(143 days)
No
The document describes a mechanical shoulder prosthesis and does not mention any AI or ML components or functionalities.
Yes.
The device is a prosthesis indicated for the treatment of a grossly deficient rotator cuff joint, involving replacement of parts of the shoulder joint to restore function and alleviate symptoms. This direct intervention in the body for treatment qualifies it as a therapeutic device.
No.
The DELTA XTEND Prosthesis is an implantable device used for surgical treatment of shoulder joint pathologies, not for diagnosing conditions.
No
The device description clearly outlines physical components like humeral stems, epiphysis, cups, glenospheres, and screws, which are hardware implants for shoulder arthroplasty.
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 components (humeral stem, epiphysis, glenosphere, etc.) are all parts of a prosthetic joint designed to be implanted in the body.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, or tissue) to diagnose a condition.
- Performance Studies: The performance studies focus on mechanical properties (fatigue, tolerance, range of motion) and biocompatibility, which are relevant to implanted devices, not IVDs.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is used in vivo (inside the body) as a replacement joint.
N/A
Intended Use / Indications for Use
The DELTA XTEND 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 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 HA coated and is intended for cementless use with the addition of screws for fixation. 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.
Product codes
PHX, KWS
Device Description
The DELTA XTEND Reverse Shoulder System consists of humeral stem, modular epiphysis, humeral spacer, humeral cup, glenosphere, metaglene and metaglene screws used for reverse shoulder arthroplasty. The humeral spacer can be added between the epiphysis and the humeral cup if necessary. Humeral head can be used in hemi-shoulder arthroplasty in place of the humeral cup and glenoid components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder Joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
The proposed Epiphysis Device of the DELTA XTEND Reverse Shoulder System was determined as substantially equivalent in terms of safety and efficacy with the predicate devices as demonstrated by the following:
Fatigue Analysis Tolerance Analysis Epiphysis Comparison and Design Justification Range of Motion Analysis Biocompatibility Study
The proposed devices also meet the requirement of bacterial endotoxin testing as specified in ANSI AAMI ST-72:2011. Additionally, MRI testing was conducted in support of adding MRI compatibility language for the currently marketed shoulder platforms, with which the proposed devices are compatible – the existing DELTA XTEND Reverse Shoulder System and GLOBAL UNITE Shoulder System.
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION:
No clinical tests were conducted to demonstrate substantial equivalence.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol on the left is a stylized representation of a human figure. The text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The words "U.S. FOOD & DRUG" are on the top line, and the word "ADMINISTRATION" is on the bottom line.
February 24, 2020
DePuy (Ireland) % Ashley Goncalo Project Manager - Regulatory Affairs Depuy Orthopaedics, Inc 325 Paramount Drive RAYNHAM MA 02767
Re: K192855
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: January 23, 2020 Received: January 24, 2020
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 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 Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K192855
Device Name DELTA XTEND™ Reverse Shoulder System
Indications for Use (Describe)
The DELTA XTEND 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 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 HA coated and is intended for cementless use with the addition of screws for fixation. 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.
| 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 | Phone: 508.977.3907 | |
| Email: agoncalo@its.jnj.com | ||
| Date prepared | 10/2/2019 | |
| 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, KWS | |
| Classification panel | Orthopedics panel | |
| Legally marketed | ||
| device(s) to which | ||
| equivalence is claimed | Predicates: DePuy Synthes GLOBAL UNITE Platform Shoulder | |
| System (K170748) and DELTA XTEND Reverse Shoulder | ||
| System (K071379, K120174) | ||
| Reference Device: Tornier Aequalis™ Ascend™ Flex Shoulder | ||
| System (K122698) | ||
| Reason for 510(k) | ||
| submission | Line extension to DELTA XTEND Reverse Shoulder System to | |
| add additional epiphysis device components. Additionally, this | ||
| submission supports the addition of MRI compatibility language | ||
| to the labeling for the currently marketed, FDA cleared, DELTA | ||
| XTEND Reverse Shoulder System and GLOBAL UNITE | ||
| Platform Shoulder System. | ||
| Device description | The DELTA XTEND Reverse Shoulder System consists of | |
| humeral stem, modular epiphysis, humeral spacer, humeral cup, | ||
| glenosphere, metaglene and metaglene screws used for reverse | ||
| shoulder arthroplasty. The humeral spacer can be added between | ||
| the epiphysis and the humeral cup if necessary. Humeral head can | ||
| be used in hemi-shoulder arthroplasty in place of the humeral cup | ||
| and glenoid components. | ||
| 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 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 HA coated and is intended for | ||
| cementless use with the addition of screws for fixation. 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. |
4
5
| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE | ||||
|---|---|---|---|---|
| PREDICATE DEVICES | ||||
| Characteristic | Subject Device: | |||
| Epiphysis Device - | ||||
| DELTA XTENDTM | ||||
| Reverse Shoulder | ||||
| System | Primary Predicate | |||
| Device: | ||||
| Epiphysis Device - | ||||
| DePuy Synthes | ||||
| GLOBAL UNITE | ||||
| Platform Shoulder | ||||
| System (reverse | ||||
| configuration) | ||||
| (K170748) | Predicate Device: | |||
| Epiphysis Device - | ||||
| DELTA XTENDTM | ||||
| Reverse Shoulder | ||||
| System (K071379, | ||||
| K120174) | Reference Device: | |||
| Epiphysis Device - | ||||
| Tornier AequalisTM | ||||
| AscendTM Flex | ||||
| Shoulder System | ||||
| (reverse configuration) | ||||
| (K122698) | ||||
| Intended Use | Reverse shoulder | |||
| arthroplasty | Reverse shoulder | |||
| arthroplasty | Reverse shoulder | |||
| arthroplasty | Reverse shoulder | |||
| arthroplasty | ||||
| Material | ||||
| Epiphysis Component | Titanium alloy with | |||
| Porocoat® porous- | ||||
| coating | Titanium alloy with | |||
| Porocoat® porous- | ||||
| coating | Titanium alloy with | |||
| hydroxyapatite coating | Titanium alloy with | |||
| titanium plasma spray | ||||
| coating | ||||
| Screw Component | Titanium alloy | Titanium alloy | Titanium alloy | N/A |
| Design | ||||
| Modularity | Epiphysis component | |||
| interfaces with stem | ||||
| component via male- | ||||
| female boss and screw | Epiphysis component | |||
| interfaces with stem | ||||
| component via male- | ||||
| female boss and screw | Epiphysis component | |||
| interfaces with stem | ||||
| component via male- | ||||
| female boss and screw | Stem component | |||
| (unified epiphysis and | ||||
| diaphysis) interfaces | ||||
| with reversed tray | ||||
| component | ||||
| Neck Shaft Angle | 145° and 155° | 155° | 155° | 145° |
| Epiphysis Sizes | Size 1 and 2 (in | |||
| centered, eccentric left | ||||
| and eccentric right | ||||
| versions) | Size 1 (in centered, | |||
| eccentric left and | ||||
| eccentric right versions) | Size 1 and 2 (in | |||
| centered, eccentric left | ||||
| and eccentric right | ||||
| versions) | N/A | |||
| PERFORMANCE DATA | ||||
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE | ||||
| The proposed Epiphysis Device of the DELTA XTEND Reverse Shoulder System was determined as substantially equivalent in | ||||
| terms of safety and efficacy with the predicate devices as demonstrated by the following: | ||||
| Fatigue Analysis Tolerance Analysis Epiphysis Comparison and Design Justification Range of Motion Analysis Biocompatibility Study | ||||
| The proposed devices also meet the requirement of bacterial endotoxin testing as specified in ANSI AAMI ST-72:2011. | ||||
| Additionally, MRI testing was conducted in support of adding MRI compatibility language for the currently marketed shoulder | ||||
| platforms, with which the proposed devices are compatible – the existing DELTA XTEND Reverse Shoulder System and GLOBAL | ||||
| UNITE Shoulder System. | ||||
| 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 proposed epiphysis device of the DELTA XTEND Reverse Shoulder System is substantially equivalent to the epiphysis devices | ||||
| of the predicate DePuy Synthes GLOBAL UNITE Platform Shoulder System and predicate DELTA XTEND Reverse Shoulder | ||||
| System. |
Traditional 510(k) – DELTA XTEND Reverse Shoulder System
6