510(k) · Cleared
ClearedImplex Radial Head Replacement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implex Corp. · KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Cleared on Jun 1, 1999 after a 182-day review. The FDA summary names its predicate without a number. 26 later devices descend from it.
- Decided
- Jun 1, 1999
- Review
- 182 days
- Class
- Class II
- Product code
- KWI
- Recalls
- None
- Predicates
- 0
26 later devices descend from it, 4 citing it directly.
- This deviceK984290 Implex Radial Head Replacement SystemImplex Corp. · 1999
- Descendant · cites it directly · 23 of its ownK012551 Liverpool Radial Head Replacement DeviceBiomet, Inc. · 2002
- Descendant · cites it directly · 22 of its ownK040611 Modular Radial Head Replacement DeviceBiomet, Inc. · 2004 · Recalled
- Descendant · cites it directly · 21 of its ownK051385 Explor Modular Radial Head Replacement DeviceBiomet, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 18 of its ownK060438 RHSTornier · 2006
- Descendant · 2 generations on · 16 of its ownK130533 Salto Talaris Total Ankle Prosthesis, RHSTornier S.A.S. · 2013 · Recalled
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · 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
- K060438RHSTornier · 2006 · 2 generations on18descendants
- K130533Salto Talaris Total Ankle Prosthesis, RHSTornier S.A.S. · 2013 · 2 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K984290 | Implex Radial Head Replacement System | Implex Corp. | 1999 | — |
| +1 | K012551 | Liverpool Radial Head Replacement Device | Biomet, Inc. | 2002 | — |
| +1 | K040611 | Modular Radial Head Replacement Device | Biomet, Inc. | 2004 | 1 |
| +1 | K051385 | Explor Modular Radial Head Replacement Device | Biomet, Inc. | 2005 | 2 |
| +2 | K060438 | RHS | Tornier | 2006 | — |
| +2 | K130533 | Salto Talaris Total Ankle Prosthesis, RHS | Tornier S.A.S. | 2013 | 19 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
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 K260624 Arthrex Radial Head Replacement Systemscore 12.1 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Wright Medical Technology, Metallic Radial Heads Named without a submission number | |
| * | — | Avanta Orthopedics, Avanta RH™ Named without a submission number |
What descends from it? (26)
See all 264 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K012551 (Biomet, Inc., 2002) has gone furthest, with 23 descendants of its own.
How does its category compare?
All KWI devicesKWI Prosthesis, Elbow, Hemi-, Radial, Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWI
1in 2024
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWI
118in 2025
MAUDE reports naming product code KWI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 15 |
| 2008 | 0 | — | 0 | 16 |
| 2009 | 0 | — | 0 | 14 |
| 2010 | 1 | — | 0 | 13 |
| 2011 | 0 | — | 0 | 10 |
| 2012 | 1 | — | 0 | 16 |
| 2013 | 1 | — | 1 | 31 |
| 2014 | 1 | — | 1 | 29 |
| 2015 | 0 | — | 0 | 103 |
| 2016 | 0 | — | 0 | 138 |
| 2017 | 1 | — | 1 | 360 |
| 2018 | 0 | — | 0 | 202 |
| 2019 | 1 | — | 0 | 214 |
| 2020 | 1 | — | 0 | 118 |
| 2021 | 1 | — | 0 | 44 |
| 2022 | 1 | — | 2 | 44 |
| 2023 | 1 | — | 0 | 77 |
| 2024 | 1 | — | 0 | 124 |
| 2025 | 0 | — | 0 | 118 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
For Cemented Use Only.
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:
Joint destruction and/or subluxation.
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984290 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984290: Implex Radial Head Replacement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984290
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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