(169 days)
No
The document describes a shoulder prosthesis system and its intended uses, focusing on the physical components and surgical procedures. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The submission is for a modification related to a coating subcontractor, not a change in functionality or technology.
Yes
The device is a prosthetic replacement indicated to relieve severe pain or significant disability caused by various degenerative pathologies, fractures, or failed previous treatments. The stated goal for all included devices in the description is to "restore the shoulder joint to its best working condition and to reduce or eliminate pain", which directly aligns with the definition of a therapeutic purpose.
No
This device is a prosthetic implant (shoulder replacement system) intended to relieve pain and disability, not to diagnose a condition. Its function is to replace damaged anatomical structures.
No
The device description clearly indicates that this submission is for physical shoulder prostheses (implants) and their coatings, not software.
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: The text clearly describes the Aequalis Shoulder Fracture System and related devices as prosthetic replacements for the shoulder joint. These are implanted devices used to restore function and relieve pain in the shoulder.
- Intended Use: The intended use is to replace damaged or diseased parts of the shoulder joint due to various conditions like fractures, arthritis, and necrosis. This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
The device is a medical device, specifically a prosthetic implant, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Aequalis Shoulder Fracture System & Aequalis Resurfacing Head:
Aequalis Range :
Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by:
- Degenerative pathologies: arthrosis, rheumatoid arthritis, post-traumatic arthrosis. Primary and secondary necrosis of the humeral head
- Displaced 4-part upper humeral fracture
- Humeral head fracture
- Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable
- Revision surgery when other treatments or devices have failed.
Aequalis monobloc stem is for uncemented use only. The Aequalis press-Fit stem is for uncemented use only. The glenoid component is for cemented use only.
Aequalis Fracture range:
- Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint, including humeral head fracture and displaced 3-or 4-part proximal humeral fractures.
- Revisions when other devices or treatments have failed.
The Aequalis fracture stem is for cemented use only. The glenoid component is for cemented use only.
Aequalis Resurfacing Head range:
The resurfacing implant is indicated as a total or hemi shoulder joint replacement where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or reconstructable.
The replacement of the joint with this device is indicated to relieve severe pain or significant disability caused by degenerative pathologies: osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, primary and secondary necrosis of the humeral head.
The resurfacing implant is intended for uncemented use only. The glenoid component is for cemented use only.
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.
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 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 cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. The humeral components are for non-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 stock appears to be insufficient to bear the reversed whose 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 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 hemiprosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosinesis in to a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.
Aequalis Reversed Fracture Shoulder Prosthesis
The Aequalis Reversed Fracture Shoulder Prosthesis is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain or significant disability following arthropathy associated to a grossly deficient rotator cuff joint:
- in case of traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint, including humeral head fracture and displaced 3-or 4-part proximal humeral fractures, or
- in case of bone defect in proximal humerus.
The Aequalis Reversed Fracture Shoulder Prosthesis is also indicated for prosthetic revisions with a grossly deficient rotator cuff joint when other treatments or devices have failed.
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 Fracture Shoulder Prosthesis into a non reversed hemi-prosthesis.
When, in case of revision of a Aequalis Reversed Fracture Shoulder 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 Fracture Shoulder Prosthesis into a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.
The Aequalis Reversed Fracture Shoulder humeral stem is used in association with the glenoid components of the Aequalis Reversed Shoulder Prosthesis.
The Aequalis Reversed Fracture Shoulder humeral stem is for cemented use only.
Product codes
PHX, KWS, HSD
Device Description
For the Aequalis Shoulder Fracture System:
The usual goal of total shoulder replacement and hemi-arthroplasty of the shoulder is to restore the shoulder joint to its best working condition and to reduce or eliminate pain. The Aequalis Shoulder Fracture System is intended to accomplish these goals. With the Aequalis Shoulder Fracture System, the natural glenoid elements of the shoulder may be conserved or replaced as warranted by the state of disease or injury. Thus the Aequalis Shoulder Fracture System is intended for use as a total shoulder replacement system, or as a hemi-shoulder. The modular nature of the system allows for the later conversion of a primary hemi-arthroplasty to a total shoulder replacement.
For the Aequalis Reversed Shoulder Prosthesis:
The Aequalis Reversed Shoulder Prosthesis is intended to relieve pain and significant disability following massive and non repairable cuff-lear associated to arthropathy and following massive cuff-lear arthropathy. In this case, the rotator muscles of the shoulder (supraspinatus. infraspinatus, 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 Acqualis Reversed Shoulder Prosthesis is a semi-constrained system composed of a humeral and a glenoid parts.
For the Aequalis Reversed Fracture Shoulder Prosthesis:
The Aequalis Reversed Fracture Shoulder Prosthesis is intended to be used to relieve pain or significant disability following massive cuff-tear associated to arthropathy and following massive cuff-tear arthropathy. In this case, the rotator nuscles 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 Fracture 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 and its Aequalis Fracture Shoulder humeral stemlike design allows to facilitate the bone reconstruction and improve the tuberosity healing and fixation. The Acqualis Reversed Fracture Shoulder Prosthesis is a semi-constrained system composed of a humeral and a glenoid parts.
For the Aequalis Resurfacing Head:
The Aequalis Resurfacing Head is a humeral head resurfacing device. It requires less bone and cartilage removal, which makes it much more conservative than total joint implants. Revision or arthrodesis can be undertaken easily because the bone stock has been maintained with no loss of length. The main advantages of humeral head resurfacing are preservation of bone and the relatively simple surgical technique.
With the Aequalis Resurfacing Head the natural glenoid elements of the shoulder may be conserved or replaced as warranted by the state of disease or injury.
The present submission corresponds to the following modification:
- Addition of a new coating subcontractor (hydroxylapatite coating and titanium + hydroxylapatite coating): Eurocoating S.p.A on cobalt chromium and titanium components.
All the prostheses of this application are strictly identical to the previously cleared devices except for the coating supplier. The indications for use of each device are not modified.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint, humeral head, glenohumeral joint, proximal humerus
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 (shear fatigue strength, static shear strength test, static tensile strength and abrasion) and coating characterization (thickness, pore size and pore volume) were performed on the coating to determinate substantial equivalence.
The design, the material, the sizes, the method of fixation and the sterilization process are identical for devices whatever the coating subcontractor is.
The results of this evaluation allow us to conclude that the proposed new coating subcontractor Eurocoating S.p.A described in this submission does not induce any new or higher risk compared to the predicate coating subcontractor BioCoat Company and therefore both coating subcontractors (proposed and predicate) are substantially equivalent.
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.
K060209, K100142, K082120, K062661
Reference Device(s):
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 & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2016
Tornier SAS Mrs. Severine Bonneton Project Regulatory Affairs Coordinator 161 rue Lavoisier 38334 Montbonnot Cedex FRANCE
Re: K131231
Trade/Device Name: Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis Reversed Fracture Shoulder Prosthesis, Aequalis Resurfacing Head Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS, HSD Dated: September 19, 2013 Received: September 20, 2013
Dear Mrs. Bonneton:
This letter corrects our substantially equivalent letter of October 16, 2013.
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
1
Page 2 - Mrs. Severine Bonneton
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); 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 (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" (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 (800) 638-2041 or (301) 796-7100 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
2
Indications for Use
510(k) Number (if known): K131231
Device Name: Aequalis Shoulder Fracture System Aequalis Reversed Shoulder Prosthesis Aequalis Reversed Fracture Shoulder Prosthesis Aequalis Resurfacing Head
Indications For Use:
Aequalis Shoulder Fracture System & Aequalis Resurfacing Head:
Aequalis Range :
Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by:
- Degenerative pathologies: arthrosis, rheumatoid arthritis, post-traumatic arthrosis. Primary and secondary necrosis of the humeral head
- Displaced 4-part upper humeral fracture i
- Humeral head fracture
- Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable
- Revision surgery when other treatments or devices have failed. .
Aequalis monobloc stem is for uncemented use only. The Aequalis press-Fit stem is for uncemented use only. The glenoid component is for cemented use only.
Aequalis Fracture range:
- Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint, including humeral head fracture and displaced 3-or 4-part proximal humeral fractures. - Revisions when other devices or treatments have failed.
The Aequalis fracture stem is for cemented use only. The glenoid component is for cemented use only.
Aequalis Resurfacing Head range:
The resurfacing implant is indicated as a total or hemi shoulder joint replacement where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or reconstructable.
The replacement of the joint with this device is indicated to relieve severe pain or significant disability caused by degenerative pathologies: osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, primary and secondary necrosis of the humeral head.
The resurfacing implant is intended for uncemented use only. The glenoid component is for cemented use only.
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.
3
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 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 cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. The humeral components are for non-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 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 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.
Aequalis Reversed Fracture Shoulder Prosthesis
The Aequalis Reversed Fracture Shoulder Prosthesis is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain or significant disability following arthropathy associated to a grossly deficient rotator cuff joint:
- in case of traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint, including humeral head fracture and displaced 3-or 4-part proximal humeral fractures, or
- in case of bone defect in proximal humerus.
The Aequalis Reversed Fracture Shoulder Prosthesis is also indicated for prosthetic revisions with a grossly deficient rotator cuff joint when other treatments or devices have failed.
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 Fracture Shoulder Prosthesis into a non reversed hemi-prosthesis.
When, in case of revision of a Aequalis Reversed Fracture Shoulder 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 Fracture Shoulder Prosthesis into a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.
The Aequalis Reversed Fracture Shoulder humeral stem is used in association with the glenoid components of the Aequalis Reversed Shoulder Prosthesis.
The Aequalis Reversed Fracture Shoulder humeral stem is for cemented use only.
4
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)
5
Implants Chirurgicau
Summary of Safety and Effectiveness information 510(k) Premarket Notification - Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis Reversed Fracture Shoulder Prosthesis, Aequalis Resurfacing Head
Date prepared: September 9th 2013
OCT 16 2013
Regulatory authority: Safe Medical Devices Act of 1990. 21 CRF 807.92
- Device name
| Trade name:
Common name:
Classification name: | Aequalis Shoulder Fracture System
Hemi or Total Shoulder Prosthesis
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented
prosthesis |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade name:
Common name:
Classification name: | Aequalis Reversed Shoulder Prosthesis
Total Shoulder Prosthesis
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented
prosthesis
§ 888.3690 Shoulder, Hemi-. Humeral. Metallic uncemented |
| Trade name:
Common name:
Classification name: | Aequalis Reversed Fracture Shoulder Prosthesis
Total Shoulder Prosthesis
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented
prosthesis |
| Trade name:
Common name:
Classification name: | Aequalis Resurfacing Head
Humeral Resurfacing Head
§ 888.3690 Shoulder joint, humeral (hemi-shoulder), metallic
uncemented prosthesis |
2) Submitter
Tornier SAS 161, Rue Lavoisier 38330 Montbonnot Saint Martin - France
3) Applicant
Tornier SAS 161, rue Lavoisier 38330 Montbonnot Saint Martin - France
Image /page/5/Picture/11 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 bar extending slightly beyond the vertical stem. The logo is simple and monochromatic, with a focus on geometric shapes and a clear, recognizable symbol.
Tel. : 33 (0)4 76 61 35 00 TORNIER S.A.S. 161. rue Lavoisier Fux : 33 (0)4 76 61 35 33 3834 MONTBONNOT CEDEX FRANCE
Section 5 - Page 1/ page 7 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
SII:GE SOCIAL 161. rue Lavoisier - 38330 MONTBONNOT SAINT MARTIN - FRANCE
6
4) Company contact
Tornier SAS Mrs Séverine Bonneton Project Regulatory Affairs Coordinator 161. rue Lavoisier 38334 Montbonnot Cedex - France Tel: 00 33 4 76 61 35 00 Fax: 00 33 4 76 61 35 59 e-mail : severine.bonneton@tornier.com
5) Classification
For the Aequalis Shoulder Fracture System:
Class II Device class: Onhopedic Classification panel: Product code: KWS
For the Aequalis Reversed Shoulder Prosthesis:
Class II Device class: Classification panel: Orthopedic KWS & HSD Product code:
For the Aequalis Reversed Fracture Shoulder Prosthesis:
Class II Device class: Orthopédic Classification panel: Product code: KWS
For the Aequalis Resurfacing Head:
Device class: Class II Classification panel: Orthopedic Product code: HSD
6) Equivalent / Predicate device
For the Aequalis Shoulder Fracture System: Aequalis Shoulder Fracture system, Tornier, K060209
For the Aequalis Reversed Shoulder Prosthesis:
Aequalis Reversed Shoulder Prosthesis, Tornier, K100142
For the Aequalis Reversed Fracture Shoulder Prosthesis:
Aequalis Reversed Fracture Shoulder System, Tornier, K082120
Image /page/6/Picture/18 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is bold and geometric, with a slightly rounded top and a thick vertical stem. The hexagon provides a clear, defined border around the letter, making it stand out. The logo appears to be a simple, modern design, possibly representing a company or brand with a name starting with 'T'.
TORNIER S.A.S. 161. rue Lavoisier 38334 MONTBONNOT CEDEX FRANCE
Tel. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33
Section 5 - Page 2/ page 7
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
SIFIGIS SOCIAL 161. rue Lavnisier - 38330 MONTBONNOT SAINT MARTIN - FRANCE
7
For the Aequalis Resurfacing Head:
Aequalis Resurfacing Head, Tornier, K062661
7) Device description
For the Aequalis Shoulder Fracture System:
The usual goal of total shoulder replacement and hemi-arthroplasty of the shoulder is to restore the shoulder joint to its best working condition and to reduce or eliminate pain. The Aequalis Shoulder Fracture System is intended to accomplish these goals. With the Aequalis Shoulder Fracture System, the natural glenoid elements of the shoulder may be conserved or replaced as warranted by the state of disease or injury. Thus the Aequalis Shoulder Fracture System is intended for use as a total shoulder replacement system, or as a hemi-shoulder. The modular nature of the system allows for the later conversion of a primary hemi-arthroplasty to a total shoulder replacement.
For the Aequalis Reversed Shoulder Prosthesis:
The Aequalis Reversed Shoulder Prosthesis is intended to relieve pain and significant disability following massive and non repairable cuff-lear associated to arthropathy and following massive cuff-lear arthropathy. In this case, the rotator muscles of the shoulder (supraspinatus. infraspinatus, 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 Acqualis Reversed Shoulder Prosthesis is a semi-constrained system composed of a humeral and a glenoid parts.
For the Aequalis Reversed Fracture Shoulder Prosthesis:
The Aequalis Reversed Fracture Shoulder Prosthesis is intended to be used to relieve pain or significant disability following massive cuff-tear associated to arthropathy and following massive cuff-tear arthropathy. In this case, the rotator nuscles 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 Fracture 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 and its Aequalis Fracture Shoulder humeral stemlike design allows to facilitate the bone reconstruction and improve the tuberosity healing and fixation. The Acqualis Reversed Fracture Shoulder Prosthesis is a semi-constrained system composed of a humeral and a glenoid parts.
For the Aequalis Resurfacing Head:
The Aequalis Resurfacing Head is a humeral head resurfacing device. It requires less bone and cartilage removal, which makes it much more conservative than total joint implants. Revision or arthrodesis can be undertaken easily because the bone stock has been maintained with no loss of
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length. The main advantages of humeral head resurfacing are preservation of bone and the relatively simple surgical technique.
With the Aequalis Resurfacing Head the natural glenoid elements of the shoulder may be conserved or replaced as warranted by the state of disease or injury.
The present submission corresponds to the following modification:
- Addition of a new coating subcontractor (hydroxylapatite coating and titanium + hydroxylapatite coating): Eurocoating S.p.A on cobalt chromium and titanium components.
All the prostheses of this application are strictly identical to the previously cleared devices except for the coating supplier. The indications for use of each device are not modified.
8) Materials (modified components)
For the Aequalis Shoulder Fracture System:
The humeral implant is manufactured from titanium alloy (Ti6AI4V) in accordance with ISO standard 5832-3.
The hydroxylapatite coating conforms to the ASTM standard F 1185.
For the Aequalis Reversed Shoulder Prosthesis:
The uncemented stem is manufactured from titanium alloy (Ti6Al4V) in accordance with ISO standard 5832-3. The metaphysis is manufactured from cobalt-chromium alloy in accordance with ISO standard 5832-4 and ultra high molecular weight polyethylene (UHMWPE) in accordance with ISO standard ISO5834-2. The baseplate of the glenoid implant is manufactured from titanium alloy (Ti6Al4V) in accordance with ISO standard 5832-3.
The hydroxylapatite coating conforms to ASTM standard F 1185.
For the Aequalis Reversed Fracture Shoulder Prosthesis:
The uncented stem is manufactured from titanium alloy (Ti6A14V) in accordance with ISO standard 5832-3.
The hydroxylapatite coating conforms to ASTM standard F 1185.
For the Aequalis Resurfacing Head:
The resurfacing head is manufactured from Cobalt-Chromium alloy according to ISO 5832-4. The bone contacting surfaces are coated with titanium plasma spray according to ASTM F1580 and hydroxylapatite according to ASTM FI185.
9) Indications
Aequalis Shoulder Fracture System & Aequalis Resurfacing Head:
Aequalis Range :
Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by:
- Degenerative pathologies: arthrosis, rheumatoid arthritis, post-traumatic arthrosis. Primary and . secondary necrosis of the humeral head
- Displaced 4-part upper humeral fracture
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- Humeral head fracture r
- Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not t acceptable
- Revision surgery when other treatments or devices have failed. i
Aequalis monobloc stem is for uncemented use only. The Aequalis press-Fit stem is for uncemented use only. The glenoid component is for cemented use only.
Aequalis Fracture range:
· Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint. including humeral head fracture and displaced 3-or 4-part proximal humeral fractures. - Revisions when other devices or treatments have failed.
The Aequalis fracture stem is for cemented use only. The glenoid component is for cemented use only.
Aequalis Resurfacing Head range:
The resurfacing implant is indicated as a total or hemi shoulder joint replacement where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or reconstructable. The replacement of the joint with this device is indicated to relieve severe pain or significant disability caused by degenerative pathologies: osteoarthritis, rheumatoid arthritis, post-traumatic arthritis. primary and secondary necrosis of the humeral head.
The resurfacing implant is intended for uncemented use only.
The glenoid component is for cemented use only.
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 prostheic revisions with massive and non repairable rotator cuffi-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 hemiprosinesis 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 again implant a base plate and a sphere of Aequalis Reversed range, the heniprosthesis 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 cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. The humeral components are for non-cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.
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Implants Chirurgica
When during the primary surgery the glenoid stock appears to be insufficient to bear the reversed whose components or when glenoid bone fracture occurs during the surgical procedures, the hemiprosinesis 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 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 hemiprosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosinesis in to a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.
Aequalis Reversed Fracture Shoulder Prosthesis
The Aequalis Reversed Fracture Shoulder Prosthesis is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain or significant disability following arthropathy associated to a grossly deficient rotator cuff joint:
- in case of traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint, including humeral head fracture and displaced 3-or 4-part proximal humeral fractures. or
- in case of bone defect in proximal humerus.
The Aequalis Reversed Fracture Shoulder Prosthesis is also indicated for prosthetic revisions with a grossly deficient rotator cuff joint when other treatments or devices have failed.
When during the primary surgery the glenoid bone stock appears to be insulTicient 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 Fracture Shoulder Prosthesis into a non reversed hemi-prosthesis.
When, in case of revision of a Aequalis Reversed Fracture Shoulder 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 Fracture Shoulder Prosthesis into a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.
The Aequalis Reversed Fracture Shoulder humeral stem is used in association with the glenoid components of the Aequalis Reversed Shoulder Prosthesis.
The Aequalis Reversed Fracture Shoulder humeral stem is for cemented use only.
10) Summary of technological characteristics
The only change to the cleared devices of the Aequalis Shoulder Fracture System. the Aequalis Reversed Shoulder Prosthesis, the Aequalis Reversed Fracture Shoulder Prosthesis and the Aequalis Resurfacing Head is the addition of a new coaling subcontractor: Eurocoating S.p.A
The Eurocoating S.p.A coating has the same specifications currently requested from BioCoat Company: coating specification drawings as well as the intended use of the implans concerned are not modified compared to the already cleared devices.
Process specifications for the application of hydroxylapatite coating, titanium + hydroxylapatite coating have been provided in Eurocoating S.p.A. Master Files MAF 2114, MAF 2119 and MAF 2144.
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plants Chirurgic
The indications for use, the other technical characteristics (design, materials, manufacturing, sizing, method of fixation) of the Aequalis Shoulder Fracture System, the Aequalis Reversed Shoulder Prosihesis, the Aequalis Reversed Fracture Shoulder Prosihesis and the Aequalis Resurfacing Head are identical to the predicate devices. The covered zones of the implants concerned remain the same ones
11) Non-clinical testing & Substantial equivalence conclusion
Non-clinical testing (shear fatigue strength, static shear strength test, static tensile strength and abrasion) and coating characterization (thickness, pore size and pore volume) were performed on the coating to determinate substantial equivalence.
The design, the material, the sizes, the method of fixation and the sterilization process are identical for devices whatever the coating subcontractor is.
The results of this evaluation allow us to conclude that the proposed new coating subcontractor Eurocoating S.p.A described in this submission does not induce any new or higher risk compared to the predicate coating subcontractor BioCoat Company and therefore both coating subcontractors (proposed and predicate) are substantially equivalent.
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