(216 days)
No
The summary describes a mechanical shoulder prosthesis and its components. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The performance studies are focused on mechanical properties and compatibility.
Yes
The device is a prosthesis intended to treat severe arthropathy, failed joint replacements, and fracture-dislocations of the proximal humerus, directly treating or alleviating a disease or injury.
No
The device is a shoulder prosthesis, an implant used in surgical procedures to replace a damaged joint, not to diagnose a condition.
No
The device description clearly outlines multiple physical components made of various materials (humeral stems, epiphysis, cups, glenospheres, metaglenes, screws). This is a hardware-based 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 treating shoulder joint conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the components of a shoulder prosthesis, which are physical implants used in surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies listed are related to the mechanical properties and compatibility of the implant, not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to replace or augment a damaged joint.
N/A
Intended Use / Indications for Use
The DePuy Synthes DELTA XTEND™ Shoulder Prosthesis is indicated for use in treatment of a grossly deficient rotator cuff joint with:
• severe arthropathy and/or;
· a previous 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. Porous-coated epiphysis are indicated for use in total shoulder replacement only.
The metaglene component is either HA coated or porous-coated and is intended for cementless use with the addition of screws for fixation. Central screws can only be used with the porous-coated metaglenes and are required to be used with porous-coating augmented metaglenes.
The modular humeral stem is HA coated and is intended for cementless use. The HA coated humeral epiphysis is intended for cementless use. The porous-coated epiphysis is intended for cementless use.
All other metallic components are intended for cemented use only.
Product codes
PHX, KWS
Device Description
The DELTA XTEND Reverse Shoulder System consists of humeral stems, modular epiphysis, humeral spacers, humeral cups, glenospheres, metaglenes and metaglene screws used for reverse shoulder arthroplasty. Humeral heads can be used in hemi-shoulder arthroplasty in place of the humeral cup and glenoid components.
The metaglenes are available in various design configurations including standard and augmented designs. The metaglenes allow for the placement of a central screw down the center of the post. A separate collet component is inserted into the metaglene post to receive the locking screw of the glenospheres.
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)
The following tests were performed on the subject devices of the DELTA XTEND Reverse Shoulder System to demonstrate substantial equivalence of safety and efficacy with the predicate devices: Pullout Evaluation Fatigue Evaluation Micromotion Evaluation Taper Dissociation Evaluation Torque to Failure Evaluation Insertion Force Evaluation Range of Motion Evaluation MRI Compatibility Evaluation.
No clinical studies were required to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K120174, K192855, K161742, K183696
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
July 22, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
DePuy Ireland UC % Jaclyn Cincotta Regulatory Project Manager DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46582
Re: K203694
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, KWS Dated: June 23, 2021 Received: June 24, 2021
Dear Jaclyn Cincotta:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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 medical devices and radiation-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,
For Michael Owens 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
2
Indications for Use
510(k) Number (if known)
K203694
Device Name DELTA XTEND Reverse Shoulder System
Indications for Use (Describe)
The DePuy Synthes DELTA XTEND™ Shoulder Prosthesis is indicated for use in treatment of a grossly deficient rotator cuff joint with:
• severe arthropathy and/or;
· a previous 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. Porous-coated epiphysis are indicated for use in total shoulder replacement only.
The metaglene component is either HA coated or porous-coated and is intended for cementless use with the addition of screws for fixation. Central screws can only be used with the porous-coated metaglenes and are required to be used with porous-coating augmented metaglenes.
The modular humeral stem is HA coated and is intended for cementless use. The HA coated humeral epiphysis is intended for cementless use. The porous-coated epiphysis is 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
| Submitter Information | |
|---|---|
| Sponsor Name | DePuy Ireland UC |
| Sponsor Address | Loughbeg |
| Ringaskiddy | |
| Co. Cork Ireland | |
| Sponsor Establishment | |
| Registration Number | 9616671 |
| 510(k) Contact | Jaclyn Cincotta |
| Regulatory Affairs Project Manager | |
| Telephone: (508) 828-3269 | |
| Fax: (508) 977-6409 | |
| Email: jcincott@its.jnj.com | |
| Address: 700 Orthopaedic Drive, Warsaw, IN 46582, USA | |
| Date Prepared | 22 July 2021 |
| 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 | II |
| Classification panel | 87 Orthopedics |
| Regulation | 21 CFR 888.3660 |
| Product Code(s) | PHX, KWS |
| Legally Marketed Device(s) | |
| to Which Equivalence is | |
| Claimed | Predicate Devices: DePuy Synthes DELTA XTEND Reverse Shoulder |
| System (K120174, K192855) and Tornier Aequalis PerFORM Reversed | |
| and Aequalis PerFORM+ Reversed Glenoid Shoulder Prosthesis | |
| (K161742, K183696) | |
| Reference Device: DePuy Synthes GLOBAL UNITE Platform Shoulder | |
| System (K170748) | |
| Reason for 510(k) | |
| Submission | Line extension to the DePuy Synthes DELTA XTEND Reverse |
| Shoulder System to add additional metaglene and metaglene screw | |
| devices. |
4
| Device Description | The DELTA XTEND Reverse Shoulder System consists of humeral
stems, modular epiphysis, humeral spacers, humeral cups, glenospheres,
metaglenes and metaglene screws used for reverse shoulder arthroplasty.
Humeral heads can be used in hemi-shoulder arthroplasty in place of the
humeral cup and glenoid components.
The metaglenes are available in various design configurations including
standard and augmented designs. The metaglenes allow for the
placement of a central screw down the center of the post. A separate
collet component is inserted into the metaglene post to receive the
locking screw of the glenospheres. |
|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use of the Device | The DELTA XTEND Reverse Shoulder System is intended for use in total
or hemi-shoulder arthroplasty 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 previous failed joint replacement and/or;
• fracture-dislocations of the proximal humerus where the articular
surface is severely communited, 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. Porous-
coated epiphysis are indicated for use in total shoulder replacement only. |
| | The metaglene component is either HA coated or porous-coated and is
intended for cementless use with the addition of screws for fixation.
Central screws can only be used with the porous-coated metaglenes and
are required to be used with porous-coated augmented metaglenes. |
| | The modular humeral stem is HA coated and is intended for cementless
use. The HA coated humeral epiphysis is intended for cementless use.
The porous-coated epiphysis is intended for cemented or cementless
use. |
| | All other metallic components are intended for cemented use only. |
| Comparison of Technological
Characteristics with the
Predicate Device | The DELTA XTEND Reverse Shoulder System has the same intended
use and the same fundamental scientific technology as the predicate
devices. The standard metaglenes are similar to those of the DePuy
Synthes DELTA XTEND Reverse Shoulder System (K120174) and the
augmented metaglenes and central screws are similar to those of the
Tornier Aequalis PerFORM Reversed and Aequalis PerFORM+
Reversed Glenoid Shoulder Prosthesis (K161742, K183696). The
porous-coating of the subject metaglene devices is similar to the
DELTA XTEND Reverse Shoulder System (epiphysis devices)
(K192855) and reference device DePuy Synthes GLOBAL UNITE
Platform Shoulder System (reverse epiphysis devices) (K170748) |
5
6
| Performance Data | The following tests were performed on the subject devices of the
DELTA XTEND Reverse Shoulder System to demonstrate substantial
equivalence of safety and efficacy with the predicate devices:
Pullout Evaluation Fatigue Evaluation Micromotion Evaluation Taper Dissociation Evaluation Torque to Failure Evaluation Insertion Force Evaluation Range of Motion Evaluation MRI Compatibility Evaluation |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Data | No clinical studies were required to demonstrate substantial equivalence. |
| Conclusion | The subject devices of the DELTA XTEND Reverse Shoulder System
are substantially equivalent to the metaglene/baseplate and screw
devices of the predicate DePuy Synthes DELTA XTEND Reverse
Shoulder System (K120174, K192855) and the Tornier Aequalis
PerFORM Reversed and Aequalis PerFORM+ Reversed Glenoid
Shoulder System (K161742, K183696). |