510(k) · Cleared
ClearedMEDPOR Customized Implant Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Leibinger GmbH & Co KG · FWP Prosthesis, Chin, Internal
Cleared on Mar 12, 2026 as substantially equivalent to K191916 (Stryker Leibinger GmbH & Co KG, 2019) after a 73-day review. Its family tree reaches back 8 generations to 1990.
- Decided
- Mar 12, 2026
- Review
- 73 days
- Class
- Class II
- Product code
- FWP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K904111 (1990). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK904111 HTR Polymer, HTR-MXUnited States Surgical, A Division of Tyco Healthc · 1990
- 7 generations backK043250 Stryker Patient Specific Polymer ImplantStryker Leibinger · 2005 · Recalled
- 6 generations backK103010 Stryker Patient Specific Polymer ImplantHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2010 · Recalled
- 5 generations backK111065 Stryker (R) Patient Specific Polymer ImplantHowmedica Osteonics Corp. Dba Stryker Orthopeadics · 2011
- 4 generations backK121315 Stryker CMF Medpor Customized ImplantHowmedica Osteonics Corp. · 2012
- 3 generations backK143173 Stryker CMF MEDPOR Customized ImplantStryker · 2015
- 2 generations backK153508 Stryker CMF MEDPOR Customized ImplantStryker · 2016
- 1 generation backK191916 Stryker CMF MEDPOR Priority Customized Implant KitStryker Leibinger GmbH & Co KG · 2019
- This deviceK254233 MEDPOR Customized Implant KitStryker Leibinger GmbH & Co KG · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K904111 | HTR Polymer, HTR-MX | United States Surgical, A Division of Tyco Healthc | 1990 | — |
| −7 | K043250 | Stryker Patient Specific Polymer Implant | Stryker Leibinger | 2005 | 4 |
| −6 | K103010 | Stryker Patient Specific Polymer Implant | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2010 | 1 |
| −5 | K111065 | Stryker (R) Patient Specific Polymer Implant | Howmedica Osteonics Corp. Dba Stryker Orthopeadics | 2011 | — |
| −4 | K121315 | Stryker CMF Medpor Customized Implant | Howmedica Osteonics Corp. | 2012 | — |
| −3 | K143173 | Stryker CMF MEDPOR Customized Implant | Stryker | 2015 | — |
| −2 | K153508 | Stryker CMF MEDPOR Customized Implant | Stryker | 2016 | — |
| −1 | K191916 | Stryker CMF MEDPOR Priority Customized Implant Kit | Stryker Leibinger GmbH & Co KG | 2019 | — |
| 0 (this device) | K254233 | MEDPOR Customized Implant Kit | Stryker Leibinger GmbH & Co KG | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 2009 | 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 FWP? 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 FWP device
- #1 K232593 FITme Customized Silicone Implantscore 6.7 · 2 generations · no Class I recall
- #2 Held for the reportin 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K191916 | Stryker CMF MEDPOR Priority Customized Implant KitSummary page 6…(a)(3)] 510(k) Number: K254233 Primary Predicate Device: Stryker CMF MEDPOR® Customized Implant Kit (also referred to as MEDPOR® CI or MEDPOR® CI Kit) – K191916 Reference Device: PEEK Customized Cranial Implant (CCI) Kit – K203055 The predicate and reference device have not be… | 2019 |
| † | K203055 | Stryker PEEK Customized Cranial Implant Kit | 2021 |
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.
What does this lineage say?
- The line of descent spans 36 years and passes through 7 companies; a new generation was cleared every 3.5 years on median.
- 4 of the 11 ancestors have a recall of any class.
How does its category compare?
All FWP devicesFWP Prosthesis, Chin, Internal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · FWP
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · FWP
Too few FWP 510(k)s in any year since 2007 to give a median.
Recalls per year · FWP
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FWP
17in 2025
MAUDE reports naming product code FWP, 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 | 3 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 1 | — | 0 | 5 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 22 |
| 2012 | 1 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 1 | — | 0 | 5 |
| 2015 | 1 | — | 0 | 8 |
| 2016 | 2 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 13 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 2 | — | 0 | 15 |
| 2020 | 1 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 13 |
| 2022 | 0 | — | 0 | 12 |
| 2023 | 1 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 10 |
| 2025 | 0 | — | 1 | 17 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The CMF MEDPOR® Customized Implant is indicated for the augmentation, and/or restoration of bony and/or soft tissue deformities in post-traumatic, post-surgical, or congenital craniofacial defects, including, but not limited to, the correction and prevention of persistent temporal hollowing (PTH).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254233 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254233: MEDPOR Customized Implant Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254233
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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