510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

Radial Head Implant

K002644510(k) TraditionalCleared Nov 20, 200088-day reviewClass II21 CFR 888.3170Recalls 21

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

Avanta Orthopaedics, Inc. · KWI Prosthesis, Elbow, Hemi-, Radial, Polymer

Cleared on Nov 20, 2000 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 27 later devices descend from it. It has been recalled 21 times.

Decided
Nov 20, 2000
Review
88 days
Class
Class II
Product code
KWI
Recalls
21
Predicates
0

27 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2004: 2 descendants cleared2002: 2 descendants cleared2005: 1 descendant cleared2013: 2 descendants cleared2006: 1 descendant cleared2010: 2 descendants cleared2012: 1 descendant cleared2016: 1 descendant cleared2017: 1 descendant cleared2020: 3 descendants cleared2018: 1 descendant cleared2023: 2 descendants cleared2024: 4 descendants cleared2021: 2 descendants cleared2025: 1 descendant cleared2022: 1 descendant cleared200020052010201520202025
  1. This deviceK002644 Radial Head ImplantAvanta Orthopaedics, Inc. · 2000
  2. Descendant · cites it directly · 23 of its ownK012551 Liverpool Radial Head Replacement DeviceBiomet, Inc. · 2002
  3. Descendant · cites it directly · 22 of its ownK040611 Modular Radial Head Replacement DeviceBiomet, Inc. · 2004 · Recalled
  4. Descendant · cites it directly · 21 of its ownK051385 Explor Modular Radial Head Replacement DeviceBiomet, Inc. · 2005 · Recalled
  5. Descendant · cites it directly · 19 of its ownK023604 Modification to Radial Head ImplantAvanta Orthopaedics, Inc. · 2002 · Recalled
  6. Descendant · 2 generations on · 18 of its ownK060438 RHSTornier · 2006

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2002: 22004: 22005: 12006: 12010: 22012: 12013: 22016: 12017: 12018: 12020: 32021: 22022: 12023: 22024: 42025: 1
2002high 4 (2024) · low 0 (2003)2026

Most influential descendants

Showing 5 of 27 · See all
  • K012551Liverpool Radial Head Replacement DeviceBiomet, Inc. · 2002 · cites it directly23descendants
  • K040611Modular Radial Head Replacement DeviceBiomet, Inc. · 2004 · cites it directly22descendants
  • K051385Explor Modular Radial Head Replacement DeviceBiomet, Inc. · 2005 · cites it directly21descendants
  • K023604Modification to Radial Head ImplantAvanta Orthopaedics, Inc. · 2002 · cites it directly19descendants
  • K060438RHSTornier · 2006 · 2 generations on18descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002644Radial Head ImplantAvanta Orthopaedics, Inc.2000—
+1K012551Liverpool Radial Head Replacement DeviceBiomet, Inc.2002—
+1K040611Modular Radial Head Replacement DeviceBiomet, Inc.20041
+1K051385Explor Modular Radial Head Replacement DeviceBiomet, Inc.20052
+1K023604Modification to Radial Head ImplantAvanta Orthopaedics, Inc.200218
+2K060438RHSTornier2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200420
200510
200610
201020
201210
201320
201610
201710
201810
202030
202120
202210
202320
202440
202510
FIG. 1 — Lineage of K002644, 2000–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Top candidate predicates for a new KWI device

  1. #1 K260624 Arthrex Radial Head Replacement Systemscore 12.1 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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? (27)

See all 27

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

NumberDeviceApplicantDecidedDescendants
K012551Liverpool Radial Head Replacement DeviceBiomet, Inc.200223
K040611Modular Radial Head Replacement DeviceBiomet, Inc.200422
K051385Explor Modular Radial Head Replacement DeviceBiomet, Inc.200521
K023604Modification to Radial Head ImplantAvanta Orthopaedics, Inc.200219
K041858Acumed Anatomic Radial Head SystemAcumed, LLC20042

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 24, 2017Class IIZ-2685-2018Under Investigation by firmRevision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Oct 24, 2017Class IIZ-2680-2018Under Investigation by firmRevision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Oct 24, 2017Class IIZ-2723-2018Under Investigation by firmRevision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Oct 24, 2017Class IIZ-2727-2018Under Investigation by firmRevision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Oct 24, 2017Class IIZ-2726-2018Under Investigation by firmRevision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Oct 24, 2017Class IIZ-2684-2018Under Investigation by firmRevision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Oct 24, 2017Class IIZ-2681-2018Under Investigation by firmRevision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Oct 24, 2017Class IIZ-2724-2018Under Investigation by firmRevision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Oct 24, 2017Class IIZ-2731-2018Under Investigation by firmRevision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Oct 24, 2017Class IIZ-2678-2018Under Investigation by firmRevision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Oct 24, 2017Class IIZ-2730-2018Under Investigation by firmRevision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Oct 24, 2017Class IIZ-2683-2018Under Investigation by firmRevision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Oct 24, 2017Class IIZ-2682-2018Under Investigation by firmRevision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Oct 24, 2017Class IIZ-2722-2018Under Investigation by firmRevision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Oct 24, 2017Class IIZ-2729-2018Under Investigation by firmRevision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Oct 24, 2017Class IIZ-2728-2018Under Investigation by firmRevision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Oct 24, 2017Class IIZ-2679-2018Under Investigation by firmRevision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Oct 24, 2017Class IIZ-2677-2018Under Investigation by firmRevision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Oct 24, 2017Class IIZ-2725-2018Under Investigation by firmRevision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Oct 24, 2017Class IIZ-2732-2018Under Investigation by firmRevision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Sep 6, 2013Class IIZ-0098-2014Packaging change controlThe recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box.

The 5 latest of 21 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K012551 (Biomet, Inc., 2002) has gone furthest, with 23 descendants of its own.

How does its category compare?

All KWI devices

KWI Prosthesis, Elbow, Hemi-, Radial, Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWI

1in 2024

2010: 12012: 12013: 12014: 12017: 12019: 12020: 12021: 12022: 12023: 12024: 12026 (partial year): 1
2007high 1 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWI

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

Recalls per year · KWI

2in 2022

2013: 12014: 12017: 12022: 2
2007high 2 (2022) · low 0 (2007)2026

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

Adverse event reports per year · KWI

118in 2025

2007: 152008: 162009: 142010: 132011: 102012: 162013: 312014: 292015: 1032016: 1382017: 3602018: 2022019: 2142020: 1182021: 442022: 442023: 772024: 1242025: 118
2007high 360 (2017) · low 10 (2011)2025

MAUDE reports naming product code KWI, 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—015
20080—016
20090—014
20101—013
20110—010
20121—016
20131—131
20141—129
20150—0103
20160—0138
20171—1360
20180—0202
20191—0214
20201—0118
20211—044
20221—244
20231—077
20241—0124
20250—0118
20261—0—

More from Avanta Orthopaedics, Inc.

18 FDA decisions under this applicant name. See the company

  • K030881Avanta Carpal Fusion Plating SystemAvanta Orthopaedics, Inc. · 2003
  • K021859Wrist ImplantAvanta Orthopaedics, Inc. · 2002
  • K023604Modification to Radial Head ImplantAvanta Orthopaedics, Inc. · 200218 recalls
  • K013629Finger Joint ProsthesisAvanta Orthopaedics, Inc. · 2002
  • K011819Radial Head ImplantAvanta Orthopaedics, Inc. · 20011 recall

Recent decisions in KWI

The KWI category page

  • K260624Arthrex Radial Head Replacement SystemArthrex, Inc. · 2026
  • K233592BioPoly Radial Head ImplantBioPoly, LLC · 2024
  • K231188ALIGN Radial Head SystemSkeletal Dynamics, Inc. · 2023
  • K213563DePuy Synthes Radial Head Replacement SystemDePuy Synthes · 2022
  • K212872Avenger Radial Head SystemIn2bones USA, LLC · 2021

https://510kreport.com/device/K002644 · printed Nov 5, 2026

Cite this page

510(k) Report. “K002644: Radial Head Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002644

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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