(55 days)
Intended Use: The subject humeral stem is designed for use as the portion of the shoulder prosthesis that replaces the proximal humerus upon which a prosthetic humeral head is attached to articulate with the natural glenoid fossa or a prosthetic glenoid replacement. The DePuy Global APTM Porous Coated Humeral Stems are intended for cemented or cementless use, with fixation provided by biological tissue ingrowth into the porous coating.
Indications for Use: Total Shoulder or hemi-shoulder replacement is indicated for:
- A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis.
- Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component).
The humeral components of the Global APTM Shoulder are intended for cemented or cementless use as a total or hemi-shoulder replacement.
Global APTM Porous Coated Humeral Stems are intended for cemented or cementless use, with fixation provided by biological tissue ingrowth into the porous coating.
Glenoid components of the Global AP™ Shoulder are indicated only for use with bone cement for the above indications.
Hemi-shoulder replacement is also indicated for:
- Ununited humeral head fractures;
- Avascular necrosis of the humeral head.
- Deformity and/or limited motion.
The subject Global APTM humeral stems are made from titanium alloy and are porouscoated with commercially pure titanium. The stems are available in six sizes. They are identical in design to the Global APTM Humeral Stems cleared in K060874 on June 28, 2006 with the addition of Porocoat® porous coating applied to the proximal portion of the stem.
The provided text is a 510(k) summary for a medical device, the DePuy Global AP™ Porous Coated Humeral Stem. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study proving a device meets specific performance-based acceptance criteria through empirical testing.
Therefore, the document does not contain information about acceptance criteria for performance metrics (like accuracy, sensitivity, specificity, etc.) of a device, nor does it describe a study specifically designed to prove the device meets such criteria.
The 510(k) summary explicitly states:
"The DePuy Global AP™ Porous Coated Humeral Stem is substantially equivalent to the previously cleared DePuy Global AP™ Shoulder System (K060874) and the Global® Advantage Shoulder Humeral Stem with Porocoat® (K011047) based upon intended use, indications for use, design, materials, packaging and sterilization. The subject device does not raise any new issues of safety or effectiveness."
This indicates that the approval is based on equivalence to existing devices that have already demonstrated safety and effectiveness, not on new performance testing with defined acceptance criteria.
Thus, I cannot fill in the requested table and information about acceptance criteria and a study given the provided text.
{0}------------------------------------------------
K 063652 pg 143
Section 5 - 510 (k) Summary
(As required by 21 CFR 807.92(c) and 21 CFR 807.93)
| NAME OF SPONSOR: | DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, Indiana 46582Establishment Registration Number: 1818910 | FEB - 1 200 |
|---|---|---|
| 510(K) CONTACT: | Rebecca LennardRegulatory Affairs Associate IITelephone: (574) 372-5023Facsimile: (574) 371-4987Electronic Mail: RLennard@dpyus.jnj.com | |
| ALTERNATE 510(K) CONTACT: | Natalie HeckManager, Regulatory AffairsTelephone: (574) 372-7469Facsimile: (574) 371-4987Electronic Mail: NHeck@dpyus.jnj.com | |
| DATE PREPARED: | August 16, 2006 | |
| PROPRIETARY NAME: | DePuy Global APTM Porous Coated HumeralStem | |
| COMMON NAME: | Shoulder Prosthesis | |
| CLASSIFICATION: | Class II Device per 21 CFR 888.3670: Shoulderjoint metal/polymer/metal nonconstrained orsemi-constrained porous-coated uncementedprosthesis | |
| Class II Device per 21 CFR 888.3660: Shoulderjoint metal/polymer semi-constrained cementedprosthesis | ||
| DEVICE PRODUCT CODE: | 87 MBF87 KWS | |
| SUBSTANTIALLY EQUIVALENTDEVICE: | DePuy Global APTM Shoulder System, K060874Global® Advantage Shoulder Humeral Stem withPorocoat®, K011047 |
0000013
= :
{1}------------------------------------------------
page 3/3
DEVICE DESCRIPTION:
The subject Global APTM humeral stems are made from titanium alloy and are porouscoated with commercially pure titanium. The stems are available in six sizes. They are identical in design to the Global APTM Humeral Stems cleared in K060874 on June 28, 2006 with the addition of Porocoat® porous coating applied to the proximal portion of the stem.
INTENDED USE AND INDICATIONS:
Intended Use:
The subject humeral stem is designed for use as the portion of the shoulder prosthesis that replaces the proximal humerus upon which a prosthetic humeral head is attached to articulate with the natural glenoid fossa or a prosthetic glenoid replacement. The DePuy Global APTM Porous Coated Humeral Stems are intended for cemented or cementless use, with fixation provided by biological tissue ingrowth into the porous coating.
Indications for Use:
Total Shoulder or hemi-shoulder replacement is indicated for:
- l . A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis.
-
- Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
-
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component).
The humeral components of the Global AP™ Shoulder are intended for cemented or cementless use as a total or hemi-shoulder replacement.
Global APTM Porous Coated Humeral Stems are intended for cemented or cementless use, with fixation provided by biological tissue ingrowth into the porous coating.
Glenoid components of the Global AP™ Shoulder are indicated only for use with bone cement for the above indications.
Hemi-shoulder replacement is also indicated for:
-
- Ununited humeral head fractures;
-
- Avascular necrosis of the humeral head.
-
- Deformity and/or limited motion.
0000014
{2}------------------------------------------------
Page 143
BASIS OF SUBSTANTIAL EQUIVALENCE:
The DePuy Global AP™ Porous Coated Humeral Stem is substantially equivalent to the previously cleared DePuy Global APTM Shoulder System (K060874) and the Global® Advantage Shoulder Humeral Stem with Porocoat® (K011047) based upon intended use, indications for use, design, materials, packaging and sterilization. The subject device does not raise any new issues of safety or effectiveness.
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DePuy Orthopaedics, Inc. % Ms. Rebecca Lennard Regulatory Affairs Associate II 700 Orthopaedic Drive Warsaw, Indiana 46582
FEB - 1 2007
Re: K063652
Trade/Device Name: DePuy Global AP™ Porous Coated Humeral Stem Regulation Number: 21 CFR 888.3670 Regulation Name: Shoulder joint metal/polymer/metal non-constrained or semiconstrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBF, KWS Dated: December 7, 2006
Received: December 8, 2006
Dear Ms. Lennard:
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.
{4}------------------------------------------------
Page 2 - Ms. Rebecca Lennard
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" (21 CFR 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,
Farbare Bonelum
Mark N. Melker Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Section 4 - Indications for Use Statement
510 (k) Number (if known): K063652____________________________________________________________________________________________________________________________________
Device Name: ________________________________________________________________________________________________________________________________________________________________
Indications for Use:
Total Shoulder or hemi-shoulder replacement is indicated for:
- A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or 1. rheumatoid arthritis.
-
- Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are 3. not acceptable (e.g. revision of a failed primary component).
The humeral components of the Global APTM Shoulder are intended for cemented or cementless use as a total or hemi-shoulder replacement.
Global APTM Porous Coated Humeral Stems are intended for cemented or cementless use, with fixation provided by biological tissue ingrowth into the porous coating.
Glenoid components of the Global AP™ Shoulder are indicated only for use with bone cement for the above indications.
Hemi-shoulder replacement is also indicated for:
-
- Ununited humeral head fractures;
-
- Avascular necrosis of the humeral head.
-
- Deformity and/or limited motion.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
510(k) Number_Kole36 Ste
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line. Continue on another page if needed.)
UUUUTAA
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| (Division Sign-Off) |
|---|
| --------------------- |
| Division of General, Restorative?) |
|---|
| and Neurological Devices |
| Page 1 of 1 |
|---|
| ------------- |
§ 888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits movement in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys such as cobalt-chromium-molybdenum (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing surface fixed in a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have a porous coating made of, in the case of Co-Cr-Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.”