510(k) · Cleared
ClearedProphecy Pre-Operative Navigation Alignment Guides
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on Oct 17, 2011 as substantially equivalent to K093405 (Wrightmedicaltechnologyinc, 2010) after a 313-day review. Its family tree reaches back 2 generations to 1997. 1 of the 5 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Oct 17, 2011
- Review
- 313 days
- Class
- Class II
- Product code
- MBH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K972626 (1997). 3 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK972626 Advance Knee SystemWrightmedicaltechnologyinc · 1997
- 1 generation backK093405 Prophecy Pre-Operative Navigation Alignment GuidesWrightmedicaltechnologyinc · 2010
- This deviceK103598 Prophecy Pre-Operative Navigation Alignment GuidesWrightmedicaltechnologyinc · 2011
- Descendant · cites it directly · 0 of its ownK213817 MPO Knee Instruments; MPO PROPHECY Knee InstrumentsMicroport Orthopedics, Inc. · 2022
Class I recalls in this family
- K061223 Advance Total Knee System2 generations back · 2006
Most influential descendants
Showing 1 of 1 · See all- K213817MPO Knee Instruments; MPO PROPHECY Knee InstrumentsMicroport Orthopedics, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972626 | Advance Knee System | Wrightmedicaltechnologyinc | 1997 | — |
| −1 | K093405 | Prophecy Pre-Operative Navigation Alignment Guides | Wrightmedicaltechnologyinc | 2010 | — |
| 0 (this device) | K103598 | Prophecy Pre-Operative Navigation Alignment Guides | Wrightmedicaltechnologyinc | 2011 | — |
| +1 | K213817 | MPO Knee Instruments; MPO PROPHECY Knee Instruments | Microport Orthopedics, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 1 |
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.
1 device in this family has a Class I recall. 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 MBH device
- #1 K241597 Freedom® Total Knee System - Porous Tibial…score 20.0 · 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 |
|---|---|---|---|
| * | K093405 | Prophecy Pre-Operative Navigation Alignment GuidesSummary page 1…Y® Pre-Operative Navigation Alignment Guides (K093405) headquarters Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 901.867.9971 phone ww… | 2010 |
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 |
|---|---|---|---|
| K213817 | MPO Knee Instruments; MPO PROPHECY Knee Instruments | 2022 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K061223Advance Total Knee SystemWrightmedicaltechnologyinc · 2006 · 2 generations back · ◆ in the 2006 ancestors bar of FIG. 111 Class I recalls
What does this lineage say?
- The line of descent spans 14 years and passes through 1 company; a new generation was cleared every 12.7 years on median.
- 1 of the 3 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K213817 (Microport Orthopedics, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K093405.
How does its category compare?
All MBH devicesMBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MBH
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBH
98in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBH
1in 2024
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · MBH
1,561in 2025
MAUDE reports naming product code MBH, 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 | 10 | 59 | 0 | 27 |
| 2008 | 3 | 70 | 0 | 21 |
| 2009 | 3 | 209 | 2 | 89 |
| 2010 | 4 | 84 | 0 | 121 |
| 2011 | 5 | 84 | 15 | 247 |
| 2012 | 5 | 90 | 1 (1) | 370 |
| 2013 | 6 | 138 | 4 (4) | 308 |
| 2014 | 9 | 114 | 0 | 385 |
| 2015 | 8 | 100 | 0 | 955 |
| 2016 | 4 | 74 | 1 | 1,034 |
| 2017 | 4 | 115 | 9 | 1,007 |
| 2018 | 6 | 89 | 1 | 1,191 |
| 2019 | 1 | — | 1 | 1,394 |
| 2020 | 7 | 112 | 2 | 1,089 |
| 2021 | 6 | 48 | 0 | 1,539 |
| 2022 | 7 | 57 | 0 | 1,261 |
| 2023 | 6 | 94 | 2 | 1,263 |
| 2024 | 10 | 84 | 1 | 1,497 |
| 2025 | 8 | 98 | 0 | 1,561 |
| 2026 | 7 | 153 | 4 | — |
What is it indicated for?
Wright's PROPHECY® Pre-Operative Navigation Alignment Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting. The PROPHECY® Pre-Operative Navigation Alignment Guides are intended for use with Wright's ADVANCE® and EVOLUTION™ Total Knee 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. The PROPHECY® Pre-Operative Navigation Alignment Guides are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103598 · printed Nov 4, 2026
Cite this page
510(k) Report. “K103598: Prophecy Pre-Operative Navigation Alignment Guides.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K103598
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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