(194 days)
Not Found
No
The summary describes a physical implantable device made of PEEK with tantalum inserts, intended to restrict cement flow during hip and knee replacement. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies focus on material properties and biocompatibility, not algorithmic performance.
No
The device, a cement restrictor, is used to occlude the medullary canal before the introduction of PMMA cement during hip or knee replacement. Its primary function is mechanical restriction, not direct therapeutic action or treatment of a disease or condition.
No
This device is described as a "Cement Restrictor" intended to occlude the medullary canal before the introduction of PMMA cement during hip or knee replacement. Its function is to physically block a passage, not to diagnose a condition or disease.
No
The device description clearly states it is a physical implantable device made of PEEK with tantalum inserts, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use in conjunction with Standard PMMA cement to occlude the medullar canal during total hip or knee replacement. This describes a surgical implant used within the body during a procedure.
- Device Description: The description details a physical implantable device made of PEEK with tantalum inserts.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status, diagnosis, or treatment.
IVD devices are used to perform tests on samples taken from the body, not implanted within the body during surgery.
N/A
Intended Use / Indications for Use
This device is intended for use in conjunction with Standard PMMA cement. The Interbody Innovations Cement Restrictors are designed to occlude the medullar canal before the introduction of PMMA, in total hip or knee replacement.
This device is not intended for use in spine applications. The safety and effectiveness have not been established when implanted into the spine.
Product codes (comma separated list FDA assigned to the subject device)
JDK
Device Description
The Interbody Innovations Cement Restrictors is a hollow curved rectangular frame that is machined from extruded Polyetheretherketone (PEEK). It contains tantalum inserts that serve as location and orientation markers for radiographs. The device is intended to be used in conjunction with standard PMMA
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, knee
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)
This device is constructed of the same material (polyetheretherketone, or PEEK-Optima) as the predicate device(s). This material complies with ASTM F2026. The manufacturer of this material has an FDA Device Master File, and has certified biocompatibility to ISO 10993-1 requirements for implantable contact greater than 30 days.
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.
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.
Not Found
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
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
K051371 p/2
DEC 6 2005
Image /page/0/Picture/2 description: The image shows the logo for Interbody Innovations. The logo is black and white and features the company name in a bold, sans-serif font. The word "INTERBODY" is on the top line, and the word "INNOVATIONS" is on the bottom line. To the left of the text is a stylized "I" that is made up of three horizontal lines and two vertical lines.
510(k) Summary
Submitter Information:
Interbody Innovations 24 Smith Road, Suite 503 Midland, TX 79705
Contact:
Todd Stanaford Phone: 432-697-7463 Fax: 432-697-1222
Date Prepared:
May 12, 2005
Product Name:
Classification Name: Surgical Mesh Trade Name(s): Interbody Innovations Cement Restrictor Panel: DCRND. Orthopedic Classification Regulation: 21 CFR 878.3300 Product Code: JDK
Predicate Device:
This device is substantially equivalent to the following predicate devices:
Fortitude Cement Restrictor, marketed under K031837 FIDJI Large Cement Restrictor, marketed under K030871 RABEA Cement Restrictor, marketed under K020836
Interbody Innovations Cement Restrictors and predicated devices listed above, are devices that are used to occlude the medullary canal prior to the introduction of PMMA in total joint arthroplasty. None of the devices are intended for use in spine surgery. Technologically they are all virtually identical in their function and principle of operation.
Comparison to Predicates:
| PROPOSED
DEVICE | FORTITUDE
(K031837) | FIDJI (K030871) | RABEA
(K020836) |
| -------------------- | ------------------------ | ----------------- | -------------------- |
|---|
1
Image /page/1/Picture/0 description: The image contains a series of alphanumeric characters, seemingly handwritten. The characters appear to be "KOS 1371 1/2". The writing style is somewhat cursive, with some characters connected and others distinct.
| Intended
use | Occlusion of
medullar canal
prior to PMMA | Occlusion of
medullar canal
prior to PMMA | Occlusion of
medullar canal
prior to PMMA | Occlusion of
medullar canal
prior to PMMA |
|---------------------|-------------------------------------------------|-------------------------------------------------|-------------------------------------------------|-------------------------------------------------|
| Anatomical
sites | Hip, knee | Hip, knee | Hip, knee | Hip, knee |
| Sterility | Nonsterile; to be
sterilized by
user | Nonsterile; to be
sterilized by
user | Nonsterile; to be
sterilized by user | Nonsterile; to be
sterilized by user |
| Material | PEEK-Optima
(ASTM F2026) | PEEK-Optima
(ASTM F2026) | PEEK-Optima
(ASTM F2026) | PEEK-Optima
(ASTM F2026) |
| Markers | Tantalum wires
(ASTM F560) | Tantalum wires
(ASTM F560) | Tantalum wires
(ASTM F560) | Tantalum wires
(ASTM F560) |
Description:
The Interbody Innovations Cement Restrictors is a hollow curved rectangular frame that is machined from extruded Polyetheretherketone (PEEK). It contains tantalum inserts that serve as location and orientation markers for radiographs. The device is intended to be used in conjunction with standard PMMA
Intended Use:
This device is intended for use in conjunction with Standard PMMA cement. The Interbody Innovations Cement Restrictors are designed to occlude the medullar canal before the introduction of PMMA, in total hip or knee replacement.
This device is not intended for use in spine applications. The safety and effectiveness have not been established when implanted into the spine.
Performance Data:
This device is constructed of the same material (polyetheretherketone, or PEEK-Optima) as the predicate device(s). This material complies with ASTM F2026. The manufacturer of this material has an FDA Device Master File, and has certified biocompatibility to ISO 10993-1 requirements for implantable contact greater than 30 days.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine and healing. The caduceus is depicted as a staff with three snakes entwined around it.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC & 2005
Interbody Innovations LLP c/o Mr. Ian P. Gordon Senior Vice President Emergo Group, Inc. 2454 McMullen Booth Road Suite 427 Clearwater, Florida 33759
Re: K051371
Trade/Device Name: Interbody Innovations Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: JDK Dated: September 15, 2005 Received: September 19, 2005
Dear Mr. Gordon:
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 for use surver in the May 28, 1976, the enactment date of the Medical Device Amendments, or to econments that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls and Cosment 100 (The Act and the limitations described below. The general controls provisions of the provisions of the Act annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this The Office of Deed for an intended use not identified in the proposed labeling and that such use acould cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following United cause in the Warnings section of the device's package insert and also as a Warning on the product label:
WARNING: THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS.
THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED.
Furthermore, the indication for use -- occlusion of the medullary canal before the introduction of PMMA in total hip or knee replacement – must be prominently displayed in all labeling,
3
Page 2 -- Mr. Ian P. Gordon
including pouch box, and carton labels, instructions for use, and other promotional materials, in metuding pouch box, and careme, of a similar point size, and in bold print.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act Please note that the above labeling innitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device. The FDA finding of substantial equivalence or your device in the market. This results in a classification for your device and period in your Section 510(k) premarket in notification if the limitation statement described above is added to your labeling.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
effecting vour device officating vour device and e If your device is classified (sec above) and vince sited in affecting your device can be
may be subject to additional controls. Existed on 800 - 800 - 800 - RDA may may be subject to addinonal confrois: Existing major regarded on 898. In addition, FDA may lound in the Code of I ederal Regarments your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised inal FDA s Issualice of a substitive only other requirements of the Act
that FDA has made a determination that your device and comples . You must compl that FDA has made a delefinination underican by other Federal agencies. You must comply
or any Federal statutes and regulations administered by other Poderal issing (21 CFR or any Federal statues and regulations administer of to: registration and listing (2 CFR Part
with all the Act's requirements, including, but not limited to: set forth in th with all the Act s requirements, mediating outscturing practice requirements as set forth in the 807); labelling (21 CFR Part 801); good manal.820); and if applicable, the electronic product
quality systems (QS) regulation (21 CFR Part 820); and if an 1990-1050 quality systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific information about the application of other labeling requirements to your If you desire specific information about the upplication of Compliance at (240) 276-0120. Also,
device (21 CFR Part 801), please contact the Office of Compliance at (240) 27 device (21 CFR Part 801), picase condecting by reference to premarket notification' (21 CFR
please note the regulation entitled, "Misbranding by reference to premarkilities u please note the regulation chilities, "Misoranants" of the mation on your responsibilities under the Act to the toll f Part 807.97). You may outain outler general international, and Consumer Assistance at its toll-free Ironi the Drvision of Billian (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Murton MD for
Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use
510(k) # (if known): _ _