(28 days)
Not Found
No
The summary describes a shoulder prosthesis and its components, focusing on materials, indications for use, and performance testing related to biological safety, packaging, sterilization, and coating characterization. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes
The device is a prosthesis explicitly indicated for the treatment of severe arthropathy, failed joint replacement, and fracture-dislocations of the proximal humerus, directly pointing to a therapeutic function.
No
Explanation: The DELTA XTEND Shoulder Prosthesis is an implant designed for treatment of severe shoulder arthropathy, failed joint replacements, or fracture-dislocations of the proximal humerus. It is a therapeutic device, not a diagnostic one. Its purpose is to replace or articulate with existing biological structures, not to identify or characterize a disease or condition.
No
The device description clearly states it is comprised of "multiple humeral and glenoid implant components" which are physical implants, not software.
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 treating shoulder joint conditions like severe arthropathy, failed joint replacements, and fracture-dislocations. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as a shoulder prosthesis comprised of implant components (stems, epiphysis, metaglenes). These are physical implants placed within the body.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, tissue, etc.) or to provide information about a patient's health status based on in vitro analysis.
- Performance Studies: The performance studies focus on biological safety, packaging, sterilization, and coating characterization – all relevant to a surgical implant, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The DELTA XTEND Shoulder Prosthesis does not fit this description.
N/A
Intended Use / Indications for Use
The DELTA XTEND Shoulder Prosthesis is indicated for use in treatment of a grossly deficient rotator cuff joint with: · severe arthropathy and/or:
· a previously failed joint replacement and/or:
· 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.
The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
DELTA XTEND hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for the 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 humeral epiphysis components are HA coated and intended for cementless use. All other metallic components are intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
PHX, HSD
Device Description
The DELTA XTEND Reverse Shoulder System is currently cleared and marketed by DePuy Synthes and is comprised of multiple humeral and glenoid implant components. These are provided as separate, standalone devices and may be used in conjunction to form a total shoulder prothesis. This submission is pertinent to only those system components which are HA coated: Humeral Implants: Modular humeral stems Modular epiphysis Glenoid Implants: Metaglenes
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint, 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)
The following tests were performed on the DELTA XTEND Reverse Shoulder System to demonstrate substantial equivalence of safety and efficacy with the predicate devices:
- Biological safety per ISO 10993-1 "Biological Evaluation of Medical Devices Part 1: ● Evaluation and Testing".
- Packaging validation per ISO 11607-1 and ISO 11607-2 utilizing ISTA 3A. ●
- Sterilization validation per AAMI ANSI ISO 11137-1: 2006/(R)2010 and AAMI ANSI ● ISO 11137-2: 2013
- Characterization testing of Hydroxyapatite Coating as recommended per FDA ● Guidance: "510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implant"
No clinical tests were conducted to demonstrate substantial equivalence.
Key results: The HA coated Modular Humeral Stem, Modular Epiphysis, and Metaglene of the DELTA XTEND Reverse Shoulder System is substantially equivalent to the HA coated Modular Humeral Stem, Modular Epiphysis, and Metaglene of the predicate DePuy Synthes DELTA XTEND Reverse Shoulder System (K062250, K071379, K120174).
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
October 04, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
DePuy(Ireland) % Ashley Goncalo Project Manager-Regulatory Affairs DePuy Orthopaedies, Inc. 700 Orthopaedies Dr. Warsaw, Indiana 46582
Re: K192448
Trade/Device 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: PHX, HSD Dated: September 4, 2019 Received: September 6, 2019
Dear Ashley Goncalo:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael C. Owens Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K192448
Device Name DELTA XTEND Reverse Shoulder System
Indications for Use (Describe)
The DELTA XTEND Shoulder Prosthesis is indicated for use in treatment of a grossly deficient rotator cuff joint with: · severe arthropathy and/or:
· a previously failed joint replacement and/or:
· 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.
The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
DELTA XTEND hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for the 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 humeral epiphysis components are HA coated and intended for cementless use. All other metallic components are intended for cemented use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
As required by 21 CFR 807.92 and 21 CFR 807.93
| Submission Information | |
|---|---|
| Sponsor Name | DePuy (Ireland) |
| Sponsor Address | Loughbeg, Ringaskiddy Co. Cork Ireland |
| Sponsor Establishment | |
| Registration Number | 9616671 |
| 510(k) Contact | Ashley Goncalo |
| DePuy Synthes | |
| Regulatory Project Manager |
|
| Date prepared | September 4, 2019 |
| Device Information | |
| Trade or proprietary name | DELTA XTEND™ Reverse Shoulder System |
| Common or usual name | Shoulder Prosthesis |
| Classification name | Shoulder joint metal/polymer semi-constrained cemented
prosthesis |
| Class, regulation | Class II, 21 CFR 888.3660 |
| Product Code | PHX, HSD |
| Classification panel | Orthopedics panel |
| Legally marketed
device(s) to which
equivalence is claimed | DELTA XTEND Reverse Shoulder System (DePuy: K062250,
K071379, K120174) |
| Reason for 510(k)
submission | Introduction of an additional manufacturing and sterilization site
for the hydroxyapatite (HA) coated system components that are
marketed as part of the DELTA XTEND Reverse Shoulder
System. Additionally, there is an update to packaging
configuration for these system components. |
| Device description | The DELTA XTEND Reverse Shoulder System is currently
cleared and marketed by DePuy Synthes and is comprised of
multiple humeral and glenoid implant components. These are
provided as separate, standalone devices and may be used in
conjunction to form a total shoulder prothesis. This submission is
pertinent to only those system components which are HA coated:
Humeral Implants: Modular humeral stems Modular epiphysis Glenoid Implants: Metaglenes |
| Intended use of the device | 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. |
| Indications for use | The DELTA XTEND Shoulder Prosthesis is indicated for use in
treatment of a grossly deficient rotator cuff joint with:
• severe arthropathy and/or;
• a previously failed joint replacement and/or:
• 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
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.
DELTA XTEND hemi-shoulder replacement is also indicated for
hemi-arthroplasty if the glenoid is fractured intraoperatively or for
the 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 humeral epiphysis components are
HA coated and intended for cementless use. All other metallic
components are intended for cemented use only. |
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| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECT
| DEVICE COMPARED TO THE PREDICATE DEVICE | ||
|---|---|---|
| Characteristic | Subject Device: | |
| DePuy Synthes DELTA | ||
| XTEND™ Reverse Shoulder | ||
| System | Predicate Device: | |
| DePuy Synthes DELTA | ||
| XTEND™ Reverse Shoulder | ||
| System (K062250, K071379, | ||
| K120174) | ||
| Intended Use | Reverse shoulder arthroplasty | Reverse shoulder arthroplasty |
| Material | ||
| Humeral Implants | ||
| (Modular | ||
| Humeral Stem, | ||
| Modular | ||
| Epiphysis) | Titanium alloy with HA coating | Titanium alloy with HA coating |
| Glenoid Implants | ||
| (Metaglene) | ||
| Design | ||
| Humeral Implants | ||
| (Modular | ||
| Humeral Stem, | ||
| Modular | ||
| Epiphysis) | Modular, without cement, | |
| composed of an epiphysis and a | ||
| humeral stem made out of titanium | ||
| and coated with hydroxyapatite. | ||
| The epiphysis is available in | ||
| standard or long version and in two | ||
| sizes in order to be able to adapt as | ||
| well as possible to the human | ||
| anatomy. The distal stem is | ||
| available in several diameters to | ||
| maximize the adaptability of | ||
| humeral canal. | Modular, without cement, | |
| composed of an epiphysis and a | ||
| humeral stem made out of titanium | ||
| and coated with hydroxyapatite. | ||
| The epiphysis is available in | ||
| standard or long version and in two | ||
| sizes in order to be able to adapt as | ||
| well as possible to the human | ||
| anatomy. The distal stem is | ||
| available in several diameters to | ||
| maximize the adaptability of | ||
| humeral canal. | ||
| Glenoid Implant | ||
| (Metaglene) | The Glenoid Implant is comprised | |
| of a glenosphere that is fixed on the | ||
| metaglene by a conical joint and a | ||
| central pin. |
The metaglene is coated with
hydroxyapatite and is fixed inside
the bone with 4 screws. This
submission pertains to the metaglene
component of the Glenoid Implant
only. | The Glenoid Implant is comprised
of a glenosphere that is fixed on the
metaglene by a conical joint and a
central pin.
The metaglene is coated with
hydroxyapatite and is fixed inside
the bone with 4 screws |
| PERFORMANCE DATA | | |
5
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The following tests were performed on the DELTA XTEND Reverse Shoulder System to demonstrate substantial equivalence of safety and efficacy with the predicate devices:
- Biological safety per ISO 10993-1 "Biological Evaluation of Medical Devices Part 1: ● Evaluation and Testing".
- Packaging validation per ISO 11607-1 and ISO 11607-2 utilizing ISTA 3A. ●
- Sterilization validation per AAMI ANSI ISO 11137-1: 2006/(R)2010 and AAMI ANSI ● ISO 11137-2: 2013
6
- Characterization testing of Hydroxyapatite Coating as recommended per FDA ● Guidance: "510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implant"
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
No clinical tests were conducted to demonstrate substantial equivalence.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The HA coated Modular Humeral Stem, Modular Epiphysis, and Metaglene of the DELTA XTEND Reverse Shoulder System is substantially equivalent to the HA coated Modular Humeral Stem, Modular Epiphysis, and Metaglene of the predicate DePuy Synthes DELTA XTEND Reverse Shoulder System (K062250, K071379, K120174).