(97 days)
Not Found
No
The document describes a mechanical implant component for shoulder surgery and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a component of a total shoulder replacement, specifically designed to convert existing anatomical shoulder stems into reverse shoulder prosthesis components without full removal during revision surgery. Its function is structural within the implant, not therapeutic in the sense of delivering treatment or therapy directly to a disease or condition.
No
Explanation: The device is an implantable adapter used in shoulder replacement surgery. Its purpose is to convert an existing shoulder stem into a component of a reverse shoulder prosthesis, not to diagnose a medical condition.
No
The device description clearly indicates it is a physical component ("Aequalis Reversed Adapter") used in shoulder replacement surgery, not a software application.
No, 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, tissue) to provide information about a person's health.
- Device Function: The Aequalis Reversed Adapter is a surgical implant designed to be placed inside the human body during a revision shoulder surgery. It is a mechanical component of a prosthetic joint.
- Intended Use: Its intended use is to convert an existing shoulder implant into a reverse shoulder prosthesis, not to analyze biological samples.
The provided information clearly describes a surgical implant, not a device used for in vitro testing.
N/A
Intended Use / Indications for Use
The Aequalis Reversed Adapter is indicated for use as a component of a total shoulder replacement and is designed to allow the transformation of Aequalis Anatomical (monobloc or press-fit) or Aequalis Fracture stems into components of a reverse shoulder prosthesis without removal during revision surgery. The Aequalis Reversed Adapter is for use only when the implanted humeral stem is well fixed along its entire length and when the patient has a functional deltoid muscle and when the arthropathy is associated with a massive and non repairable rotator cufftear.
The Aequalis Reversed Adapter is intended for uncemented use only.
The Aequalis Reversed Adapter is intended to be used with the Aequalis Reversed glenoid which is anchored to the bone with 4 screws and which is for uncemented fixation.
The Aequalis Reversed Adapter is intended to be used with a cemented (Aequalis monobloc or Aequalis Fracture) or uncemented (Aequalis press-fit) stem. The humeral component is not to be revised in the conversion to a reverse shoulder prosthesis and must be well fixed along its entire length.
Product codes
PHX, KWS
Device Description
The Aequalis Reversed Adapter offers the surgeons the possibility to convert a current implanted standard Aequalis shoulder stem into a component of a reverse prosthesis without removing the wellfixed humeral stem during revision surgery.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K053274, K061439, K050316, K041873, K030941
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine. The caduceus is made up of three intertwined snakes and a pair of wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2016
Tornier Mrs. Mireille Lemery Regulatory Affairs Manager 161, rue Lavoisier - Montbonnot 38334 Saint Ismier Cedex FRANCE
Re: K071948
Trade/Device Name: Aequalis Reversed Adapter Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS Dated: July 5, 2007 Received: July 23, 2007
Dear Mrs. Lemery:
This letter corrects our substantially equivalent letter of October 18, 2007.
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
1
Page 2 -- Mrs. Mireille Lemery
(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):
Device Name: Aequalis Reversed Adapter
Indications For Use:
The Aequalis Reversed Adapter is indicated for use as a component of a total shoulder replacement and is designed to allow the transformation of Aequalis Anatomical (monobloc or press-fit) or Aequalis Fracture stems into components of a reverse shoulder prosthesis without removal during revision surgery. The Aequalis Reversed Adapter is for use only when the implanted humeral stem is well fixed along its entire length and when the patient has a functional deltoid muscle and when the arthropathy is associated with a massive and non repairable rotator cufftear.
The Aequalis Reversed Adapter is intended for uncemented use only.
The Aequalis Reversed Adapter is intended to be used with the Aequalis Reversed glenoid which is anchored to the bone with 4 screws and which is for uncemented fixation.
The Aequalis Reversed Adapter is intended to be used with a cemented (Aequalis monobloc or Aequalis Fracture) or uncemented (Aequalis press-fit) stem. The humeral component is not to be revised in the conversion to a reverse shoulder prosthesis and must be well fixed along its entire length.
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)
| (Division Sign-Off) | |
|---|---|
| Division of General, Restorative, and Neurological Devices | Page 1 of 1 |
| 510(k) Number | K071946 |
| Section 4 |
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Image /page/3/Picture/0 description: The image shows the word "TORNIER" in bold, capital letters, followed by a hexagonal logo with the letters "T" and "P" inside. Above the word "TORNIER" is the number "K071948" in handwritten style. The logo is a simple, geometric design, and the overall image has a clean, professional look.
P. 1/2
OCT 1 8 2007
Summary of Safety and Effectiveness information 510(k) Premarket Notification - Aequalis Reversed Adapter
Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92
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Device name Aequalis Reversed Adapter Trade name: Common name: Reversed adapter Classification name: § 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis
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Submitter Tornier B.P. 11 - Rue Doyen Gosse 38330 Saint Ismier - France
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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
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Classification Device class: Class II Classification panel: Orthopedic Product code: KWS
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Equivalent / Predicate device Anatomical Shoulder™ Inverse/Reverse, Zimmer, Inc, K053274 Aequalis Reversed Prosthesis, Tornier, K061439, K050316, K041873, K030941
6) Device description
The Aequalis Reversed Adapter offers the surgeons the possibility to convert a current implanted standard Aequalis shoulder stem into a component of a reverse prosthesis without removing the wellfixed humeral stem during revision surgery.
TORNIER
161 rue Lavoisier. Monthonnot. 38334 SAINT-ISMIER Cedex. France Tél.: 33(0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33 www.tornier.com da 288 000 . SIRET 070 501 275 000 13. R.C.8. Grenchlo 070 501 275.
4
Image /page/4/Picture/0 description: The image shows the word "TORNIER" in a bold, sans-serif font, followed by a logo. The logo is a hexagon containing a stylized letter "T". Above the word "TORNIER" is the number "K071948" written in a handwritten style.
7) Materials
The metal metaphysis of the Reversed Adapter and the U-clip are manufactured from titanium alloy according to ISO 5832-3. The safety screws are manufacturing from Cobalt-Chromium alloy according to ISO 5832-7. The lateralized insert of the Aequalis Reversed Adapter is manufacturing from ultra high molecular weight polyethylene (UHMWPE) according to ISO 5834-2.
8) Indications
The Aequalis Reversed Adapter is indicated for use as a component of a total shoulder replacement and is designed to allow the transformation of Aequalis Anatomical (monobloc or press-fit) or Aequalis Fracture stems into components of a reverse shoulder prosthesis without removal during revision surgery. The Aequalis Reversed Adapter is for use only when the implanted humeral stem is well fixed along its entire length and when the patient has a functional deltoid muscle and when the arthropathy is associated with a massive and non repairable rotator cuff-tear.
The Aequalis Reversed Adapter is intended for uncemented use only.
The Aequalis Reversed Adapter is intended to be used with the Aequalis Reversed glenoid which is anchored to the bone with 4 screws and which is for uncemented fixation.
The Aequalis Reversed Adapter is intended to be used with a cemented (Aequalis monobloc or Aequalis Fracture) or uncemented (Aequalis press-fit) stem. The humeral component is not to be revised in the conversion to a reverse shoulder prosthesis and must be well fixed along its entire length.
TORNIER
161 rue Lavoisier. Monthonnot. 38334 SAINT-ISMIER Cedex. France Tél.: 33(0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33 www.tomier.com SAS su capital de 288 DOO . SIRET 070 501 275 DOO 13. R.C.S. Greecoble 070 501 275 Co