Aequalis Shoulder System (excluding Acqualis Shoulder Fracture System): Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by: Degenerative pathologies : arthrosis, rheumatoid arthritis, post-traumatic arthrosis. Primary and secondary necrosis of the humeral head Displaced 4-part upper humeral fracture Humeral head fracture Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable Revision surgery when other treatments or devices have failed. Aequalis Shoulder Fracture System Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint, including humeral head fracture and displaced 3-or 4-part proximal humeral fractures. Revision surgery when other treatments or devices have failed.

Device Description

The labeling for the Aequalis Shoulder Fracture System and Aequalis Shoulder System is being modified to indicate that, when used as total shoulder prostheses, the Aequalis Shoulder Fracture System humeral stems, Aequalis Shoulder System humeral stems and Aequalis humeral heads are compatible with the Affiniti pegged glenoid components in addition to the Aequalis glenoid components that have been previously cleared for use with these systems. The Affiniti pegged glenoid components are available in sizes 40 - 56.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Aequalis Shoulder System and Fracture System). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study or even a standalone technical performance study.

Therefore, the document does not contain the information requested about acceptance criteria, device performance, test set details (sample size, provenance, ground truth experts, adjudication), MRMC studies, or standalone algorithm performance.

The reason for this is that the submission states:

"The indications, intended uses, designs, materials and manufacturing methods for the Aequalis Shoulder Fracture System and Aequalis Shoulder System have not changed from those cleared previously in K060209. These systems, with labeling modified to include compatibility with the Affiniti pegged glenoid components, are therefore substantially equivalent to the systems that have been cleared previously."

This indicates that the submission is for a minor modification (compatibility with new glenoid components) to an already cleared device, relying on the substantial equivalence principle rather than new performance testing.

However, I can extract the following information based on the provided text:

Device Name: Aequalis Shoulder Fracture System and Aequalis Shoulder System
Device Type: Total shoulder prosthesis (Shoulder joint metal/polymer semi-constrained cemented prosthesis)
Classification: Class II
Product Codes: 87 KWS
Predicate Devices: K994392, K003728, K012212, K032679, K060209 (for Fracture System) and K952928, K980244, K012212, K041339, K043077, K060209, K060988 (for Shoulder System).

In summary, there is no information in the provided document to answer the questions about acceptance criteria and device performance studies because the submission is based on substantial equivalence to predicate devices, not new performance data.

Summary

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081707

p-1/2

TORNIT

JUL 1 7 2008

510(k) Summary

510(k) SPONSOR:	Tornier100 Capital Drive, Suite 201,Warsaw, IN 46582
CONTACT PERSON:	Jeff Ondrla,Vice President, Product Development(574) 527-9951JOndrla@Tornier.com
TRADE NAME:	, Aequalis Shoulder Fracture System and Aequalis ShoulderSystem
COMMON NAMES:	Total shoulder prosthesis
CLASSIFICATION,and CLASS:	21 CFR 888.3660 - Shoulder joint metal/polymer semi-constrained cemented prosthesis; Class II
PRODUCT CODES:	87 KWS

PREDICATE DEVICES:

Aequalis Shoulder Fracture System: K994392, K003728, K012212, K032679 and K060209

Aequalis Shoulder System: K952928, K980244, K012212, K041339, K043077 and K060209

DVO (now Tornier) Total and Hemi Shoulder System: K060988

DEVICE DESCRIPTION:

The Affiniti pegged glenoid components are available in sizes 40 - 56.

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INDICATIONS FOR USE:

Aequalis Shoulder System (excluding Acqualis Shoulder Fracture System):

Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by:

81767

· Degenerative pathologies : arthrosis, rheumatoid arthritis, post-traumatic arthrosis.
· Primary and secondary necrosis of the humeral head
· Displaced 4-part upper humeral fracture
· Humeral head fracture
· Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable
· Revision surgery when other treatments or devices have failed.

Aequalis Shoulder Fracture System

. Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint, including
- 0 humeral head fracture and displaced 3-or 4-part proximal humeral fractures.
- o Revision surgery when other treatments or devices have failed.

BASIS FOR SUBSTANTIAL EQUIVALENCE:

The indications, intended uses, designs, materials and manufacturing methods for the Aequalis Shoulder Fracture System and Aequalis Shoulder System have not changed from those cleared previously in K060209. These systems, with labeling modified to include compatibility with the Affiniti pegged glenoid components, are therefore substantially equivalent to the systems that have been cleared previously.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tornier % Mr. Jeff Ondrla Vice President, Product Development 100 Capital Drive, Suite 201 Warsaw, IN 46582

JUL 1 7 2008

Re: K081707

Trade/Device Name: Aequalis Shoulder Fracture System and Aequalis Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS Dated: June 13, 2008 Received: June 17, 2008

Dear Mr. Ondrla:

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. Jeff Ondrla

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Milliman

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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081707

Indications for Use Statement

510(k) Number (if known): ___

Device Name: Aequalis Shoulder Fracture System and Aequalis Shoulder System

Aequalis Shoulder System (excluding Acqualis Shoulder Fracture System):

Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by:

· Degenerative pathologies : arthrosis, rheumatoid arthritis, post-traumatic arthrosis.
Primary and secondary necrosis of the humeral head a
Displaced 4-part upper humeral fracture .
Humeral head fracture .
· Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable
· Revision surgery when other treatments or devices have failed.

Aequalis Shoulder Fracture System

Traumatic or pathologic conditions of the shoulder resulting in fracture of the . glenohumeral joint, including
- 0 humeral head fracture and displaced 3-or 4-part proximal humeral fractures.
- Revision surgery when other treatments or devices have failed. ಂ

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Bucheld
Page1of1

al. Restorative, and Neurological Devices

510(k) Number K081707

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.”