(90 days)
Not Found
No
The device description focuses on the material and mechanical function of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is intended for use in the treatment of Total Hip Arthroplasty, Total Knee Arthroplasty, and Total or Hemi Shoulder Arthroplasty, which are medical treatments.
No
Explanation: The device is described as a "Vented Cement Restrictor" used in arthroplasty procedures to restrict cement and vent air. Its function is interventional/therapeutic, not diagnostic.
No
The device description clearly states it is a polymeric component manufactured from polyethylene or polylactic acid, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Vented Cement Restrictor is a physical implantable device used during surgical procedures (arthroplasty) to restrict cement flow within bones. It is not used to analyze samples from the body.
- Intended Use: The intended use clearly states its purpose in surgical procedures for hip, knee, and shoulder arthroplasty. This is a surgical device, not a diagnostic test.
Therefore, the Vented Cement Restrictor falls under the category of a surgical implant or accessory, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Vented Cement Restrictor is intended for use as a cement restrictor used in the treatment of the following:
- Total Hip Arthroplasty
- Total Knee Arthroplasty
- Total or Hemi Shoulder Arthroplasty
The device is not intended for use in spinal surgeries.
Product codes (comma separated list FDA assigned to the subject device)
JDK
Device Description
The Vented Cement Restrictor used in cemented applications for hip, knee and shoulder arthroplasty, is a polymeric component manufactured from either medical grade injection molded polyethylene (ASTM F639-98a) or from 70:30 Polylactic Acid (Poly (Llactide-co-D, L-lactide) amorphous (ASTM F1925-99e1).
Moreover, the subject Vented Cement Restrictor features a ball valve which safely vents air trapped distally to the stem, thus alleviating distal intra-medullary air pressure related embolisms.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, Knee, Shoulder
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.
K013663, K811060, K900462, K830949, K72205
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
§ 888.4580 Sonic surgical instrument and accessories/attachments.
(a)
Identification. A sonic surgical instrument is a hand-held device with various accessories or attachments, such as a cutting tip that vibrates at high frequencies, and is intended for medical purposes to cut bone or other materials, such as acrylic.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 888.9.
0
510(k) Summary
In accordance with the Food and Drug Administration Interim Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a 510(k) Summary for the Amedica Corp. Vented Cement Restrictor.
| Submitter: | Amedica Corp.
2116 South Lakeline Drive
Salt Lake City, UT 84109 |
|-------------------------|------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ashok C. Khandkar |
| Classification Name: | CFR 878.3300 - Cement restrictor used in cemented
applications for hip, knee and shoulder orthopedic surgery. |
| Common/Usual Name: | Cement restrictor for cemented arthroplasty |
| Trade/Proprietary Name: | Vented Cement Restrictor |
Product Description:
The Vented Cement Restrictor used in cemented applications for hip, knee and shoulder arthroplasty, is a polymeric component manufactured from either medical grade injection molded polyethylene (ASTM F639-98a) or from 70:30 Polylactic Acid (Poly (Llactide-co-D, L-lactide) amorphous (ASTM F1925-99e1).
Moreover, the subject Vented Cement Restrictor features a ball valve which safely vents air trapped distally to the stem, thus alleviating distal intra-medullary air pressure related embolisms.
Specific Diagnostic Indications:
The Vented Cement Restrictor is intended for use as a cement restrictor used in the treatment of the following:
-
- Total Hip Arthroplasty
-
- Total Knee Arthroplasty
-
- Total or Hemi Shoulder Arthroplasty
The device is not intended for use in spinal surgeries.
Substantial Equivalence:
Substantial equivalence determination is based on comparison of the Vented Cement Restrictor to the following legally marketed predicate competitive devices:
- Medtronic Sofamor Danek Cement Restrictor, K013663 1
- 트 Polyethylene Medullary Plug, K811060
- Osteonics Cement Restrictor, K900462
- Polyethylene Medullary Plug, K830949
- I Seidel Intramedullary Plug, K72205
Page 1 of 1
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract, wave-like shapes, which are meant to represent the human form.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 4 2002
Ashok C. Khandkar CEO Amedica Corp. 2116 South Lakeline Drive Salt Lake City, Utah 84109
Re: K022729
Trade/Device Name: Vented Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: JDK Dated: August 8, 2002 Received: August 16, 2002
Dear Mr. Khandkar:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
2
Page 2 -- Mr. Ashok C. Khandkar
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device. to proceed to the market. 1
. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Sincerely yours,
L. Mark N-Millerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of
510(k) Number (if known): K022729
Device Name: Vented Cement Restrictor
Indications For Use:
The Vented Cement Restrictor is intended for use as a cement restrictor used in the treatment of the following:
-
Total Hip Arthroplasty
-
Total Knee Arthroplasty
-
Total or Hemi Shoulder Arthroplasty
The device is not intended for use in spinal surgeries.
for Mark n Milkerson
ivision Sign-Off) Division of General, Restorative and Neurological Devices K 022729
510(k) Number __
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR § 801.109) OR
Over-the-Counter Use (Optional Format 1-2-96)