(23 days)
Not Found
No
The summary describes a mechanical implant (tibial bearing) and its materials, with no mention of software, algorithms, or any AI/ML related terms or concepts. The performance studies focus on engineering analysis and equivalence to a predicate device, not algorithmic performance.
No.
The device is a knee implant used to replace a damaged knee joint, which is a restorative rather than a therapeutic function.
No
The device, "Ascent™ All-Poly PS Tibial Bearings," is indicated for the treatment of a painful and disabled knee joint due to various arthritic conditions or failed joint replacement procedures. It is a replacement part for the knee joint, not a device used to diagnose a condition.
No
The device description clearly states it is a physical implantable device made from UHMWPE, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for surgical implantation to replace a damaged knee joint. This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The device is a physical implant made of polyethylene, designed to function as part of a knee replacement. This is consistent with a surgical implant, not a diagnostic reagent or instrument.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
This device is a surgical implant used for the treatment of knee joint conditions.
N/A
Intended Use / Indications for Use
The indications for the Ascent™ All-Poly PS Tibial Bearings are for painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved; the correction of varus, valgus, or posttraumatic deformity; and the correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. The Ascent™ All-Poly PS Tibial Bearings are for use with bone cement.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The Ascent™ All-Poly PS Tibial Bearings are manufactured from ArCom®, an ultra-high molecular weight polyethylene (UHMWPE). The one-piece posterior stabilized (PS) tibial components are available in varying thicknesses and widths.
The Ascent™ All-Poly PS Tibial Bearings are used in conjunction with the Ascent™ Femoral Components (K982869).
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)
Non-Clinical Testing: Engineering Justifications and a Finite Element Analysis (FEA) determined that the Ascent All-Poly PS Tibial Bearings presented no new risks and were, therefore, substantially equivalent to the predicate device.
Clinical Testing: No clinical testing was provided as a basis for substantial equivalence.
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.
Kirschner Performance Total Knee System (K934589).
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
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
JUN 0 5 2002
021559
CORPORATE UARTERS
SUMMARY OF SAFETY AND EFFECTIVENESS
| Applicant or Sponsor: | Biomet Orthopedics, Inc.
P.O. Box 587
Warsaw, IN 46581-0587 |
|-----------------------|-------------------------------------------------------------------|
| Contact Person: | Dalene T. Binkley
Telephone: (574) 267-6639 |
| Proprietary Name: | Ascent™ All-Poly PS Tibial Bearing |
| Common Name: | All-Polyethylene Tibial Bearing |
Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer (21 CFR 888.3560)
Device Classification: Class II
Legally Marketed Device to which Substantially Equivalence is Claimed: Kirschner Performance Total Knee System (K934589).
Device Description: The Ascent™ All-Poly PS Tibial Bearings are manufactured from ArCom®, an ultra-high molecular weight polyethylene (UHMWPE). The one-piece posterior stabilized (PS) tibial components are available in varying thicknesses and widths.
The Ascent™ All-Poly PS Tibial Bearings are used in conjunction with the Ascent™ Femoral Components (K982869).
Indications for Use: The indications for the Ascent™ All-Poly PS Tibial Bearings are for painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved; the correction of varus, valgus, or posttraumatic deformity; and the correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. The Ascent™ All-Poly PS Tibial Bearings are for use with bone cement.
Summary of Technologies: The Ascent™ All-Poly PS Tibial Bearings -the materials, design, sizing, and indications are similar or identical to the predicate devices.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587 - - - -
.
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
OFFICE 219.267.6639 FAX 219.267.8137 000038
E-MAIL biomet@biomet.com
1
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Summary of Safety & Effectiveness All-Polyethylene Tibial Bearing Page 2
Non-Clinical Testing: Engineering Justifications and a Finite Element Analysis (FEA) determined that the Ascent All-Poly PS Tibial Bearings presented no new risks and were, therefore, substantially equivalent to the predicate device.
Clinical Testing: No clinical testing was provided as a basis for substantial equivalence.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
1
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
1
000039
0000
OFFICE 219.267.6639
FAX 219.267.8137
E-MAIL biomet@biomet.com
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized depiction of an eagle or bird with three distinct head profiles, suggesting a sense of community or collaboration. The overall design is simple, using a black and white color scheme.
Public Health Service
JUN 0 5 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Dalene T. Binkley Regulatory Affairs Specialist Biomet, Inc. P.O. Box 587 Warsaw, IN 46581-0587
Re: K021559
Trade Name: Ascent™ All-Poly PS Tibial Bearings Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: May 6, 2002 Received: May 13, 2002
Dear Ms. Binkley:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.
3
Page 2 - Ms. Dalene T. Binkley
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.
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" (21CFR 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,
Mark N Melkenson
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
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Page 1 of 1
510 (k) NUMBER (IF KNOWN): _ kod | 559
DEVICE NAME: Ascent™ All-Poly PS Tibial Bearings
INDICATIONS FOR USE:
The Ascent™ All-Poly PS Tibial Bearings are for the painful and disabled knee joint resulting form osteoarthritis, theumatoid arthritis, traumatic arthritis where one or more compartments are involved; the correction of varus, valgus, or posttraumatic deformity; and the correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
This device is for use with bone cement.
(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
Mark N. Milkman
Restorative and North of Callerical Devices
510(k) Number
Over-The-Counter-Use (Optional Format 1-2-96)
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