510(k) · Cleared
ClearedStryker Temporary Condylar Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker · NEI Prosthesis, Condyle, Mandibular, Temporary
Cleared on Apr 9, 2014 after a 166-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).
- Decided
- Apr 9, 2014
- Review
- 166 days
- Class
- Class II
- Product code
- NEI
- Recalls
- None
- Predicates
- 1
The summary cites one number, which could not be confirmed as its predicate (see the table below).
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? (1)
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 |
|---|---|---|---|
| Kept off the family tree | K020199 | Locking Reconstruction Plate with 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…uction plate Regulatory Class: Class 11 Device Product Code(s): NEI Predicate devices: K020199 - Locking Reconstruction Plate with Attachable Condylar Head 510(k) Contact Pers… |
What descends from it?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All NEI devicesNEI Prosthesis, Condyle, Mandibular, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Stryker Temporary Condylar Prostheses are intended for temporary (not exceeding 24 months) reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133285 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133285: Stryker Temporary Condylar Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133285
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026