510(k) · Cleared
Recalled · Class II · 2025Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tornier, Inc. · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Nov 12, 2021 as substantially equivalent to K161742 (Tornier, Inc., 2016) and 1 other predicate after a 193-day review. Its family tree reaches back 13 generations to 1991. 8 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 12, 2021
- Review
- 193 days
- Class
- Class II
- Product code
- PHX
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 13 generations to K905070 (1991). 108 ancestors in all, the oldest K800494 (1980). 8 later devices descend from it, 4 citing it directly.
- Root · 13 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 9 generations between
- 3 generations backK160555 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016
- 2 generations backK162800 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2017
- 1 generation backK203315 BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2021
- This deviceK211359 Tornier Perform™ Patient-Matched Primary Reversed Glenoid and…Tornier, Inc. · 2021
- Descendant · cites it directly · 3 of its ownK232265 BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2024
- Descendant · cites it directly · 2 of its ownK232425 Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas) · 2023
- Descendant · 2 generations on · 1 of its ownK260104 Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS · 2026
- Descendant · cites it directly · 1 of its ownK241491 Blueprint Patient-Specific Instrumentation; Shoulder iD Primary…Stryker Corporation (Tornier, S.A.S.) · 2024
- Descendant · 3 generations on · 0 of its ownK261510 Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS · 2026
Show all 13 generations
- Root · 13 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 12 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 11 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 10 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 9 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 8 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 7 generations backK031454 Acumen Surgical Navigation SystemBiomet, Inc. · 2004
- 6 generations backK111863 Signature Planner,Signature GuidesMaterialise NV · 2012
- 5 generations backK130126 Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc. · 2013
- 4 generations backK143374 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015
- 3 generations backK160555 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016
- 2 generations backK162800 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2017
- 1 generation backK203315 BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2021
- This deviceK211359 Tornier Perform™ Patient-Matched Primary Reversed Glenoid and…Tornier, Inc. · 2021
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2024 · cites it directly3descendants
- K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas) · 2023 · cites it directly2descendants
- K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS · 2026 · 2 generations on1descendant
- K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.) · 2024 · cites it directly1descendant
- K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −12 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −11 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −10 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −9 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −8 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −7 | K031454 | Acumen Surgical Navigation System | Biomet, Inc. | 2004 | — |
| −6 | K111863 | Signature Planner,Signature Guides | Materialise NV | 2012 | — |
| −5 | K130126 | Signature Personalized Patient Care System - Glenoid Guide System | Biomet, Inc. | 2013 | — |
| −4 | K143374 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2015 | — |
| −3 | K160555 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2016 | — |
| −2 | K162800 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2017 | — |
| −1 | K203315 | BLUEPRINT™ Patient Specific Instrumentation | Tornier S.A.S. | 2021 | — |
| 0 (this device) | K211359 | Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™… | Tornier, Inc. | 2021 | — |
| +1 | K232265 | BLUEPRINT™ Patient Specific Instrumentation | Tornier S.A.S. | 2024 | — |
| +1 | K232425 | Signature™ ONE System | Orthosoft Inc. (D/B/A) Zimmer Cas) | 2023 | — |
| +2 | K260104 | Signature™ ONE System | Orthosoft Inc. (d/b/a) Zimmer CAS | 2026 | — |
| +1 | K241491 | Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid | Stryker Corporation (Tornier, S.A.S.) | 2024 | — |
| +3 | K261510 | Signature™ ONE System | Orthosoft Inc. (d/b/a) Zimmer CAS | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 5 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 6 | 0 |
| 2000 | 5 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 5 | 0 |
| 2004 | 10 | 0 |
| 2005 | 6 | 0 |
| 2006 | 7 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2026 | 4 | 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.
Planning a device in PHX? 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 PHX device
- #1 K212737 INHANCE™ Reverse Shoulder Systemscore 28.4 · 15 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 |
|---|---|---|---|
| * | K161742 | Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidSummary page 5…21 CFR 888.3660 Product Codes: KWS, QHE Predicate Device Information Tornier, Inc. Primary Predicate: AEQUALISTM PERFORM Reversed Glenoid, K161742 Reference Device: ZIMMER BIOMET Comprehensive Vault Reconstruction System, K152754 Exactech E… | 2016 |
| * | K203315 | BLUEPRINT™ Patient Specific InstrumentationSummary page 5…Reconstruction System, K152754 Exactech Equinoxe, K110708 Tornier SAS Primary Predicate: BLUEPRINT™ Patient Specific Instrumentation, K203315 Tornier Perform™ Patient-Matched Primary Reversed Glenoid 1 BLUEPRINT™ Patient Specific… | 2021 |
| † | K152754 | Comprehensive Vault Reconstruction System (VRS) | 2016 |
| † | K110708 | Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere / Superior… | 2011 |
What descends from it? (8)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 10, 2025 | Class II | Z-1738-2025 | Software Design Change | A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software. |
| Apr 16, 2024 | Class II | Z-1883-2024 | Software change control | The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and anatomic humeral Tornier Flex implant configurations that are incompatible and do not have regulatory approval. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 20 of the 108 ancestors have a recall of any class.
- Of its descendants, K232265 (Tornier S.A.S., 2024) has gone furthest, with 3 descendants of its own.
- 20 other devices also cite its predicate K161742.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · PHX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PHX
72in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PHX
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PHX
2,848in 2025
MAUDE reports naming product code PHX, 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 | 5 | 97 | 0 | 0 |
| 2008 | 6 | 79 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 8 | 124 | 0 | 0 |
| 2011 | 12 | 94 | 0 | 0 |
| 2012 | 12 | 114 | 0 | 0 |
| 2013 | 8 | 143 | 0 | 0 |
| 2014 | 12 | 110 | 0 | 0 |
| 2015 | 4 | 206 | 2 | 14 |
| 2016 | 4 | 132 | 0 | 5 |
| 2017 | 11 | 141 | 0 | 25 |
| 2018 | 14 | 127 | 1 | 323 |
| 2019 | 9 | 144 | 3 | 504 |
| 2020 | 13 | 143 | 3 | 986 |
| 2021 | 21 | 143 | 8 | 1,404 |
| 2022 | 9 | 198 | 0 | 1,342 |
| 2023 | 9 | 154 | 7 | 1,401 |
| 2024 | 9 | 139 | 1 | 2,142 |
| 2025 | 9 | 72 | 3 | 2,848 |
| 2026 | 18 | 130 | 7 | — |
What is it indicated for?
Tornier Perform™ Patient-Matched Primary Reversed Glenoid The Tornier Perform™ Patient-Matched Primary Reversed Glenoid implant 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…
Read the full statement (322 words)
Tornier Perform™ Patient-Matched Primary Reversed Glenoid
The Tornier Perform™ Patient-Matched Primary Reversed Glenoid implant 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
* Traumatic arthritis
* Revision of glenohumeral joint if sufficient native glenoid bone remains
All components are single use.
The Patient-Matched Glenoid implant is anchored to the bone with screws and is for non-cemented fixation.
Note: A CT Scan is used to create the Tornier Perform Patient-Matched Primary Reversed Glenoid implant.
BLUEPRINT™ Patient Specific Instrumentation
BLUEPRINT™ Glenoid Guides
The BLUEPRINT™ Glenoid Guides are intended to be used as surgical instruments to assist in the intraoperative positioning of glenoid components used with total anatomic or reversed shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans.
BLUEPRINT™ 3D Planning Software
BLUEPRINT™ 3D Planning Software is a medical device for surgeons.
BLUEPRINT™ 3D Planning Software is intended to be used as a pre-surgical planner for shoulder replacement surgery.
BLUEPRINT™ 3D Planning Software requires CT scan images showing the anatomical shoulder structure in a DICOM format.
BLUEPRINT™ 3D Planning Software allows surgeons to visualize, measure, reconstruct, and annotate anatomic data.
BLUEPRINT™ 3D Planning Software allows surgeons to design patient specific components (Patient-Specific instruments and Tornier Perform™ Patient-Matched Primary Reversed Glenoid*) based on the pre-surgical plan.
BLUEPRINT™ 3D Planning Software leads to the generation of a planning report.
BLUEPRINT™ 3D Planning Software is to be used for adult men and women patients only whose bone maturity is reached and should not be used for diagnostic purpose.
Note: Measures and patient specific guide design are provided depending on the case profiles.
*Only if Patient-Specific instruments or Tornier Perform™ Patient-Matched Primary Reversed Glenoid are available in your geography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211359 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211359: Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211359
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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