Aequalis Shoulder Range (except Aequalis for Fracture):
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 i
Humeral head fracture
Humeral head fracture
Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are i not acceptable ·
Revision surgery when other treatments or devices have failed. i

Aequalis monobloc stem is for use with cemented applications and is labeled as such. Aequalis Inditionio stem is for uncemented applications and is labeled as such.
Aequalis Press-Fit stem is for uncemented applications and is labels as such. Aequalis Fress-Fit sich is for uncemented applications ad is labeled as such.

Aequalis for Fracture:
Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral frequres Traumatic or pathologic concilibilis of the since as and displaced 3-or 4-part proximal humeral fractures.
joint, including humeral head fracture and displaced 3-or 4-part pr Revision surgery when other treatments or devices have failed.

Aequalis fracture stem is for cemented use.

Aequalis Reversed Shoulder Prosthesis:
Acqualis Reversed Shoulder Prosthesis is indicated for patients with a functional deltoid The Aequalis Reversed Shoulder Frosthesis is the relief of panin and significant disability
muscle as a total shoulder replacement for the relief off paint and significant Th following arthropathy associated to massive and non repairshe rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rolator colfis also indicated for the prosilent revisions whiles. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.

the bone with 4 screws and is for non-cention interest to be insufficient to bear When during the primary surgery the gions one accure occurs during the surgical procedures, the hemi-prosthesis adaptor and the union screw be adapted to the humeral
procedures, the hemi-prosthesis adaptor and the union screw cases in the humeral procedures, the nemi-prosthesis adaptor and the amon before and on reversed hemi-prosthesis.

hemi-prosthesis.
When, in case of revision of a Aequalis Reversed prosthesis, the glenoid bone stock appears When, in case of revision of a Aequalis Reverse of Aequalis Reversed range again, the to be insufficient to implant a baseptate and the union screw allows for the transformation of the use of the hemi-prosthesis adaptor and the amon serow and is to the morder to avoid the revision of the humeral components.

Aequalis Reversed Fracture Shoulder Prosthesis:
The Aequalis Reversed Fracture Shoulder Prosthesis is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain or significant disability following arthropathy associated to a grossly deficient rotator cuff joint:

in case of 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, or
in case of bone defect in proximal humerus. ।

The Aequalis Reversed Fracture Shoulder Prosthesis is also indicated for prosthetic revisions with a grossly deficient rotator cuff joint when other treatments or devices have failed.

When during the primary surgery the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemiprosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed Fracture Shoulder Prosthesis into a non reversed hemi-prosthesis.

When, in case of revision of a Aequalis Reversed Fracture Shoulder Prosthesis, the glenoid bone stock appears to be insufficient to implant a base plate and a sphere of Aequalis Reversed range again, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed Fracture Shoulder Prosthesis into a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.

The Aequalis Reversed Fracture Shoulder humeral stem is used in association with the glenoid components of the Aequalis Reversed Shoulder Prosthesis.

The Aegualis Reversed Fracture Shoulder humeral stem is for cemented use only.

Device Description

For the Aequalis Fracture Shoulder System:
The usual goal of total shoulder replacement and hemi-arthroplasty of the shoulder is to restore the shoulder joint to its best working condition and to reduce or eliminate pain. The Aequalis Shoulder Fracture System is intended to accomplish these goals. With the Aequalis Shoulder Fracture System, the natural glenoid elements of the shoulder may be conserved or replaced as warranted by the state of disease or injury. Thus the Aequalis Shoulder Fracture System is intended for use as a total shoulder replacement system, or as a hemi-shoulder. The modular nature of the system allows for the later conversion of a primary hemi-arthroplasty to a total shoulder replacement.

For the Aequalis Reversed Shoulder Prosthesis:
The Aequalis Reversed Shoulder Prosthesis is intended to relieve pain and significant disability following massive and non repairable cuff-tear associated to arthropathy and following massive cuff-tear arthropathy. In this case, the rotator muscles of the shoulder (supraspinatus, infraspinatus, teres minor and long head of the biceps) are no more useful for mobility, and only the deltoid (for abduction and external rotation) and the subscapularis (for internal rotation) are functional.

Therefore, the usual goal of such surgery is to restore the shoulder joint to facilitate its working condition and to reduce or eliminate pain. The Aequalis Reversed Shoulder Prosthesis is intended to accomplish these goals. Its reversed design allows to medialize the center of the shoulder, lengthening the deltoid muscle lever arm.

The Aequalis Reversed Shoulder Prosthesis is a semi-constrained system composed of a humeral and a glenoid parts.

For the Aequalis Reversed Fracture Shoulder Prosthesis:
The Aequalis Reversed Fracture Shoulder Prosthesis is intended to relieve pain or significant disability following massive cuff-tear associated to arthropathy and following massive cuff-tear arthropathy. In this case, the rotator muscles of the shoulder (supraspinatus, infraspinatus, teres minor and long head of the biceps) are no more useful for mobility, and only the deltoid (for abduction and external rotation) and the subscapularis (for internal rotation) are functional.

Therefore, the usual goal of surgery is to restore the shoulder joint to facilitate its working condition and to reduce or eliminate pain. The Aequalis Reversed Fracture Shoulder Prosthesis is intended to accomplish these goals. Its reversed design allows to medialize the center of rotation of the shoulder, lengthening the deltoid muscle lever arm and its Aequalis Fracture Shoulder humeral stem-like design allows to facilitate the bone reconstruction and improve the tuberosity healing and fixation.

The Aequalis Reversed Fracture Shoulder Prosthesis is a semi-constrained system composed of a humeral and a glenoid parts.

The present submission corresponds to the following modification:

Addition of a new coating subcontractor (hydroxyapatite coating): APS Materials, Inc. on . titanium components (stem and baseplate).
All the prostheses of this file are strictly identical to the previously cleared devices except for the coating supplier. The indications for use of each device are not modified.

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) Premarket Notification for the Aequalis Shoulder Fracture System and related prostheses does not include information about acceptance criteria or a study proving that an AI/Software as a Medical Device (SaMD) meets such criteria.

The document is a clearance letter and a summary of safety and effectiveness for a physical medical device (shoulder prostheses). It discusses:

Device Names: Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis Reversed Fracture Shoulder Prosthesis.
Regulatory Information: Regulation number, regulation name, product codes, regulatory class (Class II).
Indications for Use: Detailed descriptions of the medical conditions for which each type of shoulder prosthesis is intended.
Device Description: Information on the components, their function, and the surgical goals.
Materials: Specifically mentions titanium alloy (Ti6Al4V) and hydroxyapatite coating, and a new coating subcontractor (APS Materials, Inc.).
Predicate Devices: Lists previously cleared devices to which the current devices are compared for substantial equivalence.

There is no mention of:

AI/Machine Learning: No algorithm, software, or AI component is described.
Acceptance Criteria for AI Performance: No metrics like sensitivity, specificity, AUC, or other performance thresholds are stipulated.
Clinical Study for AI Validation: No details of a study with a test set, ground truth establishment, expert adjudication, or MRMC studies are present.
Training Data: No information on training sets for an AI model.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves an AI/SaMD device meets them based on the provided text. The document pertains to the clearance of traditional orthopedic implants.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's seal, which includes an abstract representation of the human form. The seal is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 2, 2016

Tornier Mrs. Severine Bonneton Regulatory Affairs Specialist 161, rue Lavoisier - Montbonnot 38334 Saint Ismier Cedex FRANCE

Re: K112144

Trade/Device Name: Aequalis Shoulder Fracture System Aequalis Reversed Shoulder Prosthesis Aequalis Reversed Fracture Shoulder Prosthesis

Regulation Number: 21 CFR 888.3660

Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS Dated: February 13, 2012 Received: February 15, 2012

Dear Mrs. Bonneton:

This letter corrects our substantially equivalent letter of March 13, 2012.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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

Page 2 - Mrs. Severine Bonneton

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins -S

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

Page 1/2

510(k) Number (if known): K112144

Device Name: Aequalis Shoulder Fracture System Aequalis Reversed Shoulder Prosthesis

Acqualis Reversed Fracture Shoulder Prosthesis

Indications For Use:

Aequalis Shoulder Range (except Aequalis for Fracture):

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 i
Humeral head fracture
Humeral head fracture
Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are i not acceptable ·
Revision surgery when other treatments or devices have failed. i

Aequalis for Fracture:

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

Aequalis fracture stem is for cemented use.

Aequalis Reversed Shoulder Prosthesis:

Acqualis Reversed Shoulder Prosthesis is indicated for patients with a functional deltoid The Aequalis Reversed Shoulder Frosthesis is the relief of panin and significant disability
muscle as a total shoulder replacement for the relief off paint and significant Th following arthropathy associated to massive and non repairshe rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rolator colfis also indicated for the prosilent revisions whiles. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.

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

Aequalis Reversed Fracture Shoulder Prosthesis:

The Aequalis Reversed Fracture Shoulder Prosthesis is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain or significant disability following arthropathy associated to a grossly deficient rotator cuff joint:

in case of 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, or
in case of bone defect in proximal humerus. ।

The Aequalis Reversed Fracture Shoulder Prosthesis is also indicated for prosthetic revisions with a grossly deficient rotator cuff joint when other treatments or devices have failed.

The Aequalis Reversed Fracture Shoulder humeral stem is used in association with the glenoid components of the Aequalis Reversed Shoulder Prosthesis.

The Aegualis Reversed Fracture Shoulder humeral stem is for cemented use only.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)
	(Division Sign-Off)
	Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number	K112144
---------------	---------

Tornier Section 4 – page 2 / page 2

{4}------------------------------------------------

<112.1:44

MAR 1 3 2012

Implants Chirurgic

Summary of Safety and Effectiveness information Special 510(k) Premarket Notification - Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis Reversed fracture Shoulder Prosthesis

Date prepared: February 13th, 2012

Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92

Device name

Trade name:	Aequalis Shoulder Fracture System
Common name:	Hemi or Total Shoulder Prosthesis
Classification name:	888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis

Trade name: Common name: Classification name: Aequalis Reversed Shoulder Prosthesis Total-Shoulder System and Hemi-Shoulder System Shoulder joint metal/polymer semi-constrained cemented prosthesis

Trade name: Common name: Classification name: Aequalis Reversed Fracture Shoulder Prosthesis Total-Shoulder System and Hemi-Shoulder System Shoulder joint metal/polymer semi-constrained cemented prosthesis

2) Submitter

Tornier Rue Doyen Gosse 38330 Saint Ismier - France

3) Applicant

Tornier, Inc. 7701 France Avenue South Edina MN 55345 - USA

4) Company contact

Tornier Mrs Séverine Bonneton Regulatory affairs Specialist 161, rue Lavoisier - Montbonnot 38334 Saint Ismier Cedex - France Tel: 00 33 4 76 61 35 00 Fax: 00 33 4 76 61 35 59 e-mail : severine.bonneton(@tornier.fr

Image /page/4/Picture/18 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is bold and geometric, with a unique design where the horizontal bar at the top is connected to the vertical stem in a way that creates an enclosed shape. The hexagon provides a clear border around the letter, making the logo distinct and recognizable.

TORNIER S.A.S. 161, rue Lavoisier - Montbonnot 38334 SAINT-ISMIER CEDEX FRANCE

Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33

Section 5 - Page 1/ page 6

S.A.S. au capital de 288 000 € SIRET : 070 501 275 000 13 R.C.S. : 070 501 275 CODE APE : 331 B

{5}------------------------------------------------

Page 2/6

5) Classification

For the Aequalis Shoulder Fracture System: Class II Device class: Classification panel: Orthopedic KWS Product code:

For the Aequalis Reversed Shoulder Prosthesis: Device class: Class II Classification panel: Orthopedic Product code: KWS

For the Aequalis Reversed Fracture Shoulder Prosthesis: Device class: Class II Classification panel: Orthopedic Product code: KWS

6) Equivalent / Predicate device

For the Aequalis Fracture Shoulder System: Aequalis Shoulder System, TORNIER SA, K952928, K041339, K043077, K060209 Aequalis Fracture Shoulder System, TORNIER SA, K994392, K003728, K032679, K043077, K060209

For the Aequalis Reversed Shoulder Prosthesis:

For the Aequalis Reversed Shoulder Prosthesis, TORNIER SA, K030941, K041873, K050316, K061439, K081059 Aequalis Shoulder System, TORNIER SA, K952928, K012212, K041339, K060209

For the Aequalis Reversed Fracture Shoulder Prosthesis:

For the Reversed Shoulder Prosthesis, TORNER SA, K030941, K041873, K050316, K061439, K081059 Aequalis Fracture Shoulder System, TORNIER SA, K994392, K003728, K032679, K043077, K060209. Delta Xtend Reverse Shoulder System, DEPUY, K062250, K071379. Delta Shoulder, DEPUY, K021478 Aequalis Reversed Adapter, TORNIER SA, K071948

Image /page/5/Picture/13 description: The image is a black and white logo. The logo consists of a hexagon shape with a stylized letter "T" inside. The "T" is bold and has a unique design, with the top part of the "T" appearing to be connected to the sides of the hexagon.

TORNIER S.A.S. 161, rue Lavoisier - Montbonnot 38334 SAINT-ISMIER CEDEX FRANCE

Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33

Section 5 - Page 2/ page 6

S.A.S. au capital de 288 000 € SIRET : 070 501 275 000 13 R.C.S. : 070 501 275 CODE APE : 331 B

{6}------------------------------------------------

Page 3/6

Implants Chirurgicaux

7) Device description

For the Aequalis Fracture Shoulder System:

The usual goal of total shoulder replacement and hemi-arthroplasty of the shoulder is to restore the shoulder joint to its best working condition and to reduce or eliminate pain. The Aequalis Shoulder Fracture System is intended to accomplish these goals. With the Aequalis Shoulder Fracture System, the natural glenoid elements of the shoulder may be conserved or replaced as warranted by the state of disease or injury. Thus the Aequalis Shoulder Fracture System is intended for use as a total shoulder replacement system, or as a hemi-shoulder. The modular nature of the system allows for the later conversion of a primary hemi-arthroplasty to a total shoulder replacement.

For the Aequalis Reversed Shoulder Prosthesis:

The Aequalis Reversed Shoulder Prosthesis is intended to relieve pain and significant disability following massive and non repairable cuff-tear associated to arthropathy and following massive cuff-tear arthropathy. In this case, the rotator muscles of the shoulder (supraspinatus, infraspinatus, teres minor and long head of the biceps) are no more useful for mobility, and only the deltoid (for abduction and external rotation) and the subscapularis (for internal rotation) are functional.

The Aequalis Reversed Shoulder Prosthesis is a semi-constrained system composed of a humeral and a glenoid parts.

For the Aequalis Reversed Fracture Shoulder Prosthesis:

The Aequalis Reversed Fracture Shoulder Prosthesis is intended to relieve pain or significant disability following massive cuff-tear associated to arthropathy and following massive cuff-tear arthropathy. In this case, the rotator muscles of the shoulder (supraspinatus, infraspinatus, teres minor and long head of the biceps) are no more useful for mobility, and only the deltoid (for abduction and external rotation) and the subscapularis (for internal rotation) are functional.

The Aequalis Reversed Fracture Shoulder Prosthesis is a semi-constrained system composed of a humeral and a glenoid parts.

Image /page/6/Picture/13 description: The image shows a logo with a stylized letter "T" inside a hexagon. The "T" is bold and has a unique design, with the top part of the "T" appearing to be connected to the vertical stem by a horizontal line. The hexagon is outlined in black and provides a border for the "T". The logo is simple, clean, and easily recognizable.

TORNIER S.A.S. 161, rue Lavoisier - Montbonnot 38334 SAINT-ISMIER CEDEX FRANCE

Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33

Section 5 - Page 3/ page 6

S.A.S. au capital de 288 000 € SIRET : 070 501 275 000 13 R.C.S. : 070 501 275 CODE APE : 331 B

{7}------------------------------------------------

Page 4/6

Implants Chirurgica

The present submission corresponds to the following modification:

Addition of a new coating subcontractor (hydroxyapatite coating): APS Materials, Inc. on . titanium components (stem and baseplate).
All the prostheses of this file are strictly identical to the previously cleared devices except for the coating supplier. The indications for use of each device are not modified.

8) Materials (modified components)

For the Aequalis Fracture Shoulder System:

The humeral implant is manufactured from titanium alloy (Ti6Al4V) according to ISO standard 5832-3

The hydroxyapatite coating conforms to the ASTM standard F1185.

For the Aequalis Reversed Shoulder Prosthesis:

The base of the glenoid implant is manufactured from titanium alloy (Ti6Al4V) according to ISO standard 5832-3.

The hydroxyapatite coating conforms to the ASTM standard F1185.

For the Aequalis Reversed Fracture Shoulder Prosthesis:

The humeral component is manufactured from titanium alloy (Ti6Al4V) according to ISO standard 5832-3.

The hydroxyapatite coating conforms to the ASTM standard F1185.

TORNIER S.A.S. 161. rue Lavoisier - Montbonnot 38334 SAINT-ISMIER CEDEX FRANCE

Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33

Section 5 - Page 4/ page 6

S.A.S. au capital de 288 000 € SIRET : 070 501 275 000 13 R.C.S. : 070 501 275 CODE APE : 331 B

{8}------------------------------------------------

. Page 5/6

9) Indications

Aequalis Shoulder Range (except Aequalis for Fracture):

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 ເ
Humeral head fracture
Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not i acceptable
· Revision surgery when other treatments or devices have failed.

Aequalis monobloc stem is for use with cemented applications and is labeled as such. Aequalis Press-Fit stem is for uncemented applications and is labeled as such. Glenoid component is for use with cemented applications ad is labeled as such.

Aequalis for Fracture:

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.

Aequalis fracture stem is for cemented use.

Aequalis Reversed Shoulder Prosthesis:

The Aequalis Reversed Shoulder Prosthesis is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated to massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. Only the humeral components are for cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.

When during the primary surgery the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemi-prosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis.

When, in case of revision of a Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to implant a base plate and a sphere of Aequalis Reversed range again, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed nem prosthesis into a non reversed hemi-prosthesis in order to avoid the revision of the humeral components

Image /page/8/Picture/18 description: The image shows a logo with a stylized letter "T" inside a hexagon. The "T" is bold and has a unique design, with a smaller, stylized "P" integrated into its structure. The logo is simple, clean, and likely represents a company or organization with initials "T" and "P".

TORNER S.A.S. 161, rue Lavoisier - Montbonnot 38334 SAINT-ISMIER CEDEX FRANCE

Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33

S.A.S. au capital de 288 000 € SIRET : 070 501 275 000 13

R.C.S. : 070 501 275

CODE APE : 331 B

Section 5 - Page 5/ page 6

{9}------------------------------------------------

Page 6/6

Implants Chirurgica

Aequalis Reversed Fracture Shoulder Prosthesis:

in case of 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, or

in case of bone defect in proximal humerus.

The Aequalis Reversed Fracture Shoulder Prosthesis is also indicated for prosthetic revisions with a grossly deficient rotator cuff joint when other treatments or devices have failed.

When, in case of revision of a Aegualis Reversed Fracture Shoulder Prosthesis, the glenoid bone stock appears to be insufficient to implant a base plate and a sphere of Aegualis Reversed range again, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed Fracture Shoulder Prosthesis into a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.

The Aequalis Reversed Fracture Shoulder humeral stem is used in association with the glenoid components of the Aequalis Reversed Shoulder Prosthesis.

The Aequalis Reversed Fracture Shoulder humeral stem is for cemented use only.

Section 5 - Page 6/ page 6

Image /page/9/Picture/12 description: The image shows a logo with a stylized letter "T" inside of a hexagon. The "T" is bold and black, and it appears to be a combination of two "T" shapes, one on top of the other. The hexagon is outlined in black and provides a border for the letter.

TORNIER S.A.S. 161, rue Lavoisier - Montbonnot 38334 SAINT-ISMIER CEDEX FRANCE

Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33

S.A.S. au capital de 288 000 € SIRET : 070 501 275 000 13 R.C.S. : 070 501 275 CODE APE : 331 B

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.”