510(k) Report

510(k) · Cleared

Cleared

Amc R Metacarpal Component

K790793510(k) TraditionalCleared Jun 22, 197959-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

Howmedica Corp. · KWN Prosthesis, Wrist, Carpal Lunate

Cleared on Jun 22, 1979 after a 59-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 22, 1979
Review
59 days
Class
Class II
Product code
KWN
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K790793Source: FDA 510(k) database · 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?

No later submission names this one as a predicate yet.

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.

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 Howmedica Corp.

393 FDA decisions under this applicant name. See the company

  • N17004/S013Surgical Simplex P Bone CementHowmedica Corp. · 2000
  • N17004/S012Surgical Simplex P Radiopaque Bone CementHowmedica Corp. · 2000
  • K983528Micro Dynamic MeshHowmedica Corp. · 1998
  • K983404Type 3 Femoral ComponentsHowmedica Corp. · 19981 recall
  • K980925Duration II Tibial Inserts-Ethylene Oxide SterilizationHowmedica Corp. · 1998

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
  • K864491Swanson Titanium Carpal Lunate ImplantDow Corning Wright · 1987

https://510kreport.com/device/K790793 · printed Nov 6, 2026

Cite this page

510(k) Report. “K790793: Amc R Metacarpal Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K790793

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026