510(k) · Cleared

Cleared

Prophecy Pre-Operative Navigation Alignment Guides

K093405510(k) TraditionalCleared May 25, 2010204-day reviewClass II21 CFR 888.3565

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Wrightmedicaltechnologyinc · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Cleared on May 25, 2010 as substantially equivalent to K061223 (Wrightmedicaltechnologyinc, 2006) and 1 other predicate after a 204-day review. Its family tree reaches back 1 generation to 1997. 1 of the 5 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.

Decided: May 25, 2010
Review: 204 days
Class: Class II
Product code: MBH
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K972626 (1997). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK972626 Advance Knee SystemWrightmedicaltechnologyinc · 1997
This deviceK093405 Prophecy Pre-Operative Navigation Alignment GuidesWrightmedicaltechnologyinc · 2010
Descendant · cites it directly · 1 of its ownK103598 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 Systemdirect predicate · 2006

Most influential descendants

Showing 2 of 2 · See all

K103598Prophecy Pre-Operative Navigation Alignment GuidesWrightmedicaltechnologyinc · 2011 · cites it directly1descendant
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
−1	K972626	Advance Knee System	Wrightmedicaltechnologyinc	1997	—
0 (this device)	K093405	Prophecy Pre-Operative Navigation Alignment Guides	Wrightmedicaltechnologyinc	2010	—
+1	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
2011	1	0
2022	1	0

FIG. 1 — Lineage of K093405, 1997–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K061223	Advance Total Knee System Summary page 1 …87/ MBH, JWH, COG Predicate Device ADVANCE®)Total Knee System (K06 1223, K972626) headquarters Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 901.867.9971 phone…	Wrightmedicaltechnologyinc	2006	Class I
*	K972626	Advance Knee System Summary page 1 …WH, COG Predicate Device ADVANCE®)Total Knee System (K06 1223, K972626) headquarters Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 901.867.9971 phone WWW…	Wrightmedicaltechnologyinc	1997	—

Also cleared against K061223: 4 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K103598	Prophecy Pre-Operative Navigation Alignment Guides	Wrightmedicaltechnologyinc	2011	1
K213817	MPO Knee Instruments; MPO PROPHECY Knee Instruments	Microport Orthopedics, Inc.	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 · Direct predicate · ◆ in the 2006 ancestors bar of FIG. 111 Class I recalls

What does this lineage say?

1 of the 2 ancestors has a recall of any class; 1 has a Class I recall.
Of its descendants, K103598 (Wrightmedicaltechnologyinc, 2011) has gone furthest, with 1 descendant of its own.
4 other devices also cite its predicate K061223.

How does its category compare?

All MBH devices

MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · MBH

8in 2025

2007high 10 (2007) · low 1 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBH

98in 2025

2007high 209 (2009) · low 48 (2021)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MBH

1in 2024

2007high 15 (2011) · low 0 (2007)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · MBH

1,561in 2025

2007high 1,561 (2025) · low 21 (2008)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® Total Knee System and its 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/K093405 · printed Nov 4, 2026

Cite this page

510(k) Report. “K093405: 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/K093405

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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