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 ouff. where it is intended to provide increased mobility 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.

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 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.

Device Description

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 System is intended to relieve pain and significant disability following massive and non repairable cuff-tear associated to arthropathy and following massive cuff-tear arthroplasty. 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) 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.

This submission corresponds to the addition of 135° & 140° reversed final angle combinations and the Inlay technique, in addition to the existing 145° angle without any change in the implants design.

AI/ML Overview

This FDA 510(k) summary describes a modification to an existing device, the Aequalis™ Ascend™ Flex Shoulder System. The submission adds new reversed final angle combinations (135° & 140°) and an "Inlay" surgical technique to the existing system. The document explicitly states that clinical studies were not required to demonstrate substantial equivalence, relying instead on non-clinical performance testing. Therefore, the information typically requested about acceptance criteria, study design, and performance metrics for a clinical study is not available in these documents.

Here's a breakdown of the available information based on your request, with explicit notes about what is not provided due to the nature of this 510(k):

1. A table of acceptance criteria and the reported device performance

No specific acceptance criteria or reported device performance metrics from a clinical study are provided.
The document states that "Non-clinical bench testing and process validations were performed to demonstrate substantial equivalence... Fatigue test in anatomic and reversed configuration." This implies that the acceptance criteria would be related to mechanical properties (e.g., fatigue strength) and met by the test results, but the specific criteria and performance values are not detailed in this summary.

2. Sample size used for the test set and the data provenance

Not applicable. Since clinical studies were not performed, there is no "test set" in the context of human subjects or patient data.
For the non-clinical bench testing (fatigue testing), the sample size of the devices tested is not specified. The data provenance would be laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical ground truth was established from a patient test set for this 510(k) submission.

4. Adjudication method for the test set

Not applicable. No clinical ground truth was established from a patient test set, so no adjudication method was employed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a shoulder prosthesis, not an AI-assisted diagnostic or imaging device. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a medical implant, not an algorithm, and does not have a "standalone" or "human-in-the-loop" performance in the context of AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable for a clinical ground truth. The "ground truth" for this submission refers to the established safety and effectiveness of the predicate device, which the modified device is compared against. The primary "ground truth" for the new configurations is the demonstration through non-clinical bench testing that they perform equivalently to the predicate.

8. The sample size for the training set

Not applicable. Since clinical studies were not performed, there is no "training set" in the context of patient data.

9. How the ground truth for the training set was established

Not applicable. As above, no clinical training set was used.

Summary of the study that proves the device meets acceptance criteria (Non-clinical context):

The device (Aequalis™ Ascend™ Flex Shoulder System with new 135° & 140° reversed final angle combinations and Inlay technique) achieves substantial equivalence to its predicate device (Aequalis™ Ascend™ Flex Shoulder System, K122698, K151293) based on non-clinical bench testing.

Nature of the study: The study involved fatigue testing in both anatomic and reversed configurations.
Rationale: The submission states, "The new combinations do not raise new issues of safety or effectiveness and are supported by performance testing." It further emphasizes, "The subject device has the same design of implants, the same materials, the same manufacturing principle, the same method of fixation, the same packaging and the same sterilization process as the predicate device."
Conclusion: The results of the performance testing (specifically, fatigue testing) for the new angle combinations "support substantial equivalence to the current Aequalis Ascend Flex Shoulder System (K122698, K151293)."

Essentially, the "study" was a series of mechanical tests to confirm that the new configurations did not compromise the established mechanical integrity and performance of the existing, cleared device. The specific parameters and results of these fatigue tests are not disclosed in this public 510(k) summary, but the FDA's clearance indicates that these tests were sufficient to demonstrate substantial equivalence.

Summary

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June 12, 2019

Tornier SAS Lamia Askri Regulatory Affairs Specialist 161 rue Lavoisier 38330 Montbonnot Saint Martin France

Re: K190521

Trade/Device Name: Aequalis™ Ascend™ Flex Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder ioint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, KWT, HSD, PHX Dated: May 6, 2019 Received: May 13, 2019

Dear Lamia Askri:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

CAPT Raquel Peat, PhD, MPH, USPHS For: Director OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K190521

Device Name

Aequalis Ascend Flex Shoulder System

Indications for Use (Describe)

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.

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.

Notes:

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-cemented fixation.
Titanium humeral heads are intended for patients with suspected sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for

FORM FDA 3881 (7/17)

PSC Publishing Services (301) 443-6740 EF

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patients who lack a suspected material sensitivity to cobalt alloy.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Aequalis Ascend Flex Shoulder System

Section 4 - page 3 / page 3

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Summary of Safety and Effectiveness information Special 510(k) Premarket - Aequalis Ascend Flex Shoulder System

Regulatory authority: Safe Medical Devices Act of 1990, 21 CFR 807.92 Date Prepared: February 28,2019

Administrative Information

Name:	Tornier SAS
Address:	161 rue Lavoisier38330 Montbonnot Saint MartinFrance

Contact Person:	Lamia ASKRI
Title:	Regulatory Affairs Specialist
Phone:	+33476613540
Fax:	+33476613533
Email:	lamia.askri@wright.com

Device Information

Name of Device:	Aequalis TM Ascend TM Flex Shoulder System
Common Name (s):	Shoulder Prosthesis
Regulatory Class:	Class II
Regulation:	21 CFR § 888.3660, Shoulder joint metal/polymer semi-constrainedcemented prosthesis.
Product Codes:	KWS, KWT, HSD, PHX

Predicate Device Information

Predicate:	Aequalis™ Ascend™ Flex Shoulder System
510(k) Number:	K122698, K151293

Device Description:

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 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) 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

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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.

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.

Indications For Use

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 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:

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

Section 11 - page 2 / page 5

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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.

Comparison of Technological Characteristics with the Predicate Device

The proposed changes to the predicate device include the addition of 135° & 140° reversed final angle and an alternate surgical option (Inlay), in addition to the existing 145° angle. These changes consist of added stem/ insert combinations without any change in the implants design. The subject device has the same design of implants, the same materials, the same manufacturing principle, the same method of fixation, the same packaging and the same sterilization process as the predicate device.

The new combinations do not raise new issues of safety or effectiveness and are supported by performance testing.

Non-clinical Performance Testing

Non-clinical bench testing and process validations were performed to demonstrate substantial equivalence of the subject device to the predicate device.

Fatigue test in anatomic and reversed configuration .

Clinical Testing

Clinical studies were not required to demonstrate substantial equivalence between the subject device and the predicate device.

Conclusions

The AequalisTM Ascend™ Flex Shoulder System does not raise new questions of safety or effectiveness. with performance testing. The results of performance testing for the new angle combinations of the Aequalis Ascend Flex Shoulder System support substantial equivalence to the current Aequalis Ascend Flex Shoulder System (K122698, K151293).

Section 11 - page 3 / page 5

Regulation Number and Section

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”