510(k) · Cleared
ClearedMedpor Customized Surgical Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Porex Surgical, Inc. · JOF Polymer, Ent Synthetic, Porous Polyethylene
Cleared on Feb 3, 2009 as substantially equivalent to K922489 (Porex Technologies Corp., 1992) after a 57-day review. Its family tree reaches back 1 generation to 1992. 29 later devices descend from it.
- Decided
- Feb 3, 2009
- Review
- 57 days
- Class
- Class II
- Product code
- JOF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K922489 (1992). 29 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK922489 Medpor Surg Implant Material:Prefor Cran/Fac ImplaPorex Technologies Corp. · 1992 · Recalled
- This deviceK083621 Medpor Customized Surgical ImplantPorex Surgical, Inc. · 2009
- Descendant · cites it directly · 20 of its ownK111065 Stryker (R) Patient Specific Polymer ImplantHowmedica Osteonics Corp. Dba Stryker Orthopeadics · 2011
- Descendant · 2 generations on · 13 of its ownK121153 Peek Customized Craial Implant KitStryker · 2012
- Descendant · cites it directly · 5 of its ownK121315 Stryker CMF Medpor Customized ImplantHowmedica Osteonics Corp. · 2012
- Descendant · 3 generations on · 4 of its ownK182711 Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)Kelyniam Global, Inc. · 2019
- Descendant · 2 generations on · 4 of its ownK143173 Stryker CMF MEDPOR Customized ImplantStryker · 2015
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K111065Stryker (R) Patient Specific Polymer ImplantHowmedica Osteonics Corp. Dba Stryker Orthopeadics · 2011 · cites it directly20descendants
- K121153Peek Customized Craial Implant KitStryker · 2012 · 2 generations on13descendants
- K121315Stryker CMF Medpor Customized ImplantHowmedica Osteonics Corp. · 2012 · cites it directly5descendants
- K182711Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)Kelyniam Global, Inc. · 2019 · 3 generations on4descendants
- K143173Stryker CMF MEDPOR Customized ImplantStryker · 2015 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922489 | Medpor Surg Implant Material:Prefor Cran/Fac Impla | Porex Technologies Corp. | 1992 | 1 |
| 0 (this device) | K083621 | Medpor Customized Surgical Implant | Porex Surgical, Inc. | 2009 | — |
| +1 | K111065 | Stryker (R) Patient Specific Polymer Implant | Howmedica Osteonics Corp. Dba Stryker Orthopeadics | 2011 | — |
| +2 | K121153 | Peek Customized Craial Implant Kit | Stryker | 2012 | — |
| +1 | K121315 | Stryker CMF Medpor Customized Implant | Howmedica Osteonics Corp. | 2012 | — |
| +3 | K182711 | Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) | Kelyniam Global, Inc. | 2019 | — |
| +2 | K143173 | Stryker CMF MEDPOR Customized Implant | Stryker | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 5 | 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 JOF? 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 JOF device
- #1 K200532 StarPorescore 0.0 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K922489 | Medpor Surg Implant Material:Prefor Cran/Fac ImplaSummary page 1…ode: GWO Substantially equivalent to., MEDPOR Surgicali Implant Material; Preformed Cranial & Facial Implants, K922489 Device Description- MEDPOR Customized Surgical Implants. are prescription… | 1992 |
What descends from it? (29)
See all 295 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 JOF devicesJOF Polymer, Ent Synthetic, Porous Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · JOF
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · JOF
Too few JOF 510(k)s in any year since 2007 to give a median.
Recalls per year · JOF
No recall names JOF since 2007.
Adverse event reports per year · JOF
20in 2023
MAUDE reports naming product code JOF, 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 | 0 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 1 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 15 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 20 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MEDPOR Customized Surgical Implant is intended for the augmentation or restoration of bony contour in craniofacial defects.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K083621 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083621: Medpor Customized Surgical Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083621
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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