AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM

K140082 · Tornier S.A.S. · PHX · Jul 18, 2014 · Orthopedic

Device Facts

• Record ID: K140082
• Device Name: AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM
• Applicant: Tornier S.A.S.
• Product Code: PHX · Orthopedic
• Decision Date: Jul 18, 2014
• Decision: SESE
• Submission Type: Traditional
• 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 ioints 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 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 avascu Jar 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; Noninflammatory 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 Shoulder System total shoulder replacement and for transformation of the Aequalis Assend Flex 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 arthropatly is associated with a massive and non-repairable rotator cuff-tear.

Device Story

Aequalis Ascend Flex Shoulder System is a modular shoulder prosthesis for anatomic or reverse total shoulder arthroplasty and hemiarthroplasty. System components include humeral stems (titanium, coated/uncoated), humeral heads (cobalt-chrome or titanium), glenoid components (UHMWPE), and reverse adapters (titanium tray/UHMWPE insert). Titanium humeral heads are specifically intended for patients with suspected cobalt alloy sensitivity. Device is implanted by orthopedic surgeons in a clinical/surgical setting. It replaces diseased or damaged shoulder joints to restore mobility, stability, and relieve pain. The system allows for conversion from anatomic to reverse configuration during revision surgery without removing a well-fixed humeral stem. Clinical benefit is achieved through mechanical joint replacement, restoring function to patients with severe joint pathology.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing: wear testing comparing Ti/UHMWPE and CoCr/UHMWPE couples, and fatigue testing for both anatomical and reversed configurations to ensure structural integrity under simulated lifetime loading conditions.

Technological Characteristics

Materials: Ti6Al4V (ISO 5832-3) for humeral heads, CoCr, UHMWPE. Fixation: Cemented or cementless (coated stems). Modular design with male taper geometry. Sterilization: Terminal sterilization. Dimensions: 37-54mm diameter, 13.5-27mm height. Connectivity: None (mechanical implant).

Indications for Use

Indicated for patients requiring shoulder joint replacement due to rheumatoid arthritis, non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), functional deformity, humeral head fractures, or traumatic arthritis. Anatomic configuration requires intact/reconstructable rotator cuff. Reverse configuration requires functional deltoid muscle and massive, non-repairable rotator cuff tear. Revision use requires sufficient bone stock.

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)
• Aequalis® Shoulder System (K952928)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

November 2, 2016

Tornier SAS Mr. Aymen Azaiez Regulatory Affairs Specialist 161 rue Lavoisier 38334 Montbonnot Cedex FRANCE

Re: K140082

Trade/Device Name: Aequalis™ Ascend™ Flex Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS, KWT, HSD Dated: June 17, 2014 Received: June 19, 2014

Dear Mr. Azaiez:

This letter corrects our substantially equivalent letter of July 18, 2014.

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

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Page 2 - Mr. Aymen Azaiez

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 [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" (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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) Ki40082

Device Name

AequalisTM AscendTM Flex Shoulder System

Indications for Use (Describe)

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 ioints 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 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 avascu Jar 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; Noninflammatory 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 Shoulder System total shoulder replacement and for transformation of the Aequalis Assend Flex 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 arthropatly is associated with a massive and non-repairable rotator cuff-tear.

Notes: All components are single use. The coated humeral stem is intented or cementless use, The non-coated humeral stem is intended for cemented use only, All poly glenoid components are intended use only; The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation 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.

Type of Use (Select one or both, as applicable) O Over-The-Counter Use (21 CFR 801 Subpart C) Prescription Use (Part 21 CFR 801 Subpart D)

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### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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# 510(k) SUMMARY

JUL 1 8 2014

## Summary of Safety and Effectiveness information

510(k) Premarket Notification - Aequalis™ Ascend™ Flex Shoulder System

Date prepared: July 17, 2014

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

#### 1) Device name

#### Trade name: Aequalis™ Ascend™ Flex Shoulder System Common name: Shoulder Prosthesis Classification name:

Classification name.

- Shoulder joint metal/polymer non-constrained

- · 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 metal/polymer semi-constrained cemented prosthesis are class II devices under 21 CFR 888.3660 (product code KWS) 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

#### 2) Submitter

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

#### 3) Company contact

Tornier Mr Aymen AZAIEZ Regulatory Affairs Specialist Tornier 161 rue Lavoisier 38330 Montbonnot Saint Martin- France

Fax: [phone] Tel: [phone] E-mail: [e-mail]

#### 4) Classification

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

#### 5) Equivalent / Predicate device

Tornier SAS: Aequalis™ Ascend™ Flex Shoulder System (K122698)

Tornier SAS: Aequalis® Shoulder System (K952928)

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#### K 140082 Page 2 of 5

#### 6) Device description

The Aequalis Ascend Flex Shoulder System consists of:

- . In a Anatomic configuration: A titanium humeral stem offered in Titanium Plasma Spray (Ti PS) coated and un-coated stem versions, a compatible humeral head (COCr) 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 with compatible Aequalis Reversed glenoid implants.

The reversed adapter is comprised of two components: a titanium tray and a UHMWPE reversed insert.

The Aequalis Reversed glenoid implants is comprised of four components: Baseplate: made from Titanium; Glenoid sphere; made from of CoCr; Screw (baseplate/to glenoid sphere): made from CoCr and Fixation screws: made from Titanium.

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. This submission corresponds to the addition of Titanium Humeral Heads in anatomic to the Aequalis™ Ascend™ Flex Shoulder System.

#### 7) Materials

The Aequalis™ Ascend™ Flex Shoulder System titanium humeral head is manufactured from Ti6Al/4 according to ISO 5832-3 standard.

#### 8) 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 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 bv:

- 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 rolator cuff-tear with pain disabled by:

- Rheumatoid arthritis .

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- 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 and 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.

## 9) Summary of technological characteristics

| Main features or system<br>characteristics | | Aequalis Ascend Flex Shoulder<br>System<br>Humeral Heads (titanium) | | Aequalis Ascend Flex Shoulder<br>System<br>Humeral Heads (Cobalt Chrome) | | Aequalis<br>Shoulder<br>System<br>Aequalis<br>Humeral Heads | SE? |
|--------------------------------------------|--------------|---------------------------------------------------------------------|----------------------------------------------------|--------------------------------------------------------------------------|----------------------------------------------------|-------------------------------------------------------------|-----|
| | | Aequalis<br>Humeral<br>Heads | Soft Tissue<br>Balancing<br>(STB) Humeral<br>Heads | Aequalis<br>Humeral<br>Heads | Soft Tissue<br>Balancing<br>(STB) Humeral<br>Heads | | |
| Material | | Ti6Al4V | | CoCr | | Ti6Al4V | Yes |
| Standard | | ISO 5832-3 | | ISO 5832-7 or<br>ISO 5832-12 | | ISO 5832-3 | Yes |
| Dimensions | Diameter | 37mm to<br>54mm | 39mm to<br>55.4mm | 37mm to<br>54mm | 39mm to<br>55.4mm | 39mm to<br>50mm | Yes |
| | Height | 13.5mm to<br>27mm | 13mm to<br>24mm | 13.5mm to<br>27mm | 13mm to<br>24mm | 14mm to<br>16mm | Yes |
| | Eccentricity | 1.5mm; 3.5mm and 4mm | | 1.5mm; 3.5mm and 4mm | | 2mm; 2.2mm;<br>2.3mm;<br>3mm;3.9mm et<br>4.7mm | Yes |
| Taper gender geometry | | Male | | Male | | Female | Yes |
| Manufacturer | | Tornier | | Tornier | | Tornier | Yes |
| Terminal sterilization | | Yes | | Yes | | Yes | Yes |
| K-number | | Pending | | K122698 | | K952928 | Yes |

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#### K140082 Page 4 of 5

The indications for use, the technical characteristics (manufacturing principle and method of fixation), the packaging and the sterilization process of they are similar or identical to the predicate devices.

#### 10) Non-clinical testing

Three non-clinical testing were realized on the titanium humeral heads:

- Wear test:
The aim of the test is to demonstrate that the Titanium humeral head remain intact during its lifetime. Therefore, we have tested the wear of the frictional couple Ti / UHMWPE and compared the results with those of the frictional couple CoCr/UHMWPE.

The results of this test are equivalent between the two frictional couples CoCr / UHMWPE (already used in the predicate device "Aequalis Ascend Flex Shoulder System") and TI / UHMWPE in terms of: weight loss, wear rate and shape and size of the particles generated.

Anatomical Fatigue Test:

The aim of the test is to show that the AequalisTM Ascend Flex Shoulder System in anatomical configuration remains intact during its lifetime. The assembly humeral head/ stem must resist in normal conditions of use.

After applying a load for SM cycles, we have observed neither fracture nor damage. Thus, the Aequalis™ Ascend Flex Shoulder System in anatomical configuration is validated with the titanium humeral head as is the case with the CoCr humeral head (predicate device).

Reversed fatique test: -

The aim of the test is to show that the Aequalis™ Ascend Flex Shoulder System in reversed configuration remains intact during its lifetime after revision from an anatomical configuration to a reversed configuration after a first lifetime in an anatomical configuration. The assembly humeral headl stem must resist in normal conditions of use.

After applying a load for SM cycles. we have observed neither fracture nor damage. Thus, the Aequalis™ Ascend Flex Shoulder in reversed configuration after revision from an anatomical configuration to a reversed configuration after a first lifetime in anatomical configuration with the titanium humeral head is validated as is the case with the CoCr humeral head (predicate device).

#### 11) Substantial equivalence conclusion

Substantial equivalence of the Aequalis Ascend Flex Shoulder System titanium humeral heads to the already cleared components of the predicates can be demonstrated on the following grounds, according to the FDA's Guidelines for Substantial Equivalence Decision Making Process:

- The Aequalis Ascend Flex Shoulder System titanium humeral heads are compared to the predicate . devices.
- The Aequalis Ascend Flex Shoulder System Tianium humeral heads have the same intended use and l the same indications for use as the cleared Aequalis Ascend Flex Shoulder System Cobals Chrome humeral heads.
- The Aequalis Ascend Flex Shoulder System titanium humeral heads have equivalent intended use and indications for use as Aequalis Shoulder System Aequalis Humeral Head in titunium.

Tomier

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- Major technological characteristics are equivalent between the Aequalis Ascend Flex Shoulder System titanium humeral heuds and the predicate devices:
- Equivalence of general features -
- Equivalent technological features: materials •
- Equivalent biomechanical features: mechanical characteristics, congruence of articular surfaces.
- Equivalent means of fixation (Taper gender geometry) -
- Equivalent prosthetic dimensions -

Therefore, in light of the above information, the company believes that the Aequalis Ascend Flex Shoulder System with itanium humerul heads may be cleared via the 510(k) notification process for use as shoulder prosthesis.