510(k) · Cleared
ClearedMaven Patient-Specific Instrumentation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paragon 28, Inc. · HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Jan 14, 2021 as substantially equivalent to K170968 (Wrightmedicaltechnologyinc, 2017) and 1 other predicate after a 177-day review. Its family tree reaches back 9 generations to 1992. 1 later device descends from it.
- Decided
- Jan 14, 2021
- Review
- 177 days
- Class
- Class II
- Product code
- HSN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K920802 (1992). 35 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK920802 Alvine Total AnkleDepuy, Inc. · 1992
- 5 generations between
- 3 generations backK142117 Invision Total Ankle Revision SystemWrightmedicaltechnologyinc · 2015
- 2 generations backK162795 PROPHECY INVISION Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2017
- 1 generation backK170968 PROPHECY INVISION Pre-operative Navigation SystemWrightmedicaltechnologyinc · 2017
- This deviceK202019 Maven Patient-Specific InstrumentationParagon 28, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK223227 MAVEN™ Patient-Specific InstrumentationParagon 28, Inc. · 2022
Show all 9 generations
- Root · 9 generations backK920802 Alvine Total AnkleDepuy, Inc. · 1992
- 8 generations backK020541 Agility Ankle Revision ProsthesisDepuy, Inc. · 2002
- 7 generations backK051023 Topez Total Ankle ReplacementTopez Orthopedics, Inc. · 2005 · Recalled
- 6 generations backK100886 Inbone II Total Ankle ReplacementWrightmedicaltechnologyinc · 2010 · Recalled
- 5 generations backK123954 Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2013 · Recalled
- 4 generations backK133585 Inbone Total AnkleWrightmedicaltechnologyinc · 2014
- 3 generations backK142117 Invision Total Ankle Revision SystemWrightmedicaltechnologyinc · 2015
- 2 generations backK162795 PROPHECY INVISION Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2017
- 1 generation backK170968 PROPHECY INVISION Pre-operative Navigation SystemWrightmedicaltechnologyinc · 2017
- This deviceK202019 Maven Patient-Specific InstrumentationParagon 28, Inc. · 2021
Most influential descendants
Showing 1 of 1 · See all- K223227MAVEN™ Patient-Specific InstrumentationParagon 28, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K920802 | Alvine Total Ankle | Depuy, Inc. | 1992 | — |
| −8 | K020541 | Agility Ankle Revision Prosthesis | Depuy, Inc. | 2002 | — |
| −7 | K051023 | Topez Total Ankle Replacement | Topez Orthopedics, Inc. | 2005 | 4 |
| −6 | K100886 | Inbone II Total Ankle Replacement | Wrightmedicaltechnologyinc | 2010 | 2 |
| −5 | K123954 | Infinity Total Ankle System | Wrightmedicaltechnologyinc | 2013 | 2 |
| −4 | K133585 | Inbone Total Ankle | Wrightmedicaltechnologyinc | 2014 | — |
| −3 | K142117 | Invision Total Ankle Revision System | Wrightmedicaltechnologyinc | 2015 | — |
| −2 | K162795 | PROPHECY INVISION Preoperative Navigation Alignment System | Wrightmedicaltechnologyinc | 2017 | — |
| −1 | K170968 | PROPHECY INVISION Pre-operative Navigation System | Wrightmedicaltechnologyinc | 2017 | — |
| 0 (this device) | K202019 | Maven Patient-Specific Instrumentation | Paragon 28, Inc. | 2021 | — |
| +1 | K223227 | MAVEN™ Patient-Specific Instrumentation | Paragon 28, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 16.7 · 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? (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 |
|---|---|---|---|
| * | K170968 | PROPHECY INVISION Pre-operative Navigation SystemSummary page 5…mplants. Predicate Devices: The Paragon 28 MAVEN™ Patient-Specific Instrumentation is substantially equivalent to the PROPEHCY INFINITY Pre-Operative Navigation System (K170968). The APEX 3D Total Ankle Replacement System (K192994) is an additional predicate device and VSP Orthopedics System (K190044) is… | 2017 |
| * | K192994 | Paragon 28 APEX 3D Total Ankle Replacement SystemSummary page 5…cans. Device Description: The Paragon 28 MAVEN™ Patient-Specific Instrumentation is used in conjunction with the APEX 3D Total Ankle Replacement System instrumentation (K192994). The guides are created to fit the anatomy of the patient’s distal tibia and proximal talus, and when used in combination with t… | 2020 |
| † | K190044 | VSP Orthopedics System | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223227 | MAVEN™ Patient-Specific Instrumentation | 2022 | 0 |
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 29 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 15 of the 35 ancestors have a recall of any class.
- Of its descendants, K223227 (Paragon 28, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K170968.
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. 2021, 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?
The Paragon 28 MAVENT™ Patient-Specific Instrumentation is intended to be used as patient specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively and in guiding the marking of bone before cutting. The Paragon 28 MAVENT™ Patient-Specific Instrumentation is intended for use with the Paragon 28 APEX 3D Total Ankle Replacement System and its cleared indications for use, provided that anatomic…
Read the full statement (139 words)
The Paragon 28 MAVENT™ Patient-Specific Instrumentation is intended to be used as patient specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively and in guiding the marking of bone before cutting. The Paragon 28 MAVENT™ Patient-Specific Instrumentation is intended for use with the Paragon 28 APEX 3D Total Ankle Replacement System and its cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging CT scans. The Paragon 28 MAVENT™ Patient-Specific Instrumentation is intended for single use only. The Paragon 28 TAR Patient-Specific Case Reports are intended for use with the Paragon 28 APEX 3D Total Ankle Replacement System and its cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging CT scans.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K202019 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202019: Maven 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/K202019
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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