(61 days)
No
The document describes a physical knee implant component and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a knee femoral component intended for implantation to treat painful and disabled knee joints resulting from various arthritic conditions and deformities, which is a therapeutic purpose.
No
The device described is a medical implant (femoral component for knee replacement) used for treatment, not for diagnosing a condition.
No
The device description clearly states it is a metallic knee femoral component, which is a physical hardware implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states that the Ascent™ Porous Open Box PS Femoral Component is a metallic knee femoral component. It is an implantable device used in knee replacement surgery.
- Intended Use: The intended use describes the conditions for which the device is used in surgery (osteoarthritis, deformities, revision procedures). This is a surgical implant, not a diagnostic test.
The information provided describes a surgical implant, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
- Non-cemented total knee replacement
The indications for Biomet's Ascent™ Porous Open Box PS Femoral Component include: -
- Painful and disabled knee joint resulting from osteoarthritis, traumatic arthritis, traumatic arthritis, where one or more compartments are involved.
- Correction of varus, valgus or posttraumatic deformity 2.
- Correction of revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement 3. procedure.
Product codes
MBH
Device Description
The Ascent™ Porous Open Box PS Femoral Component is a metallic knee femoral component to be used with Biomet's Ascent™ tibial base-plate components. The device also includes distal femoral pegs. The modular pegs are designed to fasten into the existing distal augment holes of the femoral component and act as alignment devices. The device is manufactured of CoCrMo Alloy and is intended for non-cemented use. The components are identical to those cleared in the previous 510(k) submission (K002678) for cemented application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee joint
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)
Clinical and Non-Clinical Testing: None provided
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Ascent™ Porous Open Box PS Femoral Component (K002678), Biomet Non-Cement (K033489)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.
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Image /page/0/Picture/0 description: The image shows the date SEP - 8 2004 on the left side and the word BIOMET in the center. On the right side, there is handwritten text that reads k04/1872 page 1 of 1. The text appears to be part of a document or record.
510(k) Summary
Applicant/Sponsor: Biomet, Inc.
Contact Person: Patricia Sandborn Beres Senior Regulatory Specialist
Proprietary Name:
-
- Ascent™ Porous Open Box PS Component
-
- Ascent™ Posterior Stabilized (PS) Distal Femoral Pegs
Common Name: Ascent™ Knee System
Classification Name: Knee joint patellofemorotibial metal/polymer porous coated uncemented (21 CFR 888.3565)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Ascent™ Porous Open Box PS Femoral Component (K002678) and Biomet Non-Cement (K033489).
Device Description: The Ascent™ Porous Open Box PS Femoral Component is a metallic knee femoral component to be used with Biomet's Ascent™ tibial base-plate components. The device also includes distal femoral pegs. The modular pegs are designed to fasten into the existing distal augment holes of the femoral component and act as alignment devices. The device is manufactured of CoCrMo Alloy and is intended for non-cemented use. The components are identical to those cleared in the previous 510(k) submission (K002678) for cemented application.
Intended Use: Non-cemented total knee replacement
Indications for Use: The indications for Biomet's Ascent™ Porous Open Box PS Femoral Component include:
-
- Painful and disabled knee joint resulting from osteoarthritis, traumatic arthritis, traumatic arthritis, where one or more compartments are involved.
- Correction of varus, valgus or posttraumatic deformity 2.
- Correction of revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement 3. procedure.
Summary of Technologies: The device to be covered by this 510(k) is identical to devices covered by previously cleared 510(k) submissions for cemented application.
Clinical and Non-Clinical Testing: None provided
All trademarks are property of Biomet, Inc
MAHING ADDRESS 170). Box 58 ' Warsaw. IN 46581 0587
.
SHIPPING ADDRESS 56 E. Bell Drive 1 - 1 - 1 - 56 E. Bell Drive Warsaw, IN 46582
■
OFFICE 57.1.267.6639
FAX 574 267 81 37
E-MAII. biomet@biomet.com
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" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP = 8 2004
Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Manufacturing Corporation P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K041872
Ro41672
Trade/Device Name: Ascent™ Porous Open Box PS Femoral Component Regulation Number: 21 CFR 888.3565 Regulation Name: Er Cr Fr 866.5565
Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis. Regulatory Class: II Product Code: MBH Dated: July 8, 2004 Received: June 9, 2004
Dear Ms. Beres:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for the stated in the enclosure) to tegars and ment date of the Medical Device Amendments, or to commerce proof to May 20, 1976, the eccordance with the provisions of the Federal Food, Drug, devices mat have been recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mercere, manel are act include requirements for annual registration, listing of general controls provisions of arctice, 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 If your device is classified (600 world) also be regulations affecting your device can thay be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Souncements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Toase oc advised that I Dri b rosan to evice complies with other requirements of the Act that I DI Has Intatutes and regulations administered by other Federal agencies. You must or any I cacal statuated and statisments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
2
Page 2 – Patricia Sandborn Beres
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the qualis (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This iction will and in yourse organ finding of substantial equivalence of your device to a legally premaired predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific at notially at (301) 594-4659. Also, please note the regulation entitled, Contact the Office of Councemarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on Jour Corpumer 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,
Mark A. 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
Indications for Use
510(k) Number (if known): _ KO41872
Device Name: Ascent™Porous Open Box PS Femoral Component
Indications For Use:
-
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, r aimal and dioublou kire one or more compartments are involved.
-
- Correction of varus, valgus or posttraumatic deformity
-
- Correction of revision of revision of possful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Wilkerson
510(k) Number K041873
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