(184 days)
No
The summary describes a mechanical implant (shoulder prosthesis) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a shoulder prosthesis intended for arthroplasty procedures to replace a damaged joint, which is a therapeutic intervention.
No
The device is a prosthesis intended for surgical implantation to replace a shoulder joint; it does not diagnose medical conditions.
No
The device description clearly identifies the Delta Xtend™ Reverse Shoulder System as 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 Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided text describes a surgical implant – a prosthesis designed to replace a shoulder joint. It is physically implanted into the patient's body.
- Intended Use/Indications: The intended use and indications clearly state that the device is for total or hemi shoulder arthroplasty procedures in patients with non-functional rotator cuffs. This is a surgical procedure, not a diagnostic test performed on a sample outside the body.
The Delta Xtend™ Reverse Shoulder prosthesis is a Class III medical device (based on the predicate devices listed, which are also Class III) used in surgery, not an IVD.
N/A
Intended Use / Indications for Use
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.
Indications for Use:
The Delta Xtend™ Reverse Shoulder prosthesis is intended for use as total shoulder or hemi-shoulder replacement.
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.
The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation.
All other components are for cemented use only.
Product codes
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, proximal humerus, glenoid
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)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
.062250
FEB - 2 2007
$
Pursuant to Section 510(k) of the Federal Food, Drug, and Cosmetic Act and in accordance with subpart E of Part 807 of Title 21 of the Code of Federal Regulations and the Safe Medical Devices Act of 1990.
| NAME | OF | SPONSOR: | ||
|---|---|---|---|---|
510 (k) Summary
DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 Establishment Registration Number: 1818910
510(K) CONTACT:
Natalie Heck Manager, Regulatory Affairs Telephone: (574) 372-7469 Facsimile: (574) 371-4987 Electronic Mail: nheck(@dpyus.jnj.com
DATE PREPARED: July 26, 2006 Delta Xtend™ Reverse Shoulder System PROPRIETARY NAME:
COMMON NAME:
CLASSIFICATION:
Class II Device per 21 CFR 888.3660:
Shoulder Prosthesis
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Class II Device per 21 CFR §888.3690: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented 87 KWS 87 HSD
DEVICE PRODUCT CODE:
SUBSTANTIALLY EQUIVALENT DePuy Delta CTA Reverse Shoulder System, DEVICE: K021478 DePuy Global Advantage Shoulder System, K992065 DePuy Global Advantage CTA Head (cleared as the DePuy Global Advantage Extended Head) K000575
DEVICE DESCRIPTION:
The Delta Xtend™ Reverse Shoulder System is a modular shoulder prosthesis designed for use in patients with non-functional rotator cuffs.
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062250
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INTENDED USE AND INDICATIONS:
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.
Indications for Use:
The Delta Xtend™ Reverse Shoulder prosthesis is intended for use as total shoulder or hemi-shoulder replacement.
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.
The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation.
All other components are for cemented use only.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The substantial equivalence of the Delta Xtend™ Reverse Shoulder is substantiated by its similarity in intended use, indications for use, materials and design to the DePuy Delta CTA Reverse Shoulder System (K021478), the DePuy Delta CTA Head (K062116), the DePuy Global Advantage Shoulder System (K992065), and the DePuy Global Advantage CTA Head (K000575, cleared as the DePuy Global Advantage Extended Head).
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2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract eagle design, with three stylized wing strokes, symbolizing strength and freedom. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DePuy Orthopaedics, Inc. c/o Ms. Natalie Heck Manager, Regulatory Affairs P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
FEB - 2 2007
Re: K062250
Trade Name: 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: KWS. HSD Dated: December 4, 2006 Received: December 6, 2006
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 (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.
3
Page 2 – Ms. Natalie Heck
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Sincerely yours,
Barbara Buchud
Mark N. Melkerson, M.S Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
K062250 510 (k) Number (if known):
Device Name: Delta Xtend TM Reverse Shoulder System_
Indications for Use:
The Delta Xtend "10 Reverse Shoulder prosthesis is intended for use as total shoulder or hemi-shoulder replacement.
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 10 hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively.
The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation.
All other components are for cemented use only.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbare rich For MONT
and Neurologica
Page of
510(k) Number K062252
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