510(k) · Cleared

Cleared

Ascension Muh

K052137510(k) TraditionalCleared Nov 3, 200590-day reviewClass II21 CFR 888.3810

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

Ascension Orthopedics, Inc. · KXE Prosthesis, Wrist, Hemi-, Ulnar

Cleared on Nov 3, 2005 as substantially equivalent to K010786 (Avanta Orthopaedics, Inc., 2001) after a 90-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.

Decided: Nov 3, 2005
Review: 90 days
Class: Class II
Product code: KXE
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K010786 (2001). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK010786 Ulnar Head ImplantAvanta Orthopaedics, Inc. · 2001 · Recalled
This deviceK052137 Ascension MuhAscension Orthopedics, Inc. · 2005
Descendant · cites it directly · 0 of its ownK112481 First Choice Druj System, Partial Head ImplantAscension Orthopedic · 2012

Most influential descendants

Showing 1 of 1 · See all

K112481First Choice Druj System, Partial Head ImplantAscension Orthopedic · 2012 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K010786	Ulnar Head Implant	Avanta Orthopaedics, Inc.	2001	1
0 (this device)	K052137	Ascension Muh	Ascension Orthopedics, Inc.	2005	—
+1	K112481	First Choice Druj System, Partial Head Implant	Ascension Orthopedic	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0

FIG. 1 — Lineage of K052137, 2001–2012Source: 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.

Planning a device in KXE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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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	Applicant	Decided	Recalls
*	K010786	Ulnar Head Implant Summary page 1 …21 CFR §888.3810 PRODUCT CODE: 87 KXE PANEL: Orthopedic PREDICATE DEVICE: Avanta Orthopaedics, Inc., Ulnar Head Implant (K010786) DEVICE DESCRIPTION: The Ascension® MUH implant is a single-use, two-component, modular prosthesis designed for replacement of t…	Avanta Orthopaedics, Inc.	2001	1

Also cleared against K010786: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K112481	First Choice Druj System, Partial Head Implant	Ascension Orthopedic	2012	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?

Its one ancestor has a recall.
Of its descendants, K112481 (Ascension Orthopedic, 2012) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K010786.

How does its category compare?

All KXE devices

KXE Prosthesis, Wrist, Hemi-, Ulnar: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KXE

1in 2019

2007high 2 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KXE

Too few KXE 510(k)s in any year since 2007 to give a median.

Recalls per year · KXE

1in 2011

2007high 1 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KXE

1in 2023

2007high 7 (2019) · low 0 (2007)2025

MAUDE reports naming product code KXE, 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	0
2008	2	—	0	2
2009	0	—	0	2
2010	0	—	0	1
2011	0	—	1	4
2012	1	—	0	0
2013	0	—	0	2
2014	0	—	0	3
2015	1	—	0	3
2016	0	—	0	3
2017	0	—	0	5
2018	0	—	0	3
2019	1	—	0	7
2020	0	—	0	5
2021	0	—	0	1
2022	0	—	0	0
2023	0	—	0	1
2024	0	—	0	0
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

The Ascension® MUH is intended for replacement of the distal radioulnar joint:

Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis presenting the following:

* Pain and weakness of the wrist joint not improved by conservative treatment

* Instability of the ulnar head with x-ray evidence of dorsal subluxation and erosive changes

* Failed ulnar head resection

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052137 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052137: Ascension Muh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052137

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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