510(k) · Cleared
ClearedBLUEPRINT™ Patient Specific Instrumentation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tornier S.A.S. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Apr 15, 2021 as substantially equivalent to K162800 (Tornier S.A.S., 2017) after a 156-day review. Its family tree reaches back 12 generations to 1991. 18 later devices descend from it.
- Decided
- Apr 15, 2021
- Review
- 156 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K905070 (1991). 100 ancestors in all, the oldest K800494 (1980). 18 later devices descend from it, 4 citing it directly.
- Root · 12 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 8 generations between
- 3 generations backK143374 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015
- 2 generations backK160555 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016
- 1 generation backK162800 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2017
- This deviceK203315 BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2021
- Descendant · cites it directly · 8 of its ownK213546 ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho · 2022 · Recalled
- Descendant · cites it directly · 8 of its ownK211359 Tornier Perform™ Patient-Matched Primary Reversed Glenoid and…Tornier, Inc. · 2021 · Recalled
- Descendant · cites it directly · 3 of its ownK232265 BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2024
- Descendant · 2 generations on · 3 of its ownK233199 ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2024
- Descendant · 2 generations on · 2 of its ownK232425 Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas) · 2023
Show all 12 generations
- Root · 12 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 11 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 10 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 9 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 8 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 7 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 6 generations backK031454 Acumen Surgical Navigation SystemBiomet, Inc. · 2004
- 5 generations backK111863 Signature Planner,Signature GuidesMaterialise NV · 2012
- 4 generations backK130126 Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc. · 2013
- 3 generations backK143374 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015
- 2 generations backK160555 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016
- 1 generation backK162800 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2017
- This deviceK203315 BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2021
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho · 2022 · cites it directly8descendants
- K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc. · 2021 · cites it directly8descendants
- K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2024 · cites it directly3descendants
- K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2024 · 2 generations on3descendants
- K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas) · 2023 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −11 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −10 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −9 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −8 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −7 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −6 | K031454 | Acumen Surgical Navigation System | Biomet, Inc. | 2004 | — |
| −5 | K111863 | Signature Planner,Signature Guides | Materialise NV | 2012 | — |
| −4 | K130126 | Signature Personalized Patient Care System - Glenoid Guide System | Biomet, Inc. | 2013 | — |
| −3 | K143374 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2015 | — |
| −2 | K160555 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2016 | — |
| −1 | K162800 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2017 | — |
| 0 (this device) | K203315 | BLUEPRINT™ Patient Specific Instrumentation | Tornier S.A.S. | 2021 | — |
| +1 | K213546 | ExactechGPS Total Shoulder Application, Equinoxe Planning Software | Blue Ortho | 2022 | 1 |
| +1 | 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 | — |
| +2 | K233199 | ROSA® Shoulder System | Orthosoft Inc (D/B/A Zimmer Cas) | 2024 | — |
| +2 | K232425 | Signature™ ONE System | Orthosoft Inc. (D/B/A) Zimmer Cas) | 2023 | — |
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 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 5 | 0 |
| 2004 | 8 | 0 |
| 2005 | 5 | 0 |
| 2006 | 6 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 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 KWS? 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? (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 |
|---|---|---|---|
| * | K162800 | BLUEPRINT Patient Specific InstrumentationSummary page 4…Class II Classification panel: Orthopedic Product code: KWS Equivalent / Predicate device BLUEPRINTTM Patient Specific K162800 June 10, 2016 TORNIER SAS Instrumentation (PRIMARY) PROPHECY INVISION Pre- K170968 August 16, Wr… | 2017 |
| † | K170968 | PROPHECY INVISION Pre-operative Navigation System | 2017 |
What descends from it? (18)
See all 184 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)
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 30 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 19 of the 100 ancestors have a recall of any class.
- Of its descendants, K213546 (Blue Ortho, 2022) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K162800.
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. 2021, 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?
Hardware The BLUEPRINT m 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 BLUEPRINTTm 3D Planning Software is a medical device for surgeons. BLUEPRINT m 3D Planning Software is intended to…
Read the full statement (173 words)
Hardware
The BLUEPRINT m 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
BLUEPRINTTm 3D Planning Software is a medical device for surgeons. BLUEPRINT m 3D Planning Software is intended to be used as a pre-surgical planner for shoulder orthopedic surgery.
BLUEPRINTIM 3D Planning Software requires CT scan images showing the anatomical shoulder structure in a DICOM format.
BLUEPRINTM 3D Planning Software allows surgeons to visualize, measure, reconstruct, and annotate anatomic data.
BLUEPRINTIM 3D Planning Software allows surgeons to design patient specific guides based on the pre-surgical plan.
BLUEPRINTTm 3D Planning Software leads to the generation of a planning report.
BLUEPRINTM 3D Planning Software is to be used for adult men and women 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203315 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203315: BLUEPRINT™ Patient Specific Instrumentation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203315
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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