IMPLEX RADIAL HEAD REPLACEMENT SYSTEM by IMPLEX CORP.

The Implex Radial Head Replacement System is indicated for:
• Cemented Use Only.
• Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
-Joint destruction and/or subluxation.
-Resistance to conservative treatment.
• Primary replacement after fracture of the radial head.
• Symptomatic sequelae after radial head resection.
• Revision following failed radial head arthroplasty.

Device Description

The Implex Radial Head Replacement System is a modular prosthesis consisting of a metallic head and a Hedrocel porous tantalum stem. The metallic head component is offered in three diameter options of 16, 21, and 26 mm. each with 4 head extension lengths. The articulating surface of the head component is offered in Co-Cr-Mo alloy. The stem component is offered in three cross sectional sizes of 7, 9, and 11 mm, with corresponding stem lengths of 23, 30, and 37 mm, respectively. All stem size options are compatible with all head size options. The Implex Radial Head Replacement System is a modular system, and the metallic head must be inter-operatively cemented to the Hedrocel stem using PMMA bone cement.

AI/ML Overview

Acceptance Criteria and Study Details for Implex Radial Head Replacement System (K984290)

This submission describes the Implex Radial Head Replacement System, a modular prosthesis for radial head replacement. The acceptance criteria and the study that proves the device meets these criteria are outlined below.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit for equivalence)	Reported Device Performance
Mechanical Integrity: Sufficient strength and durability for its intended use.	"Performance testing of the cemented modular assembly was performed, and the results indicate that the assembly possesses a high degree of mechanical integrity."
Biocompatibility: Materials used are safe for implantation and do not elicit adverse reactions.	"Additionally, the Implex Radial Head is manufactured from materials with known performance characteristics (MAF #920) and properties which are typically used in total joint arthroplasty."
Substantial Equivalence: Device characteristics (materials, design, configuration, indications for use) are comparable to legally marketed predicate devices.	"A comparison of device characteristics (materials, design, configuration, and indications for use) included in this 510(k) Premarket Notification supports a substantial equivalence determination."

2. Sample Size and Data Provenance

The provided 510(k) summary does not explicitly describe a clinical study in terms of sample size or data provenance (e.g., country of origin, retrospective or prospective) for assessing device performance in humans. The performance data mentioned refers to mechanical testing of the device itself, rather than patient data.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This 510(k) pertains to a medical device's mechanical and material properties and its substantial equivalence to predicate devices, not a diagnostic or prognostic algorithm requiring expert-established ground truth from clinical cases.

4. Adjudication Method

Not applicable, as no clinical study requiring adjudication of patient cases is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. No MRMC study was conducted or described in this 510(k) submission. The device is a surgical implant, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance

Not applicable. The "device" is a physical implant, not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance evaluation in this 510(k) is based on:

Mechanical Testing Results: For assessing the physical integrity of the cemented modular assembly.
Material Science Data: For evaluating the known performance characteristics and properties of the materials used (referring to MAF #920).
Comparison to Predicate Devices: For establishing substantial equivalence in terms of design, configuration, and indications for use.

8. Sample Size for the Training Set

Not applicable. There is no training set for an algorithm in this context. The data used for demonstrating performance are material specifications and mechanical test results of the physical device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there's no training set for an algorithm, there's no ground truth established in that sense. The "ground truth" for the device's characteristics relies on established engineering principles and material science.

Summary

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K984290

JUN 1 1999	510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Implex Radial Head Replacement System
	Submitter Name:	Implex Corp.
	Submitter Address:	80 Commerce DriveAllendale, New Jersey 07401-1600
	Contact Person:	John Schalago or Robert Poggie, Ph.D.
	Phone Number:	(201) 818-1800
	Fax Number:	(201) 818-0567
	Date Prepared:	April 19, 1999
	Device Trade Name:	Radial Head Surface Replacement
	Device Common Name:	Elbow joint humeral (hemi-elbow) prosthesis
	Classification Numberand Name:	21 CFR § 888.3170

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.

Device Description: The Implex Radial Head Replacement System is a modular prosthesis consisting of a metallic head and a Hedrocel porous tantalum stem. The metallic head component is offered in three diameter options of 16, 21, and 26 mm. each with 4 head extension lenaths. The articulating surface of the head component is offered in Co-Cr-Mo alloy. The stem component is offered in three cross sectional sizes of 7, 9, and 11 mm, with corresponding stem lengths of 23, 30, and 37 mm, respectively. All stem size options are compatible with all head size options. The Implex Radial Head Replacement System is a modular system, and the metallic head must be inter-operatively cemented to the Hedrocel stem using PMMA bone cement.

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510(k) Summary of Safety and Effectiveness, Continued
Indications for Use:	The Implex Radial Head Replacement System is indicated for:• Cemented Use Only.• Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, anddecreased motion at the radio-humeral and/or proximalradio-ulnar joint with:-Joint destruction and/or subluxation.-Resistance to conservative treatment.• Primary replacement after fracture of the radial head.• Symptomatic sequelae after radial head resection.• Revision following failed radial head arthroplasty.
Predicate DeviceInformation:	The Implex Radial Head Replacement System issubstantially equivalent to Wright Medical Technology,Metallic Radial Heads, and the Avanta Orthopedics, AvantaRHTM.
Device TechnologicalCharacteristics andComparison toPredicate Device:	A comparison of device characteristics (materials, design,configuration, and indications for use) included in this 510(k)Premarket Notification supports a substantial equivalencedetermination.
Performance Data:	Performance testing of the cemented modular assembly wasperformed, and the results indicate that the assemblypossesses a high degree of mechanical integrity.Additionally, the Implex Radial Head is manufactured frommaterials with known performance characteristics (MAF#920) and properties which are typically used in total jointarthroplasty.
Conclusion:	The Implex Radial Head Replacement System issubstantially equivalent to the identified predicate devices.

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Public Health Service

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 11 1999

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

Re: K984290 Trade Name: Implex Radial Head Replacement System Regulatory Class: II Product Code: KWI Dated: April 20, 1999 Received: April 21, 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 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜ 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.

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Page 2 - John A. Schalago, RAC

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.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):

K984290

Device Name:

Implex Radial Head Replacement System

Indications For Use:

The Implex Radial Head Replacement System indications for use are as follows:

. For Cemented Use Only.
: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Replacement of the radial head for degenerative or post-traumatic . disabilities presenting pain, crepitation, and decreased motion at the radiohumeral and/or proximal radio-ulnar joint with:
- a) Joint destruction and/or subluxation.
- b) Resistance to conservative treatment.
. Primary replacement after fracture of the radial head.
Symptomatic sequelae after radial head resection. .
Revision following failed radial head arthroplasty. .

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Concurrence of CDRH; Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR...

Over-The-Counter Use

(Optional Format 1-2-96)

Piazzale

(Division Sign-Off) Division of General Restorative Devices 12984290 510(k) Number .

Regulation Number and Section

§ 888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.

(a)
Identification. An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.(b)
Classification. Class II.