(106 days)
K952928, K012212, K041339, K043077, K060209 (Aequalis Shoulder System, Tornier), K994392, K032679, K043077, K060209 (Aequalis Shoulder Fracture System, Tornier), K010827 (Copeland MB/HA Resurfacing Humeral Head, Biomet, Inc), K033516 (Global CAP resurfacing Replacement Shoulder, DePuy Orthopaedics, Inc)
Not Found
No
The 510(k) summary describes a mechanical implant for shoulder resurfacing and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a joint replacement intended to relieve severe pain or significant disability caused by various pathologies, which falls under the definition of a therapeutic device.
No
Explanation: The Aequalis Resurfacing Head is described as a humeral head resurfacing device used for joint replacement, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly indicates it is a physical humeral head resurfacing device, which is a hardware implant.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Description: The Aequalis Resurfacing Head is a surgical implant designed to replace a portion of the shoulder joint. It is used directly within the human body during a surgical procedure.
- Intended Use: The intended use is to replace a damaged joint to relieve pain and disability, not to analyze samples from the body to provide diagnostic information.
The information provided clearly describes a surgical implant, not a device used for testing biological samples outside of the body.
N/A
Intended Use / Indications for Use
The Aequalis Resurfacing Head 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. - Humeral head fracture. The Aequalis Resurfacing Head is intended for uncemented use only.
Product codes (comma separated list FDA assigned to the subject device)
HSD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint, humeral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K952928, K012212, K041339, K043077, K060209 (Aequalis Shoulder System, Tornier), K994392, K032679, K043077, K060209 (Aequalis Shoulder Fracture System, Tornier), K010827 (Copeland MB/HA Resurfacing Humeral Head, Biomet, Inc), K033516 (Global CAP resurfacing Replacement Shoulder, DePuy Orthopaedics, Inc)
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
§ 888.3690 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.
0
Image /page/0/Picture/0 description: The image shows the word "TORNIER" in a bold, serif font. To the right of the word is a hexagonal shape containing a stylized letter "T". The letter "T" inside the hexagon is also in a bold font and has a unique design.
Kob2661
DEC 2 2 2006
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
-
Device name Aequalis Resurfacing Head Trade name: Humeral Resurfacing Common name: 888.3690 Shoulder joint, humeral (hemi-shoulder), metallic uncemented prosthesis Classification name:
-
Submitter Tornier B.P. 11 - Rue Doyen Gosse 38330 Saint Ismier - France
3) Company contact Tornier
Mrs Mireille Lémery Regulatory affairs Manager 161. rue Lavoisier - Montbonnot 38334 Saint Ismier Cedex - France Tel: 00 33 4 76 61 38 98 Fax: 00 33 4 76 61 35 33 e-mail : mireille lemery@tornier.fr
-
Classification Class II Device class: Classification panel: Orthopedic Product code: HSD
-
Equivalent / Predicate device
Aequalis Shoulder System, Tornier, K952928, K012212, K041339, K043077, K060209 Aequalis Shoulder Fracture System, Tornier, K994392, K032679, K043077, K060209 Copeland MB/HA Resurfacing Humeral Head, Biomet, Inc, K010827 Global CAP resurfacing Replacement Shoulder, DePuy Orthopaedics, Inc, K033516
6) Device description
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.
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 SAS au capital de 288 000 €. SIRET 070 501 275 000 13. R.C.S. Grenoble 070 501 275. Code APE 331 B al : chemin Doyen Gosse. 38330 Saint-Ismier. Fra
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 also enclosed in a smaller hexagon within the larger one.
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.
7) Materials
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 F1185.
8) Indications
The Aequalis Resurfacing Head 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, theumatoid arthritis, post-traumatic arthritis. Primary and । secondary necrosis of the humeral head.
- Humeral head fracture.
The Aequalis Resurfacing Head is intended for uncemented use only.
Page 2/ 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 Doven Gosse. 38330 Saint-Ismier. Fran
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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
DEC 2 2 2006
Re: K062661
Trade/Device Name: Aequalis Resurfacing Head Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder joint humeral (hemi shoulder), metallic uncemented prosthesis Regulatory Class: Class II Product Code: HSD Dated: November 30, 2006 Received: December 04, 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 yours,
Barbara Buchud
Mark N. Melkerson 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): K (b 222 (
Device Name: Aequalis Resurfacing Head
Indications For Use:
The Aequalis Resurfacing Head 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.
Humeral head fracture. 1
The Aequalis Resurfacing Head is intended for uncemented use only.
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)
llare
CORH, Office of Device Evaluation (ODE)
Division Sign-Off
Moy
Division of General, Restorative, and Neurological Devices
510(k) Number K060261
Page 1 of 1
Tornier
Section 4