510(k) · Cleared
Recalled · Class II · 2013Radial Head Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avanta Orthopaedics, Inc. · KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Cleared on Sep 8, 1998 as substantially equivalent to K944507 (Wrightmedicaltechnologyinc, 1995) after a 70-day review. Its family tree reaches back 1 generation to 1995. 27 later devices descend from it. It has been recalled once.
- Decided
- Sep 8, 1998
- Review
- 70 days
- Class
- Class II
- Product code
- KWI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K944507 (1995). 27 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK944507 Metallic Radial Head ImplantsWrightmedicaltechnologyinc · 1995
- This deviceK982288 Radial Head ImplantAvanta Orthopaedics, Inc. · 1998
- Descendant · cites it directly · 19 of its ownK023604 Modification to Radial Head ImplantAvanta Orthopaedics, Inc. · 2002 · 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
- Descendant · 3 generations on · 15 of its ownK153452 Salto XT, Salto TalarisTornier S.A.S. · 2016 · Recalled
- Descendant · 4 generations on · 8 of its ownK192994 Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc. · 2020
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K023604Modification to Radial Head ImplantAvanta Orthopaedics, Inc. · 2002 · cites it directly19descendants
- 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944507 | Metallic Radial Head Implants | Wrightmedicaltechnologyinc | 1995 | — |
| 0 (this device) | K982288 | Radial Head Implant | Avanta Orthopaedics, Inc. | 1998 | — |
| +1 | K023604 | Modification to Radial Head Implant | Avanta Orthopaedics, Inc. | 2002 | 18 |
| +2 | K060438 | RHS | Tornier | 2006 | — |
| +2 | K130533 | Salto Talaris Total Ankle Prosthesis, RHS | Tornier S.A.S. | 2013 | 19 |
| +3 | K153452 | Salto XT, Salto Talaris | Tornier S.A.S. | 2016 | 8 |
| +4 | K192994 | Paragon 28 APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 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 |
|---|---|---|---|
| * | K944507 | Metallic Radial Head ImplantsSummary page 1…(hemi-elbow) prosthesis Radial head implant Class II Orthopedic 888.3170 87 KWI Swanson Titanium Radial Head Implant manufactured by Wright Medical Technologies (K944507). 2030506 9001389 The radial head implant like the predicate device includes various sizes of implants and accessories includi… | 1995 |
| * | — | Dow Corning Corporation Silastic Swanson Radial Head Implant Named without a submission number |
What descends from it? (27)
See all 275 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 6, 2013 | Class II | Z-0098-2014 | Packaging change control | The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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?
Avanta Orthopaedics Radial Head implant is intended for replacement of the proximal end of the radius:
Replacement of the radial head for degenerative, or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radiohumeral and or proximal radio-ulnar joint with:
joint destruction or subluxation visible on x-ray
resistance to conservative treatment
Primary replacement after fracture of the radial head
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/K982288 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982288: Radial Head Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982288
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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