(194 days)
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.
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
Let's break down the information provided in the 510(k) summary (K051371) to extract details regarding acceptance criteria and supporting studies.
Important Note: The provided document is a 510(k) summary for a Surgical Mesh, specifically a Cement Restrictor. These devices are typically cleared based on substantial equivalence to existing predicate devices, rather than extensive clinical efficacy studies with predefined acceptance criteria for performance metrics like accuracy, sensitivity, or specificity, as one might find for diagnostic AI algorithms. The "performance data" section for these types of devices usually focuses on material properties, biocompatibility, and mechanical characteristics.
Therefore, the interpretation of "acceptance criteria" and "study" will be tailored to what is relevant for this specific type of medical device submission.
Acceptance Criteria and Device Performance
For this device, the acceptance criteria are primarily related to material compliance and biocompatibility, as the function and design are substantially equivalent to existing cleared devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material: PEEK-Optima (ASTM F2026 compliant) | Device constructed of PEEK-Optima (ASTM F2026 compliant). |
| Biocompatibility: ISO 10993-1 compliant (for implantable contact > 30 days) | Manufacturer of PEEK-Optima has an FDA Device Master File and has certified biocompatibility to ISO 10993-1 requirements for implantable contact > 30 days. |
| Function: Occlude the medullary canal prior to PMMA introduction in total hip/knee replacement | The device is designed for this intended use, which is identical to the predicate devices. |
| Non-Spinal Use | Explicitly stated: "NOT INTENDED FOR ANY SPINAL INDICATIONS." |
Study and Data Details
Given the nature of this device (a cement restrictor cleared via substantial equivalence), the "study" referred to in the document is primarily the demonstration of material equivalence and biocompatibility, rather than a clinical effectiveness study.
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of clinical performance data for this type of 510(k). The "test" here refers to material and biocompatibility testing, which typically uses standardized samples of the material itself. The document does not specify the number of material samples tested.
- Data Provenance: The biocompatibility certification (ISO 10993-1) is from the manufacturer of the PEEK-Optima material. ASTM F2026 compliance is a material standard. This data is likely retrospective, based on prior testing of the raw material. The country of origin for the material manufacturer is not specified.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in the sense of expert consensus on diagnostic imaging is not relevant for this material and mechanical device submission. Material properties and biocompatibility are established through laboratory testing and standardized protocols, not expert clinical consensus review.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for subjective interpretations, typically in diagnostic imaging or clinical trials. Material testing results are objective.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI/diagnostic imaging device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/algorithm device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission are material specifications (ASTM F2026) and biocompatibility standards (ISO 10993-1).
-
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
-
How the ground truth for the training set was established:
- Not applicable. No training set is used.
Summary of the "Study" for K051371:
The "study" or performance data for the Interbody Innovations Cement Restrictor primarily consists of:
- Material Equivalence: Demonstration that the device is constructed of the same material (PEEK-Optima) as the predicate device(s) and that this material complies with ASTM F2026.
- Biocompatibility: Reliance on the manufacturer of the PEEK-Optima material having an FDA Device Master File and certifying biocompatibility to ISO 10993-1 requirements for implantable contact greater than 30 days.
This approach is typical for Class II devices that achieve market clearance through a 510(k) pathway by demonstrating substantial equivalence, often relying on material properties and existing predicate devices rather than new clinical effectiveness trials.
{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:
| PROPOSEDDEVICE | 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.
| Intendeduse | Occlusion ofmedullar canalprior to PMMA | Occlusion ofmedullar canalprior to PMMA | Occlusion ofmedullar canalprior to PMMA | Occlusion ofmedullar canalprior to PMMA |
|---|---|---|---|---|
| Anatomicalsites | Hip, knee | Hip, knee | Hip, knee | Hip, knee |
| Sterility | Nonsterile; to besterilized byuser | Nonsterile; to besterilized byuser | Nonsterile; to besterilized by user | Nonsterile; to besterilized 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): _ _ < 0 5 13 7 1 ________________________________________________________________________________________________________________________________________
Device Name: Interbody Innovations Cement Restrictor
Indications for Use:
This device is intended for use in conjunction with Standard PMMA cement. The Interbody
out of the may and the may and to the made to the madellar canal before the This device is intended for use in codigned to occlude the medullar canal before the introvations Ochons Ocholine in total hip or knee replacement.
This device is not intended for use in spine applications. The safety and effectiveness have I ms device is to is to is implanted into the spine.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General. Restorative,
Neurological Devices
Number K051371
§ 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.