510(k) · Cleared
ClearedRadial Head Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Cleared on Feb 25, 2000 as substantially equivalent to K982288 (Avanta Orthopaedics, Inc., 1998) and 2 other predicates after a 239-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it.
- Decided
- Feb 25, 2000
- Review
- 239 days
- Class
- Class II
- Product code
- KWI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K944507 (1995). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK944507 Metallic Radial Head ImplantsWrightmedicaltechnologyinc · 1995
- 1 generation backK982288 Radial Head ImplantAvanta Orthopaedics, Inc. · 1998 · Recalled
- This deviceK992220 Radial Head ProsthesisSmith & Nephew, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK001385 Howmedica Osteonics Radial Head ProthesisHowmedica Osteonics Corp. · 2000
Most influential descendants
Showing 1 of 1 · See all- K001385Howmedica Osteonics Radial Head ProthesisHowmedica Osteonics Corp. · 2000 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944507 | Metallic Radial Head Implants | Wrightmedicaltechnologyinc | 1995 | — |
| −1 | K982288 | Radial Head Implant | Avanta Orthopaedics, Inc. | 1998 | 1 |
| 0 (this device) | K992220 | Radial Head Prosthesis | Smith & Nephew, Inc. | 2000 | — |
| +1 | K001385 | Howmedica Osteonics Radial Head Prothesis | Howmedica Osteonics Corp. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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? (3)
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 |
|---|---|---|---|
| * | K982288 | Radial Head ImplantSummary page 1…nd Panel Code: 87KWI Panel: Orthopaedics/87 Substantially Equivalent, Legally Marketed Predicate Devices: Avanta Orthopaedics Radial Head Implant Avanta Orthopaedics (K982288) Swanson Titanium Radial Head Implant Wright Medical Technology (K944507) Implex Radial Head Replacement System Implex Corporatio… | 1998 |
| * | K944507 | Metallic Radial Head ImplantsSummary page 1…gally Marketed Predicate Devices: Avanta Orthopaedics Radial Head Implant Avanta Orthopaedics (K982288) Swanson Titanium Radial Head Implant Wright Medical Technology (K944507) Implex Radial Head Replacement System Implex Corporation (K984290) Subject device description: The Radial Head Prosthesis, like… | 1995 |
| * | K984290 | Implex Radial Head Replacement SystemSummary page 1…Implant Avanta Orthopaedics (K982288) Swanson Titanium Radial Head Implant Wright Medical Technology (K944507) Implex Radial Head Replacement System Implex Corporation (K984290) Subject device description: The Radial Head Prosthesis, like the predicate devices, includes various sizes of implants to accom… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K001385 | Howmedica Osteonics Radial Head Prothesis | 2000 | 0 |
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?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K001385 (Howmedica Osteonics Corp., 2000) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K982288.
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?
The Radial Head Prosthesis is intended for replacement of the proximal end of the radius due to degenerative or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radiohumeral and/or proximal radio-ulnar joint involving joint destruction or subluxation visible on x-ray, reststance to conservative treatment; primary replacement after fracture of the radial head; and symptomatic sequelae after radial head resection.
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/K992220 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992220: Radial Head Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992220
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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