510(k) · Cleared

Cleared

Swanson Titanium Carpal Scaphoid Implant

K864490510(k) TraditionalCleared Apr 15, 1987153-day reviewClass II21 CFR 888.3760

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

Dow Corning Wright · KWO Prosthesis, Wrist, Carpal Scaphoid

Cleared on Apr 15, 1987 after a 153-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.

Decided: Apr 15, 1987
Review: 153 days
Class: Class II
Product code: KWO
Recalls: None
Predicates: 0

6 later devices descend from it, 2 citing it directly.

This deviceK864490 Swanson Titanium Carpal Scaphoid ImplantDow Corning Wright · 1987
Descendant · cites it directly · 3 of its ownK050028 Maestro Carpal HemiarthroplastyBiomet Manufacturing, Inc. · 2005
Descendant · 2 generations on · 1 of its ownK141920 Wrist Hemiarthroplasty SystemArthrosurface, Inc. · 2014
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
Descendant · 3 generations on · 0 of its ownK200718 Arthrosurface WristMotion Total Wrist Arthroplasty SystemArthrosurface, Inc. · 2020

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2005high 2 (2020) · low 0 (2006)2026

Most influential descendants

Showing 5 of 6 · See all

K050028Maestro Carpal HemiarthroplastyBiomet Manufacturing, Inc. · 2005 · cites it directly3descendants
K141920Wrist Hemiarthroplasty SystemArthrosurface, Inc. · 2014 · 2 generations on1descendant
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
K200718Arthrosurface WristMotion Total Wrist Arthroplasty SystemArthrosurface, Inc. · 2020 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K864490	Swanson Titanium Carpal Scaphoid Implant	Dow Corning Wright	1987	—
+1	K050028	Maestro Carpal Hemiarthroplasty	Biomet Manufacturing, Inc.	2005	—
+2	K141920	Wrist Hemiarthroplasty System	Arthrosurface, Inc.	2014	—
+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	—
+3	K200718	Arthrosurface WristMotion Total Wrist Arthroplasty System	Arthrosurface, Inc.	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2008	1	0
2009	1	0
2014	1	0
2020	2	0

FIG. 1 — Lineage of K864490, 1987–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KWO? 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K050028	Maestro Carpal Hemiarthroplasty	Biomet Manufacturing, Inc.	2005	3
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?

Of its descendants, K050028 (Biomet Manufacturing, Inc., 2005) has gone furthest, with 3 descendants of its own.

How does its category compare?

All KWO devices

KWO Prosthesis, Wrist, Carpal Scaphoid: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWO

FDA has decided no KWO device since 2007.

Median 510(k) review, days · KWO

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

Recalls per year · KWO

No recall names KWO since 2007.

Adverse event reports per year · KWO

1in 2025

2007high 4 (2013) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	1
2012	—	0
2013	—	4
2014	—	0
2015	—	0
2016	—	2
2017	—	0
2018	—	0
2019	—	2
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	1
2026	—	—

https://510kreport.com/device/K864490 · printed Nov 6, 2026

Cite this page

510(k) Report. “K864490: Swanson Titanium Carpal Scaphoid Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K864490

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026