510(k) · Cleared
ClearedReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker GmbH · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Sep 3, 2021 as substantially equivalent to K202289 (Stryker GmbH, 2020) and 2 other predicates after a 164-day review. Its family tree reaches back 17 generations to 1991. 1 of the 122 devices in its family, counting itself, has a Class I recall.
- Decided
- Sep 3, 2021
- Review
- 164 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 17 generations to K911686 (1991). 121 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet. 1 of the 122 devices in this family, counting this one, has a Class I recall.
- Root · 17 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 13 generations between
- 3 generations backK181742 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…Stryker GmbH · 2018
- 2 generations backK183039 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…Stryker GmbH · 2019
- 1 generation backK202289 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…Stryker GmbH · 2020
- This deviceK210861 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…Stryker GmbH · 2021
Show all 17 generations
- Root · 17 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 16 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 15 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 14 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 13 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 12 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 11 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 10 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 9 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 8 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 7 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 6 generations backK130895 Reunion Rsa Shoulder SystemHowmedica Osteonics Corp. · 2013
- 5 generations backK161863 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…Stryker GmbH · 2016
- 4 generations backK172210 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…Stryker Trauma AG · 2017
- 3 generations backK181742 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…Stryker GmbH · 2018
- 2 generations backK183039 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…Stryker GmbH · 2019
- 1 generation backK202289 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…Stryker GmbH · 2020
- This deviceK210861 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…Stryker GmbH · 2021
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulderdirect predicate · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −16 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −15 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −14 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −13 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −12 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −11 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −10 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −9 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −8 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −7 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −6 | K130895 | Reunion Rsa Shoulder System | Howmedica Osteonics Corp. | 2013 | — |
| −5 | K161863 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder… | Stryker GmbH | 2016 | — |
| −4 | K172210 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder… | Stryker Trauma AG | 2017 | — |
| −3 | K181742 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder… | Stryker GmbH | 2018 | — |
| −2 | K183039 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder… | Stryker GmbH | 2019 | — |
| −1 | K202289 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder… | Stryker GmbH | 2020 | — |
| 0 (this device) | K210861 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder… | Stryker GmbH | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 3 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 11 | 0 |
| 1996 | 6 | 0 |
| 1997 | 4 | 0 |
| 1998 | 8 | 0 |
| 1999 | 5 | 0 |
| 2000 | 10 | 0 |
| 2001 | 6 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 7 | 0 |
| 2006 | 6 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
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.
1 device in this family has a Class I recall. 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
What was it cleared against? (3)
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 | Decided |
|---|---|---|---|
| * | K202289 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Summary page 7…, NJ 07430 Phone: 484-889-5804 Fax: 201-831-6500 Date Prepared: March 22, 2021 Primary Predicate: K202289: ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA),… | 2020 |
| * | K161742 | Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidSummary page 7…ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) Additional Predicates: K161742: Tornier Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid K0806… | 2016 |
| * | K080642 | Comprehensive Reverse ShoulderSummary page 7…stem (TSA) Additional Predicates: K161742: Tornier Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid K080642: Zimmer Biomet Comprehensive Reverse Shoulder… | 2008 |
| † | K190991 | Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 30 years and passes through 9 companies; a new generation was cleared every 10 months on median.
- 38 of the 121 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K202289.
How does its category compare?
All KWS devicesKWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · KWS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWS
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWS
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWS
2,281in 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 ReUnion RFX System includes a Reversible Fracture Stem (RFX Stem) that can utilize either the ReUnion Total Shoulder Arthroplasty (TSA) or ReUnion Reverse Shoulder Arthroplasty (RSA) humeral and glenoid components and is indicated for use as a hemi, total or reverse shoulder replacement. The ReUnion RFX stem is intended for cemented use only. When used with ReUnion TSA Humeral & Glenoid Components The ReUnion RFX System, when used with ReUnion TSA…
Read the full statement (943 words)
The ReUnion RFX System includes a Reversible Fracture Stem (RFX Stem) that can utilize either the ReUnion Total Shoulder Arthroplasty (TSA) or ReUnion Reverse Shoulder Arthroplasty (RSA) humeral and glenoid components and is indicated for use as a hemi, total or reverse shoulder replacement. The ReUnion RFX stem is intended for cemented use only.
When used with ReUnion TSA Humeral & Glenoid Components
The ReUnion RFX System, when used with ReUnion TSA Humeral and Glenoid components, is indicated 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.
In the case of revision, when ReUnion RFX humeral stems are well fixed, the system is indicated for conversion to a total shoulder arthroplasty. In conjunction with ReUnion TSA humeral and glenoid components, if the natural glenoid provides sufficient bone stock, ReUnion RFX humeral stems can be converted from a hemiarthroplasty to a total shoulder arthroplasty, as well as revised from an existing total shoulder arthroplasty to a secondary total shoulder arthroplasty. It is also indicated for conversion to a hemiarthroplasty. In conjunction with ReUnion TSA humeral components, ReUnion RFX humeral stems can be converted from a total or reverse shoulder arthroplasty to a hemiarthroplasty, as well as revised from an existing hemiarthroplasty to a secondary hemiarthroplasty, in treatment of previously failed shoulder arthroplasty cases where revision to a reverse shoulder arthroplasty is inappropriate.
The glenoid components are intended for cemented use only.
When used with ReUnion RSA Humeral & Glenoid Components
The ReUnion RFX System, when used with ReUnion RSA humeral & glenoid components, is intended for primary, fracture, or revision total shoulder replacement. The patient’s joint must have gross rotator cuff deficiency, a functional deltoid muscle, and be anatomically and structurally suited to receive the implant(s).
• Painful, disabling joint disease of the shoulder resulting from degenerative arthritis or rheumatoid arthritis;
• Proximal humeral fractures
• Revisions of previously failed shoulder joint replacements
In the case of revision, when ReUnion RFX humeral stems are well fixed, the system is indicated for conversion to a reverse shoulder arthroplasty. In conjunction with ReUnion RSA humeral and glenoid components, ReUnion RFX humeral stems can be converted from a hemi or total shoulder arthroplasty to a reverse shoulder arthroplasty, as well as revised from an existing reverse shoulder arthroplasty to a secondary reverse shoulder arthroplasty, in treatment of a grossly deficient rotator cuff with severe arthropathy or previously failed joint replacement with a grossly deficient rotator cuff. The patient must have a functional deltoid muscle, and be anatomically and structurally suited to receive the implant(s).
Glenoid Baseplate components are intended for cementless use with the addition of screw fixation.
The ReUnion RSA Shoulder System is intended for primary, fracture, or revision of total Shoulder replacement. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The patient’s joint must have gross rotator cuff deficiency, a functional deltoid muscle and be anatomically and structurally suited to receive the selected implant(s).
• Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis or rheumatoid arthritis.
• Proximal humeral fracture.
• Revision of previously failed shoulder joint replacement.
Glenoid Baseplate components are intended for cementless use with the addition of screw fixation.
The Humeral Stem components are intended for both cemented and cementless use.
In the case of revision, when ReUnion TSA humeral stems are well fixed, the system is indicated for conversion to a reverse shoulder arthroplasty.
In conjunction with ReUnion RSA humeral and glenoid components, ReUnion TSA humeral stems can be converted from a hemi or total shoulder arthroplasty to a reverse shoulder arthroplasty, as well as revised from an existing reverse shoulder arthroplasty to a secondary reverse shoulder arthroplasty, in treatment of a grossly deficient rotator cuff with sever arthropathy or previously failed joint replacement with a grossly deficient rotator cuff. The patient must have a functional deltoid muscle, and be anatomically and structurally suited to receive the implant(s).
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 posttraumatic arthritis.
• Proximal humeral fracture 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.
Glenoid components are intended for cemented use only. The humeral stem components are intended for both cemented and cementless use.
In the case of revision, when ReUnion TSA humeral stems are well fixed, the system is indicated for conversion to a total shoulder arthroplasty. In conjunction with ReUnion TSA humeral and glenoid components, if the natural glenoid provides sufficient bone stock, ReUnion TSA humeral stems can be converted from a hemiarthroplasty to a total shoulder arthroplasty, as well as revised from an existing total shoulder arthroplasty to a secondary total shoulder arthroplasty. It is also indicated for conversion to a hemiarthroplasty. In conjunction with ReUnion TSA humeral components, ReUnion TSA humeral stems can be converted from a total or ReUnion RSA reverse shoulder arthroplasty to a hemiarthroplasty, as well as revised from an existing hemiarthroplasty to a secondary hemiarthroplasty, in treatment of previously failed shoulder arthroplasty cases where revision to a reverse shoulder arthroplasty is inappropriate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210861 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210861: ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210861
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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