510(k) · Cleared
Recalled · Class II · 2017Modification to Radial 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 Nov 27, 2002 as substantially equivalent to K982288 (Avanta Orthopaedics, Inc., 1998) and 1 other predicate after a 30-day review. Its family tree reaches back 2 generations to 1995. 19 later devices descend from it. It has been recalled 18 times.
- Decided
- Nov 27, 2002
- Review
- 30 days
- Class
- Class II
- Product code
- KWI
- Recalls
- 18
- Predicates
- 2
Its longest line of descent runs back 2 generations to K944507 (1995). 3 ancestors in all. 19 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK944507 Metallic Radial Head ImplantsWrightmedicaltechnologyinc · 1995
- 1 generation backK982288 Radial Head ImplantAvanta Orthopaedics, Inc. · 1998 · Recalled
- This deviceK023604 Modification to Radial Head ImplantAvanta Orthopaedics, Inc. · 2002
- Descendant · cites it directly · 18 of its ownK060438 RHSTornier · 2006
- Descendant · cites it directly · 16 of its ownK130533 Salto Talaris Total Ankle Prosthesis, RHSTornier S.A.S. · 2013 · Recalled
- Descendant · 2 generations on · 15 of its ownK153452 Salto XT, Salto TalarisTornier S.A.S. · 2016 · Recalled
- Descendant · 3 generations on · 8 of its ownK192994 Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc. · 2020
- Descendant · 4 generations on · 2 of its ownK210390 Apex 3D Total Ankle Replacement SystemParagon 28, Inc. · 2021
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · 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
| 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) | K023604 | Modification to Radial Head Implant | Avanta Orthopaedics, Inc. | 2002 | — |
| +1 | K060438 | RHS | Tornier | 2006 | — |
| +1 | K130533 | Salto Talaris Total Ankle Prosthesis, RHS | Tornier S.A.S. | 2013 | 19 |
| +2 | K153452 | Salto XT, Salto Talaris | Tornier S.A.S. | 2016 | 8 |
| +3 | K192994 | Paragon 28 APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2020 | — |
| +4 | K210390 | Apex 3D Total Ankle Replacement System | Paragon 28, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K982288 | Radial Head ImplantSummary page 1…87 KWI Original Predicate Device: Original 5 1Ok application Avanta Orthopaedics (K982288, K002644). Registration Number: 2030506 Owner Operator Number: 9001389 Devic… | 1998 |
| * | K002644 | Radial Head ImplantSummary page 1…87 KWI Original Predicate Device: Original 5 1Ok application Avanta Orthopaedics (K982288, K002644). Registration Number: 2030506 Owner Operator Number: 9001389 Device Descrip… | 2000 |
What descends from it? (19)
See all 192 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 |
|---|---|---|---|---|
| Oct 24, 2017 | Class II | Z-2686-2018 | Under Investigation by firm | Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery. |
| Oct 24, 2017 | Class II | Z-2715-2018 | Under Investigation by firm | Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery. |
| Oct 24, 2017 | Class II | Z-2719-2018 | Under Investigation by firm | Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery. |
| Oct 24, 2017 | Class II | Z-2713-2018 | Under Investigation by firm | Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery. |
| Oct 24, 2017 | Class II | Z-2714-2018 | Under Investigation by firm | Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery. |
| Oct 24, 2017 | Class II | Z-2687-2018 | Under Investigation by firm | Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery. |
| Oct 24, 2017 | Class II | Z-2689-2018 | Under Investigation by firm | Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery. |
| Oct 24, 2017 | Class II | Z-2691-2018 | Under Investigation by firm | Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery. |
| Oct 24, 2017 | Class II | Z-2692-2018 | Under Investigation by firm | Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery. |
| Oct 24, 2017 | Class II | Z-2718-2018 | Under Investigation by firm | Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery. |
| Oct 24, 2017 | Class II | Z-2717-2018 | Under Investigation by firm | Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery. |
| Oct 24, 2017 | Class II | Z-2712-2018 | Under Investigation by firm | Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery. |
| Oct 24, 2017 | Class II | Z-2721-2018 | Under Investigation by firm | Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery. |
| Oct 24, 2017 | Class II | Z-2716-2018 | Under Investigation by firm | Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery. |
| Oct 24, 2017 | Class II | Z-2720-2018 | Under Investigation by firm | Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery. |
| Oct 24, 2017 | Class II | Z-2711-2018 | Under Investigation by firm | Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery. |
| Oct 24, 2017 | Class II | Z-2690-2018 | Under Investigation by firm | Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery. |
| Oct 24, 2017 | Class II | Z-2688-2018 | Under Investigation by firm | Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery. |
The 5 latest of 18 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K060438 (Tornier, 2006) has gone furthest, with 18 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?
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 as stated in the FDA summary.
https://510kreport.com/device/K023604 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023604: Modification to Radial Head Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023604
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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