Primary, secondary or post-traumatic osteoarthritis, rheumatoid arthritis, severe joint pain of osteoarticular origin compromising the patients quality of life, joints which are defective in shape and function, a revision intervention on a previous arthroplasty, and disorders in which arthrodesis is not an acceptable option.

Device Description

The present device modification submits the addition of one larger diameter to the previous The present device modification submission concerns and includes in one size already covered by the range of Acqualis Press-in Shoulder Prosthesis. The glenoid component are unchanged. previous STV(k) clearance. The numeral lead and die grenote of the subjected device are identical to the predicate device.

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria. The document is a 510(k) premarket notification for a device modification (addition of one larger diameter) to the AEQUALIS Press-fit Shoulder Prosthesis, and it primarily focuses on regulatory approval based on substantial equivalence to a predicate device.

The document contains information such as:

Device name: AEQUALIS Press-fit Shoulder Prosthesis
Manufacturer: Tornier S.A.
Classification: Class II
Indications for use: Primary, secondary or post-traumatic osteoarthritis, rheumatoid arthritis, severe joint pain of osteoarticular origin compromising the patient's quality of life, joints which are defective in shape and function, a revision intervention on a previous arthroplasty, and disorders in which arthrodesis is not an acceptable option.
Device description: Addition of one larger diameter to the previous range of Acqualis Press-in Shoulder Prosthesis. The humeral head and glenoid components are unchanged.
Materials: Stem from Titanium alloy, Humeral head from Cobalt-Chromium alloy, Glenoid components from UHMWPE with a cobalt-chrome pin.

However, it does not include:

A table of acceptance criteria and reported device performance.
Sample sizes or data provenance for any test sets.
Number or qualifications of experts for ground truth establishment.
Adjudication methods.
Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
Results of standalone (algorithm only) performance studies.
The type of ground truth used (expert consensus, pathology, outcomes data).
Sample size for the training set.
How the ground truth for the training set was established.

This is a regulatory submission for a device modification, and the provided text primarily addresses the administrative aspects of FDA clearance based on substantial equivalence, rather than detailing clinical study results or performance data against specific acceptance criteria.

Summary

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K011942

JUL 1 3 2001

Special 510(k): Device modification - Premarket Notification 510(k) AEQUALIS Shoulder Prosthesis

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Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92

1) Device name

Trade name:	AEQUALIS Press-fit Shoulder Prosthesis
Common name:	Total Shoulder System and Hemi-Shoulder System
Classification name:	- Shoulder joint, humeral (hemi-shoulder) metallic uncemented prosthesis- Shoulder joint, metal/polymer semi-constrained cemented prosthesis

2) Manufacturer

Tornier S.A. B.P. 11 - Rue Doyen Gosse 38330 Saint Ismier - France

Classification 3)

$ 888.3690 Shoulder joint humeral (hcmi-shoulder) metallio uncemented prosthesis. $ 888.3660 Shoulder joint metal/polymer semi-constraince cemented prosthesis.

Orthopedic Classification panel: 87 HSD and 87KWS Product code: Class II Device class:

4) Indications:

Indications:
Primary, secondary or post-traumatic osteoarthritis, sever ioint pain of ottane and fination, a revision, a revision, a revision, origin compromising the patients quality of lice indentify over yeard finction, a revision, a revision, a revision, a revision, a revision, a revision, origin compromising the patterlis quality of the, joins which arthrodesis is not an acceptable option.

5) Device description :

The present device modification submits the addition of one lisgers to diameter to the previous The present device modification submission concerns and includes in onese already covered by the range of Acqualis Press-in Shoulder I rosulosis we glenoid component are unchanged. previous STV(k) clearance. The numeral lead and die grenote of the subjected device are identival to the predicate device_

6) Materials :

The stem is nade from Titanium alloy (6Al-4V-Ti) according to ISO 5832-3. It is grit-blasted on its proximal nart

The humeral head is made of Cobalt-Chromium alloy according to ISO 583-7. The glenoid components are The humeral head is made of Cobali-Chromum and actived. (THMWPE) according to ISO 5834-1
produced from implant grade ultra-high molecular weight polyethylor (THMWPE) accordin 2, with a small cobalt-chrome pin included as an opaque radiographic marker.

Tornier S.A.

VI-1

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.

JUL 1 3 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Irene Gossett Regulatory Affairs Department Tornier S.A. 161. rue Lavoisier 38330 Montbonnot FRANCE

Re: K011942

Trade/Device Name: Aequalis Press-Fit Shoulder Prosthesis Regulation Number: 21 CFR §888.3690, §888.3660 Regulatory Class: II Product Code: HSD, KWS Dated: June 6, 2001 Received: June 21, 2001

Dear Ms. Gossett:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Irene Gossett

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Mark N. Millhusan

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page of

KO11942 510(k) Number (if known):

Device name: AEQUALIS Shoulder Prosthesis

Indication for use:

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark N Milkerson
Division Sign Off

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K011942

Prescription use

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional format 1-2-96)

Tornier S.A.

Regulation Number and Section

§ 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.