(81 days)
Not Found
Not Found
No
The 510(k) summary describes a mechanical implant (femoral spacers) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is clearly indicated for the revision or salvage of failed knee procedures, addressing conditions like degenerative arthritis, trauma, and non-union, which are therapeutic interventions.
No.
The device description and indicated uses clearly show it is an orthopedic implant (femoral spacers) used in knee revision surgeries, not a device designed to diagnose medical conditions.
No
The device description clearly states the device is comprised of Hedrocel porous tantalum and is a physical implant (femoral spacers).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description and intended use clearly state that this device is a surgical implant designed to be placed inside the body (in vivo) during knee revision surgery. It is a physical component used to replace or augment bone structure.
The information provided about the device's materials, intended surgical use, and placement within the body confirms it is a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Implex CKS Hedrocel Revision Femoral Spacers are indicated in the revision or salvage of failed previously reconstructed knee procedures and implants; particularly in situations where bone loss has occurred from removal of prior implantations, infection or trauma. This device is intended for cemented use only.
The use of the Continuum Knee System Hedrocel Revision Femoral Spacers are indicated for:
- For cemented use only.
- Total Knee Replacement (TKR) in severely disabled joints as a result of degenerative arthritis;
- Secondary revision of a previously unsuccessful revision femoral component;
- Other knee problems where clinical experience has shown that alternative modes of treatment are less likely to achieve satisfactory results;
- Trauma, or other fractures in which adequate bony fixation cannot be obtained;
- Non-union of the proximal tibia; and
- Salvage of a failed primary or secondary total knee or uni-knee arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The CKS Hedrocel Distal Femoral Spacers will have 4 thickness options of 4, 8, 12, and 16 mm. The distal femoral spacers will be available in both full and chamfered spacer options. The CKS Hedrocel Posterior Femoral Spacers will be available in 3 thickness options of 4, 8, and 12 mm. The CKS Hedrocel Spacers are comprised of Hedrocel porous tantalum and are to be fastened to Implex Continuum Knee System Revision Femoral Components using the same Instrumentation and fastener bolts.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee, Femoral
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 their respective materials are sufficient for substantial equivalence determination. The relevant data is found in Master File MAF #920 and K962468.
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.
The Implex CKS Revision Femoral Spacers, the Implex Continuum Porous Patella, and the Implex Hedrocel Acetabular Restrictor.
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
ставительных вича
ﺳﺮ
ANNOSS COLLECTION COLLECTION
MAY 22 1998
510(k) SUMMARY - IMPLEX CKS Hedrocel® Revision Femoral Spacers
| 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: | May 14, 1998 |
| Device Trade Name: | Implex Continuum Knee System Hedrocel Revision Femoral Spacers |
| Device Common Name: | Revision Femoral Spacers |
| Classification Name: | Prosthesis, Knee, Femoral Spacers, Cemented |
| Substantial Equivalence: | The term "substantial equivalence" as used in this 510(k) |
| notification is limited to the definition of substantial | |
| equivalence found in the Federal Food, Drug and Cosmetic | |
| Act, as amended and as applied under 21 CFR 807, Subpart E | |
| under which a device can be marketed without premarket | |
| approval or reclassification. A determination of substantial | |
| equivalency under this notification is not intended to have any | |
| bearing whatsoever on the resolution of patent infringement | |
| suits or any other patent matters. No statements related to, or | |
| in support of substantial equivalence herein shall be construed | |
| as an admission against interest under the US Patent Laws or | |
| their application by the courts. | |
| Predicate Devices: | The Implex CKS Revision Femoral Spacers, the Implex Continuum |
| Porous Patella, and the Implex Hedrocel Acetabular Restrictor. | |
| Device Description: | The CKS Hedrocel Distal Femoral Spacers will have 4 thickness |
| options of 4, 8, 12, and 16 mm. The distal femoral spacers will be | |
| available in both full and chamfered spacer options. The CKS | |
| Hedrocel Posterior Femoral Spacers will be available in 3 | |
| thickness options of 4, 8, and 12 mm. The CKS Hedrocel Spacers | |
| are comprised of Hedrocel porous tantalum and are to be fastened | |
| to Implex Continuum Knee System Revision Femoral | |
| Components using the same Instrumentation and fastener bolts. | |
| Intended Use: | The Implex CKS Hedrocel Revision Femoral Spacers are |
| indicated in the revision or salvage of failed previously | |
| reconstructed knee procedures and implants; particularly in | |
| situations where bone loss has occurred from removal of prior | |
| implantations, infection or trauma. This device is intended for | |
| cemented use only. |
Allendale, New Jersey 07401-1600 :
Phone: (201) 818-1800 Fax: (201) 818-0567
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Image /page/1/Picture/3 description: The image shows the word "Implex" in a bold, sans-serif font. To the left of the word is a geometric shape that includes a triangle and a circle. The triangle is on the bottom left, and the circle is on the top left. The word "Implex" is written in all lowercase letters, and there is a small symbol to the upper right of the word.
Indications For Use:
The use of the Continuum Knee System Hedrocel Revision Femoral Spacers are indicated for:
- For cemented use only. a)
- Total Knee Replacement (TKR) in severely disabled joints b) as a result of degenerative arthritis;
- Secondary revision of a previously unsuccessful revision c) femoral component;
- Other knee problems where clinical experience has shown d) that alternative modes of treatment are less likely to achieve satisfactory results;
- Trauma, or other fractures in which adequate bony fixation ૯) cannot be obtained;
- Non-union of the proximal tibia; and f)
- Salvage of a failed primary or secondary total knee or unig) knee arthroplasty.
Performance Data:
Previous testing of the predicate devices and their respective materials are sufficient for substantial equivalence determination. The relevant data is found in Master File MAF #920 and K962468.
2
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
A. A. C.
MAY 2 2 1998
Robert A. Poggie, Ph.D. Director of Applied Research Implex Corporation 80 Commerce Drive 07401-1600 Allendale, New Jersey
Re : K980781 Implex Continuum Knee System Hedrocel Trade Name: Revision Femoral Spacers Regulatory Class: II Product Code: JWH February 27, 1998 Dated: Received: March 2, 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 Food, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations 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 Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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 action. In addition, FDA may publish further announcements 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 regulations.
3
Page 2 - Robert A. Poggie, Ph.D.
This letter will allow you to begin marketing your device as described in your 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 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 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.qov/cdrh/dsmamain.html".
Sincerely yours,
O Celia M. Witten, Ph.D., M
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Implex Hedrocci@ Femoral Spacers 510(k) Premarket Notification K980781
Submitted by: Implex Corp.
510(k) Number (if known):
Device Name:
Implex Continuum Knee – Hedrocel Revision Femoral Spacers
Indications For Use:
The use of the Continuum Knee System Hedrocel Revision Femoral Spacers are indicated for:
- For cemented use only. a)
- Total Knee Replacement (TKR) in severely disabled joints as a result of b) degenerative arthritis;
- Secondary revision of a previously unsuccessful revision femoral c) component;
- Other knee problems where clinical experience has shown that alternative d) modes of treatment are less likely to achieve satisfactory results;
- Trauma, or other fractures in which adequate bony fixation cannot be e) obtained;
- f) Non-union of the proximal tibia; and
- Salvage of a failed primary or secondary total knee or uni-knee g) arthroplasty.
(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 Devices | |
| 510(k) Number | K980781 |
| Prescription Use
| (Per 21 CFR 801.109) | X |
|---|---|
| ------------------------------------------ | --- |
OR...
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
(Optional Format 1-2-96)