510(k) · Cleared
Recalled · Class II · 2024Tornier Perform Humeral System – Stemless
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tornier, Inc. · PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Cleared on Sep 14, 2022 as substantially equivalent to K143552 (Tornier, Inc., 2015) and 1 other predicate after a 212-day review. Its family tree reaches back 18 generations to 1991. 1 of the 143 devices in its family, counting itself, has a Class I recall. It has been recalled once.
- Decided
- Sep 14, 2022
- Review
- 212 days
- Class
- Class II
- Product code
- PKC
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 18 generations to K911686 (1991). 142 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet. 1 of the 143 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 deviceK220418 Tornier Perform Humeral System – StemlessTornier, Inc. · 2022
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 deviceK220418 Tornier Perform Humeral System – StemlessTornier, Inc. · 2022
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder6 generations back · 2008
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) | K220418 | Tornier Perform Humeral System – Stemless | Tornier, Inc. | 2022 | — |
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 | 4 | 0 |
| 2011 | 4 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 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 PKC device
- #1 K240716 AETOS Shoulder System Stemless Humeral…score 22.2 · 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 |
|---|---|---|---|
| * | K143552 | Simpliciti Shoulder SystemSummary page 4…i-constrained cemented prosthesis. Product Codes: PKC Predicate Device Information Primary Predicate: Simpliciti Shoulder System, K143552 Additional Predicate: Perform Humeral System – Stem, K201315 Reference Device: Aequalis Perform Reversed Glenoid, Aequali… | 2015 |
| * | K201315 | PERFORM Humeral System – StemSummary page 4…uct Codes: PKC Predicate Device Information Primary Predicate: Simpliciti Shoulder System, K143552 Additional Predicate: Perform Humeral System – Stem, K201315 Reference Device: Aequalis Perform Reversed Glenoid, Aequalis Perform + Reversed Glenoid, K161742 a… | 2020 |
| † | K161742 | Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid | 2016 |
| † | K183696 | Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 29, 2024 | Class II | Z-3155-2024 | Under Investigation by firm | One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/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 31 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 34 of the 142 ancestors have a recall of any class; 1 has a Class I recall.
- 9 other devices also cite its predicate K143552.
How does its category compare?
All PKC devicesPKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · PKC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PKC
167in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PKC
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PKC
86in 2025
MAUDE reports naming product code PKC, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 5 |
| 2019 | 1 | — | 1 | 8 |
| 2020 | 4 | 116 | 0 | 5 |
| 2021 | 2 | — | 0 | 14 |
| 2022 | 3 | 148 | 0 | 31 |
| 2023 | 1 | — | 0 | 46 |
| 2024 | 3 | 167 | 0 | 54 |
| 2025 | 1 | — | 0 | 86 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The nucleus, humeral head coupler and humeral head are used in conjunction with a glenoid implant as a total replacement. The Tornier Perform® Humeral System – Stemless is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide mobility, stability, and to relieve pain. The Tornier Perform Humeral System – Stemless is indicated for use as a replacement of shoulder joints disabled by: • Non-inflammatory…
Read the full statement (163 words)
The nucleus, humeral head coupler and humeral head are used in conjunction with a glenoid implant as a total replacement.
The Tornier Perform® Humeral System – Stemless is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide mobility, stability, and to relieve pain. The Tornier Perform Humeral System – Stemless is indicated for use as a replacement of shoulder joints disabled by:
• Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis
• Post-traumatic arthritis
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 without a suspected material sensitivity to cobalt alloy.
All components are single use and intended for cementless use.
The Tornier Perform Humeral System – Stemless is intended to be used with cemented polyethylene glenoid components, in an anatomic total shoulder arthroplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220418 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220418: Tornier Perform Humeral System – Stemless.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220418
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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