510(k) · Cleared
ClearedQUANTUM® Patient Specific Instrumentation (PSI) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
In2bones Sas · HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Apr 23, 2024 as substantially equivalent to K211883 (In2bones Sas, 2021) after a 316-day review. Its family tree reaches back 10 generations to 1992.
- Decided
- Apr 23, 2024
- Review
- 316 days
- Class
- Class II
- Product code
- HSN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K920802 (1992). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK920802 Alvine Total AnkleDepuy, Inc. · 1992
- 6 generations between
- 3 generations backK162795 PROPHECY INVISION Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2017
- 2 generations backK170968 PROPHECY INVISION Pre-operative Navigation SystemWrightmedicaltechnologyinc · 2017
- 1 generation backK211883 QUANTUM® Patient Specific Instrumentation (PSI) SystemIn2bones Sas · 2021
- This deviceK231699 QUANTUM® Patient Specific Instrumentation (PSI) SystemIn2bones Sas · 2024
Show all 10 generations
- Root · 10 generations backK920802 Alvine Total AnkleDepuy, Inc. · 1992
- 9 generations backK020541 Agility Ankle Revision ProsthesisDepuy, Inc. · 2002
- 8 generations backK051023 Topez Total Ankle ReplacementTopez Orthopedics, Inc. · 2005 · Recalled
- 7 generations backK100886 Inbone II Total Ankle ReplacementWrightmedicaltechnologyinc · 2010 · Recalled
- 6 generations backK123954 Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2013 · Recalled
- 5 generations backK133585 Inbone Total AnkleWrightmedicaltechnologyinc · 2014
- 4 generations backK142117 Invision Total Ankle Revision SystemWrightmedicaltechnologyinc · 2015
- 3 generations backK162795 PROPHECY INVISION Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2017
- 2 generations backK170968 PROPHECY INVISION Pre-operative Navigation SystemWrightmedicaltechnologyinc · 2017
- 1 generation backK211883 QUANTUM® Patient Specific Instrumentation (PSI) SystemIn2bones Sas · 2021
- This deviceK231699 QUANTUM® Patient Specific Instrumentation (PSI) SystemIn2bones Sas · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K920802 | Alvine Total Ankle | Depuy, Inc. | 1992 | — |
| −9 | K020541 | Agility Ankle Revision Prosthesis | Depuy, Inc. | 2002 | — |
| −8 | K051023 | Topez Total Ankle Replacement | Topez Orthopedics, Inc. | 2005 | 4 |
| −7 | K100886 | Inbone II Total Ankle Replacement | Wrightmedicaltechnologyinc | 2010 | 2 |
| −6 | K123954 | Infinity Total Ankle System | Wrightmedicaltechnologyinc | 2013 | 2 |
| −5 | K133585 | Inbone Total Ankle | Wrightmedicaltechnologyinc | 2014 | — |
| −4 | K142117 | Invision Total Ankle Revision System | Wrightmedicaltechnologyinc | 2015 | — |
| −3 | K162795 | PROPHECY INVISION Preoperative Navigation Alignment System | Wrightmedicaltechnologyinc | 2017 | — |
| −2 | K170968 | PROPHECY INVISION Pre-operative Navigation System | Wrightmedicaltechnologyinc | 2017 | — |
| −1 | K211883 | QUANTUM® Patient Specific Instrumentation (PSI) System | In2bones Sas | 2021 | — |
| 0 (this device) | K231699 | QUANTUM® Patient Specific Instrumentation (PSI) System | In2bones Sas | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 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 HSN? 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 HSN device
- #1 K192994 Paragon 28 APEX 3D Total Ankle Replacement…score 16.8 · 8 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 |
|---|---|---|---|
| * | K211883 | QUANTUM® Patient Specific Instrumentation (PSI) SystemSummary page 6…ftware related to the In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides for Total Ankle Replacement (TAR) previously cleared in K211883. Predicate Primary predicate: Devices QUANTUM® Patient Specific Instrumentation (PSI) System (K211883),… | 2021 |
| † | K230313 | QUANTUM Patient Specific Instrumentation (PSI) System | 2023 |
| † | K191380 | Quantum® Total Ankle Prosthesis | 2020 |
| † | K221432 | Customize | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 4 of the 16 ancestors have a recall of any class.
- 1 other device also cites its predicate K211883.
How does its category compare?
All HSN devicesHSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · HSN
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSN
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSN
1,645in 2025
MAUDE reports naming product code HSN, 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 | 0 | — | 0 | 50 |
| 2008 | 0 | — | 0 | 66 |
| 2009 | 1 | — | 0 | 66 |
| 2010 | 2 | — | 0 | 120 |
| 2011 | 1 | — | 0 | 139 |
| 2012 | 2 | — | 0 | 100 |
| 2013 | 4 | 89 | 3 | 106 |
| 2014 | 2 | — | 0 | 65 |
| 2015 | 3 | 233 | 0 | 73 |
| 2016 | 3 | 216 | 1 | 111 |
| 2017 | 4 | 148 | 2 | 96 |
| 2018 | 4 | 89 | 0 | 187 |
| 2019 | 2 | — | 1 | 277 |
| 2020 | 6 | 234 | 0 | 281 |
| 2021 | 4 | 109 | 3 | 237 |
| 2022 | 1 | — | 2 | 453 |
| 2023 | 6 | 112 | 1 | 796 |
| 2024 | 7 | 115 | 0 | 1,095 |
| 2025 | 3 | 58 | 0 | 1,645 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
In2Bones PSI: In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides for Total Ankle Replacement (TAR) is indicated as an orthopaedic instrument system to assist in the instrumentation positioning dedicated to In2Bones QUANTUM® Total Ankle Replacement implantation. In2Bones QUANTUM® PSI guides are compatible with QUANTUM® tibial tray, QUANTUM® tibial inlay, as well as standard and Flat-Cut QUANTUM® talar implants. PSI Guides are intended for…
Read the full statement (226 words)
In2Bones PSI: In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides for Total Ankle Replacement (TAR) is indicated as an orthopaedic instrument system to assist in the instrumentation positioning dedicated to In2Bones QUANTUM® Total Ankle Replacement implantation. In2Bones QUANTUM® PSI guides are compatible with QUANTUM® tibial tray, QUANTUM® tibial inlay, as well as standard and Flat-Cut QUANTUM® talar implants.
PSI Guides are intended for single use only. PSI Guides are manufactured in correlation with a pre-operative planning validated by the surgeon on the TAR Planning Software and assist in the positioning of the dedicated QUANTUM® instrumentation with which drillings or bone cuts will be performed. In2Bones QUANTUM® PSI guides are indicated for patient population fulfilling the QUANTUM® Total Ankle Replacement indications and for which X-rays and CT-scan images are available and compliant with imaging protocol provided by In2Bones.
TAR Planning software: The TAR Planning Software is a preoperative surgical planning software intended to be used with In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides and QUANTUM® Total Ankle Replacement. TAR Planning Software allows the surgeon to use advanced display and positioning tools to guide the marking of bone before cutting and preview the total ankle replacement components intraoperatively, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient X-rays and imaging scans. X-rays and CT-scan are the accepted imaging modalities for these procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231699 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231699: QUANTUM® Patient Specific Instrumentation (PSI) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231699
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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