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 Feb 22, 2017 as substantially equivalent to K160555 (Tornier S.A.S., 2016) after a 140-day review. Its family tree reaches back 11 generations to 1991. 23 later devices descend from it.
- Decided
- Feb 22, 2017
- Review
- 140 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K905070 (1991). 99 ancestors in all, the oldest K800494 (1980). 23 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 7 generations between
- 3 generations backK130126 Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc. · 2013
- 2 generations backK143374 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015
- 1 generation backK160555 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016
- This deviceK162800 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2017
- Descendant · cites it directly · 18 of its ownK203315 BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2021
- Descendant · 2 generations on · 8 of its ownK213546 ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho · 2022 · Recalled
- Descendant · 2 generations on · 8 of its ownK211359 Tornier Perform™ Patient-Matched Primary Reversed Glenoid and…Tornier, Inc. · 2021 · Recalled
- Descendant · 2 generations on · 3 of its ownK232265 BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2024
- Descendant · 3 generations on · 3 of its ownK233199 ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2024
Show all 11 generations
- Root · 11 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 10 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 9 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 8 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 7 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 6 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 5 generations backK031454 Acumen Surgical Navigation SystemBiomet, Inc. · 2004
- 4 generations backK111863 Signature Planner,Signature GuidesMaterialise NV · 2012
- 3 generations backK130126 Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc. · 2013
- 2 generations backK143374 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015
- 1 generation backK160555 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016
- This deviceK162800 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2017
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2021 · cites it directly18descendants
- K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho · 2022 · 2 generations on8descendants
- K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc. · 2021 · 2 generations on8descendants
- K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2024 · 2 generations on3descendants
- K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2024 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −10 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −9 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −8 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −7 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −6 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −5 | K031454 | Acumen Surgical Navigation System | Biomet, Inc. | 2004 | — |
| −4 | K111863 | Signature Planner,Signature Guides | Materialise NV | 2012 | — |
| −3 | K130126 | Signature Personalized Patient Care System - Glenoid Guide System | Biomet, Inc. | 2013 | — |
| −2 | K143374 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2015 | — |
| −1 | K160555 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2016 | — |
| 0 (this device) | K162800 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2017 | — |
| +1 | K203315 | BLUEPRINT™ Patient Specific Instrumentation | Tornier S.A.S. | 2021 | — |
| +2 | K213546 | ExactechGPS Total Shoulder Application, Equinoxe Planning Software | Blue Ortho | 2022 | 1 |
| +2 | K211359 | Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™… | Tornier, Inc. | 2021 | 2 |
| +2 | K232265 | BLUEPRINT™ Patient Specific Instrumentation | Tornier S.A.S. | 2024 | — |
| +3 | K233199 | ROSA® Shoulder System | Orthosoft Inc (D/B/A Zimmer Cas) | 2024 | — |
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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 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 |
|---|---|---|---|
| * | K160555 | BLUEPRINT Patient Specific InstrumentationSummary page 5…Trade name 510(k) Number Decision date Applicant %/8(35,17Œ3DWLHQW6SHFLILF Instrumentation K160555 10th June 2016 TORNIER SAS (PRIMARY) Materialise Glenoid Positioning System… | 2016 |
| † | K153602 | Materialise Glenoid Positioning System | 2016 |
| † | K160001 | TraumaCad Mobile Release 2.0 | 2016 |
| † | K132636 | Dyonics Plan Hip Impingement Planning System | 2013 |
| † | K101342 | Osirix MD | 2010 |
What descends from it? (23)
See all 232 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 26 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 19 of the 99 ancestors have a recall of any class.
- Of its descendants, K203315 (Tornier S.A.S., 2021) has gone furthest, with 18 descendants of its own.
- 1 other device also cites its predicate K160555.
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. 2017, 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™ 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™ 3D Planning Software is a medical device for surgeon composed of one software component. It is intended…
Read the full statement (203 words)
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™ 3D Planning Software is a medical device for surgeon composed of one software component. It is intended to be used as a pre-surgical planner for shoulder orthopedic surgery.
BLUEPRINT™ 3D Planning Software runs on standard personal and business computers running Microsoft Windows or Mac OS operating systems.
The software supports DICOM standard to import the CT scan (Computed Tomography) images of the patient. Only CT scan modality can be loaded with BLUEPRINT™ 3D Planning Software.
BLUEPRINT™ 3D Planning Software allows surgeon to visualize, measure, reconstruct, annotate and edit anatomic data. It allows surgeon to design glenoid patient-specific guides based on the pre-surgical plan.
The software leads to the generation of a surgery report along with a 3D file of the glenoid patient-specific guide.
BLUEPRINT™ 3D Planning Software does not include any system to manufacture the glenoid patient-specific guide.
BLUEPRINT™ 3D Planning Software is to be used for adult patients only and should not be used for diagnostic purpose.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162800 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162800: 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/K162800
Report an extraction error
Are you the manufacturer?
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