(132 days)
Not Found
No
The document describes a mechanical shoulder implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is intended for the replacement of shoulder joints, aiming to provide increased mobility, stability, and pain relief for patients suffering from various conditions like arthritis, avascular necrosis, fractures, and rotator cuff tears. These are all therapeutic outcomes.
No
The device is a system of shoulder joint replacements, indicated for surgical implantation to replace damaged shoulder joints. It is a therapy device, not a diagnostic one.
No
The device description clearly states it is a system of physical components (humeral stem, head, glenoid, adapter, sphere, baseplate, screws) intended for surgical implantation as a shoulder joint replacement. It does not describe any software component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use clearly state that the Aequalis Ascend Flex Shoulder System and Aequalis Reversed Shoulder Prosthesis are implants designed to replace or revise shoulder joints. They are surgically implanted into the body to restore function and relieve pain.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze any biological specimens. Its function is purely mechanical and structural within the body.
Therefore, this device falls under the category of a surgical implant or prosthesis, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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:
- . 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 : 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.
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
KWS. PHX, KWT, HSD
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 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint
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)
Non-clinical testing, No further details provided.
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.
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
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.
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure.
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
1
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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (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 (800) 638-2041 or (301) 796-7100 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
2
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
3
| 10 -7 |
|---|
| I |
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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Page 2 of 2
information unless if displays a currently valid OMB number."
FORM FDA 3881 (B114
4
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 | |
|---|---|
| Trade name: | Aequalis ™ Ascend ™ Flex Shoulder System |
| Common name: | Shoulder Prosthesis |
| Classification name: |
- 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 |
-
Submitter : TORNIER SAS 161 rue Lavoisier 38330 Montbonnot Saint Martin- France Registration Number: 3000931034
-
Company contact : Tornier Mrs Séverine BONNETON Regulatory Affairs Manager, New Products 161, rue Lavoisier 38334 Montbonnot Saint-Martin - FRANCE Tel: 00 33 4 76 61 35 51 Fax: 00 33 4 76 61 35 59 E-mail: severine.bonneton@tornier.com
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. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33
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
5
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 |
- 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. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33
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
6
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. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33
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
7
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.
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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
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. Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
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Correction of functional deformity
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Fractures of the humeral head
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Traumatic arthritis
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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. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33
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
8
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
or system
characteristics | Aequalis Ascend
Flex Shoulder
System reversed
configuration
(pending reversed
inserts) | Aequalis Ascend Flex
Shoulder System
reversed configuration
(cleared reversed
inserts) | Aequalis Reversed
Shoulder
Prosthesis
(reversed inserts) | Surgical Reverse Shoulder
Prosthesis (RSP)
(reversed inserts) |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|---------------------------------------------------------------------|
| Material | Polyethylene
+titanium (locking
ring) | Polyethylene +titanium
(locking ring) | Polyethylene | Polyethylene |
| Reversed insert
diameters | 33mm, 39 mm | 36 mm, 42 mm | 36 mm, 42 mm | 32 mm, 36 mm, 40 mm |
| Method of
fixation
Glenoid
components | Uncemented | Uncemented | Uncemented | Unknown |
| Terminal
sterilization | Gamma | Gamma | Gamma | Unknown |
| Manufacturer | Tornier | Tornier | Tornier | DJO |
| K-number | pending | K122698 | K030941,K050316,
K061439,K081059,
K100142, K140478 | K041066,K051075,
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. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33
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
characteristics | Aequalis Reversed II
(pending glenoid spheres) | Aequalis Reversed
II (cleared glenoid
spheres) | Surgical Reverse Shoulder
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
base plate | Taper + Glenoid sphere
Screw | Taper + Glenoid
sphere Screw | Taper + Glenoid sphere
Screw |
| Method of fixation glenoid
components | Uncemented | Uncemented | Unknown |
| Terminal sterilization | Gamma | Gamma | Unknown |
| Manufacturer | Tornier | Tornier | DJO |
| K-number | Pending | K030941, K050316,
K061439, K081059,
K100142, K140478 | K041066, K051075,
K092873, K112069,
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. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33
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