510(k) · Cleared

Cleared

Ascension Pyrocarbon Lunate

K080997510(k) TraditionalCleared Jun 17, 200870-day reviewClass II21 CFR 888.3750

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

Ascension Orthopedics, Inc. · KWN Prosthesis, Wrist, Carpal Lunate

Cleared on Jun 17, 2008 as substantially equivalent to K864491 (Dow Corning Wright, 1987) and 1 other predicate after a 70-day review. Its family tree reaches back 4 generations to 1987. 2 later devices descend from it.

Decided: Jun 17, 2008
Review: 70 days
Class: Class II
Product code: KWN
Recalls: None
Predicates: 2

Its longest line of descent runs back 4 generations to K864488 (1987). 6 ancestors in all, the oldest K864491 (1987). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 4 generations backK864488 Swanson Titanium Condylar ImplantDow Corning Wright · 1987
3 generations backK964472 Riopro Cobalt Trapeziometarcarpal Resurfacing ComponentBiologically Oriented Prostheses · 1997
2 generations backK041451 Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30…Ascension Orthopedics, Inc. · 2004 · Recalled
1 generation backK061451 Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40Ascension Orthopedics, Inc. · 2006 · Recalled
This deviceK080997 Ascension Pyrocarbon LunateAscension Orthopedics, Inc. · 2008
Descendant · cites it directly · 1 of its ownK092548 Extremity Medical Trapezium ProsthesisExtremity Medical, LLC · 2009
Descendant · 2 generations on · 0 of its ownK201072 Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161Ensemble Orthopedics, LLC · 2020

Most influential descendants

Showing 2 of 2 · See all

K092548Extremity Medical Trapezium ProsthesisExtremity Medical, LLC · 2009 · cites it directly1descendant
K201072Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161Ensemble Orthopedics, LLC · 2020 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K864488	Swanson Titanium Condylar Implant	Dow Corning Wright	1987	—
−3	K964472	Riopro Cobalt Trapeziometarcarpal Resurfacing Component	Biologically Oriented Prostheses	1997	—
−2	K041451	Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30…	Ascension Orthopedics, Inc.	2004	2
−1	K061451	Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40	Ascension Orthopedics, Inc.	2006	1
0 (this device)	K080997	Ascension Pyrocarbon Lunate	Ascension Orthopedics, Inc.	2008	—
+1	K092548	Extremity Medical Trapezium Prosthesis	Extremity Medical, LLC	2009	—
+2	K201072	Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161	Ensemble Orthopedics, LLC	2020	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1987	1	0
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2020	1	0

FIG. 1 — Lineage of K080997, 1987–2020Source: 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 KWN? 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K864491	Swanson Titanium Carpal Lunate Implant Summary page 1 …Wrist Carpal Lunate CLASSIFICATION: 21 CFR 888.3750 PRODUCT CODE: KWN PANEL: Orthopedic PREDICATE DEVICES: K864491 - Swanson Titanium Carpal Lunate Implant K061451 - Ascension PyroCarbon CMC DEVICE DESCRIPTION: The Ascension® PyroCarbon Lunate…	Dow Corning Wright	1987	—
*	K061451	Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 Summary page 1 …21 CFR 888.3750 PRODUCT CODE: KWN PANEL: Orthopedic PREDICATE DEVICES: K864491 - Swanson Titanium Carpal Lunate Implant K061451 - Ascension PyroCarbon CMC DEVICE DESCRIPTION: The Ascension® PyroCarbon Lunate is an anatomically designed lunate replacement w…	Ascension Orthopedics, Inc.	2006	1

Also cleared against K864491: 2 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K092548	Extremity Medical Trapezium Prosthesis	Extremity Medical, LLC	2009	1

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 21 years and passes through 3 companies; a new generation was cleared every 7.6 years on median.
2 of the 6 ancestors have a recall of any class.
Of its descendants, K092548 (Extremity Medical, LLC, 2009) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K864491.

How does its category compare?

All KWN devices

KWN Prosthesis, Wrist, Carpal Lunate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · KWN

1in 2014

2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWN

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

Recalls per year · KWN

No recall names KWN since 2007.

Adverse event reports per year · KWN

2in 2020

2007high 3 (2019) · low 0 (2008)2025

MAUDE reports naming product code KWN, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	2
2008	1	—	0
2009	0	—	0
2010	0	—	2
2011	0	—	0
2012	0	—	0
2013	0	—	1
2014	1	—	0
2015	0	—	0
2016	0	—	1
2017	0	—	1
2018	0	—	2
2019	0	—	3
2020	0	—	2
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The Ascension® PyroCarbon Lunate is intended for replacement of the lunate bone in the proximal carpal row of the wrist in the presence of:

Avascular necrosis (Kienboch's disease)

Localized osteoarthritic changes

Long-Standing dislocations

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K080997 · printed Nov 3, 2026

Cite this page

510(k) Report. “K080997: Ascension Pyrocarbon Lunate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080997

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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