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.

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.

AI/ML Overview

This document is a 510(k) Pre-market Notification for the Implex Continuum Knee System Hedrocel Revision Femoral Spacers. It seeks to establish substantial equivalence to previously marketed devices. The document does not describe an acceptance criteria and study that proves the device meets specific performance metrics in the way modern device submissions or AI/software validation studies would.

Instead, the "acceptance criteria" here is the regulatory standard of "substantial equivalence" to predicate devices already on the market. The "study" proving this is a comparison to existing predicate devices and a reliance on their previously accepted performance data.

Here’s a breakdown based on your request, highlighting what is present and what is absent in this type of regulatory submission:

Description of Acceptance Criteria and Study to Prove Device Meets Criteria

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Regulatory Standard)	Reported Device Performance (Basis for Equivalence)
Substantial Equivalence: The device is as safe and effective as a legally marketed predicate device. This is primarily evaluated by comparing:	The Implex CKS Hedrocel Revision Femoral Spacers are compared to: - Implex CKS Revision Femoral Spacers (original) - Implex Continuum Porous Patella - Implex Hedrocel Acetabular Restrictor The claim of substantial equivalence is based on the device having: - Similar intended use: Revision/salvage of failed knee procedures, cemented use. - Similar technological characteristics: Comprised of Hedrocel porous tantalum. - Reliance on previous testing of predicate devices and their materials.
* Intended Use	* The intended use for the new device is consistent with the predicate devices: Total Knee Replacement (TKR) in severely disabled joints, secondary revision, trauma, non-union, salvage of failed arthroplasty (for cemented use only).
* Technological Characteristics (e.g., material, design principles)	* The device is comprised of Hedrocel porous tantalum, similar to components in the predicate devices. Design features (thickness options, full/chamfered) are described.
* Performance Data (to demonstrate safety and effectiveness for its intended use, typically through non-clinical bench testing or clinical studies for new technology)	* The submission states: "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." This indicates a reliance on prior mechanical/material testing data associated with the predicate devices and the Hedrocel material, rather than new device-specific performance data in this submission.

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

Sample Size for Test Set: Not applicable in the context of a 510(k) submission relying on predicate device data for mechanical performance. There isn't a "test set" of patient data or new device performance data described in this summary. The "test" is the comparison process itself to the predicates.
Data Provenance: The provenance for the underlying material and predicate device testing (MAF #920 and K962468) is not detailed in this summary. These would typically involve bench testing (e.g., fatigue, wear, strength) of materials and components, which is laboratory-based and not patient-data driven.

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

Not applicable. This submission is for a medical implant (revision femoral spacers for knee replacement). "Ground truth" in this context would generally refer to a definitive diagnosis or outcome for a patient, which is not being established or used as a "test set" here. The assessment is regulatory by the FDA based on the provided technical comparison.

4. Adjudication method for the test set

Not applicable. There is no "test set" in the sense of clinical cases requiring adjudication. The FDA (specifically the Division of General and Restorative Devices, Office of Device Evaluation) reviewed the submission to determine substantial equivalence.

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 is not an AI/software device. It's a medical implant.

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

Not applicable. This is not an AI/software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable in the human data sense. The "ground truth" for the material and mechanical properties of the Hedrocel technology and the predicate devices would have been established through a combination of:
- Engineering specifications and standards: Defining required material properties and mechanical performance.
- Bench testing: Laboratory measurements of strength, fatigue, wear, etc.
- Histopathology/biological studies: For biocompatibility and osseo-integration (though not explicitly mentioned as "ground truth" here, it's relevant for porous materials).
- Clinical experience/outcomes data: For the predicate devices, showing they were safe and effective when previously marketed (though not specified as a "test set" for this submission).

8. The sample size for the training set

Not applicable. This is not an AI/software device. There is no "training set."

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

Not applicable. This is not an AI/software device.

In summary: This 510(k) submission is a regulatory pathway for orthopedic implants based on demonstrating similarity to previously cleared devices. It relies heavily on the safety and effectiveness already established for the predicate devices and the material technology (Hedrocel). It does not involve a "study" in the sense of a clinical trial or a performance validation for a novel AI/software product.

Summary

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ANNOSS COLLECTION COLLECTION

MAY 22 1998

510(k) SUMMARY - IMPLEX CKS Hedrocel® Revision Femoral Spacers

Submitter Name:	Implex Corp.
Submitter Address:	80 Commerce DriveAllendale, 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 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 Femoral Spacers, the Implex ContinuumPorous Patella, and the Implex Hedrocel Acetabular Restrictor.
Device Description:	The CKS Hedrocel Distal Femoral Spacers will have 4 thicknessoptions of 4, 8, 12, and 16 mm. The distal femoral spacers will beavailable in both full and chamfered spacer options. The CKSHedrocel Posterior Femoral Spacers will be available in 3thickness options of 4, 8, and 12 mm. The CKS Hedrocel Spacersare comprised of Hedrocel porous tantalum and are to be fastenedto Implex Continuum Knee System Revision FemoralComponents using the same Instrumentation and fastener bolts.
Intended Use:	The Implex CKS Hedrocel Revision Femoral Spacers areindicated in the revision or salvage of failed previouslyreconstructed knee procedures and implants; particularly insituations where bone loss has occurred from removal of priorimplantations, infection or trauma. This device is intended forcemented 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.

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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.

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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

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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
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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.