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® Shoulder System for a fracture humeral stem. Fracture humeral stems will be based on the humeral component designs of the Solar® Shoulder, Solar® PureFix® HA Shoulder, and the Tornier Aequalis Shoulder Fracture System. The subject stems have suture holes and a bone-grafting window.

AI/ML Overview

This is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with acceptance criteria for device performance as would be found in a Premarket Approval (PMA) application or a clinical trial report.

Therefore, many of the requested data points (such as sample size for test/training set, number of experts, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment) are generally not part of a 510(k) submission unless specific performance testing beyond comparison to a predicate is required.

Based on the provided text, here's what can be extracted and what cannot:

1. Table of acceptance criteria and reported device performance:

The document states: "The test results demonstrate that the subject components are substantially equivalent in strength to the predicate components." However, it does not provide a specific table of acceptance criteria (e.g., minimum tensile strength, fatigue life thresholds) or specific quantitative performance values for the Solar® ReUnion™ Fracture Stem, only a qualitative statement about substantial equivalent strength.

Acceptance Criteria (Implied)	Reported Device Performance
Substantially equivalent in strength to predicate components.	The subject components are substantially equivalent in strength to the predicate components.

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

Sample Size for Test Set: Not specified. The document refers to "test results" but does not detail the number of devices or components tested.
Data Provenance: Not specified, but generally, such tests are conducted in a laboratory setting by the manufacturer. It is implicitly retrospective as it compares the new device to existing predicate devices.

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

Number of Experts: Not applicable/not specified. The evaluation is based on mechanical strength testing, not human expert assessment of a condition.
Qualifications of Experts: N/A.

4. Adjudication method for the test set:

Adjudication Method: Not applicable. The "test results" would refer to objective mechanical testing data, not subjective assessments requiring adjudication.

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:

MRMC Study: No. This is a medical implant (shoulder prosthesis), not an AI-enabled diagnostic imaging device or an AI assistant. Therefore, MRMC studies are not relevant to this submission.
Effect Size of AI Improvement: Not applicable.

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

Standalone Performance: Not applicable. This is a physical medical device (implant), not an algorithm or software.

7. The type of ground truth used:

Ground Truth: For demonstrating "substantial equivalence in strength," the ground truth would be accepted engineering standards and validated mechanical testing methods (e.g., measuring forces to failure, fatigue testing, etc.) and comparison to the known performance of predicate devices. The document implies a direct comparison of physical properties.

8. The sample size for the training set:

Sample Size for Training Set: Not applicable. This device is a physical implant, not an AI/ML model that requires a training set. The "training" for such devices involves design, material selection, and manufacturing processes, which are not based on data sets in the AI sense.

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

How Ground Truth for Training Set was Established: Not applicable. As explained above, this is not an AI/ML device. The "ground truth" for its development would be based on biomechanical principles, material science, and clinical needs for shoulder prostheses.

Summary

{0}------------------------------------------------

K062/113

OCT - 3 2006

510(k) Summary of Safety and Effectiveness Solar" ReUnion™ Fracture Stem

Proprietary Name:	Solar ReUnion™ Fracture Stem
Common Name:	Shoulder Prosthesis
Classification Name/Reference:	Shoulder joint metal/polymer semi constrainedcemented prosthesis. 21 CFR §888.3660Shoulder joint humeral (hemi-shoulder) metallicuncemented prosthesis. 21 CFR §888.3690
Device Product Code:	87 KWS, 87 HSD
Proposed Regulatory Class:	Class II
For Information contact:	Francisco Haro, Regulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5493 Fax: (201) 831-6038
Date Summary Prepared:	July 21, 2006

Description

Indications:

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:

{1}------------------------------------------------

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 Solar® ReUnion™ Fracture Stem is substantially equivalent to the Solar® Shoulder Humeral Components, Solar® PureFix® HA Shoulder, and the Tornier Aequalis Shoulder Fracture System in regards to intended use, design, materials, and operational principles as humeral components. The test results demonstrate that the subject components are substantially equivalent in strength to the predicate components.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized depiction of a human figure with three arms extending upwards, symbolizing growth and vitality. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 3 2006

Howmedica Osteonics Corp. % Mr. Francisco Haro Regulatory Affairs Specialist 325 Corporate Drive Mahwah. New Jersey 07432

Re: K062113

Trade/Device Name: Solar® ReUnion™ Fracture Stem Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS and HSD Dated: July 21, 2006 Received: July 24, 2006

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.

{3}------------------------------------------------

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Barbara Buchner
for

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

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Solar® ReUnion™ 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 Over-The-Counter Use X 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) (FULLOR W (Ju

(Division Sign-Off) Division of General, Restorative, and Neurologica: Devices

Page	1 of 1
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510(k) Number K062113

Regulation Number and Section

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder 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 humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”