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 Jun 10, 2016 as substantially equivalent to K143374 (Tornier S.A.S., 2015) after a 102-day review. Its family tree reaches back 10 generations to 1991. 25 later devices descend from it.
- Decided
- Jun 10, 2016
- Review
- 102 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K905070 (1991). 98 ancestors in all, the oldest K800494 (1980). 25 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 6 generations between
- 3 generations backK111863 Signature Planner,Signature GuidesMaterialise NV · 2012
- 2 generations backK130126 Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc. · 2013
- 1 generation backK143374 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015
- This deviceK160555 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016
- Descendant · cites it directly · 23 of its ownK162800 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2017
- Descendant · 2 generations on · 18 of its ownK203315 BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2021
- Descendant · 3 generations on · 8 of its ownK213546 ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho · 2022 · Recalled
- Descendant · 3 generations on · 8 of its ownK211359 Tornier Perform™ Patient-Matched Primary Reversed Glenoid and…Tornier, Inc. · 2021 · Recalled
- Descendant · 3 generations on · 3 of its ownK232265 BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2024
Show all 10 generations
- Root · 10 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 9 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 8 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 7 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 6 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 5 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 4 generations backK031454 Acumen Surgical Navigation SystemBiomet, Inc. · 2004
- 3 generations backK111863 Signature Planner,Signature GuidesMaterialise NV · 2012
- 2 generations backK130126 Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc. · 2013
- 1 generation backK143374 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015
- This deviceK160555 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2017 · cites it directly23descendants
- K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2021 · 2 generations on18descendants
- K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho · 2022 · 3 generations on8descendants
- K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc. · 2021 · 3 generations on8descendants
- K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2024 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −9 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −8 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −7 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −6 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −5 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −4 | K031454 | Acumen Surgical Navigation System | Biomet, Inc. | 2004 | — |
| −3 | K111863 | Signature Planner,Signature Guides | Materialise NV | 2012 | — |
| −2 | K130126 | Signature Personalized Patient Care System - Glenoid Guide System | Biomet, Inc. | 2013 | — |
| −1 | K143374 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2015 | — |
| 0 (this device) | K160555 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2016 | — |
| +1 | K162800 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2017 | — |
| +2 | K203315 | BLUEPRINT™ Patient Specific Instrumentation | Tornier S.A.S. | 2021 | — |
| +3 | K213546 | ExactechGPS Total Shoulder Application, Equinoxe Planning Software | Blue Ortho | 2022 | 1 |
| +3 | K211359 | Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™… | Tornier, Inc. | 2021 | 2 |
| +3 | K232265 | BLUEPRINT™ Patient Specific Instrumentation | Tornier S.A.S. | 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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K143374 | BLUEPRINT Patient Specific InstrumentationSummary page 4…Class II Classification panel: Orthopedic Product code: KWS 5) Equivalent / Predicate device : BLUEPRINT™ Patient Specific Instrumentation, Tornier SAS (K143374) Delta TT Acetabular System, Limacorporate S.p.A. (K112898) GFM-00000123 REV B - Tornier… | 2015 |
| † | K112898 | Delta TT Cups, Delta TT Liners, Bone Screws | 2012 |
What descends from it? (25)
See all 252 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 25 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 19 of the 98 ancestors have a recall of any class.
- Of its descendants, K162800 (Tornier S.A.S., 2017) has gone furthest, with 23 descendants of its own.
- 2 other devices also cite its predicate K143374.
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. 2016, 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?
The hardware The Aequalis 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 shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT-scans. Aequalis PerFORM Anatomic Glenoid Guide is used by surgeons to facilitate the placement of the Aequalis PerFORM glenoids. The software…
Read the full statement (236 words)
The hardware
The Aequalis 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 shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT-scans.
Aequalis PerFORM Anatomic Glenoid Guide is used by surgeons to facilitate the placement of the Aequalis PerFORM glenoids.
The software
The 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 BLUEPRINT3D planning software.
BLUEPRINT 3D planning software allows surgeon to visualize, measure, reconstruct, and annotate anatomic data. It allows surgeon to design patient specific guides based on the presurgical plan.
This device is intended for use provided anatomic reference points necessary for positioning of the guide are present on the CT scan.
The software leads to the generation of a surgery report along with a 3D file of the patient-specific guide.
BLUEPRINT 3D planning software does not include any system to manufacture the 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/K160555 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160555: 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/K160555
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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