510(k) · Cleared
ClearedSignature Personalized Patient Care System - Glenoid Guide System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Cleared on Aug 6, 2013 as substantially equivalent to K050897 (Kinamed, Inc., 2005) and 1 other predicate after a 201-day review. Its family tree reaches back 8 generations to 1991. 38 later devices descend from it.
- Decided
- Aug 6, 2013
- Review
- 201 days
- Class
- Class II
- Product code
- MBF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K905070 (1991). 29 ancestors in all, the oldest K861692 (1986). 38 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 7 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 6 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 5 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 4 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 3 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 2 generations backK031454 Acumen Surgical Navigation SystemBiomet, Inc. · 2004
- 1 generation backK111863 Signature Planner,Signature GuidesMaterialise NV · 2012
- This deviceK130126 Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc. · 2013
- Descendant · cites it directly · 31 of its ownK143374 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015
- Descendant · 2 generations on · 25 of its ownK160555 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016
- Descendant · 3 generations on · 23 of its ownK162800 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2017
- Descendant · 4 generations on · 18 of its ownK203315 BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2021
- Descendant · cites it directly · 10 of its ownK190595 Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015 · cites it directly31descendants
- K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016 · 2 generations on25descendants
- K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2017 · 3 generations on23descendants
- K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2021 · 4 generations on18descendants
- K190595Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019 · cites it directly10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −7 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −6 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −5 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −4 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −3 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −2 | K031454 | Acumen Surgical Navigation System | Biomet, Inc. | 2004 | — |
| −1 | K111863 | Signature Planner,Signature Guides | Materialise NV | 2012 | — |
| 0 (this device) | K130126 | Signature Personalized Patient Care System - Glenoid Guide System | Biomet, Inc. | 2013 | — |
| +1 | K143374 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2015 | — |
| +2 | K160555 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2016 | — |
| +3 | K162800 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2017 | — |
| +4 | K203315 | BLUEPRINT™ Patient Specific Instrumentation | Tornier S.A.S. | 2021 | — |
| +1 | K190595 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 5 | 0 |
| 2025 | 7 | 0 |
| 2026 | 6 | 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 MBF? 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 MBF device
- #1 K202716 Ignite Anatomic Shoulder Systemscore 20.3 · 14 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 |
|---|---|---|---|
| * | K050897 | Navipro Shoulder Software ModuleSummary page 1…Shoulder Instruments (Biomet, Inc.)- 510(k) Exempt " NaviPro Shoulder System (Kinamed, Inc.)- K050897 " Signature Personalized Patient Care System- Acetabular Guide… | 2005 |
| * | K111863 | Signature Planner,Signature GuidesSummary page 1…97 " Signature Personalized Patient Care System- Acetabular Guide System (Materialise, NV)- K(111863 Reason for 510(k) submission New patient specific glenoid guides Device description Patient specific guides are… | 2012 |
What descends from it? (38)
See all 382 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 22 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 4 of the 29 ancestors have a recall of any class.
- Of its descendants, K143374 (Tornier S.A.S., 2015) has gone furthest, with 31 descendants of its own.
How does its category compare?
All MBF devicesMBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · MBF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBF
144in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBF
255in 2025
MAUDE reports naming product code MBF, 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 | — | 0 | 2 |
| 2008 | 1 | — | 0 | 7 |
| 2009 | 1 | — | 1 | 16 |
| 2010 | 0 | — | 0 | 24 |
| 2011 | 0 | — | 0 | 32 |
| 2012 | 2 | — | 0 | 30 |
| 2013 | 1 | — | 0 | 40 |
| 2014 | 1 | — | 0 | 28 |
| 2015 | 0 | — | 0 | 49 |
| 2016 | 0 | — | 0 | 85 |
| 2017 | 2 | — | 1 | 193 |
| 2018 | 1 | — | 1 | 99 |
| 2019 | 2 | — | 2 | 47 |
| 2020 | 2 | — | 0 | 24 |
| 2021 | 1 | — | 0 | 36 |
| 2022 | 4 | 164 | 8 | 114 |
| 2023 | 4 | 144 | 1 | 143 |
| 2024 | 2 | — | 0 | 164 |
| 2025 | 2 | — | 0 | 255 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Signature Personalized Patient Care System - Glenoid Guide System is intended to be used as a surgical instrument to assist in the positioning of glenoid components intra-operatively using anatomical landmarks of the shoulder that are identifiable on preoperative imaging scans. The Signature Personalized Patient Care System - Glenoid Guide System can be used in conjunction with the Comprehensive Total and Reverse Shoulder Systems (including the…
Read the full statement (103 words)
The Signature Personalized Patient Care System - Glenoid Guide System is intended to be used as a surgical instrument to assist in the positioning of glenoid components intra-operatively using anatomical landmarks of the shoulder that are identifiable on preoperative imaging scans.
The Signature Personalized Patient Care System - Glenoid Guide System can be used in conjunction with the Comprehensive Total and Reverse Shoulder Systems (including the Modular Hybrid Glenoid, Bio-Modular Heads and Stems), and their respective components, which require placement of an initial center pin or hole to guide the associated system instruments.
The Signature Glenoid Guide is intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130126 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130126: Signature Personalized Patient Care System - Glenoid Guide System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130126
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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