510(k) · Cleared
ClearedSynthes (Usa) Condylar Head Add-on System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · NEI Prosthesis, Condyle, Mandibular, Temporary
Cleared on Jan 5, 2007 as substantially equivalent to K990637 (Synthes (Usa), 1999) after a 78-day review. Its family tree reaches back 1 generation to 1999. 1 later device descends from it.
- Decided
- Jan 5, 2007
- Review
- 78 days
- Class
- Class II
- Product code
- NEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K990637 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK990637 Synthes Locking Reconstruction Plate (LRP) with Condylar HeadSynthes (Usa) · 1999
- This deviceK063181 Synthes (Usa) Condylar Head Add-on SystemSynthes (Usa) · 2007
- Descendant · cites it directly · 0 of its ownK183113 DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC · 2019
Most influential descendants
Showing 1 of 1 · See all- K183113DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K990637 | Synthes Locking Reconstruction Plate (LRP) with Condylar Head | Synthes (Usa) | 1999 | — |
| 0 (this device) | K063181 | Synthes (Usa) Condylar Head Add-on System | Synthes (Usa) | 2007 | — |
| +1 | K183113 | DePuy Synthes Maxillofacial Portfolio - MR Conditional | Synthes (USA) Products, LLC | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 NEI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K990637 | Synthes Locking Reconstruction Plate (LRP) with Condylar HeadSummary page 1…21 CFR 872.3960: Mandibular condyle prosthesis Predicate Devices: Synthes Locking Reconstruction Plate (LRP) with Condylar Head (K990637) Stryker Leibinger, Attachable Condylar Head (K020199) Device Description: The Synthes (USA)… | 1999 |
| Kept off the family tree | K020199 | Stryker Leibinger, Attachable Condylar Head Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…thes Locking Reconstruction Plate (LRP) with Condylar Head (K990637) Stryker Leibinger, Attachable Condylar Head (K020199) Device Description: The Synthes (USA) Condylar Head Add-on System is an adjustable height s… |
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 |
|---|---|---|---|
| K183113 | DePuy Synthes Maxillofacial Portfolio - MR Conditional | 2019 | 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?
How does its category compare?
All NEI devicesNEI Prosthesis, Condyle, Mandibular, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · NEI
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · NEI
Too few NEI 510(k)s in any year since 2007 to give a median.
Recalls per year · NEI
No recall names NEI since 2007.
Adverse event reports per year · NEI
2in 2024
MAUDE reports naming product code NEI, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 8 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063181 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063181: Synthes (Usa) Condylar Head Add-on System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063181
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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