510(k) · Cleared
ClearedMedpor Contain Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Porex Surgical, Inc. · NPK Barrier, Synthetic, Intraoral
Cleared on Mar 19, 2010 as substantially equivalent to K922489 (Porex Technologies Corp., 1992) and 4 other predicates after a 336-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it.
- Decided
- Mar 19, 2010
- Review
- 336 days
- Class
- Class II
- Product code
- NPK
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K922627 (1994). 17 ancestors in all, the oldest K862482 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK922627 Gore-Tex Regenerative MaterialW. L. Gore & Associates, Inc. · 1994
- 2 generations backK964342 Cytoplast GBROsteogenics Co. · 1997
- 1 generation backK972278 Cytoplast Regentex Titanium 250Osteogenics Co. · 1997 · Recalled
- This deviceK091120 Medpor Contain ImplantPorex Surgical, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK102184 Medpor Contain Can ImplantPorex Surgical, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K102184Medpor Contain Can ImplantPorex Surgical, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922627 | Gore-Tex Regenerative Material | W. L. Gore & Associates, Inc. | 1994 | — |
| −2 | K964342 | Cytoplast GBR | Osteogenics Co. | 1997 | — |
| −1 | K972278 | Cytoplast Regentex Titanium 250 | Osteogenics Co. | 1997 | 1 |
| 0 (this device) | K091120 | Medpor Contain Implant | Porex Surgical, Inc. | 2010 | — |
| +1 | K102184 | Medpor Contain Can Implant | Porex Surgical, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 NPK? 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 NPK device
- #1 K221851 Lumina-PTFE Titaniumscore 7.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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…: II, 21 CER 872.3930 Bone grafting material Product Code: NPK Substantially equivalent to: 1) MEDPOR® Surgical Implant Material; Preformed Cranial & Facial Implants, K922489 2) GORE RESOLUr*ADAPT Regenerative Membrane, K05 1267 3) Osteo-Mesh TM-300 (Titanium Ridge Augmentation Mesh), K984230 4) Cytopia… | 1992 |
| * | K051267 | Gore Resolut Regenerative Material, Gore Resolut XT Regenerative Membrane, Gore…Summary page 1…Code: NPK Substantially equivalent to: 1) MEDPOR® Surgical Implant Material; Preformed Cranial & Facial Implants, K922489 2) GORE RESOLUr*ADAPT Regenerative Membrane, K05 1267 3) Osteo-Mesh TM-300 (Titanium Ridge Augmentation Mesh), K984230 4) CytopiastTm Regentex Titanium 250, K972278 5) IMTECfTitaniurn… | 2005 |
| * | K984230 | Osteo-Mesh TM-300Summary page 1…ant Material; Preformed Cranial & Facial Implants, K922489 2) GORE RESOLUr*ADAPT Regenerative Membrane, K05 1267 3) Osteo-Mesh TM-300 (Titanium Ridge Augmentation Mesh), K984230 4) CytopiastTm Regentex Titanium 250, K972278 5) IMTECfTitaniurn Mesh, K970841 Device Description: MEDPOR CONTAIN Implant is a… | 1999 |
| * | K972278 | Cytoplast Regentex Titanium 250Summary page 1…nts, K922489 2) GORE RESOLUr*ADAPT Regenerative Membrane, K05 1267 3) Osteo-Mesh TM-300 (Titanium Ridge Augmentation Mesh), K984230 4) CytopiastTm Regentex Titanium 250, K972278 5) IMTECfTitaniurn Mesh, K970841 Device Description: MEDPOR CONTAIN Implant is a thin, highly porous, biocompatible semi-rigid… | 1997 |
| * | K970841 | Imtec/Titanium MeshSummary page 1…T Regenerative Membrane, K05 1267 3) Osteo-Mesh TM-300 (Titanium Ridge Augmentation Mesh), K984230 4) CytopiastTm Regentex Titanium 250, K972278 5) IMTECfTitaniurn Mesh, K970841 Device Description: MEDPOR CONTAIN Implant is a thin, highly porous, biocompatible semi-rigid sheet, made from the same biocomp… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102184 | Medpor Contain Can Implant | 2011 | 0 |
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 16 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 4 of the 17 ancestors have a recall of any class.
- Of its descendants, K102184 (Porex Surgical, Inc., 2011) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K922489.
How does its category compare?
All NPK devicesNPK Barrier, Synthetic, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · NPK
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NPK
529in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NPK
No recall names NPK since 2007.
Adverse event reports per year · NPK
3in 2022
MAUDE reports naming product code NPK, 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 | 1 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 2 | — | 0 | 13 |
| 2011 | 1 | — | 0 | 35 |
| 2012 | 0 | — | 0 | 17 |
| 2013 | 1 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 3 | 529 | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MEDPOR CONTAIN Implant is intended to stabilize, support and provide space maintenance for bone graft materials in the maxilla, mandible and zygoma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091120 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091120: Medpor Contain Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091120
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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