(123 days)
No
The description focuses on the mechanical design, materials, and surgical application of a shoulder prosthesis. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a prosthesis intended for hemi-shoulder replacement, which is a medical intervention to treat conditions like rotator cuff tear arthropathy and arthritis, aiming to restore function and alleviate symptoms.
No
The device is a prosthesis intended for surgical implantation to replace a joint, not to diagnose a condition.
No
The device description clearly details a physical implant made of cobalt-chrome-molybdenum alloy, intended for surgical implantation. It is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for hemi-shoulder arthroplasty, which is a surgical procedure involving the replacement of a joint. This is a therapeutic intervention, not a diagnostic test performed on samples from the human body.
- Device Description: The device is a physical implant (a shoulder prosthesis) made of metal alloy, designed to be surgically implanted into the body. IVD devices are typically reagents, instruments, or systems used to examine specimens from the body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
Therefore, the DePuy Global C.A.P.™ CTA Resurfacing Shoulder is a medical device intended for surgical implantation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DePuy Global C.A.P.™ CTA Resurfacing Shoulder prosthesis is intended for use in hemi-shoulder arthroplasty.
The DePuy Global C.A.P.™ CTA Resurfacing Shoulder is indicated for hemi-shoulder replacement in patients with rotator cuff tears and arthritis. Specific indications include:
- Rotator cuff tear arthropathy.
- Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate.
CAUTION: The DePuy Global C.A.P.™ CTA Resurfacing Shoulder is intended for cementless use only.
Product codes (comma separated list FDA assigned to the subject device)
87HSD, HSD
Device Description
The DePuy Global C.A.P.™ CTA Resurfacing Shoulder is a conservative Cuff Tear Arthropathy (CTA) device designed for resurfacing of the humeral head (hemi-shoulder). Resurfacing requires less bone and cartilage removal than is required in total shoulder replacement. Because bone stock is preserved, future revision or arthrodesis can be more easily performed. The prosthesis is intended for uncemented (i.e., press-fit) fixation, and is designed to mimic the normal humeral head geometry.
Composed of a cobalt-chrome-molybdenum allov (ASTM F-75), the DePuy Global C.A.P." CTA Resurfacing Shoulder is available in a variety of diameters. The proposed implant will be available in curvatures of 40. 44. 48. 52 and 56mm. with head heights of 15mm (40 and 44mm curvatures), 18mm (all curvatures) or 21mm (48, 52 and 56mm curvatures).
The proposed humeral head is a one-piece shell, manufactured from cobalt-chromemolybdenum alloy (ASTM F-75). The inner surface of the dome, or humeral head, has a cobalt-chrome-molybdenum porous coating. The stem has a cobalt-chrome-molybdenum porous coating proximally and is glass bead blasted distally. The distal stem has a cruciate design with a tapered distal tip. A thin layer of plasma-sprayed hydroxyapatite (Duofix") has been applied to the inner surface of the dome and proximal stem.
The hydroxyapatite (HA) coating applied to the DePuy Global C.A.P. CTA Resurfacing Shoulder is substantially equivalent to the HA coating process used in previously cleared products (e.g., DePuy Global C.A.P." Resurfacing Replacement Shoulder, K031971; DePuy Global C.A.P." HA Resurfacing Shoulder Humeral Heads, K033516). The composition of the coating is the same as that used for previously cleared products, (e.g., DePuy Global C.A.P." Resurfacing Replacement Shoulder, K031971; DePuy Global CAP™ HA Resurfacing Shoulder Humeral Heads, K033516).
The DePuy Global C.A.P." CTA Resurfacing Shoulder features an extended articulation surface to cover the superior-lateral aspect of the resurfacing head. This additional material keeps the implant surface in contact with the coracoacromial arch for a longer period of time during abduction.
This device also features a stem with a distal cruciate press fit to provide initial fixation. For long-term fixation and implant support, a surface-to-surface contact between the underside of the cup and the humeral head is created because of a flat located on the underside of the cup. Fixation is also provided by biological tissue in-growth into the porous coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
humeral head (hemi-shoulder)
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.
K000575, K051843, K073331, K031971, K010827
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
§ 888.3690 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
KON990
510(k) Summary
AUG - 8 2008
(As required by 21 CFR 807.92 and 21 CFR 807.93)
| NAME OF SPONSOR: | DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988
Establishment Registration Number: 1818910 |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MANUFACTURER: | DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988
Establishment Registration Number: 1818910 |
| 510(K) CONTACT: | Dawn Sinclair
Regulatory Affairs Associate
Telephone: (574) 372-5023
Facsimile: (574) 371-4987
Electronic Mail: Dsincla3@dpyus.jnj.com |
| DATE PREPARED: | March 17, 2008 |
| PROPRIETARY NAME: | DePuy Global C.A.P.™ CTA Resurfacing
Shoulder |
| COMMON NAME: | Resurfacing Shoulder |
| CLASSIFICATION: | Class II per 21 CFR 888.3690, Shoulder joint
humeral (hemi-shoulder) metallic uncemented
prosthesis |
| DEVICE PRODUCT CODE: | 87HSD |
| SUBSTANTIALLY EQUIVALENT
DEVICE(S): | DePuy Global Advantage® Extended Humeral
Head, K000575
Copeland™ EAS Humeral Resurfacing Heads,
K051843
DVO™ Total Extended Articulation Humeral
Heads, K073331
DePuy Global C.A.P.™ Resurfacing Replacemen
Shoulder, K031971
Copeland™ MB/HA Resurfacing Humeral Heads,
K010827 |
1
DEVICE DESCRIPTION:
The DePuy Global C.A.P.™ CTA Resurfacing Shoulder is a conservative Cuff Tear Arthropathy (CTA) device designed for resurfacing of the humeral head (hemi-shoulder). Resurfacing requires less bone and cartilage removal than is required in total shoulder replacement. Because bone stock is preserved, future revision or arthrodesis can be more easily performed. The prosthesis is intended for uncemented (i.e., press-fit) fixation, and is designed to mimic the normal humeral head geometry.
Composed of a cobalt-chrome-molybdenum allov (ASTM F-75), the DePuy Global C.A.P." CTA Resurfacing Shoulder is available in a variety of diameters. The proposed implant will be available in curvatures of 40. 44. 48. 52 and 56mm. with head heights of 15mm (40 and 44mm curvatures), 18mm (all curvatures) or 21mm (48, 52 and 56mm curvatures).
The proposed humeral head is a one-piece shell, manufactured from cobalt-chromemolybdenum alloy (ASTM F-75). The inner surface of the dome, or humeral head, has a cobalt-chrome-molybdenum porous coating. The stem has a cobalt-chrome-molybdenum porous coating proximally and is glass bead blasted distally. The distal stem has a cruciate design with a tapered distal tip. A thin layer of plasma-sprayed hydroxyapatite (Duofix") has been applied to the inner surface of the dome and proximal stem.
The hydroxyapatite (HA) coating applied to the DePuy Global C.A.P. CTA Resurfacing Shoulder is substantially equivalent to the HA coating process used in previously cleared products (e.g., DePuy Global C.A.P." Resurfacing Replacement Shoulder, K031971; DePuy Global C.A.P." HA Resurfacing Shoulder Humeral Heads, K033516). The composition of the coating is the same as that used for previously cleared products, (e.g., DePuy Global C.A.P." Resurfacing Replacement Shoulder, K031971; DePuy Global CAP™ HA Resurfacing Shoulder Humeral Heads, K033516).
The DePuy Global C.A.P." CTA Resurfacing Shoulder features an extended articulation surface to cover the superior-lateral aspect of the resurfacing head. This additional material keeps the implant surface in contact with the coracoacromial arch for a longer period of time during abduction.
This device also features a stem with a distal cruciate press fit to provide initial fixation. For long-term fixation and implant support, a surface-to-surface contact between the underside of the cup and the humeral head is created because of a flat located on the underside of the cup. Fixation is also provided by biological tissue in-growth into the porous coating.
Prastelli Pro
2
INTENDED USE AND INDICATIONS FOR USE:
Intended Use:
The DePuy Global C.A.P."" CTA Resurfacing Shoulder prosthesis is intended for use in hemi-shoulder arthroplasty.
Indications for Use:
The DePuy Global C.A.P."" CTA Resurfacing Shoulder is indicated for hemi-shoulder replacement in patients with rotator cuff tears and arthritis. Specific indications include:
-
- Rotator cuff tear arthropathy.
-
- Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate.
CAUTION: The DePuy Global C.A.P."" CTA Resurfacing Shoulder is intended for cementless use only.
BASIS OF SUBSTANTIAL EQUIVALENCE
The DePuy Global C.A.P.™ CTA Resurfacing Shoulder described in this submission is, in our opinion, substantially equivalent to the previously cleared DePuy Global Advantage® Extended Humeral Head (K000575), the Copeland™ EAS Humeral Resurfacing Heads (K051843), the DVO™ Total Extended Articulation Humeral Heads (K073331), the DePuy Global C.A.P." Resurfacing Shoulder (K031971), and the Copeland" MB/HA Resurfacing Humeral Heads (K010827), based upon the similarities in design, material composition (cobalt-chrome-molybdenum alloy), methods of sterilization (gamma irradiation) and intended use/indications for use. 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 seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a staff entwined with a serpent, a common symbol associated with medicine and health.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DePuy Orthopaedics, Inc. % Ms. Dawn Sinclair Regulatory Affairs Associate P. O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
AUG - 8 2008
Re: K080990
Trade/Device Name: DePuy Global C.A.P.TM CTA Resurfacing Shoulder Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: Class II Product Code: HSD Dated: June 18, 2008 Received: June 19, 2008
Dear Ms. Sinclair:
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 (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 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. Dawn Sinclair
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark N Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510 (k) Number (if known): ______________ K080990
Device Name: DePuy Global C.A.P." CTA. Resurfacing Shoulder
Indications for Use:
The DePuy Global C.A.P. ** CTA Resurfacing Shoulder is indicated for hemi-shoulder replacement in patients with rotator cuff tears and arthritis. Specific indications include:
-
- Rotator cuff tear arthropathy.
-
- Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate.
CAUTION: The DePuy Global C.A.P.™ CTA Resurfacing Shoulder is intended for cementless use only.
Prescription Use X
(Part 21 CFR 801 Subpart D)
barbara buchner
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Division of General, Restorative. and Neurological Devices
510(k) Number KDS0990
08843