(155 days)
No
The device description focuses on the materials and mechanical components of a plate and screw system for cranial surgery. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a plate and screw system intended to fixate cranial implants to the surrounding cranial skeleton, not to treat a disease or condition.
No
Explanation: The device is described as a "plate and screw system" intended for "craniofacial surgery to fixate MEDPOR cranial implants to the surrounding cranial skeleton." This indicates it is a surgical fixation device, not a diagnostic one.
No
The device description explicitly states it is a plate and screw system composed of physical components like titanium plates, screws, and surgical instruments. It is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "fixate MEDPOR cranial implants to the surrounding cranial skeleton" during cranial surgery. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a system of plates, screws, and instruments made of titanium and stainless steel. These are physical components used for mechanical fixation within the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
The MEDPOR Fixation System - Cranial is a surgical implant and fixation system, not an IVD.
N/A
Intended Use / Indications for Use
The MEDPOR Fixation System - Cranial is intended for use in cranial surgery to fixate MEDPOR cranial implants to the surrounding cranial skeleton.
Product codes (comma separated list FDA assigned to the subject device)
HBW
Device Description
The MEDPOR Fixation System - Cranial is a plate and screw system to be used in Cranial Surgery. The components that comprise the system are composed of titanium plates. titanium alloy bone screws, titanium alloy implant screws, and surgical stainless steel instruments for the installation of the plates and screws. The plates are manufactured of grade 4 titanium and adhere to the American Society of Testing Materials (A.S.T.M.) F67 Standard. The bone and implant screws are manufactured of 6-4 ELI titanium that meets the ASTM F136 standard. The implant screws are designed to be used with MEDPOR polyethylene implants manufactured by Porex Surgical under K832283. K922489. K952677, K040364 and K083621. The screws and plates have been color anodized for ease of use by a surgeon. The blue anodized side of the plate corresponds to the blue anodized bone screw and the magenta anodized side of the plate corresponds to the magenta anodized implant screw. The MEDPOR Fixation System -- Cranial is sterilized by ethylene oxide sterilization. The instruments and unused components can be resterilized via steam sterilization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial skeleton
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K073006, K022012, K021642, K963546, K031659
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K832283, K922489, K952677, K040364, K083621
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5360 Cranioplasty plate fastener.
(a)
Identification. A cranioplasty plate fastener is a screw, wire, or other article made of tantalum, vitallium, or stainless steel used to secure a plate to the patient's skull to repair a skull defect.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 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 text "SURGICAL PRODUCTS GROUP" in a smaller font size.
510(k) SUMMARY
DEC - 3 2010
KI 01 835
Date of Summary: September 17, 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® Fixation System - Cranial
Common Name: Plates and Screws
Class: II, 21 CFR 882.5360 - Cranioplasty plate fastener
Product Code: HBW
Substantially equivalent to:
-
- Takiron Co., Ltd OSTEOTRANS™-MX Bioabsorbable Bone Fixation System K073006
-
- Synthes (USA) Synthes Low Profile Neuro System K022012
-
- Synthes (USA) Synthes (USA) Craniofacial Plates K021642
-
- Synthes (USA) SMF Titanium (TI) Alloy Bone Screws K963546
-
- Stryker Leibinger Stryker Leibinger Universal Neuro System K031659
1
Device Description:
The MEDPOR Fixation System - Cranial is a plate and screw system to be used in Cranial Surgery. The components that comprise the system are composed of titanium plates. titanium alloy bone screws, titanium alloy implant screws, and surgical stainless steel instruments for the installation of the plates and screws. The plates are manufactured of grade 4 titanium and adhere to the American Society of Testing Materials (A.S.T.M.) F67 Standard. The bone and implant screws are manufactured of 6-4 ELI titanium that meets the ASTM F136 standard. The implant screws are designed to be used with MEDPOR polyethylene implants manufactured by Porex Surgical under K832283. K922489. K952677, K040364 and K083621. The screws and plates have been color anodized for ease of use by a surgeon. The blue anodized side of the plate corresponds to the blue anodized bone screw and the magenta anodized side of the plate corresponds to the magenta anodized implant screw. The MEDPOR Fixation System -- Cranial is sterilized by ethylene oxide sterilization. The instruments and unused components can be resterilized via steam sterilization.
Indications for Use:
The MEDPOR Fixation System - Cranial is intended for use in cranial surgery to fixate MEDPOR cranial implants to the surrounding cranial skeleton.
Technological Characteristics:
Documentation is provided which demonstrates that the MEDPOR Fixation System -Cranial is substantially equivalent to other legally marketed devices. The technological characteristics of the design are substantially equivalent to the predicate devices and any slight differences do not raise new issues of safety and effectiveness.
Substantial Equivalence:
The following matrix is a comparison of the MEDPOR Fixation System - Cranial to the predicate devices. The MEDPOR Fixation System - Cranial is substantially equivalent in design and intended use to each of the predicate devices. The MEDPOR Fixation System - Cranial is substantially equivalent in material to the predicate devices that are manufactured from titanium. Titanium has a long history of use in surgical implantable products.
2
| Device | Proposed Device | Predicate Device #1 | Predicate Device #2 | Predicate Device #3 | Predicate Device #4 | Predicate Device #5 |
|---|---|---|---|---|---|---|
| MEDPOR | ||||||
| Fixation System |
- Cranial | OSTEOTRANS-
MX Bioabsorbable
Bone Fixation
System | Synthes Low
Profile Neuro
System | Synthes
Craniofacial
Plates | SMF Titanium
(TI) Alloy Bone
Screws | Stryker
Leibenger
Universal Neuro
System |
| 510(k) Number | This Submission | K073006 | K022012 | K021642 | K963546 | K031659 |
| Device
Classification | Class II,
Code HBW,
Reg. No.
882.5360 | Class II,
Code GWO, HBW
Reg. No.
882.5320,
882.5360 | Class II,
Code JEY, GXR,
DZL
Reg. No.
872.4760,
882.5250,
872.4880 | Class II,
Code JEY
Reg. No.
872.4760 | Class II,
Code DZL
Reg. No.
872.4880 | Class II,
Code JEY
Reg. No.
872.4760 |
| Intended Use | The MEDPOR
Fixation System - Cranial is
intended for use
in cranial surgery
to fixate
MEDPOR
cranial implants
to the
surrounding
cranial skeleton. | The
OSTEOTRANS -
MX Bioabsorbable
Bone Fixation
System is intended
for use in trauma
and reconstructive
procedures of the
craniofacial
skeleton, including
fracture of the
cranium, infant
craniofacial
surgery (i.e.
craniosynotosis,
congenital
malformations),
pediatric
reconstructive
procedures,
reconstructive
procedures of the
cranium,
craniotomy flap
fixation. | The Synthes Low
Profile Neuro
System is
intended for use
in selective
trauma of the
midface and
craniofacial
skeleton;
craniofacial
surgery;
reconstructive
procedures; and
selective
orthognathic
surgery of the
maxilla and chin. | The Synthes
Craniofacial
Plates are
intended for use
in selective
trauma of the
midface and
craniofacial
skeleton;
craniofacial
surgery;
reconstructive
procedures; and
selective
orthognathic
surgery of the
maxilla and
chin. | The SMF Ti
Alloy Bone
Screws are
intended for
craniofacial and
mandibular
trauma and
reconstruction. | The Stryker
Leibinger
Universal Neuro
System is a low-
profile plate and
screw system
intended for
osteotomy,
craniotomy,
stabilization and
rigid fixation of
craniofacial
fractures and
reconstruction of
non-load bearing
areas. |
| Materials | Plates - CP 4
Titanium
Screws - 6/4 ELI
Titanium Alloy | Bone Plates,
Meshes and
Screws
manufactured
from composites
of Hydroxyapatite
and Poly-L-
Lactide
(HA/PLLA) | Plates -
Titanium
Screws - Ti-6Al-
7Nb Titanium
Alloy | Titanium | Titanium Alloy | CP Titanium or
Ti6Al4V Alloy |
| Dedicated
Instrumentation | Yes | Not Stated | Yes | Yes | Yes | Yes |
| Sterile/
Nonsterile | Supplied Sterile | Sterile | Nonsterile or
Sterile-packed | Nonsterile or
Sterile-packed | Nonsterile or
Sterile-packed | Nonsterile |
| Sterilization
Methods | Ethylene Oxide
& Steam | Not Stated | Steam | Steam | Steam | Steam |
ﻪ
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its wings and tail feathers. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Porex Surgical, Inc. C/O Stephanie Fullard Regulatory Affairs Manager 15 Dart Road Newnan, GA 30265
Re: K101835
Trade/Device Name: MEDPOR Fixation System - Cranial Regulation Number: 21 CFR 882.5360 Regulation Name: Cranioplasty plate fastener Regulatory Class: Class II Product Code: HBW Dated: November 22, 2010 Received: November 23, 2010
DEC -- 3 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 iudicions 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, Or ve 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.
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
4
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/ucm115809.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/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Keoin Alexander
Image /page/4/Picture/7 description: The image shows the handwritten word "for" in cursive. The letter "f" has a long, descending loop that extends below the baseline, and the "o" and "r" are connected with a smooth, flowing line. The writing appears to be done with a pen or marker, and the ink is black. The background is plain white.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic. Neurological, and Ear.
Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
DEC - 3 2010
510(k) Number (if known): K101835
Device Name: MEDPOR® Fixation System - Cranial
Indications for Use: The MEDPOR Fixation System - Cranial is intended for use in cranial surgery to fixate MEDPOR cranial implants to the surrounding cranial skeleton.
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)
Page 1 of 1
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K101835