(30 days)
The Implex Continuum Knee Hedrocel® Tibial Spacers are indicated for use in the reconstruction of bony defects in knee reconstruction due to severe degeneration, trauma, or other pathology of the knee joint, and in the revision or salvage of failed, previously reconstructed knee procedures and implants. This device is intended for cemented use only.
Not Found
The provided document is a 510(k) premarket notification for a medical device (Implex Continuum Knee System Hedrocel® Tibial Spacers), not a study evaluating device performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth, experts, and MRMC studies cannot be extracted from this document.
However, I can extract the following limited information:
1. Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria for the device. Instead, it relies on a statement that "Previous testing of the Hedrocel® porous tantalum demonstrates that Hedrocel® should function as intended."
| Criteria Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional Performance | Not specified | "should function as intended" based on previous testing of the Hedrocel® porous tantalum. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified, other than "Previous testing of the Hedrocel® porous tantalum." It does not mention country of origin or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The document does not describe a study involving expert assessment of device performance or ground truth establishment in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No such study or adjudication method is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a physical implant (tibial spacer), not an AI diagnostic tool involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not explicitly stated. The performance is based on "Previous testing of the Hedrocel® porous tantalum," which likely refers to biomechanical, biocompatibility, and material properties testing, rather than clinical ground truth like pathology or outcomes data in the context of diagnostic accuracy.
8. The sample size for the training set:
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this device type.
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JUL 3 | 1998
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510(k) SUMMARY - IMPLEX CKS Hedrocel® Tibial Spacers
| Submitter Name: | Implex Corp. | |
|---|---|---|
| Submitter Address: | 80 Commerce DriveAllendale, New Jersey 07401-1600 | |
| Contact Person(s): | John Schalago, RAC or Robert Poggie, Ph.D. | |
| Phone Number: | (201) 818-1800 | |
| Fax Number: | (201) 818-0567 | |
| Date Prepared: | June 30, 1998 | |
| Device Trade Name: | Implex Continuum Knee System Hedrocel® Tibial Spacers | |
| Device Common Name: | Tibial Spacers | |
| Classification Name: | Prosthesis, Knee, Spacers, Cemented | |
| Substantial Equivalence: | The term "substantial equivalence" as used in this 510(k)notification is limited to the definition of substantialequivalence found in the Federal Food, Drug and CosmeticAct, as amended and as applied under 21 CFR 807, Subpart Eunder which a device can be marketed without premarketapproval or reclassification. A determination of substantialequivalency under this notification is not intended to have anybearing whatsoever on the resolution of patent infringementsuits or any other patent matters. No statements related to orin support of substantial equivalence herein shall be construedas an admission against interest under the US Patent Laws ortheir application by the courts. | |
| Predicate Devices: | The Implex CKS Revision Tibial Spacers, the ImplexHedrocel® Revision Femoral Spacers, the Johnson &Johnson PFC Modular Knee System, and the Zimmer IB IIModular Knee System |
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Intended Use:
The Implex Continuum Knee Hedrocel® Tibial Spacers are indicated for use in the reconstruction of bony defects in knee reconstruction due to severe degeneration, trauma, or other pathology of the knee joint, and in the revision or salvage of failed, previously reconstructed knee procedures and implants. This device is intended for cemented use only.
Performance Data:
testing of the Hedrocel® porous tantalum Previous demonstrates that Hedrocel® should function as intended. The relevant data is found in MAF #920.
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Image /page/2/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 a stylized human figure or a caduceus, with three overlapping profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 | 1998
John A. Schalago, RAC Requlatory Affairs Manager Implex Corporation 80 Commerce Drive Allendale, New Jersey 07401-1600
Re : K982302 Hedrocel® Tibial Spacers Implex Continuum Knee System: Requlatory Class: II Product Code: JWH Dated: June 30, 1998 Received: July 1, 1998
Dear Mr. Schalago:
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, Drug, and Cosmetic Act (Act). This decision is based on 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:
- This device may not be labeled or promoted for non-1. cemented use.
-
- All labeling for this device, including package label and labeling included within the package, must prominently state that-the-device is intended for cemented use only.
- 3 . Any non-cemented fixation of this device is considered investigational and may only be investigated as a significant risk device in accordance with the 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.
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Page 2 - John A. Schalago, RAC
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 regulation (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. Please note: concerning your device in the Federal Register. 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.
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 regulation (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 ene rogazation (21 CFR 807.97). Other general concreasing information on your responsibilities under the Act may be
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Page 3 - John A. Schalago, RAC
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,
Colia M. Witton, Ph.D.
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
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Submitted by: Implex Corp.
Implex Continuum Knee System Hedrocel Revision Tibial Spacers 510(k) Premarket Notification
K982302
510(k) Number (if known):
Device Name:
Implex Continuum Knee - Hedrocel® Tibial Spacers
Indications For Use:
The Implex Continuum Knee Hedrocel Tibial Spacers are indicated for use in the reconstruction of bony defects in knee reconstruction due to severe degeneration, trauma, or other pathology of the knee joint, and in the revision or salvage of failed, previously reconstructed knee procedures and implants. This device is intended for cemented use only.
(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 | K982302 |
| Prescription Use (Per 21 CFR 801.109) | X |
| OR... | Over-The-Counter Use |
| (Optional Format 1-2-96) |
§ 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.