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 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. 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. Acqualis 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. 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 prosthesis into a non reversed hemi-prosthesis in order to avoid the revision of the humeral components. 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 hemiprosthesis. 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 Aequalis Reversed Fracture Shoulder humeral stem is for cemented use only.
Device Story
Modular shoulder prosthesis system; includes humeral stems, glenoid components, and adapters. Designed for total shoulder replacement or hemi-arthroplasty. Reversed design medializes center of rotation to lengthen deltoid lever arm; restores function in patients with deficient rotator cuffs. Used in orthopedic surgery; implanted by surgeons. Provides structural replacement of glenohumeral joint; relieves pain; restores mobility. Modular components allow conversion between reversed and non-reversed configurations during primary or revision surgery if glenoid bone stock is insufficient. Humeral stems available for cemented or uncemented fixation depending on model.
Clinical Evidence
No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics.
Technological Characteristics
Materials: Titanium alloy (Ti6Al4V) per ISO 5832-3. Coating: Hydroxyapatite per ASTM F1185. System: Semi-constrained shoulder prosthesis. Components: Humeral stems, glenoid baseplates, spheres, adapters. Fixation: Cemented or uncemented (press-fit) depending on stem type; glenoid baseplate uses 4 screws (non-cemented).
Indications for Use
Indicated for patients with severe shoulder pain/disability due to degenerative pathologies (arthrosis, rheumatoid arthritis, post-traumatic arthrosis), humeral head necrosis, or fractures (displaced 3/4-part proximal humeral, humeral head). Reversed systems indicated for patients with functional deltoid and massive/non-repairable rotator cuff tears or grossly deficient rotator cuff joints, including fracture or bone defect cases. Applicable for primary replacement or revision surgery.
Regulatory Classification
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).
Special Controls
*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.”
{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 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.
{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.
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.
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
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<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
1) 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.
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.
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:
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 hemiprosthesis.
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
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TORNIER S.A.S. 161, rue Lavoisier - Montbonnot 38334 SAINT-ISMIER CEDEX FRANCE
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Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
