510(k) · Cleared
ClearedTornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corporation (Tornier, Inc.) · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Dec 6, 2024 as substantially equivalent to K191318 (Tornier, Inc., 2019) and 1 other predicate after a 161-day review. Its family tree reaches back 18 generations to 1991. 1 of the 144 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Dec 6, 2024
- Review
- 161 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 18 generations to K911686 (1991). 142 ancestors in all, the oldest K790987 (1979). 1 later device descends from it, 1 citing it directly. 1 of the 144 devices in this family, counting this one, has a Class I recall.
- Root · 18 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 14 generations between
- 3 generations backK151293 Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder…Tornier S.A.S. · 2015
- 2 generations backK190521 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2019
- 1 generation backK201315 PERFORM Humeral System – StemTornier, Inc. · 2020 · Recalled
- This deviceK241878 Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform…Stryker Corporation (Tornier, Inc.) · 2024
- Descendant · cites it directly · 0 of its ownK251686 Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc. · 2025 · Recalled
Show all 18 generations
- Root · 18 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 17 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 16 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 15 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 14 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 13 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 12 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 11 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 10 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 9 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 8 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 7 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 6 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 5 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- 4 generations backK132285 Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2013
- 3 generations backK151293 Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder…Tornier S.A.S. · 2015
- 2 generations backK190521 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2019
- 1 generation backK201315 PERFORM Humeral System – StemTornier, Inc. · 2020 · Recalled
- This deviceK241878 Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform…Stryker Corporation (Tornier, Inc.) · 2024
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder6 generations back · 2008
Most influential descendants
Showing 1 of 1 · See all- K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −17 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −16 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −15 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −14 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −13 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −12 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −11 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −10 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −9 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −8 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −7 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −6 | K112615 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −5 | K122698 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2013 | 2 |
| −4 | K132285 | Aequalis Reversed Shoulder Prosthesis | Tornier S.A.S. | 2013 | — |
| −3 | K151293 | Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis | Tornier S.A.S. | 2015 | — |
| −2 | K190521 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2019 | — |
| −1 | K201315 | PERFORM Humeral System – Stem | Tornier, Inc. | 2020 | 1 |
| 0 (this device) | K241878 | Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral… | Stryker Corporation (Tornier, Inc.) | 2024 | — |
| +1 | K251686 | Tornier Humeral Reconstruction System Max (Tornier HRS Max) | Tornier, Inc. | 2025 | 1 |
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 | 3 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 2 | 0 |
| 1996 | 7 | 0 |
| 1997 | 2 | 0 |
| 1998 | 6 | 0 |
| 1999 | 5 | 0 |
| 2000 | 9 | 0 |
| 2001 | 7 | 0 |
| 2002 | 3 | 0 |
| 2003 | 6 | 0 |
| 2004 | 3 | 0 |
| 2005 | 7 | 0 |
| 2006 | 11 | 0 |
| 2007 | 5 | 0 |
| 2008 | 7 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (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 |
|---|---|---|---|
| * | K191318 | AEQUALIS FLEX REVIVE Shoulder SystemSummary page 7…Product Code(s) KWS, PHX, HSD I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K191318 Aequalis Flex Revive Shoulder System KWS K201315 Perform Humeral System - Stem (PHS-Stem) KWS Device Description Summary 21 CFR 8… | 2019 |
| * | K201315 | PERFORM Humeral System – StemSummary page 7…Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K191318 Aequalis Flex Revive Shoulder System KWS K201315 Perform Humeral System - Stem (PHS-Stem) KWS Device Description Summary 21 CFR 807.92(a)(4) Tornier HRS (formerly branded Aequal… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251686 | Tornier Humeral Reconstruction System Max (Tornier HRS Max) | 2025 | 0 |
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 · 6 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 33 years and passes through 9 companies; a new generation was cleared every 1.2 years on median.
- 35 of the 142 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K251686 (Tornier, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K191318.
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. 2024, 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?
Tornier Humeral Reconstruction System (Tornier HRS) IN ANATOMIC: The Tornier HRS is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain. The Tornier HRS 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) *…
Read the full statement (668 words)
Tornier Humeral Reconstruction System (Tornier HRS)
IN ANATOMIC:
The Tornier HRS is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain. The Tornier HRS 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
* Revision of other devices if sufficient bone stock remains
IN REVERSE:
The Tornier HRS is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle 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
» Traumatic arthritis
* Massive and non-repairable rotator cuff tear
* Revision of other devices if sufficient bone stock remains
The reversed tray and polyethylene insert are indicated for use in the conversion from an anatomic to reversed shoulder arthroplasty without the removal of the humeral assembly during revision surgery for patients with a functional deltoid muscle.
Notes:
* 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.
Tornier Perform Humeral System - Stem (Tornier PHS-Stem)
In Anatomic:
The humeral stem, humeral head coupler and humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid implant, as a total replacement.
The PERFORM™ Humeral System — Stem is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility, stability, and to relieve pain. The PERFORM Humeral System — Stem is indicated for use as a replacement of shoulder joints disabled by:
* Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis
* Proximal humeral malunions
* Post-traumatic arthritis
* Revisions or fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains
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 recommended for patients with a suspected material sensitivity to cobalt alloy.
All components are single use. The humeral stems are intended for cemented or cementless use.
The PERFORM Humeral System — Stem is intended to be used with cemented polyethylene glenoid components, in a total shoulder arthroplasty.
In Reverse:
The PERFORM™ Humeral System — Stem is indicated for use as a replacement of a shoulder joint for patients with a functional deltoid muscle, grossly deficient rotator cuff, and pain disabled by one or more of the following:
* Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis
* Pseudoparalysis or anterior superior escape
* Rotator cuff tear arthropathy
* Proximal humeral malunions
* Post-traumatic arthritis
* Revisions or fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains
The reversed insert is indicated for use for the conversion from an anatomic to reverse shoulder prosthesis without the removal of a well fixed humeral stem for patients with a functional deltoid muscle.
All components are single use. The humeral stems are intended for cemented or cementless use. The PERFORM Humeral System — Stem is intended to be used with glenoid implants that are anchored to the bone with screws for non-cemented fixation.
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/K241878 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241878: Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241878
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