510(k) · Cleared
Recalled · Class II · 2016Synthes Radial Head Prosthesis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes USA, LLC · KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Cleared on Jun 19, 2012 as substantially equivalent to K051385 (Biomet, Inc., 2005) and 1 other predicate after a 340-day review. Its family tree reaches back 4 generations to 1999. It has been recalled 2 times.
- Decided
- Jun 19, 2012
- Review
- 340 days
- Class
- Class II
- Product code
- KWI
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 4 generations to K984290 (1999). 9 ancestors in all, the oldest K944507 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK984290 Implex Radial Head Replacement SystemImplex Corp. · 1999
- 3 generations backK012551 Liverpool Radial Head Replacement DeviceBiomet, Inc. · 2002
- 2 generations backK040611 Modular Radial Head Replacement DeviceBiomet, Inc. · 2004 · Recalled
- 1 generation backK051385 Explor Modular Radial Head Replacement DeviceBiomet, Inc. · 2005 · Recalled
- This deviceK112030 Synthes Radial Head Prosthesis SystemSynthes USA, LLC · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K984290 | Implex Radial Head Replacement System | Implex Corp. | 1999 | — |
| −3 | K012551 | Liverpool Radial Head Replacement Device | Biomet, Inc. | 2002 | — |
| −2 | K040611 | Modular Radial Head Replacement Device | Biomet, Inc. | 2004 | 1 |
| −1 | K051385 | Explor Modular Radial Head Replacement Device | Biomet, Inc. | 2005 | 2 |
| 0 (this device) | K112030 | Synthes Radial Head Prosthesis System | Synthes USA, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K051385 | Explor Modular Radial Head Replacement DeviceSummary page 2…s the same indications for use, Equivalence: the same fundamental technological characteristics, and similar materials as the predicate Biomet ExploRTM (K051385) and Ascension® (K032686) Modular Radial Head Devices. In vitro performance testing demonstrates the ability of… | 2005 |
| * | K032686 | Ascension Modular Radial HeadSummary page 1…sis Product Code: KWI Predicate Biomet ExploRTm Radial Head Prosthesis System (KOS51385) Device: Ascension® Modular Radial Head (K032686) Titan Endoskeleton Interbody Fusion Devices (K 111626, K 102067, K 100889, K(083714, and K… | 2003 |
| † | K111626 | Endoskeleton (R) Tas | 2011 |
| † | K102067 | Endoskeleton to | 2010 |
| † | K100889 | Endoskeleton TC | 2010 |
| † | K083714 | Endoskeleton TT Interbody Fusion Device (Ibd) | 2009 |
| † | K080615 | Endoskeleton TA Interbody Fusion Device (Ibd) | 2008 |
| † | K111272 | Rhausler Plage Anterior Cervical Fusion System | 2011 |
| † | K053088 | Slactive Implants | 2006 |
| † | K033984 | Straumann Dental Implant System | 2004 |
| † | K072578 | Synthes (Usa) Epoca Shoulder Prosthesis System | 2007 |
| † | K083439 | Synthes Epoca Shoulder Prosthesis System | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 29, 2016 | Class II | Z-1124-2017 | Under Investigation by firm | There is the possibility that the radial stem may loosen post-operatively at the stem bone interface. |
| Feb 22, 2013 | Class II | Z-1238-2013 | Device Design | The Trial Head may come loose from the implant stem during manipulation of the arm during surgery. To date, no adverse events have been reported related to this issue and this recall is not being initiated as a result of adverse events. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 5 of the 9 ancestors have a recall of any class.
- 3 other devices also cite its predicate K051385.
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. 2012, this device’s year, is highlighted.
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 Synthes Radial Head Prosthesis System is intended for:
1. The replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radlo-humeral and/or proximal radlo-ulnar joint with
a. Joint destruction and/or subluxation visible on x-ray
b. Resistance to conservative treatment
2. Primary replacement after fracture of the radial head.
3. Symptomatic sequelae after radial head resection
4. Revision following failed radial head arthroplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112030 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112030: Synthes Radial Head Prosthesis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112030
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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