510(k) Report

510(k) · Cleared

Cleared

Evolve Ceramic Radial Head Implant

K030384510(k) SpecialCleared Aug 12, 2003188-day reviewClass II21 CFR 888.3170

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

Wrightmedicaltechnologyinc · KWI Prosthesis, Elbow, Hemi-, Radial, Polymer

Cleared on Aug 12, 2003 as substantially equivalent to K991915 (Wrightmedicaltechnologyinc, 1999) and 1 other predicate after a 188-day review. Its family tree reaches back 1 generation to 1997.

Decided
Aug 12, 2003
Review
188 days
Class
Class II
Product code
KWI
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K960659 (1997). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1999: 1 other ancestorK960659 · Ceramic Spherical CMC Implant (Subject to Marketing Approval) · Wrightmedicaltechnologyinc · 199719961998200020022004
Other ancestors, by generation 1 generation back: 1 other ancestor K960659 · Ceramic Spherical CMC Implant (Subject to Marketing Approval) · Wrightmedicaltechnologyinc · 19970
  1. Root · 1 generation backK960659 Ceramic Spherical CMC Implant (Subject to Marketing Approval)Wrightmedicaltechnologyinc · 1997
  2. This deviceK030384 Evolve Ceramic Radial Head ImplantWrightmedicaltechnologyinc · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K960659Ceramic Spherical CMC Implant (Subject to Marketing Approval)Wrightmedicaltechnologyinc1997—
0 (this device)K030384Evolve Ceramic Radial Head ImplantWrightmedicaltechnologyinc2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
FIG. 1 — Lineage of K030384, 1997–2003Source: 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? (2)

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
*K991915Modular Radial Head
Summary page 1
…. DEVICE DESCRIPTION The EVOLVE@ Ceramic Radial Head Implant is identical to the head component previously submitted and cleared under 5 1O(k): K991915- EVOLVE@Modular Radial Head. The only difference between the two devices is the type of materials used to 5 6 ” 7…
Wrightmedicaltechnologyinc19993
*K960659Ceramic Spherical CMC Implant (Subject to Marketing Approval)
Summary page 2
…al used to manufacture the EVOLVE@ Ceramic Radial Head Implant is substantially equivalent to the ORTHOSPHERE' Ceramic Spherical CMC Implant - 5 1O(k): K960659. Additionally, the safety and effectiveness of the EVOLVE* Ceramic Radial Head Implant is adequately supported by the su…
Wrightmedicaltechnologyinc1997—

Also cleared against K991915: 8 other devices →

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.

What does this lineage say?

  • 1 of the 2 ancestors has a recall of any class.
  • 8 other devices also cite its predicate K991915.

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?

Use of the Modular Radial Head Implant may be considered for:

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; and/or

b. resistance to conservative treatment.

Primary replacement after fracture of the radial head.

Symptomatic sequelae after radial head resection.

Revision following failed radial head arthroplasty.

Indications for use as stated in the FDA summary.

Also cleared against K991915

8 other devices cite the same predicate.

  • K212872Avenger Radial Head SystemIn2bones USA, LLC · 2021
  • K192754Avenger Radial Head SystemIn2bones USA, LLC · 2020
  • K060731Evolve Modular Radial HeadWrightmedicaltechnologyinc · 20065 recalls
  • K051385Explor Modular Radial Head Replacement DeviceBiomet, Inc. · 20052 recalls
  • K041858Acumed Anatomic Radial Head SystemAcumed, LLC · 2004
  • K040611Modular Radial Head Replacement DeviceBiomet, Inc. · 20041 recall

More from Wrightmedicaltechnologyinc

311 FDA decisions under this applicant name. See the company

  • K222835Prophecy Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2023
  • K213342PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc · 2022
  • K212996Sterile PHALINX Hammertoe SystemWrightmedicaltechnologyinc · 2021
  • K202815PROPHECY Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2021
  • K201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemWrightmedicaltechnologyinc · 2021

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/K030384 · printed Nov 3, 2026

Cite this page

510(k) Report. “K030384: Evolve Ceramic Radial Head Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030384

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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