510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

Modular Radial Head Replacement Device

K040611510(k) TraditionalCleared Jun 4, 200488-day reviewClass II21 CFR 888.3170Recalls 1

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

Biomet, Inc. · KWI Prosthesis, Elbow, Hemi-, Radial, Polymer

Cleared on Jun 4, 2004 as substantially equivalent to K012551 (Biomet, Inc., 2002) and 3 other predicates after an 88-day review. Its family tree reaches back 2 generations to 1999. 22 later devices descend from it. It has been recalled once.

Decided
Jun 4, 2004
Review
88 days
Class
Class II
Product code
KWI
Recalls
1
Predicates
4

Its longest line of descent runs back 2 generations to K984290 (1999). 4 ancestors in all. 22 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1999: 1 other ancestor2005: 1 descendant cleared2013: 1 descendant cleared2010: 2 descendants cleared2012: 1 descendant cleared2006: 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 clearedK984290 · Implex Radial Head Replacement System · Implex Corp. · 1999K012551 · Liverpool Radial Head Replacement Device · Biomet, Inc. · 20021995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 4 descendants3 generations forward: 3 descendants4 generations forward: 5 descendants5 generations forward: 6 descendants6 generations forward: 2 descendants7 generations forward: 1 descendant K012551 · Liverpool Radial Head Replacement Device · Biomet, Inc. · 2002K984290 · Implex Radial Head Replacement System · Implex Corp. · 19990+5
  1. Root · 2 generations backK984290 Implex Radial Head Replacement SystemImplex Corp. · 1999
  2. 1 generation backK012551 Liverpool Radial Head Replacement DeviceBiomet, Inc. · 2002
  3. This deviceK040611 Modular Radial Head Replacement DeviceBiomet, Inc. · 2004
  4. Descendant · cites it directly · 21 of its ownK051385 Explor Modular Radial Head Replacement DeviceBiomet, Inc. · 2005 · Recalled
  5. Descendant · 2 generations on · 18 of its ownK060438 RHSTornier · 2006
  6. Descendant · 2 generations on · 16 of its ownK130533 Salto Talaris Total Ankle Prosthesis, RHSTornier S.A.S. · 2013 · Recalled
  7. Descendant · 3 generations on · 15 of its ownK153452 Salto XT, Salto TalarisTornier S.A.S. · 2016 · Recalled
  8. Descendant · 4 generations on · 8 of its ownK192994 Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc. · 2020

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12010: 22012: 12013: 12016: 12017: 12018: 12020: 32021: 22022: 12023: 22024: 42025: 1
2005high 4 (2024) · low 0 (2007)2026

Most influential descendants

Showing 5 of 22 · See all
  • K051385Explor Modular Radial Head Replacement DeviceBiomet, Inc. · 2005 · cites it directly21descendants
  • K060438RHSTornier · 2006 · 2 generations on18descendants
  • K130533Salto Talaris Total Ankle Prosthesis, RHSTornier S.A.S. · 2013 · 2 generations on16descendants
  • K153452Salto XT, Salto TalarisTornier S.A.S. · 2016 · 3 generations on15descendants
  • K192994Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc. · 2020 · 4 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K984290Implex Radial Head Replacement SystemImplex Corp.1999—
−1K012551Liverpool Radial Head Replacement DeviceBiomet, Inc.2002—
0 (this device)K040611Modular Radial Head Replacement DeviceBiomet, Inc.2004—
+1K051385Explor Modular Radial Head Replacement DeviceBiomet, Inc.20052
+2K060438RHSTornier2006—
+2K130533Salto Talaris Total Ankle Prosthesis, RHSTornier S.A.S.201319
+3K153452Salto XT, Salto TalarisTornier S.A.S.20168
+4K192994Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
201020
201210
201310
201610
201710
201810
202030
202120
202210
202320
202440
202510
FIG. 1 — Lineage of K040611, 1999–2025Source: 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), 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 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? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K012551Liverpool Radial Head Replacement Device
Summary page 1
…radial (hemi-elbow) polymer prosthesis (21 CFR 888.3170) Legally Marketed Devices to Which Substantial Equivalence Is Claimed: Liverpool Radial Head Replacement Device (K012551), Radial Head Surface Replacement (Implex Corp. K984290), Radial Head Implant (Avanta Orthop., Inc., K002644) and Modular Radial…
Biomet, Inc.2002—
*K984290Implex Radial Head Replacement System
Summary page 1
…Legally Marketed Devices to Which Substantial Equivalence Is Claimed: Liverpool Radial Head Replacement Device (K012551), Radial Head Surface Replacement (Implex Corp. K984290), Radial Head Implant (Avanta Orthop., Inc., K002644) and Modular Radial Head (Wright Medical Tech. Inc., K991915) Device Descri…
Implex Corp.1999—
*K002644Radial Head Implant
Summary page 1
…alence Is Claimed: Liverpool Radial Head Replacement Device (K012551), Radial Head Surface Replacement (Implex Corp. K984290), Radial Head Implant (Avanta Orthop., Inc., K002644) and Modular Radial Head (Wright Medical Tech. Inc., K991915) Device Description: The Modular Radial Head Replacement Device is…
Avanta Orthopaedics, Inc.200021
*K991915Modular Radial Head
Summary page 1
…K012551), Radial Head Surface Replacement (Implex Corp. K984290), Radial Head Implant (Avanta Orthop., Inc., K002644) and Modular Radial Head (Wright Medical Tech. Inc., K991915) Device Description: The Modular Radial Head Replacement Device is a two-piece prosthesis consisting of a stem (Ti-6AI-4V) and a…
Wrightmedicaltechnologyinc19993

What descends from it? (22)

See all 22

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

NumberDeviceApplicantDecidedDescendants
K051385Explor Modular Radial Head Replacement DeviceBiomet, Inc.200521

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

Recalls of this device

DateClassRecallRoot causeReason
Apr 22, 2014Class IIZ-1615-2014Process controlThis lot of the ExploR Modular Radial Stem may be missing the wedge ramp threads. If the wedge ramp threads are missing from the stem, the likelihood of the set screw loosening from the radial stem intraoperatively is increased. If the…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
  • 2 of the 4 ancestors have a recall of any class.
  • Of its descendants, K051385 (Biomet, Inc., 2005) has gone furthest, with 21 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—

What is it indicated for?

The Modular Radial Head Replacement Device is intended for:

1) Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, creptation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:

a) Joint destruction and/or subluxation visible on x-ray

b) Resistance to conservative treatment

2) Primary replacement after fracture of the radial head

3) Symptomatic sequelae after radial head resection

4) Revision following failed radial head arthroplasty

The device is intended for single use with bone cement.

Indications for use as stated in the FDA summary.

More from Biomet, Inc.

449 FDA decisions under this applicant name. See the company

  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K251270Taperloc® Complete Hip StemBiomet, Inc. · 2026
  • K241014Biomet Kirschner Wires (K-Wires)Biomet, Inc. · 2024
  • K222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc. · 2022
  • K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc. · 2022

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/K040611 · printed Nov 5, 2026

Cite this page

510(k) Report. “K040611: Modular Radial Head Replacement Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040611

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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