510(k) · Cleared
ClearedAscension Modular Radial Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ascension Orthopedics, Inc. · KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Cleared on Oct 22, 2003 as substantially equivalent to K982288 (Avanta Orthopaedics, Inc., 1998) and 1 other predicate after a 54-day review. Its family tree reaches back 2 generations to 1995. 3 later devices descend from it.
- Decided
- Oct 22, 2003
- Review
- 54 days
- Class
- Class II
- Product code
- KWI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K944507 (1995). 3 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK944507 Metallic Radial Head ImplantsWrightmedicaltechnologyinc · 1995
- 1 generation backK982288 Radial Head ImplantAvanta Orthopaedics, Inc. · 1998 · Recalled
- This deviceK032686 Ascension Modular Radial HeadAscension Orthopedics, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK213827 TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System…Smith & Nephew, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK112030 Synthes Radial Head Prosthesis SystemSynthes USA, LLC · 2012 · Recalled
- Descendant · cites it directly · 0 of its ownK102180 Rhead Radial Head Extended StemsSmall Bone Innovations, Inc. · 2010 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc. · 2022 · cites it directly0descendants
- K112030Synthes Radial Head Prosthesis SystemSynthes USA, LLC · 2012 · cites it directly0descendants
- K102180Rhead Radial Head Extended StemsSmall Bone Innovations, Inc. · 2010 · 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) | K032686 | Ascension Modular Radial Head | Ascension Orthopedics, Inc. | 2003 | — |
| +1 | K213827 | TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN… | Smith & Nephew, Inc. | 2022 | — |
| +1 | K112030 | Synthes Radial Head Prosthesis System | Synthes USA, LLC | 2012 | 2 |
| +1 | K102180 | Rhead Radial Head Extended Stems | Small Bone Innovations, Inc. | 2010 | 9 |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2022 | 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…RODUCT CODE: 87 KWI PANEL: Orthopedic and Rehabilitation Devices PREDICATE DEVICE: Avanta Orthopaedics, Inc., Radial Head Implant (K982288) Wright Medical Technology, Inc., Modular Radial Head (K9919 15) DEVICE DESCRIPTION: The Ascension@Modular Radial Head is an ana… | 1998 |
| * | K991915 | Modular Radial HeadSummary page 1…Orthopedic and Rehabilitation Devices PREDICATE DEVICE: Avanta Orthopaedics, Inc., Radial Head Implant (K982288) Wright Medical Technology, Inc., Modular Radial Head (K9919 15) DEVICE DESCRIPTION: The Ascension@Modular Radial Head is an anatomically designed, single-use, modular prosthesis designed for… | 1999 |
What descends from it? (3)
3 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?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K213827 (Smith & Nephew, Inc., 2022) 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 Ascension@Modular Radial Head is intended 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:
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
Revision following failed radial head arthroplasty
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032686 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032686: Ascension Modular Radial Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032686
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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