510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

Explor Modular Radial Head Replacement Device

K051385510(k) TraditionalCleared Aug 5, 200570-day reviewClass II21 CFR 888.3170Recalls 2

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 Aug 5, 2005 as substantially equivalent to K040611 (Biomet, Inc., 2004) and 3 other predicates after a 70-day review. Its family tree reaches back 3 generations to 1999. 21 later devices descend from it. It has been recalled 2 times.

Decided
Aug 5, 2005
Review
70 days
Class
Class II
Product code
KWI
Recalls
2
Predicates
4

Its longest line of descent runs back 3 generations to K984290 (1999). 5 ancestors in all. 21 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1999: 1 other ancestor2013: 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. · 2002K040611 · Modular Radial Head Replacement Device · Biomet, Inc. · 2004 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 4 descendants2 generations forward: 3 descendants3 generations forward: 5 descendants4 generations forward: 6 descendants5 generations forward: 2 descendants6 generations forward: 1 descendant K040611 · Modular Radial Head Replacement Device · Biomet, Inc. · 2004 · recalledK012551 · Liverpool Radial Head Replacement Device · Biomet, Inc. · 2002K984290 · Implex Radial Head Replacement System · Implex Corp. · 19990+5
  1. Root · 3 generations backK984290 Implex Radial Head Replacement SystemImplex Corp. · 1999
  2. 2 generations backK012551 Liverpool Radial Head Replacement DeviceBiomet, Inc. · 2002
  3. 1 generation backK040611 Modular Radial Head Replacement DeviceBiomet, Inc. · 2004 · Recalled
  4. This deviceK051385 Explor Modular Radial Head Replacement DeviceBiomet, Inc. · 2005
  5. Descendant · cites it directly · 18 of its ownK060438 RHSTornier · 2006
  6. Descendant · cites it directly · 16 of its ownK130533 Salto Talaris Total Ankle Prosthesis, RHSTornier S.A.S. · 2013 · Recalled
  7. Descendant · 2 generations on · 15 of its ownK153452 Salto XT, Salto TalarisTornier S.A.S. · 2016 · Recalled
  8. Descendant · 3 generations on · 8 of its ownK192994 Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc. · 2020
  9. Descendant · 4 generations on · 2 of its ownK210390 Apex 3D Total Ankle Replacement SystemParagon 28, Inc. · 2021

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2006: 12010: 22012: 12013: 12016: 12017: 12018: 12020: 32021: 22022: 12023: 22024: 42025: 1
2006high 4 (2024) · low 0 (2007)2026

Most influential descendants

Showing 5 of 21 · See all
  • K060438RHSTornier · 2006 · cites it directly18descendants
  • K130533Salto Talaris Total Ankle Prosthesis, RHSTornier S.A.S. · 2013 · cites it directly16descendants
  • K153452Salto XT, Salto TalarisTornier S.A.S. · 2016 · 2 generations on15descendants
  • K192994Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc. · 2020 · 3 generations on8descendants
  • K210390Apex 3D Total Ankle Replacement SystemParagon 28, Inc. · 2021 · 4 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K984290Implex Radial Head Replacement SystemImplex Corp.1999—
−2K012551Liverpool Radial Head Replacement DeviceBiomet, Inc.2002—
−1K040611Modular Radial Head Replacement DeviceBiomet, Inc.20041
0 (this device)K051385Explor Modular Radial Head Replacement DeviceBiomet, Inc.2005—
+1K060438RHSTornier2006—
+1K130533Salto Talaris Total Ankle Prosthesis, RHSTornier S.A.S.201319
+2K153452Salto XT, Salto TalarisTornier S.A.S.20168
+3K192994Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc.2020—
+4K210390Apex 3D Total Ankle Replacement SystemParagon 28, Inc.2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
201020
201210
201310
201610
201710
201810
202030
202120
202210
202320
202440
202510
FIG. 1 — Lineage of K051385, 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
*K040611Modular Radial Head Replacement Device
Summary page 1
…t radial (hemi-elbow) polymer prosthesis (21 CFR 888.3170) Legally Marketed Devices to Which Substantial Equivalence Is Claimed: Modular Radial Head Replacement Device (K04061 1), Radial Head Surface Replacement (Implex Corp. K984290), Radial Head Implant (Avanta Orthop., Inc., K002644) and Evolve Modular…
Biomet, Inc.20041
*K984290Implex Radial Head Replacement System
Summary page 1
…) Legally Marketed Devices to Which Substantial Equivalence Is Claimed: Modular Radial Head Replacement Device (K04061 1), Radial Head Surface Replacement (Implex Corp. K984290), Radial Head Implant (Avanta Orthop., Inc., K002644) and Evolve Modular Radial Head (Wright Medical Tech. Inc., K991915) Device…
Implex Corp.1999—
*K002644Radial Head Implant
Summary page 1
…valence Is Claimed: Modular Radial Head Replacement Device (K04061 1), Radial Head Surface Replacement (Implex Corp. K984290), Radial Head Implant (Avanta Orthop., Inc., K002644) and Evolve Modular Radial Head (Wright Medical Tech. Inc., K991915) Device Description: The ExploR TM Modular Radial Head Repla…
Avanta Orthopaedics, Inc.200021
*K991915Modular Radial Head
Summary page 1
…), Radial Head Surface Replacement (Implex Corp. K984290), Radial Head Implant (Avanta Orthop., Inc., K002644) and Evolve Modular Radial Head (Wright Medical Tech. Inc., K991915) Device Description: The ExploR TM Modular Radial Head Replacement Device is a two-piece cobalt alloy prosthesis consisting of a…
Wrightmedicaltechnologyinc19993

What descends from it? (21)

See all 21

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

NumberDeviceApplicantDecidedDescendants
K060438RHSTornier200618
K130533Salto Talaris Total Ankle Prosthesis, RHSTornier S.A.S.201316
K112030Synthes Radial Head Prosthesis SystemSynthes USA, LLC20120
K092721Align Radial Head SystemSkeletal Dynamics, LLC20100

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

Recalls of this device

DateClassRecallRoot causeReason
Jun 16, 2017Class IIZ-0269-2018Packaging change controlZimmer Biomet is conducting a medical device recall for the ExploR 6x24mm Implantable Stem with Screw due to a complaint alleging that the Modular Radial HD lock screw was not included in the package for the stem.
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 6 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
  • 3 of the 5 ancestors have a recall of any class.
  • Of its descendants, K060438 (Tornier, 2006) has gone furthest, with 18 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 ExploRTM Modular Radial Head Replacement Device is intended for:

1) Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, 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 or without 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/K051385 · printed Nov 5, 2026

Cite this page

510(k) Report. “K051385: Explor 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/K051385

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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