IMPLEX HEDROCEL PS TIBIAL COMPONENT, MODEL HEDROCEL POSTERIOR STABILIZED TIBIAL COMPONENT 05-XXX-YYYYY by IMPLEX CORP.

The Implex Hedrocel Posterior Stabilized (PS) Tibial Component is intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates cemented total knee arthroplasty. In addition, the Hedrocel PS Tibial Component is indicated for use in the presence of knee instability caused by a compromised or non-functional posterior cruciate ligament.

Device Description

The Implex Hedrocel PS 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 Hedrocel PS Tibial Component is comprised of Hedrocel porous tantalum and UHMWPE and is intended to be implanted using the Implex Continuum Knee System Instrumentation and Surgical Protocol. In addition, the Hedrocel PS Tibial component is offered in two fixation post options; option A with hexagonal Hedrocel® posts, and option B with polyethylene fixation pegs.

AI/ML Overview

This 510(k) summary describes a medical device (The Implex Hedrocel Posterior Stabilized (PS) Tibial Component, Cemented), not an AI/ML powered medical device. Therefore, the questions related to AI/ML powered medical device performance, ground truth establishment, reader studies, and training/test sets are not applicable.

Here's the relevant information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated as acceptance criteria in the document, but the basis for approval is "substantial equivalence" to predicate devices.	Previous testing of the predicate devices and associated materials supports a determination of substantial equivalence.

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

Not applicable as this is a medical device, not an AI/ML powered medical device. Performance is based on prior testing of predicate devices and their materials.

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

Not applicable.

4. Adjudication method for the test set

Not applicable.

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.

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

Not applicable.

7. The type of ground truth used

Not applicable for an AI/ML context. For this medical device, the "ground truth" for demonstrating safety and effectiveness implicitly refers to established clinical performance and material properties of the predicate devices.

8. The sample size for the training set

Not applicable.

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

Not applicable.

Summary

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

The Hedrocel Posterior Stabilized (PS) Tibial Component, Cemented

Submitter Name:	Implex Corp.
Submitter Address:	80 Commerce DriveAllendale, New Jersey 07401-1600
Contact Person(s):	John Schalago or Robert Poggie
Phone Number:	(201) 818-1800
Fax Number:	(201) 995-9722
Date Prepared:	November 29, 1999
Device Trade Name:	The Implex Hedrocel PS Tibial Component, Cemented
Device Common Name:	Tibial Component
Classification Name:	Prosthesis, Knee, Tibial Component, Cemented

The term "substantial equivalence" as used in this Substantial Equivalence: 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 A determination of substantial reclassification. 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.

The CKS Posterior Stabilized Knee System (the tibial Predicate Devices: component), Cemented, and the Hedrocel Unity Tibial Component, Cemented.

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510(K) Summary of Safety and Effectiveness - Continued...

Device Description: The Implex Hedrocel PS 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 The Hedrocel PS Tibial Component is comprised of mm. Hedrocel porous tantalum and UHMWPE and is intended to be implanted using the Implex Continuum Knee System Instrumentation and Surgical Protocol. In addition, the Hedrocel PS Tibial component is offered in two fixation post options; option A with hexagonal Hedrocel® posts, and option B with polyethylene fixation pegs.
The Implex Hedrocel Posterior Stabilized (PS) Tibial Intended Use: Component is intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates cemented total knee arthroplasty. In addition, the Hedrocel PS Tibial Component is indicated for use in the presence of knee instability caused by a compromised or non-functional posterior cruciate ligament.
Previous testing of the predicate devices and associated Performance Data: materials support a determination of substantial equivalence.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

FEB 1 8 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John A. Schalago, RAC Manager, Regulatory Affairs Implex Corporation 80 Commerce Drive Allendale, New Jersey 07401

Re: K994076

Implex Hedrocel PS Tibial Component, Cemented Regulatory Class: II Product Code: JWH Dated: November 29, 1999 Received: December 2, 1999

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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 regulations affecting your device can be found in the Code of Federal Regulations, 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 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.

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.

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Page 2 - Mr. John A. Schalago, RAC

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 obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Nel AP Ogden
James E. Dillard III

Acting 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):	K994076
Device Name:	The Hedrocel PS Tibial Component

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of Device Evaluation (ODE)
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Nho for JZD

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K994076

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.