(28 days)
Not Found
No
The device description and intended use clearly describe a physical implant (glenoid component) for shoulder replacement surgery. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
Yes
The device is an implant for total shoulder replacement surgery, which is a therapeutic intervention for patients with severely painful and/or disabled joints.
No
Explanation: The device is a Glenoid component, which is a surgically implanted prosthesis used in total shoulder replacement surgery. Its intended use is to replace a damaged joint, not to diagnose a condition.
No
The device description clearly describes physical components (anchor peg and fin designs, sizes, fixation surface, central fin, peripheral pegs) intended for surgical implantation, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for total shoulder replacement. It addresses structural and functional issues within the body (osteoarthritis, fractures, etc.).
- Device Description: The description details a physical implant designed to be surgically placed within the shoulder joint.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze biological samples. This device is an implant used inside the body to replace a joint.
N/A
Intended Use / Indications for Use
The Crosslink Glenoids are intended for use in total shoulder replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, nost-traumatic arthritis, trauma or failed prior surgical intervention.
The Crosslink Glenoids are intended for cemented use only.
The Glenoid is intended for use in total shoulder replacement surgery for patients suffering from:
-
- 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 Fracture ansiountine , separated from its blood supply or where the surgeon's severience 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).
Glenoid components are intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
KWS
Device Description
The DePuy Global™ Crosslink Glenoids are offered in an anchor peg and a fin design. The Crosslink Glenoid anchor peg design consists of sizes: 40mm, 48mm, 48mm, 52mm, 56mm and 56mmXL. The Crosslink Glenoid in the fin design consists of seven sizes: 40mmXS, 40mm, 44mm, 52mm, 52mm, 56mm and 56mmXL. Both the anchor peg and fin designs have a lateral surface that is concave and designed to articulate with the DePuy Global™ line humeral heads indicated for ase in total shoulder arthroplasty. The fixation surface has a central fin or peripheral pegs and is intended to be attached to the glenoid fossa of the scapula with bone cement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Glenoid fossa of the scapula, 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
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
0
OCT 6 - 2005
SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF FIRM: | DePuy Orthopaedics, Inc.
P.O. Box 988
709 Orthopaedic Drive
Warsaw, IN 46581-0988 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Natalie Heck
Manager, Regulatory Affairs
Tel: (574) 372-7469
Fax: (574) 371-4987 |
| TRADE NAME: | DePuy Global™ Shoulder Crosslink Glenoid |
| COMMON NAME: | Shoulder Prosthesis |
| CLASSIFICATION: | 888.3660 Shoulder joint metal/polymer semi-
constrained cemented prosthesis; Class II |
| DEVICE PRODUCT CODE: | KWS |
| SUBSTANTIALLY EQUIVALENT
DEVICES: | DePuy Global™ Shoulder Glenoid - K981487
DePuy Global™ Shoulder - K914000
DePuy Sigma XLK Tibal Inserts - K040166 |
DEVICE DESCRIPTION:
The DePuy Global™ Crosslink Glenoids are offered in an anchor peg and a fin design. The Crosslink Glenoid anchor peg design consists of sizes: 40mm, 48mm, 48mm, 52mm, 56mm and 56mmXL. The Crosslink Glenoid in the fin design consists of seven sizes: 40mmXS, 40mm, 44mm, 52mm, 52mm, 56mm and 56mmXL. Both the anchor peg and fin designs have a lateral surface that is concave and designed to articulate with the DePuy Global™ line humeral heads indicated for ase in total shoulder arthroplasty. The fixation surface has a central fin or peripheral pegs and is intended to be attached to the glenoid fossa of the scapula with bone cement.
INTENDED USE:
The Crosslink Glenoids are intended for use in total shoulder replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, nost-traumatic arthritis, trauma or failed prior surgical intervention.
The Crosslink Glenoids are intended for cemented use only.
0000000
1
Kb53472
BASIS OF SUBSTANTIAL EQUIVALENCE:
The DePuy Global™ Crosslink Glenoids have the same design, intended use and indications as the Glenoid components cleared in K981497 and K914000 as part of DePuy's Global Shoulder System. The difference between the Crosslink Glenoids proposed in this submission and the Glenoids in the Global Shoulder System is the type of polyethylene used to manufacture the components. The Crosslink Glenoids are made from highly cross-linked polyethylene, which has been to shown to have a reduction in wear compared to currently available Enduron polyethylene. The Crosslink Glenoids are made from the same cross-linked polyethylene as that cleared in the DePuy Sigma XI.K. Tibial Inserts, listed in K040166. Due to the similarities noted DePuy believes the Crosslink Glenoids to be substantially equivalent in design to the Glenoids of DePuv Global Shoulder System and in material to the DePuy Sigma XLK Tibial Inserts, with the additional claim of reduced wear, based on results of shoulder simulator wear studies of these devices.
CC00007
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized human figure with three wavy lines representing the body. The figure is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter.
OCT 6 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Natalie Heck Manager, Regulatory Affairs DePuy Orthopaedics, Inc. PO Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re: K052472
Trade/Device Name: DePuy Global™ Shoulder Crosslink Glenoid Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: KWS Dated: September 3, 2005 Received: September 8, 2005
Dear Ms. Heck:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
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" (21CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Mark N. Mellon
Co Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _K 02472
Device Name: DePuy Global™ Shoulder Crosslink Glenoid
Indications for Use:
The Glenoid is intended for use in total shoulder replacement surgery for patients suffering from:
-
- 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 Fracture ansiountine , separated from its blood supply or where the surgeon's severience 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).
Glenoid components are intended for cemented use only.
| Prescription Use | X | AND/OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER
PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| Page | 1 of 1 |
|---|---|
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| 510(k) Number | K052472 | 0000005 |
|---|---|---|
| --------------- | --------- | --------- |