(86 days)
No
The document describes a shoulder replacement system and its components, focusing on materials, indications for use, and predicate devices. There is no mention of AI, ML, image processing, or any data-driven algorithms typically associated with AI/ML in medical devices.
Yes
The device is a shoulder replacement system (humeral stem and glenoid components) indicated for use in severely painful and/or disabled joints resulting from various conditions like osteoarthritis, rheumatoid arthritis, fracture-dislocations, and other clinical problems, which directly addresses disease or injury.
No
The document describes a medical device for shoulder replacement surgery, not for diagnosing medical conditions. It outlines indications for use, device components, and materials, which are typical for an implantable prosthetic device.
No
The device description clearly describes a physical implant (humeral stem) made of cobalt-chromium-molybdenum alloy, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text describes a shoulder replacement system, specifically a humeral stem and associated components. Its intended use is to replace a damaged shoulder joint due to various conditions like osteoarthritis, fractures, or failed previous surgeries.
- Mechanism of Action: This device is an implantable prosthetic. It functions by physically replacing the damaged joint components, allowing for improved movement and reduced pain. It does not analyze biological specimens.
The information provided clearly indicates a surgical implant, not a device used for testing biological samples outside the body.
N/A
Intended Use / Indications for Use
The Global Fx Porous-coated humeral stem, in combination with Global shoulder humeral heads, is intended for use in total or hemi-arthroplasty.
Total 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).
- Rotator cuff tear arthropathy.
Hemi-shoulder replacement is also indicated for:
- Ununited humeral head fractures;
- Avascular necrosis of the humeral head.
The Global Fx porous-coated humeral stem is intended for cemented or cementless use with fixation provided by biological tissue in-growth into the porous coating.
Porocoat® Porous-Coated Components
Porous-coated humeral stem prostheses are indicated for cementless use with fixation provided by biological tissue in-growth into the porous coating.
Cemented Components
Humeral stem and Glenoid components labeled "For cemented use only" are indicated only for use with bone cement.
Product codes (comma separated list FDA assigned to the subject device)
87 MBF, 87 KWS
Device Description
The Porous-coated Global Fx humeral stem is a modified Global Fx humeral stem. Porocoat® porous coating has been added to the proximal portion of the stem. The stem is manufactured from cobalt-chromium -molybdenum alloy conforming to ASTM F-75. The stem mates with humeral heads previously cleared as Global Advantage Head (K984541), Global Advantage CTA Heads (K000575) and the Global Advantage Eccentric Humeral Head (K992065).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint (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.
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
JUL - 6 2001
510(k) Summary
| Name of Sponsor: | DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988
Est. Reg. No. 1818910 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Marcia J. Arentz
Senior Regulatory Associate
Phone: (219) 371-4944
FAX: (219) 371-4987 |
| Trade Name: | Global™ Fx Porous-Coated Humeral Stem |
| Common Name: | Shoulder prosthesis, humeral head |
| Classification: | Class II (special controls) per 21 CFR 888.3670
Shoulder joint metal/polymer/metal non-constrained or
semi-constrained porous-coated uncemented prosthesis. |
| | Class II (special controls) per 21 CFR 888.3660
Shoulder joint metal/polymer semi-constrained
cemented prosthesis. |
| Device Product Code: | Code: 87 MBF Prosthesis, Shoulder, semi-constrained, metal/polymer, Uncemented.
Code: 87 KWS Prosthesis, Shoulder, Semi-con-strained, metal/polymer Cemented. |
| Substantially Equivalent Devices: | Global Fx Shoulder System
K984541
Porous Coated Global Shoulder
K943300 |
| Device Description: | The Porous-coated Global Fx humeral stem is a
modified Global Fx humeral stem. Porocoat® porous
coating has been added to the proximal portion of the
stem. The stem is manufactured from cobalt-
chromium --molybdenum alloy conforming to ASTM
F-75. The stem mates with humeral heads previously
cleared as Global Advantage Head (K984541),
Global Advantage CTA Heads (K000575) and the
Global Advantage Eccentric Humeral Head
(K992065). |
| Intended use: | The Global Fx Porous-coated humeral stem, in
combination with Global shoulder humeral heads, is
intended for use in total or hemi-arthroplasty. |
| Indications for use: | Total or hemi-shoulder replacement is indicated for: |
| | 1. A severely painful and/or disabled joint resulting
from osteoarthritis, traumatic arthritis or rheumatoid
arthritis; |
1
Fracture-dislocations of the proximal humerus. 2. 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 3. or resection arthroplasty are not arthrodesis acceptable (e.g., revision of a failed primary component).
Rotator cuff tear arthropathy. 4.
Hemi-shoulder replacement is also indicated for:
-
- Ununited humeral head fractures;
Avascular necrosis of the humeral head. 2.
- Ununited humeral head fractures;
The Global Fx porous-coated humeral stem is intended for cemented or cementless use with fixation provided by biological tissue in-growth into the porous coating.
Substantial equivalence:
The Global Advantage Extended Humeral Head is substantially equivalent to the Global Fx Humeral Stem cleared in K984541. Both humeral stems have identical locking tapers, are tapered in design, come in similar sizes and are manufactured from the same materials. The only difference between the two stems is the addition of porous coating to the proximal portion of the stem.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human face in profile, with three curved lines representing the hair or head.
JUL - 6 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Marcia J. Arentz Senior Regulatory Associate DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re: K011099
Trade Name: Global™ Fx Porous-Coated Humeral Stem Regulation Number: 888.3670 and 888.3660 Regulatory Class: II Product Code: MBF and KWS Dated: April 10, 2001 Received: April 11, 2001
Dear Ms. Arentz:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have have determined the device is substantially equivalent (for the indications for use above and we nave actering in interstate commerce prior to May 28, 1976, the stated in the oneroune) to were amendments, or to devices that have been reclassified in oncentions 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, cond 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 ( remainer ripple any in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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.
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
3
Page 2 - Ms. Marcia J. Arentz
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 If you desire specific advice for your do rices), please contact the Office of Compliance at additionally 809.10 for in This diagnotions on the promotion and advertising of your device, (301) 394-4639. Addinonally, for questions on (301) 594-4639. Also, please note the regulation please comact the Orifice or Compilance at (2017) of the Station" (21 CFR 807.97). Other general entitled, TMIsoraliumly by releveles to pearler to act may be obtained from the Division of Small
information on your responsibilities under the Act may be obtained from 11, miorination on your responsionates and in more (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
thlulln
S.M. White, Ph.D., M.D.
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
4
510(k) Number (if known): Κοι/ο 99
Device Name: Global™ Fx Porous-Coated Humeral Stem
Indications for Use:
Total 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 Fracture chooseneed 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).
-
- Rotator cuff tear arthropathy.
Hemi-shoulder replacement is also indicated for:
-
- Ununited humeral head fractures;
-
- Avascular necrosis of the humeral head.
Porocoat® Porous-Coated Components
I orocoal " orous-coated humeral stem prostheses are indicated for cementless use with fixation provided by biological tissue in-growth into the porous coating.
Cemented Components
Humeral stem and Glenoid components labeled "For cemented use only" are indicated only for use with bone cement.
Concurrence of CDRH, Office of Device Evaluation
Prescription Use
(Pcr 21 CFR/801.109)
OR
Over-The-Counter Use
No
comiraveto orcm
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K011097