IMPLEX CONTINUUM KNEE SYSTEM: POROUS TIBIAL COMPONENT MODEL NUMBER 05-230 SYSTEM by IMPLEX CORP.

The Continum Knee System (CKS):Porous Tibial Component is intended for use in the total kee joint where severe degenration, trauma, or pathology of the knee indicates cemented total knee arthroplasty. The CKS is indicated for:

Total Knee Replacement in severely disabled joints as a result of degenerative a) arthritis;
Secondary revision of a previously unsuccessful tibial component; b)
Other knee problems where clinical experience has shown that alternative c) modes of treatment are less likely to achieve satisfactory results;
d) Trauma, or other fractures in which adequate bony fixation cannot be obtained;
Non-union of the proximal tibia; and e)
f) Salvage of a failed primary or secondary total knee or uni-knee arthroplasty.

Device Description

Components are machined from forged titanium, which provides excellent fatigue strength, load transfer and biocompatibility. For use where severe degeneration, trauma, or other Intended Use: pathology of the knee joint indicates cemented total knee arthroplasty. This device is intended for cemented use only.

AI/ML Overview

The provided text describes a 510(k) submission for the Implex CK Porous Tibial Component, Cemented. It details the device's intended use and the basis for its substantial equivalence to predicate devices, but it does not contain information about specific "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in terms of performance metrics like sensitivity, specificity, or improvement with AI.

Instead, the performance data section states: "The CK Porous Tibial Tray has demonstrated acceptable Performance data: performance in mechanical tests that were conducted in accordance with CDRH recognized standards and Design Verification requirements of 21 CFR § 820.30."

This indicates that the device's "performance" was assessed based on engineering and materials testing to ensure it meets mechanical and design verification standards, not clinical performance metrics in the way one might evaluate an AI-powered diagnostic device.

Therefore, many of the requested fields are not applicable to the information provided in this 510(k) summary, as it pertains to a mechanical orthopedic implant rather than a software or AI medical device.

Here's a breakdown of the requested information based only on the provided text, with explanations where information is missing or not applicable:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Mechanical standards and Design Verification requirements of 21 CFR § 820.30 (as recognized by CDRH)	"Acceptable performance in mechanical tests" conducted in accordance with these standards.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. (The text refers to mechanical tests, not a clinical test set with patient data).
Data Provenance: Not applicable. (The tests are mechanical in nature, likely conducted in a lab).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth as typically understood for diagnostic devices (e.g., expert consensus on a diagnosis) is not relevant for mechanical performance testing of an implant. The "ground truth" would be the engineering specifications and test methodologies themselves.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation of data where consensus is needed to establish ground truth, which is not relevant here.

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 knee implant, not an AI software.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a physical knee implant, not an algorithm.

7. The type of ground truth used

Engineering specifications and validated mechanical test methodologies (e.g., fatigue strength, load transfer properties).

8. The sample size for the training set

Not applicable. This device is a physical knee implant, not an AI software that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This device is a physical knee implant, not an AI software.

Summary based on the provided text:

The Implex CK Porous Tibial Component, Cemented, demonstrated "acceptable performance in mechanical tests that were conducted in accordance with CDRH recognized standards and Design Verification requirements of 21 CFR § 820.30." The study supporting this is described as "mechanical tests," implying laboratory-based testing of the physical properties and durability of the implant. No details about sample sizes for these mechanical tests, specific ground truth establishment methodologies by experts, or any human-reader involvement are provided, as these concepts are generally not relevant for the regulatory approval of a mechanical orthopedic implant based on substantial equivalence and engineering performance.

Summary

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Submitted by: Implex Corp.

K981560

JUN - 8 1998

510(k) SUMMARY - IMPLEX CK Porous Tibial Component, Cemented

Submitter Name:	Implex Corp.
Submitter Address:	80 Commerce DriveAllendale, New Jersey 07401-1600
EstablishmentRegistration Number:	2247737
Contact Person(s):	John Schalago, RAC, Regulatory Affairs DepartmentRobert, Poggie, Ph.D, Applied Science
Phone Number:	(201) 818-1800
Fax Number:	(201) 818-0567
Date Prepared:	April, 1998
Device Trade Name:	Implex Continuum Knee System: Porous Tibial Component,Cemented
Device Common Name:	Tibial Component
Classification Name:	Prosthesis, Knee, Tibial Component, 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 andCosmetic Act, as amended and as applied under 21 CFR807, Subpart E under which a device can be marketedwithout premarket approval or reclassification. Adetermination of substantial equivalency under thisnotification is not intended to have any bearingwhatsoever on the resolution of patent infringement suitsor any other patent matters. No statements related to, orin support of substantial equivalence herein shall beconstrued as an admission against interest under the USPatent Laws or their application by the courts.

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without significantly sacrificing coverage of proximal tibia. Components are machined from forged titanium, which provides excellent fatigue strength, load transfer and biocompatibility. For use where severe degeneration, trauma, or other Intended Use: pathology of the knee joint indicates cemented total knee arthroplasty. This device is intended for cemented use only. The CK Porous Tibial Tray has demonstrated acceptable Performance Data: performance in mechanical tests that were conducted in accordance with CDRH recognized standards and Design Verification requirements of 21 CFR § 820.30. Implex Corp believes that the CK Porous Tibial Tray is Subtantial Equivalence substantially equivalent to the predicate devices in the table below. This determination of substantial equivalence is supported by a comparison of the intended use, technological characteristics, dimensions, geometry, materials and configuration.

The manufacturer name, device name, 510(k) number and 510(k) clearance date of the predicate devices are provided below:

Manufacturer	Device Name	510(k) Number	Clearance Date
Implex Corp	Continuum Knee System	K882322	2/8/89
Osteonics	Series 7000	K940813	1/30/95
Smith & Nephew	Genesis II	K951987	8/22/95
Howmedica	Duracon	K926228	2/22/94

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of three wavy lines, which are likely meant to represent water or movement. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 8 1998

John A. Schalago, RAC Requlatory Affairs Manager Implex Corporation 80 Commerce Drive Allendale, New Jersey 07401-1600

Re : K981560 Implex Continuum Knee System: Porous Tibial Component Requlatory Class: II Product Code: JWH Dated: April 30, 1998 Received: May 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:

1. This device may not be labeled or promoted for noncemented use... ... ..
1. 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.
1. 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) requlation 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 Regulations, Title 21, Parts 800 to 895. ਚੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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 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 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
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be

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Paqe 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, 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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510(k) Number (if known):
---------------------------	--

<981560

Device Name:

Implex Continuum Knee Porous Tibial Component

Indications For Use:

Total Knee Replacement in severely disabled joints as a result of degenerative a) arthritis;
Secondary revision of a previously unsuccessful tibial component; b)
Other knee problems where clinical experience has shown that alternative c) modes of treatment are less likely to achieve satisfactory results;
d) Trauma, or other fractures in which adequate bony fixation cannot be obtained;
Non-union of the proximal tibia; and e)
f) Salvage of a failed primary or secondary total knee or uni-knee 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	2981560

Prescription Use(Per 21 CFR 801.109)	X	OR...		Over-The-Counter Use
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(Optional Format 1-2-96)

Regulation Number and Section

§ 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.