510(k) · Cleared
ClearedStryker CMF Medpor Customized Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · FWP Prosthesis, Chin, Internal
Cleared on Nov 1, 2012 as substantially equivalent to K083621 (Porex Surgical, Inc., 2009) and 2 other predicates after a 183-day review. Its family tree reaches back 4 generations to 1990. 5 later devices descend from it.
- Decided
- Nov 1, 2012
- Review
- 183 days
- Class
- Class II
- Product code
- FWP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K904111 (1990). 7 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK904111 HTR Polymer, HTR-MXUnited States Surgical, A Division of Tyco Healthc · 1990
- 3 generations backK043250 Stryker Patient Specific Polymer ImplantStryker Leibinger · 2005 · Recalled
- 2 generations backK103010 Stryker Patient Specific Polymer ImplantHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2010 · Recalled
- 1 generation backK111065 Stryker (R) Patient Specific Polymer ImplantHowmedica Osteonics Corp. Dba Stryker Orthopeadics · 2011
- This deviceK121315 Stryker CMF Medpor Customized ImplantHowmedica Osteonics Corp. · 2012
- Descendant · cites it directly · 4 of its ownK143173 Stryker CMF MEDPOR Customized ImplantStryker · 2015
- Descendant · 2 generations on · 2 of its ownK153508 Stryker CMF MEDPOR Customized ImplantStryker · 2016
- Descendant · 3 generations on · 1 of its ownK191916 Stryker CMF MEDPOR Priority Customized Implant KitStryker Leibinger GmbH & Co KG · 2019
- Descendant · 4 generations on · 0 of its ownK254233 MEDPOR Customized Implant KitStryker Leibinger GmbH & Co KG · 2026
- Descendant · 2 generations on · 0 of its ownK152463 SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific…Poriferous, LLC · 2016
Most influential descendants
Showing 5 of 5 · See all- K143173Stryker CMF MEDPOR Customized ImplantStryker · 2015 · cites it directly4descendants
- K153508Stryker CMF MEDPOR Customized ImplantStryker · 2016 · 2 generations on2descendants
- K191916Stryker CMF MEDPOR Priority Customized Implant KitStryker Leibinger GmbH & Co KG · 2019 · 3 generations on1descendant
- K254233MEDPOR Customized Implant KitStryker Leibinger GmbH & Co KG · 2026 · 4 generations on0descendants
- K152463SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial ImplantPoriferous, LLC · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K904111 | HTR Polymer, HTR-MX | United States Surgical, A Division of Tyco Healthc | 1990 | — |
| −3 | K043250 | Stryker Patient Specific Polymer Implant | Stryker Leibinger | 2005 | 4 |
| −2 | K103010 | Stryker Patient Specific Polymer Implant | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2010 | 1 |
| −1 | K111065 | Stryker (R) Patient Specific Polymer Implant | Howmedica Osteonics Corp. Dba Stryker Orthopeadics | 2011 | — |
| 0 (this device) | K121315 | Stryker CMF Medpor Customized Implant | Howmedica Osteonics Corp. | 2012 | — |
| +1 | K143173 | Stryker CMF MEDPOR Customized Implant | Stryker | 2015 | — |
| +2 | K153508 | Stryker CMF MEDPOR Customized Implant | Stryker | 2016 | — |
| +3 | K191916 | Stryker CMF MEDPOR Priority Customized Implant Kit | Stryker Leibinger GmbH & Co KG | 2019 | — |
| +4 | K254233 | MEDPOR Customized Implant Kit | Stryker Leibinger GmbH & Co KG | 2026 | — |
| +2 | K152463 | SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant | Poriferous, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2019 | 1 | 0 |
| 2026 | 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 K254233 MEDPOR Customized Implant Kitscore 13.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K083621 | Medpor Customized Surgical ImplantSummary page 1…d Regulatory Class: Class 11 Product Codes: FWP Predicate Devices: MEOPOR Customized Surgical Implant (YK08362 1) Stryker Patient Specific Polymer Implant (K1030 10) Stryke… | 2009 |
| * | K103010 | Stryker Patient Specific Polymer ImplantSummary page 1…FWP Predicate Devices: MEOPOR Customized Surgical Implant (YK08362 1) Stryker Patient Specific Polymer Implant (K1030 10) Stryker Patient Specific Polymer Implant (KI 11065) Striker C0lFA'IEDPOR Cusu… | 2010 |
| * | K111065 | Stryker (R) Patient Specific Polymer Implant | 2011 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143173 | Stryker CMF MEDPOR Customized Implant | 2015 | 4 |
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 22 years and passes through 5 companies; a new generation was cleared every 5.5 years on median.
- 4 of the 7 ancestors have a recall of any class.
- Of its descendants, K143173 (Stryker, 2015) has gone furthest, with 4 descendants of its own.
- 4 other devices also cite its predicate K083621.
How does its category compare?
All FWP devicesFWP Prosthesis, Chin, Internal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Stryker CMF MEDPOR Customized Implant is intended for the augmentation or restoration of bony contour in craniofacial defects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121315 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121315: Stryker CMF Medpor Customized Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121315
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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