(55 days)
Not Found
No
The document describes a mechanical implant (humeral stem) and its intended use and materials. There is no mention of software, algorithms, or data processing that would indicate the presence of AI/ML.
Yes.
The device is a humeral stem for shoulder replacement, indicated for treating painful and/or disabled joints, fracture-dislocations, and other difficult clinical problems, which are therapeutic interventions.
No
The device description clearly states it is a humeral stem, a prosthetic implant designed to replace the proximal humerus in shoulder arthroplasty, not to diagnose medical conditions.
No
The device description explicitly states the device is a humeral stem made from titanium alloy and porous-coated, indicating it is a physical implant, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a humeral stem used in shoulder replacement surgery. This is a surgical implant, not a device used to perform tests on biological samples in vitro (outside the body).
- Indications for Use: The indications are for conditions requiring surgical intervention to replace the shoulder joint (osteoarthritis, fractures, etc.). These are clinical conditions treated with surgery, not diagnosed or monitored with in vitro tests.
- Device Description: The description details the material and design of a surgical implant (titanium alloy humeral stem).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic devices.
Therefore, this device is a surgical implant intended for use in vivo (within the body) during shoulder replacement surgery, not an IVD.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
87 MBF, 87 KWS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, proximal humerus
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.
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
§ 888.3670 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.”
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 Drive
Warsaw, Indiana 46582
Establishment Registration Number: 1818910 | FEB - 1 200 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| 510(K) CONTACT: | Rebecca Lennard
Regulatory Affairs Associate II
Telephone: (574) 372-5023
Facsimile: (574) 371-4987
Electronic Mail: RLennard@dpyus.jnj.com | |
| ALTERNATE 510(K) CONTACT: | Natalie Heck
Manager, Regulatory Affairs
Telephone: (574) 372-7469
Facsimile: (574) 371-4987
Electronic Mail: NHeck@dpyus.jnj.com | |
| DATE PREPARED: | August 16, 2006 | |
| PROPRIETARY NAME: | DePuy Global APTM Porous Coated Humeral
Stem | |
| COMMON NAME: | Shoulder Prosthesis | |
| CLASSIFICATION: | Class II Device per 21 CFR 888.3670: Shoulder
joint metal/polymer/metal nonconstrained or
semi-constrained porous-coated uncemented
prosthesis | |
| | Class II Device per 21 CFR 888.3660: Shoulder
joint metal/polymer semi-constrained cemented
prosthesis | |
| DEVICE PRODUCT CODE: | 87 MBF
87 KWS | |
| SUBSTANTIALLY EQUIVALENT
DEVICE: | DePuy Global APTM Shoulder System, K060874
Global® Advantage Shoulder Humeral Stem with
Porocoat®, 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
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