Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis

K151293 · Tornier S.A.S. · KWS · Sep 24, 2015 · Orthopedic

Device Facts

• Record ID: K151293
• Device Name: Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis
• Applicant: Tornier S.A.S.
• Product Code: KWS · Orthopedic
• Decision Date: Sep 24, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Aequalis Ascend Flex Shoulder System is intended for use as: A replacement of shoulder joints in primary anatomic or in primary reverse. A replacement of other shoulder joints devices in case of revisions if sufficient bone stock remains. The Aequalis Ascend Flex Shoulder System also allows for conversions from anatomic to reverse shoulder prosthesis in case of revision. The stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement, where it is intended to provide increased mobility and to relieve pain. The Aequalis Ascend Flex Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain. The Aequalis Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints disabled by: Rheumatoid arthritis with pain; Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis); Correction of functional deformity; Fractures of the humeral head; Traumatic arthritis; Revision of other devices if sufficient bone stock remains. IN REVERSE: The Aequalis Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by: Rheumatoid arthritis; Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis); Correction of functional deformity; Fractures of the humeral head; Traumatic arthritis; Revision of the devices if sufficient bone stock remains.

Device Story

The Aequalis Ascend Flex Shoulder System and Aequalis Reversed Shoulder Prosthesis are semi-constrained shoulder joint replacements. The system includes humeral stems (titanium, coated or uncoated), humeral heads (CoCr or titanium), glenoid components (UHMWPE), and reversed configurations (titanium tray, UHMWPE insert with titanium locking ring, and glenoid spheres). The device is used by surgeons in clinical settings to replace shoulder joints disabled by arthritis, fractures, or previous failed implants. The system allows for conversion between anatomic and reverse configurations without removing a well-fixed humeral stem. By replacing damaged articular surfaces with prosthetic components, the device aims to relieve pain, correct deformity, and restore mobility. The current submission adds new 33mm and 39mm reversed inserts and glenoid spheres to the existing product line.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on comparative analysis of technological characteristics, materials, and biomechanical design.

Technological Characteristics

System components: UHMWPE reversed inserts with Ti6Al4V locking rings; Ti6Al4V and CoCr glenoid spheres. Fixation: Uncemented glenoid components (screws), cemented or cementless humeral stems. Sterilization: Gamma radiation. Design: Semi-constrained shoulder prosthesis. Materials comply with standard orthopedic implant specifications.

Indications for Use

Indicated for patients with functional deltoid muscle and massive, non-repairable rotator cuff-tear, or those requiring primary anatomic/reverse shoulder replacement or revision of previous shoulder devices where sufficient bone stock remains. Conditions include rheumatoid arthritis, non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), functional deformity, humeral head fractures, and traumatic arthritis.

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.”

Predicate Devices

• Aequalis Ascend Flex Shoulder System (K122698, K140082)
• Aequalis Reversed Shoulder Prosthesis (K030941, K050316, K061439, K081059, K100142, K132285, K140478)
• Surgical Reverse Shoulder Prosthesis (RSP) (K041066, K051075, K092873, K112069, K140904)

Submission Summary (Full Text)

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

September 24, 2015

Tornier SAS Séverine Bonneton Regulatory Affairs Manager, New Products 161 Rue Lavoisier 38334 Montbonnot Saint Martin France

Re: K151293 Trade/Device Name: Aequalis™ Ascend™ Flex Shoulder System, Aequalis Reversed Prosthesis Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS. PHX, KWT, HSD Dated: August 25, 2015 Received: August 27, 2015

Dear Séverine Bonneton:

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 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

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Page 2 - Séverine Bonneton

Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 [phone] or [phone] 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" (21 CFR 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Mark N. Melkerson -S

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

Enclosure

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SPARTMENT OF HEATH AND HUUNN SEPICES udications for Use Food and Drug Administration

Expiration Date: January 31, 201 Form Approved: OMB No. 0910-0120 see PAA Statement below

K151793 510(k) Number (if known

Device Name

Asqualis PM Assending Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis

Indications for Use (Describe)

Device Name : Aequalis™ Ascend™ Flex Shoulder System Indications For Use:

SYSTEM INTENDED USE :

The Aequalis Ascend Flex Shoulder System is intended for use as:

A replacement of shoulder joints in primary anatomic or in primary reverse.

A 1 persones of other shoulder points devices in ease of revisions if sufficient bours stock remains.

case of revision. ai if siles Assessed Flex System also allows for conversions from andomic to reverse shoulder prostleris

sufficient bearing surface, or in conjunction with the glenoid, as a total replacement, s All All Clife the star and their de need by themselves, as a provinsion in MACUNACIAN NI

where it is intended to provide increased mobility and to relieve pain. The Assend Flex Shoulder System is to be used only in patients with an into to reconstructable rotator of the

The Assess Flex Shoulder System is indicated for use as replacement of Shoulder joints disabled by

- · Rheummatoid arthritis with pain
Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis

Correction of functional deformity

Fractures of the humeral head

Traumatic arthritis

· Revision of other devices if sufficient bone stock remains

IN REVERSE:

finations deloid muscle and with massive and non-repaired with pain disabled by: divis since 10 Floured to researches in in interest program in the shoulder joint in the Association in the mainents on in

Rheumatoid arthritis

- Non-Inflammatory degenerative joint disease (i.e. ostoorthritis and avasular necrosis

Correction of functional deformity

Fractures of the humeral head

Traumatic arthritis

- Revision of the devices if sufficient bone stock remains.

Notes: permitted to be used in the transformation from andomic to reverse if the humeral siem is well fixed, the patient has s the removal of the humeral stem during to patients with a functional delfoid muscle. The components are which issement and for the Asqualis Assend Flex Shoulder prostiness without respons later is indicated for use a components of the strong of the should be should should Innstional defroid muscle; the arthropatity is associated with a massive and non-repairable rotator cuff-fear.

all components are single use.

the coated humeral stem is intended for cemented or cementless use

- the non-coated humeral stem is for cemented use only.

the all-poly glenoid components are intended for cemented use only

the glenoid sphere implant is anchored to the bone with screws and is for non-cernented fixation.

of themium alloys are inferior to the interior to the result and is not recommended be patients who lack a suspected material sensitivity to cobalt alloy The were heads are intended for patients with alloy material sensitivity. The west propries of

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Indications For Use: Device Name: Aequalis Reversed Shoulder Prosthesis

Cemented Aequalis Reversed prosthesis:

of incented for the productions with massive offices. Only the huments components reversed hemi-prosthesis. minon screw can be adapted to the humers components in order to the Asqualis Reversed prostices into a non supper of while of while one fracture occurs during the surgical process, the hemicosthesis and the When during the primary surgery the glenoid bone stook appears to be insufficient to bear the reversed glenoid for for cemented use. The glenoid is anchored to the bone with is for non-cemented fixation inclined issubility to lowing arthropathy associated with the massive with the beviews. This bevice is If it is intelest paties with a fith a futus have a stotal body to the realise of the realise

of the the the sunstinent of the A secures in to a newsersed hemi-ones in one to rol to are the revision of the humeral components. implant a base plate and a sphere of Asquerses, the use of the trem-prosthesis adaptor and the think screw When in as of revision of a depublis Reversed process to be insufficient to again

Uncemented Aequalis Reversed prosthesis:

indicated on the first revisions with massive and non repairable colulior cuffice. The humorely and prosthesis. be to the humeral components in order to transform the Asqualis Reversed prosthers in to a non reversed hemiwiew short of surving during the surgical procedures, the features, the features and the unions screw and When diffing the primary surgent to be insufficient to be insufficient to bear the reversed genoid components a uncemented use. The glenoid is anchored to the bone with 4 screws and is for non-cenented fixation of also disellity following attropadly as sensive and non experiment for the device is also It is indicated for patients with a functional dellow musels as a total shoulder replacement for the relief of pain and

the revision of the humeral components. allows the transformation of the Asqualis Reversed prosthesis in to a non reversed hem-prosities: in order to svoil we in the a sphere of Asqualis Reversed range, the use of the field is and the union screen While in ease of revision of an Aequipelis, the glenoid pour stock appears to be insulfilizient to again

Note:

patients who lack a suspected material sensitivity to cobalt alloy of Titanium and Titanium alloys are interior to that of cobalt alloy. A Titamim glenoid spirere is not recommended for The war grouped spheres are intended for suspected cobalt alloy material sensitivity. The war properties

Type of Use (Select one or both, as applicable)

A Pressription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (2) CFR B01 Subpart C

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (B114

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Image /page/4/Picture/1 description: The image shows the logo for TORNIE. The first line of the logo is the word "TORNIER" in a large, bold, sans-serif font. The second line of the logo is the phrase "Implants Chirurgicaux" in a smaller, bold, sans-serif font. Both lines of text are in a dark blue color.

## Summary of Safety and Effectiveness information Special 510(k) Premarket - Aequalis™ Ascend™ Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis

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

Date prepared: September 17, 2015

| 1) Device name | |
|-----------------------------|--------------------------------------------------------|
| <b>Trade name:</b> | <i>Aequalis</i> ™ <i>Ascend</i> ™ Flex Shoulder System |
| <b>Common name:</b> | Shoulder Prosthesis |
| <b>Classification name:</b> | |

- Shoulder joint metal/polymer semi-constrained cemented prosthesis are class II devices under 21 . CFR 888.3660 (product code KWS ; PHX) and are classified by the Orthopedic Devices Panel
- Shoulder joint metal/polymer non-constrained cemented prosthesis are class II devices under 21 . CFR 888.3650 (product code KWT) and are classified by the Orthopedic Devices Panel
- Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis are class II devices under . CFR 888.3690 (product code HSD) and are classified by the Orthopedic Devices Panel

| Trade name: | Aequalis Reversed Shoulder Prosthesis |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common name: | Shoulder Prosthesis |
| Classification name: | Shoulder joint metal/polymer semi-constrained cemented prosthesis under 21CFR 888.3660 (product code PHX, KWS) and are classified by the Orthopedic Devices Panel |

2) Submitter : TORNIER SAS 161 rue Lavoisier 38330 Montbonnot Saint Martin- France Registration Number: 3000931034

3) Company contact : Tornier Mrs Séverine BONNETON Regulatory Affairs Manager, New Products 161, rue Lavoisier 38334 Montbonnot Saint-Martin - FRANCE Tel: [phone] Fax: [phone] E-mail: [e-mail]

Image /page/4/Picture/12 description: The image shows a logo with a stylized letter "T" inside a hexagon. The "T" is constructed from geometric shapes, giving it a modern and abstract appearance. The hexagon and the "T" are both colored in a light blue or lavender hue. The logo is simple and clean, suggesting a focus on design and possibly technology or innovation.

TORNIER S.A.S. 161, rue Lavoisier 38334 MONTBONNOT CEDEX FRANCE

Tél. : [phone] Fax : [phone]

S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 21 R.C.S. : 070 501 275 CODE APE : 3250 A

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#### 4) Classification

#### Aequalis™ Ascend™ Flex Shoulder System :

Device class: Class II Classification panel: Orthopedic Product code: KWS: PHX; KWT; HSD

#### Aequalis Reversed Shoulder Prosthesis :

| Device class: | Class II |
|-----------------------|------------|
| Classification panel: | Orthopedic |
| Product code: | PHX, KWS |

5) Equivalent / Predicate device : Aequalis™ Ascend™ Flex Shoulder System : Aequalis Ascend Flex Shoulder System, Tornier K122698, K140082

Aequalis Reversed Shoulder Prosthesis, Tornier, K030941, K050316, K061439, K08142, K132285, K140478

Surgical Reverse Shoulder Prosthesis (RSP), DJO, K041066, K051075, K092873, K112069, K140904

#### Aequalis Reversed Shoulder Prosthesis :

Aequalis Reversed Shoulder Prosthesis, TORNIER, K030941, K050316, K061439, K081059, K100142, K132285. K140478

Surgical Reverse Shoulder Prosthesis (RSP), DJO, K041066, K051075, K092873, K 112069, K140904

## 6) Device description : Aequalis™ Ascend™ Flex Shoulder System & Aequalis Reversed :

The Aequalis Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear.

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. It is a semi-constrained system composed of a humeral and a glenoid parts.

#### The Aequalis Ascend Flex Shoulder System consists of:

- . In an Anatomic configuration: A titanium humeral stem offered in Titanium Plasma Spray (Ti PS) coated and un-coated stem versions, a compatible humeral head (CoCr or titanium) with a compatible UHMWPE Aequalis glenoid; or UHMWPE Affiniti Anatomic glenoid.
The Aequalis Ascend Flex Shoulder System stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid, as a total shoulder joint replacement.

- In a Reversed configuration: a titanium humeral stem offered in Titanium Plasma Spray (Ti PS) coated and un-coated stem versions, a reversed adapter compatible with Aequalis Reversed glenoid implants (consisting of a sphere, a baseplate and screws). The reversed adapter consists of two
Image /page/5/Picture/20 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is constructed from geometric shapes, giving it a modern and abstract appearance. The hexagon and the 'T' are both light blue. The logo is simple and clean, making it easily recognizable.

TORNIER S.A.S. 161, rue Lavoisier 38334 MONTBONNOT CEDEX FRANCE

Tél. : [phone] Fax : [phone]

S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 21 R.C.S. : 070 501 275 CODE APE : 3250 A

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Image /page/6/Picture/1 description: The image shows the logo for Tornier Implants Chirurgicaux. The word "TORNIER" is in large, bold, blue font on the top line. The words "Implants Chirurgicaux" are in a smaller, bold, blue font on the second line.

components: a titanium tray and a UHMWPE reversed insert which includes a titanium locking ring.

This submission corresponds to the addition of new reversed inserts Aequalis Ascend Flex and glenoid spheres Aequalis Reversed II in diameter 33 mm and 39 mm compatible with each other. The indications for use, the materials, the manufacturing principle, the method of fixation, the packaging and the sterilization process of the pending reversed insert and glenoid spheres are identical or equivalent to the predicate devices.

#### 7) Materials :

#### AequalisTM Ascend™ Flex Shoulder System reversed inserts :

The new reversed inserts are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE), The reversed insert includes a locking ring which is manufactured form titanium (Ti6Al4V).

#### Aequalis Reversed Shoulder Prosthesis glenoid spheres:

The new glenoid spheres are manufactured from titanium alloy (Ti6Al4V) and chrome cobalt.

#### 8) Indications :

#### Aequalis™ Ascend™ Flex Shoulder System :

#### SYSTEM INTENDED USE :

The Aequalis Ascend Flex Shoulder System is intended for use as:

- A replacement of shoulder joints in primary anatomic or in primary reverse.
- A replacement of other shoulder joints devices in case of revisions if sufficient bone stock remains.
- . The Aequalis Ascend Flex Shoulder System also allows for conversions from anatomic to reverse shoulder prosthesis in case of revision.

IN ANATOMIC : The stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement.

The Aequalis Ascend Flex Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain.

The Aequalis Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints disabled by:

- . Rheumatoid arthritis with pain
- Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
- Correction of functional deformity
- Fractures of the humeral head
- . Traumatic arthritis

Image /page/6/Picture/31 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is formed by overlapping geometric shapes, creating a three-dimensional effect. The hexagon and the 'T' are both light blue. The logo is simple and modern.

TORNIER S.A.S. 161, rue Lavoisier 38334 MONTBONNOT CEDEX FRANCE

Tél. : [phone] Fax : [phone]

S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 21 R.C.S. : 070 501 275 CODE APE : 3250 A

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Image /page/7/Picture/1 description: The image shows the word "TORNIER" in large, bold, blue font. Below that, the words "Implants Chirurgicaux" are written in a smaller, bold, blue font. The text appears to be a logo or heading for a company or product related to surgical implants.

- Revision of other devices if sufficient bone stock remains ●
IN REVERSE : The Aequalis Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by:

- Rheumatoid arthritis
- . Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
- Correction of functional deformity
- Fractures of the humeral head
- Traumatic arthritis
- Revision of the devices if sufficient bone stock remains

The reversed adapter is indicated for use as components of the Aequalis Ascend Flex Shoulder System total shoulder replacement and for transformation of the Aequalis Ascend Flex Shoulder System into a reverse shoulder prosthesis without the removal of the humeral stem during revision surgery for patients with a functional deltoid muscle. The components are permitted to be used in the transformation from anatomic to reverse if the humeral stem is well fixed, the patient has a functional deltoid muscle; the arthropathy is associated with a massive and non-repairable rotator cuff-tear.

#### Notes:

- All components are single use.
- The coated humeral stem is intended for cemented or cementless use.
- . The non-coated humeral stem is intended for cemented use only.
- . All poly glenoid components are intended for cemented use only.
- . The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation.
- Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack a suspected material sensitivity to cobalt alloy.

#### Aequalis Reversed Shoulder Prosthesis :

#### Cemented Aequalis Reversed prosthesis :

It 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 with the 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 hemiprosthesis 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.

Image /page/7/Picture/22 description: The image shows a logo with a stylized letter "T" inside a hexagon. The "T" is constructed from geometric shapes, giving it a modern and abstract appearance. The hexagon and the "T" are both colored in a light purple or lavender hue, set against a white background. The logo is simple, clean, and visually appealing.

TORNIER S.A.S. 161, rue Lavoisier 38334 MONTBONNOT CEDEX FRANCE

Tél. : [phone] Fax : [phone]

S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 21 R.C.S. : 070 501 275 CODE APE : 3250 A

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# Implants Chirurgicaux

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

#### Uncemented Aequalis Reversed prosthesis:

It 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 cufftear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cufftear. The humeral components are for uncemented 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 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 in to a non reversed hemi-prosthesis.

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

Note:

- Titanium glenoid spheres are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of Titanium alloys are inferior to that of cobalt alloy. A Titanium glenoid sphere is not recommended for patients who lack a suspected material sensitivity to cobalt alloy.

| Main features<br>or system<br>characteristics | Aequalis Ascend<br>Flex Shoulder<br>System reversed<br>configuration<br>(pending reversed<br>inserts) | Aequalis Ascend Flex<br>Shoulder System<br>reversed configuration<br>(cleared reversed<br>inserts) | Aequalis Reversed<br>Shoulder<br>Prosthesis<br>(reversed inserts) | Surgical Reverse Shoulder<br>Prosthesis (RSP)<br>(reversed inserts) |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|---------------------------------------------------------------------|
| Material | Polyethylene<br>+titanium (locking<br>ring) | Polyethylene +titanium<br>(locking ring) | Polyethylene | Polyethylene |
| Reversed insert<br>diameters | 33mm, 39 mm | 36 mm, 42 mm | 36 mm, 42 mm | 32 mm, 36 mm, 40 mm |
| Method of<br>fixation<br>Glenoid<br>components | Uncemented | Uncemented | Uncemented | Unknown |
| Terminal<br>sterilization | Gamma | Gamma | Gamma | Unknown |
| Manufacturer | Tornier | Tornier | Tornier | DJO |
| K-number | pending | K122698 | K030941,K050316,<br>K061439,K081059,<br>K100142, K140478 | K041066,K051075,<br>K092873,K112069, K140904 |

### 9) Summary of technological characteristics

#### Aequalis™ Ascend™ Flex Shoulder System reversed inserts :

The indications for use, the materials, the manufacturing principle, the method of fixation, the packaging and the sterilization process of the pending reversed insert are identical or equivalent to the predicate devices.

Image /page/8/Picture/13 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is constructed from geometric shapes, giving it a modern and abstract appearance. The hexagon and the 'T' are both colored in a light shade of blue or purple. The logo is simple, clean, and likely represents a company or organization whose name starts with the letter 'T'.

TORNIER S.A.S. 161, rue Lavoisier 38334 MONTBONNOT CEDEX FRANCE

Tél. : [phone] Fax : [phone]

S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 21 R.C.S. : 070 501 275 CODE APE : 3250 A

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

#### Aequalis Reversed Shoulder Prosthesis glenoid spheres :

| Main features or system<br>characteristics | Aequalis Reversed II<br>(pending glenoid spheres) | Aequalis Reversed<br>II (cleared glenoid<br>spheres) | Surgical Reverse Shoulder<br>Prosthesis (RSP spheres ) |
|--------------------------------------------|---------------------------------------------------|------------------------------------------------------------|--------------------------------------------------------|
| Material | Titanium, CoCr | Titanium, CoCr | CoCr |
| Glenoid sphere diameters | 33mm, 39mm | 36mm, 42mm | 32 mm, 36mm, 40 mm |
| Method of fixation with the<br>base plate | Taper + Glenoid sphere<br>Screw | Taper + Glenoid<br>sphere Screw | Taper + Glenoid sphere<br>Screw |
| Method of fixation glenoid<br>components | Uncemented | Uncemented | Unknown |
| Terminal sterilization | Gamma | Gamma | Unknown |
| Manufacturer | Tornier | Tornier | DJO |
| K-number | Pending | K030941, K050316,<br>K061439, K081059,<br>K100142, K140478 | K041066, K051075,<br>K092873, K112069,<br>K140904 |

The indications for use, the materials, the manufacturing principle, the method of fixation, the packaging and the sterilization process of the pending glenoid spheres are identical or equivalent to the predicate devices.

#### 10) Non-clinical testing

NA

### 11) Substantial conclusion equivalence

Based upon this comparative study, substantial equivalence of the new Aequalis™ Ascend™ Flex reversed inserts and the new Aequalis Reversed glenoid spheres to the predicates can be demonstrated on the following grounds, according to the FDA's Guidelines for Substantial Equivalence Decision Making Process:

- The new Aequalis™ Ascend™ Flex reversed inserts and the new Aequalis Reversed II glenoid spheres are compared to the predicate devices.
- The new Aequalis™ Ascend™ Flex reversed inserts and the new Aequalis Reversed II glenoid spheres have the same intended use as the cleared predicates and have very similar indications for use.
- Major technological characteristics are equivalent between new Aequalis™ Flex reversed inserts and their predicate devices and the new Aequalis Reversed glenoid spheres and their predicate devices:
- Equivalence of general features
- -Equivalent materials,
- -Equivalent biomechanical features: mechanical characteristics, congruence of articular surfaces,
- Equivalent means of fixation -
- -Equivalent prosthetic dimensions

Therefore, in light of the above information, the new Aequalis™ Ascend™ Flex reversed inserts and the new Aequalis Reversed II glenoid spheres are found to be equivalent to their predicate devices respectively.

Image /page/9/Picture/18 description: The image shows a logo with a stylized letter "T" inside a hexagon. The "T" is formed by two overlapping shapes, creating a three-dimensional effect. The hexagon and the "T" are both light blue. The logo is simple and modern.

TORNIER S.A.S. 161, rue Lavoisier 38334 MONTBONNOT CEDEX FRANCE

Tél. : [phone] Fax : [phone]

S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 21 R.C.S. : 070 501 275 CODE APE : 3250 A