(21 days)
Not Found
No
The summary describes a mechanical shoulder prosthesis and does not mention any AI or ML components or functionalities.
Yes
This device is a prosthesis intended for joint replacement, which is a therapeutic intervention.
No
This device is a shoulder prosthesis, indicated for joint replacement in patients with specific shoulder conditions, not for diagnosing those conditions.
No
The device description clearly states it is a "modular shoulder prosthesis," which is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description and Intended Use: The provided text clearly describes a surgical implant (a shoulder prosthesis) that is placed inside the body to replace a damaged joint. It is used during a surgical procedure.
The device's function is to provide mechanical support and restore function to the shoulder joint, not to analyze biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Delta Xtend Reverse Shoulder prosthesis is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff joint.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
In cases of bone defects in the proximal humerus, the monobloc implant should be used and then only in cases where the residual bone permits firm fixation of this implant.
Delta Xtend hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for revision of a previously failed Della Xtend Reverse Shoulder.
The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation.
The modular humeral stem and epiphysis components are HA coated and intended for cementless use.
All other components are for cemented use only.
Intended Use:
The Delta Xtend Reverse Shoulder prosthesis is intended for use in total or hemi shoulder arthroplasty procedures in patients with non-functional rotator cuffs, with or without bone cement. HA coated components are for cementless use only.
Product codes
PHX, KWS, HSD
Device Description
The Delta Xtend Reverse Shoulder System is a modular shoulder prosthesis designed for use in patients with non-functional rotator cuffs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Reference Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2016
DePuy Orthopaedics, Incorporated Ms. Rhonda Myer Regulatory Affairs Associate 700 Orthopaedic Drive Warsaw, Indiana 46581
Re: K081620
Trade/Device Name: DePuy Delta Xtend Reverse Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS, HSD Dated: June 6, 2008 Received: June 9, 2008
Dear Ms. Myer:
This letter corrects our substantially equivalent letter of June 30, 2008.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical
1
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
KO 81620
Indications for Use Statement
510 (k) Number (if known):
Device Name: DePuy Delta Xtend Reverse Shoulder System
Indications for Use:
The Delta Xtend Reverse Shoulder prosthesis is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff joint.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
In cases of bone defects in the proximal humerus, the monobloc implant should be used and then only in cascs where the residual bone permits firm fixation of this implant.
Delta Xtend hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for revision of a previously failed Della Xtend Reverse Shoulder.
The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation.
The modular humeral stem and epiphysis components are HA coated and intended for cementless use.
All other components are for cemented use only.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off)
Page of 1
DePuy Orthopaedics, Inc.
510(k) Number K081162
Delta Xtend Reverse Shoulder System
Page 11 of 66
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| | JUN 30 2008
510 (k) Summary
(As required by 21 CFR 807.92 and 21 CFR 807.93) |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| NAME OF SPONSOR: | DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46582
Establishment Registration Number: 1818910 |
| MANUFACTURER: | DePuy France SAS
7 Allée Irène Joliot Curie
69801 Saint Priest Cedex France
Establishment Registration: 3003895575 |
| 510(K) CONTACT: | Rhonda Myer
Regulatory Affairs Associate
Telephone: (574) 371-4927
Facsimile: (574) 371-4987
Electronic Mail: Rmyer7@dpyus.jnj.com |
| DATE PREPARED: | June 4, 2008 |
| PROPRIETARY NAME: | DePuy Delta Xtend Reverse Shoulder System |
| COMMON NAME: | Shoulder Prosthesis |
| CLASSIFICATION: | Class II per 21 CFR 888.3660: Prosthesis,
Shoulder, Semi-Constrained, Metal/Polymer
Cemented |
| DEVICE PRODUCT CODE: | 87 KWS
87 HSD |
| SUBSTANTIALLY EQUIVALENT
DEVICE: | DePuy Delta Xtend Reverse Shoulder System
K062250 and K073676 |
DEVICE DESCRIPTION:
The Delta Xtend Reverse Shoulder System is a modular shoulder prosthesis designed for use in patients with non-functional rotator cuffs.
INDICATIONS AND INTENDED USE:
Indications:
. A
The Delta Xtend Reverse Shoulder prosthesis is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff joint.
4
p.2/2
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
In cases of bone defects in the proximal humerus, the monobloc implant should be used and then only in cases where the residual bone permits firm fixation of this implant.
Delta Xtend hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for revision of a previously failed Delta Xtend Reverse Shoulder.
The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation.
The modular humeral stem and epiphysis components are HA coated and intended for cementless use.
All other components are for cemented use only.
Intended Use:
P
The Delta Xtend Reverse Shoulder prosthesis is intended for use in total or hemi shoulder arthroplasty procedures in patients with non-functional rotator cuffs, with or without bone cement. HA coated components are for cementless use only.
BASIS OF SUBSTANTIAL EQUIVALENCE:
Based on the similarities in intended use, indications for use, materials, design, method of manufacture, sterilization and packaging methods, DePuy believes the subject Delta Xtend Reverse Shoulder System is substantially equivalent to the previously cleared Delta Xtend Reverse Shoulder System, K062250 and K073676.