K102184 · Porex Surgical, Inc. · NPK · Jan 7, 2011 · Dental
Device Facts
Record ID
K102184
Device Name
MEDPOR CONTAIN CAN IMPLANT
Applicant
Porex Surgical, Inc.
Product Code
NPK · Dental
Decision Date
Jan 7, 2011
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 872.3930
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The MEDPOR CONTAIN CAN Implant is intended to stabilize, support and provide space maintenance for bone graft materials in the maxilla, mandible and zygoma.
Device Story
The MEDPOR CONTAIN CAN Implant is a cylinder-shaped, thin-walled, highly porous, non-resorbable implant made of pure porous high-density polyethylene (pHDPE). It is designed to contain and support bone graft materials in the maxilla, mandible, or zygoma. Used by surgeons in clinical settings, the device provides space maintenance for regenerative healing and supports new bone formation for dental implants. The 'can' configuration is pre-formed to minimize the need for intraoperative shaping, trimming, or cutting, thereby reducing procedure time and the risk of introducing contaminants. The implant may be stabilized using tacks, sutures, wires, craniofacial screws, or dental implant retention screws. It benefits patients by providing a stable environment for bone grafting, facilitating predictable bone regeneration.
Clinical Evidence
No clinical data. The submission relies on bench testing and design comparison to the predicate device.
Technological Characteristics
Material: Porous high-density polyethylene (pHDPE). Form factor: Cylinder (can) shape, 8-10mm diameter, 0.40mm thickness. Sterilization: Ethylene Oxide. Single-use. Shelf life: 10 years. Packaging: Double peel pouch. No software or electronic components.
Indications for Use
Indicated for patients requiring stabilization, support, and space maintenance for bone graft materials in the maxilla, mandible, or zygoma to re-establish missing bone or establish new bone for dental implant support.
Regulatory Classification
Identification
Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.
Special Controls
*Classification.* (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
*Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
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KI02184
Image /page/0/Picture/1 description: The image shows the logo for POREX Surgical Products Group. The word "POREX" is in large, bold, black letters. Below the word "POREX" is the phrase "SURGICAL PRODUCTS GROUP" in smaller, black letters.
# 510(k) Summary
JAN - 7 2011
Date of Summary: July 30, 2010
#### Manufacturer and Submitter:
Porex Surgical, Inc. 15 Dart Road Newnan, GA 30265 Tel: (678) 479-1610 Fax: (678) 479-4495
Contact: Stephanie Fullard E-mail: stephanie.fullard(@)porex.com
Trade Name: MEDPOR® CONTAIN™ CAN Implant
Descriptive Name: MEDPOR CONTAIN Implant
Classification: II, 21 CFR 872.3930 - Bone grafting material
Product Code: NPK
Predicate Device: MEDPOR CONTAIN Implant (K091120)
#### Device Description:
The purpose of this Special 510(k) is to add the CAN configuration to MEDPOR CONTAIN Implants. The MEDPOR CONTAIN CAN Implant is a cylinder shaped, thin walled, highly porous, implant that is closed on one end and open on the other. It is made from the same biocompatible pure porous high-density polyethylene (pHDPE) material as MEDPOR CONTAIN Implants in sheet form.
Like the sheet configuration, the CAN is non-resorbable, allows for host integration and is designed to stabilize and support bone graft materials and provide space maintenance necessary for regenerative healing.
The CAN configuration will minimize the need for the surgeon to shape the MEDPOR CONTAIN Sheet Implant, which will reduce the time required for performing the procedure and reduce the possibility of introducing contaminants or debris to the surgical site.
ર - I
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Image /page/1/Picture/1 description: The image shows the logo for POREX Surgical Products Group. The word "POREX" is in large, bold, black letters. Below the word "POREX" is the phrase "SURGICAL PRODUCTS GROUP" in smaller, black letters.
## Indications for Use:
The MEDPOR CONTAIN CAN Implant is intended to stabilize, support and provide space maintenance for bone graft materials in the maxilla, mandible and zygoma.
Technological Characteristics: The MEDPOR CONTAIN CAN Implant can be used to contain, support, and maintain the space for bone graft material that is used in the maxilla, mandible or zygoma to re-establish missing bone or establish new bone for support of dental implants. The MEDPOR CONTAIN CAN Implant is designed to minimize the surgeon's need to shape, trim or cut the implant to fit a patient's specific needs. It may be stabilized with tacks, sutures, wires, craniofacial screws or dental implant retention screws. The MEDPOR CONTAIN CAN Implant is manufactured from the same material, packaged, labeled and sterilized the same as all other MEDPOR CONTAIN Implants.
Substantial Equivalence: The MEDPOR CONTAIN CAN Implant is substantially equivalent in intended use, material, function and design principles to the MEDPOR CONTAIN Implant.
| | MEDPOR CONTAIN CAN | Predicate Device<br>MEDPOR CONTAIN Implant |
|------------------------|-----------------------------------------|--------------------------------------------|
| | Implant | |
| 510(k) Number | This Submission | K091120 |
| Device Classification | Class II, Code NPK | Class II, Code NPK |
| | Reg. No. 872.3930 | Reg. No. 872.3930 |
| Intended Use | The MEDPOR CONTAIN CAN | The MEDPOR CONTAIN |
| | Implant is intended to stabilize, | Implant is intended to stabilize, |
| | support and provide space | support and provide space |
| | maintenance for bone graft | maintenance for bone graft |
| | materials in the maxilla, | materials in the maxilla, |
| | mandible and zygoma. | mandible and zygoma. |
| Material | Linear high-density | Linear high-density |
| | polyethylene biomaterial | polyethylene biomaterial |
| Shape | Cylinder (Can) | Flat (Sheet) |
| Diameter (mm) | 8, 9, 10 | Not Applicable |
| Thickness (mm) | 0.40 | 0.25, 0.35, 0.45 |
| Sterility | Sterile/Ethylene Oxide | Sterile/Ethylene Oxide |
| Single Use Only | Yes | Yes |
| Packaging | Double peel pouch | Double peel pouch |
| Shelf life | 10 years | 10 years |
| Safety & Effectiveness | No changes in function and intended use | |
- Substantial Equivalence Matrix
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Stephanie Fullard Regulatory Affairs Manager Porex Surgical, Incorporated 15 Dart Road Newnan, Georgia 30265
JAN - 7 2011
Re: K102184
Trade/Device Name: MEDPOR® CONTAIN™ CAN Implant Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPK Dated: November 22, 2010 Received: November 24, 2010
Dear Ms. Fullard:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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## Page 2- Ms. Fullard
Enclosure
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820), and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ ucml 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
h for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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# Indications for Use
510(k) Number: K102184
JAN - 7 2011
Device Name: MEDPOR® CONTAIN™ CAN Implant
Indications for Use: The MEDPOR CONTAIN CAN Implant is intended to stabilize, support and provide space maintenance for bone graft materials in the maxilla, mandible and zygoma.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runoe
(Division Sign-Off) Division of Anesthesiology, General Hospltal Infection Control, Dental Devices
510(k) Number:
Page 1 of 1
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
