleared

Cleared

Aequalis Ascend Modular Anatomic Shoulder System

K102924510(k) TraditionalCleared Jan 31, 2011123-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 Jan 31, 2011 as substantially equivalent to K071147 (Nexa Orthopedics, Inc., 2007) and 6 other predicates after a 123-day review. Its family tree reaches back 8 generations to 1980. 110 later devices descend from it.

Decided: Jan 31, 2011
Review: 123 days
Class: Class II
Product code: KWS
Recalls: None
Predicates: 7

Its longest line of descent runs back 8 generations to K800494 (1980). 56 ancestors in all, the oldest K790987 (1979). 110 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 8 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
7 generations backK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
6 generations backK002998 Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000 · Recalled
5 generations backK010827 Copeland MB/HA Resurfacing Humeral HeadsBiomet Orthopedics, Inc. · 2001 · Recalled
4 generations backK031971 Global Cap Resurfacing Replacement ShoulderDePuy Orthopaedics, Inc. · 2003
3 generations backK033516 Depuy Global Cap HA Resurfacing Shoulder Humeral HeadsDePuy Orthopaedics, Inc. · 2003
2 generations backK061862 Axiom Orthopaedics Shoulder Resurfacing SystemAxiom Orthopaedics, Inc. · 2006
1 generation backK071147 Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc. · 2007
This deviceK102924 Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc. · 2011
Descendant · cites it directly · 108 of its ownK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
Descendant · 2 generations on · 97 of its ownK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
Descendant · 3 generations on · 96 of its ownK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
Descendant · 4 generations on · 29 of its ownK140082 Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S. · 2014
Descendant · 4 generations on · 26 of its ownK132285 Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2013

Showing 5 of 110 descendants. See all descendants

Descendants cleared per year

2011high 14 (2022) · low 1 (2012)2026

Most influential descendants

Showing 5 of 110 · See all

K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · cites it directly108descendants
K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · 2 generations on97descendants
K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · 3 generations on96descendants
K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S. · 2014 · 4 generations on29descendants
K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2013 · 4 generations on26descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−8	K800494	New Jersey Hemiarthroplasty Sholder Pros	Depuy, Inc.	1980	—
−7	K991585	Bipolar Shoulder Prosthesis	Biomet, Inc.	1999	—
−6	K002998	Biomet BI-Polar Shoulder System	Biomet, Inc.	2000	1
−5	K010827	Copeland MB/HA Resurfacing Humeral Heads	Biomet Orthopedics, Inc.	2001	1
−4	K031971	Global Cap Resurfacing Replacement Shoulder	DePuy Orthopaedics, Inc.	2003	—
−3	K033516	Depuy Global Cap HA Resurfacing Shoulder Humeral Heads	DePuy Orthopaedics, Inc.	2003	—
−2	K061862	Axiom Orthopaedics Shoulder Resurfacing System	Axiom Orthopaedics, Inc.	2006	—
−1	K071147	Nexa Orthopedics Total Shoulder System	Nexa Orthopedics, Inc.	2007	—
0 (this device)	K102924	Aequalis Ascend Modular Anatomic Shoulder System	Tornier, Inc.	2011	—
+1	K110599	Aequalis Ascend Modular Reverse Shoulder System	Tornier, Inc.	2011	—
+2	K112615	Aequalis Ascend Modular Reverse Shoulder System	Tornier, Inc.	2011	—
+3	K122698	Aequalis Ascend Flex Shoulder System	Tornier S.A.S.	2013	2
+4	K140082	Aequalis (TM) Ascent (TM) Flex Shoulder System	Tornier S.A.S.	2014	—
+4	K132285	Aequalis Reversed Shoulder Prosthesis	Tornier S.A.S.	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1979	1	0
1980	1	0
1987	4	0
1988	1	0
1991	3	0
1992	2	0
1993	1	0
1994	1	0
1995	2	0
1996	2	0
1997	1	0
1998	2	0
1999	6	0
2000	4	0
2001	5	0
2002	1	0
2003	4	0
2004	2	0
2006	5	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	3	0
2012	1	0
2013	3	0
2014	4	0
2015	2	0
2016	2	0
2017	4	0
2018	5	0
2019	8	0
2020	9	0
2021	10	0
2022	14	0
2023	10	0
2024	10	0
2025	12	0
2026	13	0

FIG. 1 — Lineage of K102924, 1980–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K220847 AETOS Shoulder Systemscore 21.1 · 16 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (7)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K071147	Nexa Orthopedics Total Shoulder System Summary page 2 …Product code: HSD; KWT; KWS 5) Legally Marketed Device to which Equivalence is Claimed: " Tornier Nexa Orthopedics Total Shoulder System: K07 1147 " Tomnier Aequalis Shoulder Prosthesis: K980244, KOI 1942, K06308 1, K952928 " Tornier OVO Total and Hemi…	Nexa Orthopedics, Inc.	2007	—
*	K980244	Aequalis Shoulder Prosthesis Summary page 2 …rketed Device to which Equivalence is Claimed: " Tornier Nexa Orthopedics Total Shoulder System: K07 1147 " Tomnier Aequalis Shoulder Prosthesis: K980244, KOI 1942, K06308 1, K952928 " Tornier OVO Total and Hemi Shoulder System: K060988 * Biomet Comprehensive…	Tornier	1999	—
*	K011942	Aequalis Press-Fit Shoulder Prosthesis	Tornier	2001	—
*	K063081	Aequalis Shoulder System Summary page 2 …ich Equivalence is Claimed: " Tornier Nexa Orthopedics Total Shoulder System: K07 1147 " Tomnier Aequalis Shoulder Prosthesis: K980244, KOI 1942, K06308 1, K952928 " Tornier OVO Total and Hemi Shoulder System: K060988 * Biomet Comprehensive Primary Shoulder St…	Tornier	2006	—
*	K952928	Aequalis Shoulder System for Total & Hemishoulder Applications Summary page 2 …lence is Claimed: " Tornier Nexa Orthopedics Total Shoulder System: K07 1147 " Tomnier Aequalis Shoulder Prosthesis: K980244, KOI 1942, K06308 1, K952928 " Tornier OVO Total and Hemi Shoulder System: K060988 * Biomet Comprehensive Primary Shoulder Stemns: K06…	Tornier	1995	—
*	K060988	Total and Hemi Shoulder System Summary page 2 …ulder System: K07 1147 " Tomnier Aequalis Shoulder Prosthesis: K980244, KOI 1942, K06308 1, K952928 " Tornier OVO Total and Hemi Shoulder System: K060988 * Biomet Comprehensive Primary Shoulder Stemns: K060692 Notes: * The Tomnier Nexa Orthopedics To…	Dvo Extremity Solutions, LLC	2006	13
*	K060692	Comprehensive Primary Shoulder Stems Summary page 2 …hesis: K980244, KOI 1942, K06308 1, K952928 " Tornier OVO Total and Hemi Shoulder System: K060988 * Biomet Comprehensive Primary Shoulder Stemns: K060692 Notes: * The Tomnier Nexa Orthopedics Total Shoulder System (K07 1147) is presently named Asc…	Biomet Manufacturing Corp	2006	6

Also cleared against K071147: 1 other device →

What descends from it? (110)

See all 110

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

Number	Device	Applicant	Decided	Descendants
K110599	Aequalis Ascend Modular Reverse Shoulder System	Tornier, Inc.	2011	108
K120739	Aequalis Adjustable Modular Reverse Shoulder System	Tornier, Inc.	2012	12
K110865	Aequalis Ascend Modular Anatomic Shoulder System	Tornier, Inc.	2011	0

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 31 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
9 of the 56 ancestors have a recall of any class.
Of its descendants, K110599 (Tornier, Inc., 2011) has gone furthest, with 108 descendants of its own.
1 other device also cites its predicate K071147.

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. 2011, this device’s year, is highlighted.

FDA decisions per year · KWS

3in 2025

2007high 12 (2013) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWS

97in 2025

2007high 250 (2023) · low 33 (2010)2026

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

Recalls per year · KWS

2in 2023

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	21	158
2008	4	37	29	238
2009	4	108	0	294
2010	7	33	10	393
2011	11	90	11	486
2012	7	86	10	542
2013	12	120	0	818
2014	7	89	1	1,066
2015	8	129	0	1,170
2016	10	114	1	970
2017	7	120	4	1,681
2018	4	152	1	1,545
2019	9	106	2	1,728
2020	3	98	5	1,567
2021	5	151	0	1,358
2022	5	158	0	1,268
2023	4	250	2	1,750
2024	2	—	0	2,122
2025	3	97	0	2,281
2026	2	—	1	—

What is it indicated for?

The Aequalis Ascend Modular Anatomic Shoulder System is indicated for use as a replacement of Shoulder joints disabled by:

Rheumatoid arthritis with pain

Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)

Correction of functional deformity

Fractures of the humeral head

Traumatic arthritis

Notes:

All components are single use

The humeral stem is intended for cemented or cementless use

The glenoid component is intended for cemented use

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K102924 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102924: Aequalis Ascend Modular Anatomic Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102924

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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