K Number
K061439
Device Name
AEQUALIS REVERSED PROSTHESIS
Manufacturer
Date Cleared
2006-07-20

(57 days)

Product Code
Regulation Number
888.3660
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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 prosthesis into a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.
Device Description
The Aequalis Reversed Shoulder Prosthesis is a semi-constrained system composed of a humeral and a glenoid parts. The present device modification submission consists in some additions and changes for metaphyseal screw, glenoid baseplate, glenoid sphere and insert. Metaphyseal inserts are made of ultra high molecular weight polyethylene (UHMWPE). The base of the glenoid implant is manufactured from Titanium alloy. The sphere is manufactured from Cobalt-Chromium alloy and the screw is manufactured from Titanium alloy. The hydroxylapatite coating conforms to the ASTM standard F 1185. The coating is performed by BioCoat, Inc. according to their Master File MAF-339.
More Information

No
The document describes a mechanical shoulder prosthesis and its components. There is no mention of software, algorithms, or any technology related to AI or ML.

Yes

The device is a total shoulder replacement indicated for the relief of pain and significant disability, which directly addresses a medical condition to improve health.

No

The Aequalis Reversed Shoulder Prosthesis is a medical implant designed for total shoulder replacement to relieve pain and disability, not for diagnosing conditions.

No

The device description clearly states it is a "semi-constrained system composed of a humeral and a glenoid parts" and lists various physical components made of materials like Titanium alloy, Cobalt-Chromium alloy, and UHMWPE. This indicates it is a physical implant, not a software-only device.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body.
  • Device Description: The provided text describes a surgical implant - a shoulder prosthesis designed to be surgically implanted into a patient's body to replace a damaged shoulder joint.
  • Intended Use: The intended use clearly states it's a "total shoulder replacement" for the relief of pain and disability. This is a therapeutic intervention performed within the body.

The device is a medical device, but it falls under the category of implantable devices or surgical devices, not In Vitro Diagnostics.

N/A

Intended Use / Indications for Use

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 prosthesis into a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.

Product codes (comma separated list FDA assigned to the subject device)

KWS

Device Description

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, 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 rotation 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.

The present device modification submission consists in some additions and changes for metaphyseal screw, glenoid baseplate, glenoid sphere and insert.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Shoulder

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K030941, K041873, K050316

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K952928, K012212, K041339, K060209, K021478

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.”

0

JUL 20 2006

1061439 (pg 1 of 2) Implants Chirurgicaux

Summary of Safety and Effectiveness information Special 510(k) Premarket Notification - Aegualis Reversed Shoulder Prosthesis

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

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

  2. Submitter Tornier Rue Doven Gosse 38330 Saint Ismier - France

3) Company contact

Tornier Mrs Mireille Lémery Regulatory affairs Manager 161, rue Lavoisier - Montbonnot 38334 Saint Ismier Cedex - France Tel: 00 33 4 76 61 38 98 Fax: 00 33 4 76 61 35 33 e-mail : mireille lemery@tornier.fr

  1. Classification Device class: Class II Classification panel: Orthopedic Product code: KWS

  2. Equivalent / Predicate device

Aequalis Reversed Shoulder Prosthesis, TORNIER SA, K030941, K041873, K050316 Aequalis Shoulder System, TORNIER SA, K952928, K012212, K041339, K060209 Delta Shoulder, DePuy Inc, K021478

6) Device description

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, 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

Image /page/0/Picture/14 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. The logo is simple and monochromatic, with a clean and modern aesthetic. The hexagon provides a defined border for the central 'T' symbol.

Tél. : 33 (0)4 76 61 35 00 TORNIER S.A.S. 161, rue Lavoisier - Montbonnot Fax : 33 (0)4 76 61 35 33 38334 SAINT-ISMIER CEDEX FRANCE

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

Page 1/ page 2

1

K06)439 (pg 2 of 2)

goals. Its reversed design allows to medialize the center of rotation 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.

The present device modification submission consists in some additions and changes for metaphyseal screw, glenoid baseplate, glenoid sphere and insert.

7) Materials

Metaphyseal inserts are made of ultra high molecular weight polyethylene (UHMWPE). The base of the glenoid implant is manufactured from Titanium alloy. The sphere is manufactured from Cobalt-Chromium alloy and the screw is manufactured from Titanium alloy.

The hydroxylapatite coating conforms to the ASTM standard F 1185. The coating is performed by BioCoat, Inc. according to their Master File MAF-339.

8) Indications

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 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.

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 hemiprosthesis 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.

Image /page/1/Picture/12 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, geometric shape integrated into its upper portion. The logo is black and white, with the 'T' standing out against the white background 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

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

Page 2/ page 2

2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the bird-like figure. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 20 2006

Tornier S.A.S % Mireille Lemery Regulatory Affairs Manager 161, Rue Lavoisier - Montbonnot 38334 Saint-Ismier Cedex France

Re: K061439

Trade/Device Name: Aequalis Reversed Shoulder Prosthesis Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS Dated: June 30, 2006 Received: July 3, 2006

Dear Ms. Lemery:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rowed your be received the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) is ttgeenactment date of the Medical Device Amendments, or to conimer to rial to rial to rise and 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 r ou may, aterers, interes of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is elaborned toor as courols. 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 Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

3

Page 2 - Ms. Mireille Lemery

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at 240-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Invelmo

Mark N. Melkerson Director Division of Generative, Restorative And Neurological Devices Center for Devices and Radiological Health

Enclosure

4

Indications for Use

Kob1431

510(k) Number (if known):

Device Name: Aequalis Reversed Shoulder Prosthesis

Indications For Use:

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 when darmy the primary over 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 the union the Aequalis Reversed prosthesis into a non reversed hemiprosthesis.

When, in case of revision of a Aequalis Reversed prosthesis, the glenoid bone which, in base of roinsufficient 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.

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)

signature

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

Page 1 of 1
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Tornier510(k) NumberSection 4
K961439