510(k) · Cleared
Recalled · Class II · 2024PERFORM Humeral System – Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tornier, Inc. · PAO Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
Cleared on Sep 11, 2020 as substantially equivalent to K190521 (Tornier S.A.S., 2019) after a 116-day review. Its family tree reaches back 17 generations to 1991. 1 of the 151 devices in its family, counting itself, has a Class I recall. 11 later devices descend from it. It has been recalled once.
- Decided
- Sep 11, 2020
- Review
- 116 days
- Class
- Class II
- Product code
- PAO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 17 generations to K911686 (1991). 139 ancestors in all, the oldest K790987 (1979). 11 later devices descend from it, 6 citing it directly. 1 of the 151 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 backK132285 Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2013
- 2 generations backK151293 Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder…Tornier S.A.S. · 2015
- 1 generation backK190521 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2019
- This deviceK201315 PERFORM Humeral System – StemTornier, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK212800 PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A. · 2022 · Recalled
- Descendant · cites it directly · 1 of its ownK241878 Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform…Stryker Corporation (Tornier, Inc.) · 2024
- Descendant · cites it directly · 1 of its ownK240876 Identity Shoulder SystemZimmer, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK233712 PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A. · 2024
- Descendant · cites it directly · 1 of its ownK230572 AETOS Shoulder SystemSmith & Nephew, Inc. · 2023
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 backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 5 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 4 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- 3 generations backK132285 Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2013
- 2 generations backK151293 Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder…Tornier S.A.S. · 2015
- 1 generation backK190521 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2019
- This deviceK201315 PERFORM Humeral System – StemTornier, Inc. · 2020
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder5 generations back · 2008
Most influential descendants
Showing 5 of 11 · See all- K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A. · 2022 · cites it directly2descendants
- K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.) · 2024 · cites it directly1descendant
- K240876Identity Shoulder SystemZimmer, Inc. · 2024 · cites it directly1descendant
- K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A. · 2024 · 2 generations on1descendant
- K230572AETOS Shoulder SystemSmith & Nephew, Inc. · 2023 · cites it directly1descendant
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 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −5 | K112615 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −4 | K122698 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2013 | 2 |
| −3 | K132285 | Aequalis Reversed Shoulder Prosthesis | Tornier S.A.S. | 2013 | — |
| −2 | K151293 | Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis | Tornier S.A.S. | 2015 | — |
| −1 | K190521 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2019 | — |
| 0 (this device) | K201315 | PERFORM Humeral System – Stem | Tornier, Inc. | 2020 | — |
| +1 | K212800 | PRIMA Humeral System and SMR Glenosphere Ø42 | Lima Corporate S.P.A. | 2022 | 2 |
| +1 | K241878 | Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral… | Stryker Corporation (Tornier, Inc.) | 2024 | — |
| +1 | K240876 | Identity Shoulder System | Zimmer, Inc. | 2024 | — |
| +2 | K233712 | PRIMA Humeral System; PRIMA TT Glenoid | Lima Corporate S.P.A. | 2024 | — |
| +1 | K230572 | AETOS Shoulder System | Smith & Nephew, Inc. | 2023 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K190521 | Aequalis Ascend Flex Shoulder SystemSummary page 5…sis. Product Codes: KWT, KWS, HSD, PHX, PAO Predicate Device Information Predicate: AEQUALIS ASCEND™ FLEX Shoulder System 510(k) Number: K190521 Reference Device: AEQUALIS™ REVERSED Shoulder System 510(k) Number: K151293 Device Description The PERFORM Humer… | 2019 |
| † | K151293 | Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis | 2015 |
What descends from it? (11)
See all 116 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212800 | PRIMA Humeral System and SMR Glenosphere Ø42 | 2022 | 2 |
| K241878 | Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -… | 2024 | 1 |
| K240876 | Identity Shoulder System | 2024 | 1 |
| K230572 | AETOS Shoulder System | 2023 | 1 |
| K260721 | Tornier Perform Advanced Glenoid | 2026 | 0 |
| K220418 | Tornier Perform Humeral System – Stemless | 2022 | 0 |
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-3309-2024 | Under Investigation by firm | Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer. |
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 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 29 years and passes through 8 companies; a new generation was cleared every 1.0 years on median.
- 33 of the 139 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K212800 (Lima Corporate S.P.A., 2022) has gone furthest, with 2 descendants of its own.
How does its category compare?
All PAO devicesPAO Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · PAO
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · PAO
Too few PAO 510(k)s in any year since 2007 to give a median.
Recalls per year · PAO
No recall names PAO since 2007.
Adverse event reports per year · PAO
88in 2025
MAUDE reports naming product code PAO, 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 | 30 |
| 2015 | 0 | — | 0 | 55 |
| 2016 | 0 | — | 0 | 63 |
| 2017 | 0 | — | 0 | 176 |
| 2018 | 0 | — | 0 | 96 |
| 2019 | 0 | — | 0 | 17 |
| 2020 | 1 | — | 0 | 7 |
| 2021 | 0 | — | 0 | 7 |
| 2022 | 0 | — | 0 | 9 |
| 2023 | 0 | — | 0 | 64 |
| 2024 | 0 | — | 0 | 85 |
| 2025 | 0 | — | 0 | 88 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (369 words)
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
• Correction of functional deformity
• 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 not recommended for patients without 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
• Correction of functional deformity
• 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 as stated in the FDA summary.
https://510kreport.com/device/K201315 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201315: PERFORM Humeral System – Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201315
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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