510(k) · Cleared

Recalled · Class II · 2015

Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) Reunion Tsa System N

K103835510(k) TraditionalCleared May 5, 2011126-day reviewClass II21 CFR 888.3660Recalls 1

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

Howmedica Osteonics Corp. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Cleared on May 5, 2011 as substantially equivalent to K955731 (Osteonics Corp., 1996) and 8 other predicates after a 126-day review. Its family tree reaches back 4 generations to 1994. 43 later devices descend from it. It has been recalled once.

Decided: May 5, 2011
Review: 126 days
Class: Class II
Product code: KWS
Recalls: 1
Predicates: 9

Its longest line of descent runs back 4 generations to K943462 (1994). 22 ancestors in all, the oldest K905786 (1991). 43 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 4 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
3 generations backK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
2 generations backK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
1 generation backK052472 Depuy Global Shoulder Crosslink GlenoidDePuy Orthopaedics, Inc. · 2005
This deviceK103835 Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model…Howmedica Osteonics Corp. · 2011
Descendant · cites it directly · 31 of its ownK130759 Humelock II Cementless Shoulder SystemFx Solutions · 2013
Descendant · 2 generations on · 30 of its ownK150488 Humelock II Reversible Shoulder SystemFx Solutions · 2015
Descendant · 3 generations on · 20 of its ownK163669 Humeris ShoulderFx Solutions · 2017
Descendant · 3 generations on · 17 of its ownK162455 Humelock Reversed ShoulderFx Solutions · 2017
Descendant · cites it directly · 13 of its ownK161863 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…Stryker GmbH · 2016

Showing 5 of 43 descendants. See all descendants

Descendants cleared per year

2013high 6 (2020) · low 0 (2014)2026

Most influential descendants

Showing 5 of 43 · See all

K130759Humelock II Cementless Shoulder SystemFx Solutions · 2013 · cites it directly31descendants
K150488Humelock II Reversible Shoulder SystemFx Solutions · 2015 · 2 generations on30descendants
K163669Humeris ShoulderFx Solutions · 2017 · 3 generations on20descendants
K162455Humelock Reversed ShoulderFx Solutions · 2017 · 3 generations on17descendants
K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH · 2016 · cites it directly13descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K943462	Darwin Knee System	Johnson & Johnson Professionals, Inc.	1994	8
−3	K033272	Depuy Sigma Tibial Inserts	DePuy Orthopaedics, Inc.	2004	51
−2	K040166	Depuy Sigma XLK Tibial Inserts	DePuy Orthopaedics, Inc.	2004	—
−1	K052472	Depuy Global Shoulder Crosslink Glenoid	DePuy Orthopaedics, Inc.	2005	—
0 (this device)	K103835	Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model 5569-YY-20XX…	Howmedica Osteonics Corp.	2011	—
+1	K130759	Humelock II Cementless Shoulder System	Fx Solutions	2013	—
+2	K150488	Humelock II Reversible Shoulder System	Fx Solutions	2015	—
+3	K163669	Humeris Shoulder	Fx Solutions	2017	—
+3	K162455	Humelock Reversed Shoulder	Fx Solutions	2017	—
+1	K161863	ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…	Stryker GmbH	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	3	0
1992	1	0
1995	2	0
1996	3	0
1997	1	0
1998	2	0
1999	3	0
2000	1	0
2006	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2015	1	0
2016	1	0
2017	3	0
2018	2	0
2019	3	0
2020	6	0
2021	5	0
2022	4	0
2023	4	0
2024	4	0
2025	3	0
2026	6	0

FIG. 1 — Lineage of K103835, 1994–2026Source: 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? (9)

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
*	K955731	Osteonics Shoulder Humeral Components Summary page 1 …mi-humeral, metallic, cemented Legally marketed device to which substantial equivalence is claimed: Oisteonics Shoulder Humeral Components: K95 5731 Solar ReUnion Fracture Stem: K0621 13 Osteonics All Polyethylene Glenoid Shoulder Component: K950521 Osteonics All Polyethylene G…	Osteonics Corp.	1996	1
*	K062113	Solar Reunion Fracture Stem Summary page 1 …cemented Legally marketed device to which substantial equivalence is claimed: Oisteonics Shoulder Humeral Components: K95 5731 Solar ReUnion Fracture Stem: K0621 13 Osteonics All Polyethylene Glenoid Shoulder Component: K950521 Osteonics All Polyethylene Glenoid Shoulder Component: K962082 Sol…	Howmedica Osteonics Corp.	2006	1
*	K950521	Osteonics All Polyethylene Glenoid Shoulder Component Summary page 1 …ial equivalence is claimed: Oisteonics Shoulder Humeral Components: K95 5731 Solar ReUnion Fracture Stem: K0621 13 Osteonics All Polyethylene Glenoid Shoulder Component: K950521 Osteonics All Polyethylene Glenoid Shoulder Component: K962082 Solar Shoulder Offset Humeral Head: KOO01419 Osteonics Solar Shoul…	Osteonics Corp.	1995	—
*	K962082	Osteonics All Polyethylene Glenoid Shoulder Component Summary page 1 …nts: K95 5731 Solar ReUnion Fracture Stem: K0621 13 Osteonics All Polyethylene Glenoid Shoulder Component: K950521 Osteonics All Polyethylene Glenoid Shoulder Component: K962082 Solar Shoulder Offset Humeral Head: KOO01419 Osteonics Solar Shoulder Humeral Bearing Head: K990598 Depuy Global Advantage Should…	Osteonics Corp.	1996	1
*	K001419	Solar Shoulder Offset Humeral Head	Howmedica Osteonics Corp.	2000	—
*	K990598	Osteonics Solar Shoulder Humeral Bearing Head Summary page 1 …onent: K950521 Osteonics All Polyethylene Glenoid Shoulder Component: K962082 Solar Shoulder Offset Humeral Head: KOO01419 Osteonics Solar Shoulder Humeral Bearing Head: K990598 Depuy Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head: K992065 Depuy Global Shoulder Cr…	Howmedica Osteonics Corp.	1999	—
*	K992065	Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head Summary page 1 …al Head: KOO01419 Osteonics Solar Shoulder Humeral Bearing Head: K990598 Depuy Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head: K992065 Depuy Global Shoulder Crosslinked Glenoid: K052472 DVO Extremity Solutions Total and Hemi Shoulder System: K060988 Device Descri…	DePuy Orthopaedics, Inc.	1999	—
*	K052472	Depuy Global Shoulder Crosslink Glenoid Summary page 1 …Bearing Head: K990598 Depuy Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head: K992065 Depuy Global Shoulder Crosslinked Glenoid: K052472 DVO Extremity Solutions Total and Hemi Shoulder System: K060988 Device Description: The subject Reunion® Total Shoulder Arthropl…	DePuy Orthopaedics, Inc.	2005	—
*	K060988	Total and Hemi Shoulder System Summary page 1 …vantage Humeral Stem, Global Advantage Eccentric Head: K992065 Depuy Global Shoulder Crosslinked Glenoid: K052472 DVO Extremity Solutions Total and Hemi Shoulder System: K060988 Device Description: The subject Reunion® Total Shoulder Arthroplasty (TSA) System is intended for shoulder arthroplasty. The com…	Dvo Extremity Solutions, LLC	2006	13

Also cleared against K955731: 3 other devices →

What descends from it? (43)

See all 43

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

Number	Device	Applicant	Decided	Descendants
K130759	Humelock II Cementless Shoulder System	Fx Solutions	2013	31
K161863	ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…	Stryker GmbH	2016	13

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 12, 2015	Class II	Z-2363-2015	Process control	A package labeled as Part #5901-S-4818, Lot MAC7C14, standard humeral head trial, contained part # 5901-E-4818 Lot MAC7C14, offset humeral head trial.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
8 of the 22 ancestors have a recall of any class.
Of its descendants, K130759 (Fx Solutions, 2013) has gone furthest, with 31 descendants of its own.
3 other devices also cite its predicate K955731.

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?

For use as a Hemi or Total Shoulder Replacement:

Aseptic necrosis of the humeral head

Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis.

Proximal humeral fractures and/or dislocation.

Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.

The glenoid components are intended for cemented use only. The humeral stem components are intended for both cemented and cementless use.

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

https://510kreport.com/device/K103835 · printed Nov 5, 2026

Cite this page

510(k) Report. “K103835: Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) Reunion Tsa System N.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103835

Report an extraction error

Are you the manufacturer?

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