510(k) · Cleared
Recalled · Class II · 2026Tornier Humeral Reconstruction System Max (Tornier HRS Max)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tornier, Inc. · KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Cleared on Oct 30, 2025 as substantially equivalent to K223631 (Biomet Orthopedics, 2023) and 1 other predicate after a 150-day review. Its family tree reaches back 19 generations to 1991. 1 of the 172 devices in its family, counting itself, has a Class I recall. It has been recalled once.
- Decided
- Oct 30, 2025
- Review
- 150 days
- Class
- Class II
- Product code
- KWT
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 19 generations to K911686 (1991). 171 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet. 1 of the 172 devices in this family, counting this one, has a Class I recall.
- Root · 19 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 15 generations between
- 3 generations backK190521 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2019
- 2 generations backK201315 PERFORM Humeral System – StemTornier, Inc. · 2020 · Recalled
- 1 generation backK241878 Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform…Stryker Corporation (Tornier, Inc.) · 2024
- This deviceK251686 Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc. · 2025
Show all 19 generations
- Root · 19 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 18 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 17 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 16 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 15 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 14 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 13 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 12 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 11 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 10 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 9 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 8 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 7 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 6 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- 5 generations backK132285 Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2013
- 4 generations backK151293 Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder…Tornier S.A.S. · 2015
- 3 generations backK190521 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2019
- 2 generations backK201315 PERFORM Humeral System – StemTornier, Inc. · 2020 · Recalled
- 1 generation backK241878 Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform…Stryker Corporation (Tornier, Inc.) · 2024
- This deviceK251686 Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc. · 2025
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder7 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −18 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −17 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −16 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −15 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −14 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −13 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −12 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −11 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −10 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −9 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −8 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −7 | K112615 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −6 | K122698 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2013 | 2 |
| −5 | K132285 | Aequalis Reversed Shoulder Prosthesis | Tornier S.A.S. | 2013 | — |
| −4 | K151293 | Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis | Tornier S.A.S. | 2015 | — |
| −3 | K190521 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2019 | — |
| −2 | K201315 | PERFORM Humeral System – Stem | Tornier, Inc. | 2020 | 1 |
| −1 | K241878 | Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral… | Stryker Corporation (Tornier, Inc.) | 2024 | — |
| 0 (this device) | K251686 | Tornier Humeral Reconstruction System Max (Tornier HRS Max) | Tornier, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 5 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 7 | 0 |
| 1995 | 2 | 0 |
| 1996 | 9 | 0 |
| 1997 | 2 | 0 |
| 1998 | 7 | 0 |
| 1999 | 5 | 0 |
| 2000 | 11 | 0 |
| 2001 | 9 | 0 |
| 2002 | 5 | 0 |
| 2003 | 9 | 0 |
| 2004 | 4 | 0 |
| 2005 | 11 | 0 |
| 2006 | 11 | 0 |
| 2007 | 7 | 0 |
| 2008 | 7 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 0 |
| 2012 | 6 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2023 | 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 KWT device
- #1 K231657 AGILON® XO Shoulder Replacement Systemscore 17.7 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K223631 | Comprehensive Segmental Revision System (SRS)Summary page 5…ct Code(s) KWT, KWS, HSD, PHX | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K223631 Comprehensive Segmental Revision System (SRS) KWT K241878 Tornier Humeral Reconstruction System (Tornier HRS); Tornier KWS Perfo… | 2023 |
| * | K241878 | Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Summary page 5…e Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K223631 Comprehensive Segmental Revision System (SRS) KWT K241878 Tornier Humeral Reconstruction System (Tornier HRS); Tornier KWS Perform Humeral System -Stem (Tornier PHS - Stem) Device Descr… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 5, 2026 | Class II | Z-1769-2026 | Labeling design | Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system. |
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 · 7 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 34 years and passes through 9 companies; a new generation was cleared every 1.0 years on median.
- 45 of the 171 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All KWT devicesKWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · KWT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWT
242in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWT
749in 2025
MAUDE reports naming product code KWT, 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 | 1 | — | 0 | 32 |
| 2008 | 0 | — | 1 | 48 |
| 2009 | 0 | — | 0 | 58 |
| 2010 | 1 | — | 7 | 71 |
| 2011 | 5 | 165 | 0 | 112 |
| 2012 | 1 | — | 2 | 83 |
| 2013 | 1 | — | 1 | 113 |
| 2014 | 1 | — | 0 | 168 |
| 2015 | 2 | — | 0 | 176 |
| 2016 | 2 | — | 1 | 445 |
| 2017 | 1 | — | 1 | 560 |
| 2018 | 2 | — | 1 | 480 |
| 2019 | 4 | 91 | 3 | 419 |
| 2020 | 1 | — | 0 | 215 |
| 2021 | 1 | — | 0 | 228 |
| 2022 | 1 | — | 0 | 273 |
| 2023 | 1 | — | 1 | 361 |
| 2024 | 1 | — | 0 | 601 |
| 2025 | 4 | 242 | 0 | 749 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
In Anatomic: Tornier HRS Max humeral assembly can be used for anatomic arthroplasty when used with a humeral head. It can be used as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid, as a total replacement. Tornier HRS Max is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with an intact or reconstructable rotator cuff with pain…
Read the full statement (337 words)
In Anatomic:
Tornier HRS Max humeral assembly can be used for anatomic arthroplasty when used with a humeral head. It can be used as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid, as a total replacement.
Tornier HRS Max is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with an intact or reconstructable rotator cuff with pain disabled by:
• Rheumatoid arthritis
• Non-inflammatory degenerative joint disease (i.e., osteoarthritis and avascular necrosis)
• Fractures of the humeral head
• Post-Traumatic arthritis
• Oncology applications including bone loss due to tumor resection
• Significant humeral resection where adequate fixation can be achieved
In Reverse:
Tornier HRS Max is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by:
• Rheumatoid arthritis
• Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
• Correction of functional deformity
• Fractures of the humeral head
• Post-Traumatic arthritis
• Massive and non-repairable rotator cuff tear
• Oncology applications including bone loss due to tumor resection.
• Significant humeral resection where adequate fixation can be achieved
The reversed tray and polyethylene insert are indicated for use in the conversion from an anatomic to reversed shoulder arthroplasty without the removal of a well-fixed humeral assembly during revision surgery for patients with a functional deltoid muscle.
Notice:
• All components are single-use.
• The coated humeral stem is intended for cemented or cementless use
• The all-poly glenoid components are intended for cemented use only.
• The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation.
• Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of titanium and titanium alloys are inferior to that of cobalt alloy. A titanium humeral head is not recommended for patients who lack a suspected material sensitivity to cobalt alloy.
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/K251686 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251686: Tornier Humeral Reconstruction System Max (Tornier HRS Max).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251686
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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