510(k) · Cleared

Cleared

Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid

K241491510(k) TraditionalCleared Oct 10, 2024139-day reviewClass II21 CFR 888.3660

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Stryker Corporation (Tornier, S.A.S.) · PHX Shoulder Prosthesis, Reverse Configuration

Cleared on Oct 10, 2024 as substantially equivalent to K232265 (Tornier S.A.S., 2024) and 1 other predicate after a 139-day review. Its family tree reaches back 15 generations to 1991. 1 later device descends from it.

Decided: Oct 10, 2024
Review: 139 days
Class: Class II
Product code: PHX
Recalls: None
Predicates: 2

Its longest line of descent runs back 15 generations to K905070 (1991). 110 ancestors in all, the oldest K800494 (1980). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 15 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
11 generations between
3 generations backK203315 BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2021
2 generations backK211359 Tornier Perform™ Patient-Matched Primary Reversed Glenoid and…Tornier, Inc. · 2021 · Recalled
1 generation backK232265 BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2024
This deviceK241491 Blueprint Patient-Specific Instrumentation; Shoulder iD Primary…Stryker Corporation (Tornier, S.A.S.) · 2024
Descendant · cites it directly · 0 of its ownK253674 Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.) · 2026

Show all 15 generations

Root · 15 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
14 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
13 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
12 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
11 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
10 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
9 generations backK031454 Acumen Surgical Navigation SystemBiomet, Inc. · 2004
8 generations backK111863 Signature Planner,Signature GuidesMaterialise NV · 2012
7 generations backK130126 Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc. · 2013
6 generations backK143374 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015
5 generations backK160555 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016
4 generations backK162800 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2017
3 generations backK203315 BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2021
2 generations backK211359 Tornier Perform™ Patient-Matched Primary Reversed Glenoid and…Tornier, Inc. · 2021 · Recalled
1 generation backK232265 BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2024
This deviceK241491 Blueprint Patient-Specific Instrumentation; Shoulder iD Primary…Stryker Corporation (Tornier, S.A.S.) · 2024

Most influential descendants

Showing 1 of 1 · See all

K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.) · 2026 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−15	K905070	Vistar	Philips Medical Systems (Cleveland), Inc.	1991	—
−14	K961168	Viewpoint	Philips Medical Systems (Cleveland), Inc.	1996	—
−13	K963221	Optical Digitizer Option for View Point	Philips Medical Systems (Cleveland), Inc.	1997	—
−12	K970604	Viewpoint - 3.0 Software	Philips Medical Systems (Cleveland), Inc.	1997	—
−11	K984298	Z Kat Flurotactic Guidance System Mki	Z-Kat, Inc.	1999	—
−10	K013025	Modification to Flourolab Plus	Z-Kat, Inc.	2001	—
−9	K031454	Acumen Surgical Navigation System	Biomet, Inc.	2004	—
−8	K111863	Signature Planner,Signature Guides	Materialise NV	2012	—
−7	K130126	Signature Personalized Patient Care System - Glenoid Guide System	Biomet, Inc.	2013	—
−6	K143374	BLUEPRINT Patient Specific Instrumentation	Tornier S.A.S.	2015	—
−5	K160555	BLUEPRINT Patient Specific Instrumentation	Tornier S.A.S.	2016	—
−4	K162800	BLUEPRINT Patient Specific Instrumentation	Tornier S.A.S.	2017	—
−3	K203315	BLUEPRINT™ Patient Specific Instrumentation	Tornier S.A.S.	2021	—
−2	K211359	Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™…	Tornier, Inc.	2021	2
−1	K232265	BLUEPRINT™ Patient Specific Instrumentation	Tornier S.A.S.	2024	—
0 (this device)	K241491	Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid	Stryker Corporation (Tornier, S.A.S.)	2024	—
+1	K253674	Blueprint Patient-Specific Instrumentation	Stryker Corporation (Tornier, S.A.S.)	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
2026	1	0

FIG. 1 — Lineage of K241491, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K232265	BLUEPRINT™ Patient Specific Instrumentation	Tornier S.A.S.	2024	—
*	K211359	Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient… Summary page 6 …u_m_en_ t_a_tio_n______� ___� P_H_X I K211359 I BLUEPRINT ™ Patient Specific Inst…	Tornier, Inc.	2021	2
†	K222987	Akunah REFLECT	Akunah Pty, Ltd.	2023	—

Also cleared against K232265: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K253674	Blueprint Patient-Specific Instrumentation	Stryker Corporation (Tornier, S.A.S.)	2026	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 33 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
21 of the 110 ancestors have a recall of any class.
Of its descendants, K253674 (Stryker Corporation (Tornier, S.A.S.), 2026) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K232265.

How does its category compare?

All PHX devices

PHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · PHX

9in 2025

2007high 21 (2021) · low 1 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PHX

72in 2025

2007high 206 (2015) · low 72 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · PHX

3in 2025

2007high 8 (2021) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · PHX

2,848in 2025

2007high 2,848 (2025) · low 0 (2007)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?

BLUEPRINT Patient Specific Instrumentation IFU: Hardware The BLUEPRINT Glenoid Guides are patient-specific drill guides. They have been specially designed 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. Software Blueprint is a medical device for surgeons. Blueprint is intended to…

Read the full statement (297 words)

BLUEPRINT Patient Specific Instrumentation IFU:

Hardware

The BLUEPRINT Glenoid Guides are patient-specific drill guides. They have been specially designed 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.

Software

Blueprint is a medical device for surgeons.

Blueprint is intended to be used as a pre-surgical planner for shoulder replacement surgery.

Blueprint requires CT scan images showing the anatomical shoulder structure in a DICOM format.

Blueprint allows surgeons to visualize, measure, reconstruct, and annotate anatomic data.

Blueprint allows surgeons to design patient specific components (patient-specific instruments and Shoulder iD Primary Reversed Glenoid*) based on the pre-surgical plan.

Blueprint leads to the generation of a planning report.

Blueprint 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 Shoulder iD Primary Reversed Glenoid are available in your geography.

Shoulder iD Primary Reversed Glenoid IFU:

The Shoulder iD 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 Shoulder iD Primary Reversed Glenoid implant is anchored to the bone with screws and is for non-cemented fixation.

Note: A CT Scan is used to create the Shoulder iD Primary Reversed Glenoid implant

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K241491 · printed Nov 6, 2026

Cite this page

510(k) Report. “K241491: Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241491

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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