(300 days)
MAF #920
No
The summary describes a physical knee implant component and its materials, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is a knee implant indicated for use in total knee arthroplasty, which is a surgical procedure to treat knee joint pathology and restore function. This falls under the definition of a therapeutic device designed to treat a medical condition.
No
Explanation: This device is a tibial component for total knee arthroplasty, which is an implant used in surgery, not a device used to diagnose a medical condition.
No
The device description clearly states it is a physical tibial component made of Hedrocel porous tantalum and UHMWPE, available in various sizes and fixation options. This is a hardware device, 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, or tissue) to detect diseases, conditions, or infections.
- Device Description: The provided information describes a surgical implant – a component of a total knee replacement system. It is designed to be surgically implanted into the knee joint.
- Intended Use: The intended use is for cemented total knee arthroplasty, which is a surgical procedure to replace a damaged knee joint.
The device is a physical implant used in vivo (within the body), not a test performed in vitro (outside the body) on a sample.
N/A
Intended Use / Indications for Use
The Implex Continuum Knee Unity Tibial Component is indicated for use where severe degeneration, trauma, or other pathology of the knee joint indicates cemented total knee arthroplasty.
Product codes
JWH
Device Description
The Implex Continuum Knee Unity Tibial Component, Cemented, is available in 8 thickness sizes from 10 mm to 22 mm, in 2 mm increments, and a 26 mm option; and A-P dimensions from 41 mm to 57 mm, and M-L dimensions from 62 mm to 89 mm. The Implex CK Unity Tibial Component is comprised of Hedrocel porous tantalum and UHMWPE. The CK Unity Tibial component is offered in two fixation post options; option A with hexagonal Hedrocel® posts, and option B with polyethylene fixation pegs. The CK Unity Tibial Component is to be implanted using the Implex Continuum Knee System Instrumentation and Surgical Protocol.
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)
Previous testing of the predicate devices and associated materials are sufficient for substantial equivalence determination. The relevant data is found in Master File MAF #920 and K964509.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
MAF #920
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEC 16 008
Implex Corp
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Implex Continuum Knee Unity Tibial Component For Cemented Fixation Supplement 2: K980637
510(k) SUMMARY - IMPLEX CK Unity Tibial Component, Cemented
| Submitter Name: | Implex Corp. |
|---|---|
| Submitter Address: | 80 Commerce Drive |
| Allendale, New Jersey 07401-1600 | |
| Contact Person(s): | Robert Poggie or Robert Cohen |
| Phone Number: | (201) 818-1800 |
| Fax Number: | (201) 818-0567 |
| Date Prepared: | October 29, 1998 |
| Device Trade Name: | Implex Continuum Knee Unity Tibial Component, Cemented |
| Device Common Name: | Tibial Component |
| Classification Name: | Prosthesis, Knee, Tibial Component, Cemented |
| Predicate Devices: | The Implex Continuum Knee System, Cemented, the Implex |
| Continuum All-Poly Tibial Component, Cemented, the | |
| Continuum Porous Patella, Cemented, and the HEP | |
| Acetabular Cup, Cemented, Protek All-Poly Component, | |
| Richards Medical Tricon-P and Tricon-M. | |
| Device Description: | The Implex Continuum Knee Unity Tibial Component, |
| Cemented, is available in 8 thickness sizes from 10 mm to 22 | |
| mm, in 2 mm increments, and a 26 mm option; and A-P | |
| dimensions from 41 mm to 57 mm, and M-L dimensions from | |
| 62 mm to 89 mm. The Implex CK Unity Tibial Component is | |
| comprised of Hedrocel porous tantalum and UHMWPE. The | |
| CK Unity Tibial component is offered in two fixation post | |
| options; option A with hexagonal Hedrocel® posts, and | |
| option B with polyethylene fixation pegs. The CK Unity Tibial | |
| Component is to be implanted using the Implex Continuum | |
| Knee System Instrumentation and Surgical Protocol. | |
| Intended Use: | For use where severe degeneration, trauma, or other |
| pathology of the knee joint indicates cemented total knee | |
| arthroplasty. This device is intended for cemented use only. | |
| Performance Data: | Previous testing of the predicate devices and associated |
| materials are sufficient for substantial equivalence | |
| determination. The relevant data is found in Master File MAF | |
| #920 and K964509. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 6 1998
Robert Poqqie, Ph.D. Director of Applied Research Implex Corporation 80 Commerce Drive Allendale, New Jersey 07401-1600
Re: K980637 Implex Continuum Knee Unity Tibial Component, Cemented Requlatory Class: II Product Code: JWH Dated: November 3, 1998 Received: November 4, 1998
Dear Dr. Poggie:
We have reviewed your Section 510(k) 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 This decision is based on Food, Drug, and Cosmetic Act (Act). this device being equivalent only to similar devices labeled and intended to be fixed within bone with acrylic "bone cement." You may, therefore, market your device subject to the general controls provisions of the Act and the following limitations :
- The thinnest tibial component available is the nominal 1. "10mm" sized component, which has a minimum polyethylene thickness under the condyles of 6mm.
- This device may not be labeled or promoted for non-2. cemented use.
- All labeling for this device, including package label 3 . and labeling included within the package, must prominently state that the device is intended for cemented use only.
- Any non-cemented fixation of this device is considered 4 . investigational and may only be investigated as a significant risk device in accordance with the
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investigational device exemption (IDE) regulation under 21 CFR, Part 812. All users of the device for noncemented fixation must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) to conduct the investigation.
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 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 807.97). Other general information on your responsibilities under the Act may be
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obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Brolustion
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name:
Implex Continuum Knee Unity Tibial Component
Indications For Use:
The Implex Continuum Knee Unity Tibial Component is indicated for use where severe degeneration, trauma, or other pathology of the knee joint indicates cemented total knee arthroplasty.
(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)
signature
(Division Sign-Off) Division of General Restorative De 510(k) Numbe