The subject humeral stem is a single-use, sterile device intended for use in shoulder replacement. It is intended for the reconstruction of the proximal humerus. This humeral stem is intended for primary or revision reconstruction of the shoulder joint.

For use as a Bipolar Shoulder Replacement:

Aseptic necrosis of the humeral head
Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis.
Proximal humeral fractures and/or dislocation.
Clinical management problems where arthodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
Pathological conditions or age considerations which indicate a more conservative glenoid procedure and avoidance of the use of bone cement in the glenoid.

For use as a Total Shoulder Replacement:

Aseptic necrosis of the humeral head
Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis.
Proximal humeral fractures and/or dislocation.
Clinical management problems where arthodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.

Device Description

This submission is a line extension to the Solar® ReUnion™ Fracture Stem for fracture humeral stem with no CP Ti plasma spray. Fracture humeral stems will be based on the Solar® ReUnion™ Fracture Stem.

AI/ML Overview

This document is a 510(k) premarket notification for the ReUnion™ HA Fracture Stem, a shoulder prosthesis. The purpose of this notification is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish safety and effectiveness through clinical studies with acceptance criteria.

Therefore, the requested information regarding acceptance criteria and a study proving device conformance is not applicable in this context.

Here's why and what the document does provide:

Substantial Equivalence: The document states, "The ReUnion™ HA Fracture Stem is substantially equivalent to the Solar® ReUnion™ Fracture Stem in regards to intended use, design, materials, and operational principles as humeral components. The engineering analysis demonstrates that the subject components are substantially equivalent in strength to the predicate components."
Engineering Analysis: The document mentions "engineering analysis" to demonstrate equivalence in strength. This implies non-clinical testing (e.g., mechanical or bench testing) rather than a clinical study with human subjects, ground truth, or expert review. However, no specific details about this engineering analysis (e.g., methods, sample sizes, specific criteria, or results) are provided in the summary.
Predicate Device: The core of a 510(k) submission is to show that a new device is "substantially equivalent" to a device already on the market (the predicate). This avoids the need for extensive new clinical trials if the risks and performance are considered similar.

In summary, this document does not contain information about:

Acceptance Criteria and Reported Device Performance: No such table is presented, as clinical performance criteria are typically not required for 510(k) submissions where substantial equivalence is demonstrated through other means (like design and material comparison, and bench testing).
Sample Size and Data Provenance (for test set): Not applicable, as there's no clinical test set described.
Number and Qualifications of Experts for Ground Truth: Not applicable.
Adjudication Method: Not applicable.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.
Standalone (Algorithm Only) Performance: Not applicable, as this is a physical medical device, not an AI algorithm.
Type of Ground Truth Used: Not applicable.
Sample Size for Training Set: Not applicable.
How Ground Truth for Training Set was Established: Not applicable.

Summary

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4 2007

K570963

MAY - 4 2007

Summary of Safety and Effectiveness ReUnion™ HA Fracture Stem

Proprietary Name:	ReUnion™ HA Fracture Stem
Common Name:	Shoulder Prosthesis
Classification Name and Reference:	Shoulder joint metal/polymer semiconstrained cemented prosthesis. 21 CFR§888.3660
	Shoulder joint humeral (hemi-shoulder)metallic uncemented prosthesis. 21 CFR§888.3690
Device Product Code:	87 KWS, 87 HSD
For Information Contact:	Francisco Haro, Regulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5493Fax: (201) 831-6038
Date Summary Prepared:	April 3, 2007

Description:

Intended Use:

Indications for Use:

For use as a Bipolar Shoulder Replacement:

. Aseptic necrosis of the humeral head

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K070963

Painful, disabling joint disease of the shoulder resulting from: degenerative . arthritis, rheumatoid arthritis, or post-traumatic arthritis.
. Proximal humeral fractures and/or dislocation.
. Clinical management problems where arthodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
. Pathological conditions or age considerations which indicate a more conservative glenoid procedure and avoidance of the use of bone cement in the glenoid.

For use as a Total Shoulder Replacement:

. Aseptic necrosis of the humeral head
. Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis.
. Proximal humeral fractures and/or dislocation.
Clinical management problems where arthodesis or alternative reconstructive . techniques are less likely to achieve satisfactory results.
. Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.

Substantial Equivalence:

The ReUnion™ HA Fracture Stem is substantially equivalent to the Solar® ReUnion™ Fracture Stem in regards to intended use, design, materials, and operational principles as humeral components. The engineering analysis demonstrates that the subject components are substantially equivalent in strength to the predicate components.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in all capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 4 2007

Howmedica Osteonics Corporation % Mr. Francisco Haro Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

Re: K070963

Trade/Device Name: ReUnion™ HA Fracture Stem Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder Joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: II Product Code: HSD Dated: April 3, 2007 Received: April 5, 2007

Dear Mr. Haro:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Francisco Haro

This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Валеше Вuekup

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: ReUnion™ HA Fracture Stem

Indications for Use:

For use as a Bipolar Shoulder Replacement:

. Aseptic necrosis of the humeral head
Painful, disabling joint disease of the shoulder resulting from: degenerative . arthritis, rheumatoid arthritis, or post-traumatic arthritis.
. Proximal humeral fractures and/or dislocation.
Clinical management problems where arthodesis or alternative reconstructive . techniques are less likely to achieve satisfactory results.
Pathological conditions or age considerations which indicate a more conservative . glenoid procedure and avoidance of the use of bone cement in the glenoid.

For use as a Total Shoulder Replacement:

Aseptic necrosis of the humeral head .
Painful, disabling joint disease of the shoulder resulting from: degenerative . arthritis, rheumatoid arthritis, or post-traumatic arthritis.
. Proximal humeral fractures and/or dislocation.
Clinical management problems where arthodesis or alternative reconstructive ● techniques are less likely to achieve satisfactory results.
Revision of previous unsuccessful total shoulder replacement, resurfacing or other . procedure.

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ision Sign-Off Division of General, Restorative. and Neurological Devices

510(k) Number K070963

Regulation Number and Section

§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.

(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.