510(k) Report

510(k) · Cleared

Cleared

Swanson Titanium Carpal Lunate Implant

K864491510(k) TraditionalCleared Apr 15, 1987153-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

Dow Corning Wright · KWN Prosthesis, Wrist, Carpal Lunate

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. 7 later devices descend from it.

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

7 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2008: 2 descendants cleared2005: 1 descendant cleared2009: 1 descendant cleared2014: 1 descendant cleared2020: 2 descendants cleared1990200020102020
  1. This deviceK864491 Swanson Titanium Carpal Lunate ImplantDow Corning Wright · 1987
  2. Descendant · cites it directly · 3 of its ownK050028 Maestro Carpal HemiarthroplastyBiomet Manufacturing, Inc. · 2005
  3. Descendant · cites it directly · 2 of its ownK080997 Ascension Pyrocarbon LunateAscension Orthopedics, Inc. · 2008
  4. Descendant · 2 generations on · 1 of its ownK141920 Wrist Hemiarthroplasty SystemArthrosurface, Inc. · 2014
  5. Descendant · cites it directly · 1 of its ownK092548 Extremity Medical Trapezium ProsthesisExtremity Medical, LLC · 2009
  6. Descendant · 2 generations on · 0 of its ownK201072 Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161Ensemble Orthopedics, LLC · 2020

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2005: 12008: 22009: 12014: 12020: 2
2005high 2 (2008) · low 0 (2006)2026

Most influential descendants

Showing 5 of 7 · See all
  • K050028Maestro Carpal HemiarthroplastyBiomet Manufacturing, Inc. · 2005 · cites it directly3descendants
  • K080997Ascension Pyrocarbon LunateAscension Orthopedics, Inc. · 2008 · cites it directly2descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K864491Swanson Titanium Carpal Lunate ImplantDow Corning Wright1987—
+1K050028Maestro Carpal HemiarthroplastyBiomet Manufacturing, Inc.2005—
+1K080997Ascension Pyrocarbon LunateAscension Orthopedics, Inc.2008—
+2K141920Wrist Hemiarthroplasty SystemArthrosurface, Inc.2014—
+1K092548Extremity Medical Trapezium ProsthesisExtremity Medical, LLC2009—
+2K201072Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161Ensemble Orthopedics, LLC2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200820
200910
201410
202020
FIG. 1 — Lineage of K864491, 1987–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 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
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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? (7)

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

NumberDeviceApplicantDecidedDescendants
K050028Maestro Carpal HemiarthroplastyBiomet Manufacturing, Inc.20053
K080997Ascension Pyrocarbon LunateAscension Orthopedics, Inc.20082
K092548Extremity Medical Trapezium ProsthesisExtremity Medical, LLC20091

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 KWN devices

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

FDA decisions per year · KWN

1in 2014

2008: 12014: 1
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

2007: 22010: 22013: 12016: 12017: 12018: 22019: 32020: 2
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—02
20081—00
20090—00
20100—02
20110—00
20120—00
20130—01
20141—00
20150—00
20160—01
20170—01
20180—02
20190—03
20200—02
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Dow Corning Wright

75 FDA decisions under this applicant name. See the company

  • K932210Ortholoc Advantim Revision Femoral ComponentDow Corning Wright · 1994
  • K932911Ortholoc Advantim L.S. Tibial ComponentDow Corning Wright · 1994
  • K934354Lacey All Polyethylene Tibial ComponentDow Corning Wright · 1994
  • K932222SLT Femoral HeadDow Corning Wright · 1994
  • K932858Ortholoc Advantim Tibial Base ComponentDow Corning Wright · 1994

Recent decisions in KWN

The KWN category page

  • K141920Wrist Hemiarthroplasty SystemArthrosurface, Inc. · 2014
  • K080997Ascension Pyrocarbon LunateAscension Orthopedics, Inc. · 2008
  • K050028Maestro Carpal HemiarthroplastyBiomet Manufacturing, Inc. · 2005
  • K790793Amc R Metacarpal ComponentHowmedica Corp. · 1979

https://510kreport.com/device/K864491 · printed Nov 4, 2026

Cite this page

510(k) Report. “K864491: Swanson Titanium Carpal Lunate Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K864491

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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