(30 days)
Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by:
- Degenerative pathologies: arthrosis, rheumatoid arthritis, posttraumatic 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.
The usual goal of total shoulder and hemi-arthroplasty replacement of the shoulder is to restore the shoulder joint to its best working condition and to reduce or eliminate pain. The Aequalis Shoulder System is intended to accomplish these goals.
It consists of a humeral stem and a humeral head. With these systems 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-arthrosplasty to a total shoulder replacement.
The present device submission corresponds to the addition of a new glenoid model to the current cleared model. The new glenoid model is a modification of the shape of the current model. The technological characteristics (materials, manufacturing, sterilization, sizing and indications) of the new glenoid of the Aequalis Shoulder System are similar or identical to the predicate devices.
The glenoid component is made of ultra high molecular weight polyethylene (UHMWPE) according to ISO standard 5834-2.
The provided text describes a medical device submission (Aequalis Shoulder System, K063081) but does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.
This document is a 510(k) premarket notification for a medical device (Aequalis Shoulder System). Such notifications primarily aim to demonstrate substantial equivalence to a legally marketed predicate device, rather than providing detailed performance study results against predefined acceptance criteria.
The information provided describes:
- Device Name: Aequalis Shoulder System
- Submitter: Tornier
- Device Classification: Class II, Orthopedic product, Product code HSD
- Equivalent/Predicate Devices: Aequalis Shoulder System (K952928, K043077, K060209); DePuy Global Shoulder System (K060874)
- Device Description: A humeral stem and humeral head for total shoulder replacement or hemi-shoulder. The specific submission is for a new glenoid model, a modification of an existing cleared model, with similar/identical technological characteristics (materials, manufacturing, sterilization, sizing, indications) to predicate devices.
- Materials: Glenoid component made of UHMWPE (ISO standard 5834-2).
- Indications for Use: 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 are unacceptable, and revision surgery.
- FDA Conclusion: The FDA reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot extract the requested information regarding acceptance criteria and study details because it is not present in the provided document. The document focuses on regulatory approval through substantial equivalence, not detailed performance testing against acceptance criteria.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the word "TORNIER" in a bold, serif font, followed by a hexagonal logo. Inside the hexagon is a stylized letter "T" with a smaller, incomplete hexagon around the middle of the "T". The logo is positioned to the right of the word "TORNIER".
1/2
Summary of Safety and Effectiveness information 510(k) Premarket Notification – Aequalis Resurfacing Head
Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92
NOV - 9 2006 1) Device name Trade name: Aequalis Shoulder System Common name: Total shoulder prosthesis Classification name: 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis
-
Submitter Tornier B.P. 11 - Rue Doyen Gosse 38330 Saint Ismier - France
-
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
| 4) Classification | |
|---|---|
| Device class: | Class II |
| Classification panel: | Orthopedic |
| Product code: | HSD |
- Equivalent / Predicate device Aequalis Shoulder System, Tornier, K952928, K043077, K060209 DePuy Global Shoulder System, DePuy Orthopaedics, Inc K060874
6) Device description
The usual goal of total shoulder and hemi-arthroplasty replacement of the shoulder is to restore the shoulder joint to its best working condition and to reduce or eliminate pain. The Aequalis Shoulder System is intended to accomplish these goals.
It consists of a humeral stem and a humeral head. With these systems 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.
Page 1/ page 2
TORNIER SAS
161 rue Lavoisier. Montbonnot. 38334 SAINT-ISMIER Cedex. France Tél. : 33(0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33 www.tornier.com au capital de 288 000 €. SIRET 070 501 275 000 13. R. C.S. Grenoble 070 501 275. Code APE 331 B social : chemin Doyen Gosse. 38330 Saint-Ismier. France
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows the word "TORNIER" in all capital letters, followed by a logo. The logo is a hexagon with a stylized letter "T" inside. The letter "T" is made up of two parts: a larger "T" and a smaller "T" inside the larger one.
Image /page/1/Picture/1 description: The image shows handwritten text on a white background. On the left side, the text "Kof 3001" is written in a slightly messy, cursive style. To the right, the fraction "2/2" is written, also in a handwritten style. The overall impression is that of a quick note or label.
The modular nature of the system allows for the later conversion of a primary hemi-arthrosplasty to a total shoulder replacement.
The present device submission corresponds to the addition of a new glenoid model to the current cleared model. The new glenoid model is a modification of the shape of the current model. The technological characteristics (materials, manufacturing, sterilization, sizing and indications) of the new glenoid of the Aequalis Shoulder System are similar or identical to the predicate devices.
7) Materials
The glenoid component is made of ultra high molecular weight polyethylene (UHMWPE) according to ISO standard 5834-2.
8) Indications
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.
Page 2/ page 2
TORNIER SAS
rue Lavoisier. Montbonnot. 38334 SAINT-ISMIER Cedex. France él. : 33(0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33 www.tornier.com al de 288 000 €. SIRET 070 501 275 000 13. R.C.S. Grenoble 070 501 275. Code APE 331 B al : chemin Doven Gosse, 38330 S
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
DEPARTMENT OF HEALTH & HUMAN SERVICES, USA
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
TORNIER S.A.S % Ms. Mireille Lemery Regulatory Affairs Manager 161 rue Lavoisier - Montbonnot 38334 Saint --Ismier Cedex France
NOV - 9 2006
Re: K063081 Trade/Device Name: Aequalis Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/ polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: HSD Dated: September 5, 2006 Received: October 10, 2006
Dear Ms. Lemery:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 Part 807); labeling (21 CFR Part 801); 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.
{3}------------------------------------------------
Page 2 - Ms. Mireille Lemery
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Barbara Preup
Mark N. Me kerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name: Aequalis Shoulder System
Indications For Use:
Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by:
- Degenerative pathologies: arthrosis, rheumatoid arthritis, posttraumatic 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.
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)
Barbara Buchins
Division Sign-Off Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K063081
Tornier
Section 4
§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.