510(k) · Cleared
Recalled · Class II · 2017Omnipore Customized Surgical Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Matrix Surgical Holdings, LLC/Matrix Surgical USA · KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Cleared on May 14, 2014 as substantially equivalent to K123908 (Matrix Surgical USA, 2013) and 1 other predicate after a 229-day review. Its family tree reaches back 2 generations to 1992. It has been recalled once.
- Decided
- May 14, 2014
- Review
- 229 days
- Class
- Class II
- Product code
- KKY
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K922489 (1992). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK922489 Medpor Surg Implant Material:Prefor Cran/Fac ImplaPorex Technologies Corp. · 1992 · Recalled
- 1 generation backK083621 Medpor Customized Surgical ImplantPorex Surgical, Inc. · 2009
- This deviceK133046 Omnipore Customized Surgical ImplantsMatrix Surgical Holdings, LLC/Matrix Surgical USA · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922489 | Medpor Surg Implant Material:Prefor Cran/Fac Impla | Porex Technologies Corp. | 1992 | 1 |
| −1 | K083621 | Medpor Customized Surgical Implant | Porex Surgical, Inc. | 2009 | — |
| 0 (this device) | K133046 | Omnipore Customized Surgical Implants | Matrix Surgical Holdings, LLC/Matrix Surgical USA | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 KKY? 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 KKY device
- #1 K211514 Longeviti PorousFit implantscore 2.0 · 2 generations · no Class I recall
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K123908 | Omnipore Surgical Implants and AccessoriesSummary page 4…composite implant material Product Code: KKY Legally Marketed Predicate Device: Matrix Surgical USA - OmniPore® Surgical Implants - 510(k) # K123908 POREX Surgical Inc. (now owned by Stryker® Craniomaxillofacial) - MEDPOR® Customized Surgical Implant - 510(k) # K0… | 2013 |
| * | K083621 | Medpor Customized Surgical ImplantSummary page 4…Pore® Surgical Implants - 510(k) # K123908 POREX Surgical Inc. (now owned by Stryker® Craniomaxillofacial) - MEDPOR® Customized Surgical Implant - 510(k) # K083621 Device Description: The OmniPore® Customized Surgical Implants are marketed as single patient use sterile implants tha… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 25, 2017 | Class II | Z-1382-2017 | Other | Mislabeling. The packaging labeled as left mandible contained a right mandible. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 16.4 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 2 other devices also cite its predicate K123908.
How does its category compare?
All KKY devicesKKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · KKY
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · KKY
224in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KKY
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KKY
1in 2025
MAUDE reports naming product code KKY, 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 | — | 4 | 3 |
| 2009 | 0 | — | 0 | 9 |
| 2010 | 1 | — | 0 | 5 |
| 2011 | 1 | — | 0 | 13 |
| 2012 | 0 | — | 0 | 22 |
| 2013 | 1 | — | 1 | 17 |
| 2014 | 3 | 224 | 0 | 9 |
| 2015 | 1 | — | 0 | 18 |
| 2016 | 2 | — | 0 | 25 |
| 2017 | 0 | — | 0 | 19 |
| 2018 | 0 | — | 0 | 17 |
| 2019 | 0 | — | 0 | 20 |
| 2020 | 0 | — | 0 | 13 |
| 2021 | 1 | — | 0 | 12 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
OmniPore® Customized Surgical Implants are intended for non-weight bearing applications of craniofacial reconstruction/ cosmetic surgery and repair of craniofacial trauma. OmniPore Customized Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133046 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133046: Omnipore Customized Surgical Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133046
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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