510(k) · Cleared
ClearedProphecy Incompass Surgical Planning System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wright Medical Technology, Inc. (Stryker) · HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Jun 16, 2026 as substantially equivalent to K131283 (Wrightmedicaltechnologyinc, 2013) and 3 other predicates after a 263-day review. Its family tree reaches back 12 generations to 1992.
- Decided
- Jun 16, 2026
- Review
- 263 days
- Class
- Class II
- Product code
- HSN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K920802 (1992). 24 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK920802 Alvine Total AnkleDepuy, Inc. · 1992
- 8 generations between
- 3 generations backK202815 PROPHECY Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2021
- 2 generations backK222835 Prophecy Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2023
- 1 generation backK241999 Prophecy Surgical Planning SystemWright Medical Technology, Inc. (Stryker) · 2024
- This deviceK253159 Prophecy Incompass Surgical Planning SystemWright Medical Technology, Inc. (Stryker) · 2026
Show all 12 generations
- Root · 12 generations backK920802 Alvine Total AnkleDepuy, Inc. · 1992
- 11 generations backK020541 Agility Ankle Revision ProsthesisDepuy, Inc. · 2002
- 10 generations backK051023 Topez Total Ankle ReplacementTopez Orthopedics, Inc. · 2005 · Recalled
- 9 generations backK100886 Inbone II Total Ankle ReplacementWrightmedicaltechnologyinc · 2010 · Recalled
- 8 generations backK123954 Infinity Total Ankle SystemWrightmedicaltechnologyinc · 2013 · Recalled
- 7 generations backK133585 Inbone Total AnkleWrightmedicaltechnologyinc · 2014
- 6 generations backK142117 Invision Total Ankle Revision SystemWrightmedicaltechnologyinc · 2015
- 5 generations backK162795 PROPHECY INVISION Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2017
- 4 generations backK170968 PROPHECY INVISION Pre-operative Navigation SystemWrightmedicaltechnologyinc · 2017
- 3 generations backK202815 PROPHECY Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2021
- 2 generations backK222835 Prophecy Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2023
- 1 generation backK241999 Prophecy Surgical Planning SystemWright Medical Technology, Inc. (Stryker) · 2024
- This deviceK253159 Prophecy Incompass Surgical Planning SystemWright Medical Technology, Inc. (Stryker) · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K920802 | Alvine Total Ankle | Depuy, Inc. | 1992 | — |
| −11 | K020541 | Agility Ankle Revision Prosthesis | Depuy, Inc. | 2002 | — |
| −10 | K051023 | Topez Total Ankle Replacement | Topez Orthopedics, Inc. | 2005 | 4 |
| −9 | K100886 | Inbone II Total Ankle Replacement | Wrightmedicaltechnologyinc | 2010 | 2 |
| −8 | K123954 | Infinity Total Ankle System | Wrightmedicaltechnologyinc | 2013 | 2 |
| −7 | K133585 | Inbone Total Ankle | Wrightmedicaltechnologyinc | 2014 | — |
| −6 | K142117 | Invision Total Ankle Revision System | Wrightmedicaltechnologyinc | 2015 | — |
| −5 | K162795 | PROPHECY INVISION Preoperative Navigation Alignment System | Wrightmedicaltechnologyinc | 2017 | — |
| −4 | K170968 | PROPHECY INVISION Pre-operative Navigation System | Wrightmedicaltechnologyinc | 2017 | — |
| −3 | K202815 | PROPHECY Preoperative Navigation Alignment System | Wrightmedicaltechnologyinc | 2021 | — |
| −2 | K222835 | Prophecy Preoperative Navigation Alignment System | Wrightmedicaltechnologyinc | 2023 | — |
| −1 | K241999 | Prophecy Surgical Planning System | Wright Medical Technology, Inc. (Stryker) | 2024 | — |
| 0 (this device) | K253159 | Prophecy Incompass Surgical Planning System | Wright Medical Technology, Inc. (Stryker) | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 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? (4)
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 |
|---|---|---|---|
| * | K131283 | Prophecy Infinity Preoperative Navigation Alignment GuidesSummary page 5…(a)(3). Primary Predicate Device: Prophecy Infinity Preoperative Navigation Alignment Guides (K131283) (a)(4). Secondary Predicate Device(s): Prophecy Surgical Planning – 3D Planner 2.0.0… | 2013 |
| * | K241999 | Prophecy Surgical Planning SystemSummary page 5…s (K131283) (a)(4). Secondary Predicate Device(s): Prophecy Surgical Planning – 3D Planner 2.0.0 (K241999), Prophecy Surgical Planning – Footprint™ (K202815), Incompass Total Ankle… | 2024 |
| * | K202815 | PROPHECY Preoperative Navigation Alignment SystemSummary page 5…r 2.0.0 (K241999), Prophecy Surgical Planning – Footprint™ (K202815), Incompass Total Ankle System (K250037) (a)(5). Device Description… | 2021 |
| * | K250037 | Incompass Total Ankle SystemSummary page 5…nning – Footprint™ (K202815), Incompass Total Ankle System (K250037) (a)(5). Device Description The Prophecy Surgical Planning System consists of three components: • Prophecy® P… | 2025 |
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 34 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 24 ancestors have a recall of any class.
- 3 other devices also cite its predicate K131283.
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. 2026, 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?
Prophecy® Surgical Planning is intended to be used as patient specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively, in guiding the marking of bone before cutting, and in the pre-surgical planning of the ankle and surrounding anatomy to support the total ankle implant. The Prophecy® Surgical Planning Guides and Reports are intended for use with the Inbone®, Infinity®, Invision®, and…
Read the full statement (110 words)
Prophecy® Surgical Planning is intended to be used as patient specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively, in guiding the marking of bone before cutting, and in the pre-surgical planning of the ankle and surrounding anatomy to support the total ankle implant. The Prophecy® Surgical Planning Guides and Reports are intended for use with the Inbone®, Infinity®, Invision®, and Incompass™ Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (e.g. CT scans and X-rays). The Prophecy® Surgical Planning Guides are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253159 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253159: Prophecy Incompass Surgical Planning System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253159
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026