(193 days)
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.
The Delta Xtend Reverse Shoulder System consists of humeral stem, modular epiphysis, humeral spacer, humeral cup, glenosphere, metaglene and metaglene screws. The glenosphere and metaglene are used for total 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.
The provided document pertains to the 510(k) premarket notification for the DePuy Delta Xtend™ Reverse Shoulder System, specifically for the addition of lateralized glenosphere components. This document is a regulatory submission for a medical device (a shoulder prosthesis), NOT an AI/ML medical device. Therefore, the information requested regarding acceptance criteria and study proving device performance for an AI/ML device (e.g., sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth sources) is not applicable here.
The document discusses the substantial equivalence of the new components to predicate devices based on:
- Biocompatibility: Confirmed per ISO10993-1.
- Range of Motion: Theoretical simulated range of motion analyses showed an increase compared to the predicate non-lateralized glenosphere.
- Glenoid Loosening/Disassociation: A study demonstrated substantial equivalency of glenoid fixation performance to the predicate.
The document explicitly states:
- "Summary of animal study: Animal study was not necessary."
- "Summary of clinical study: Clinical study was not necessary."
This indicates that clinical trials or studies that would involve human patient data, ground truth establishment by experts, or detailed statistical analysis of performance (as would be typical for AI/ML device validation) were not required for this specific 510(k) submission, as it focused on demonstrating substantial equivalence through non-clinical performance and design comparisons.
Therefore, I cannot extract the information required for an AI/ML device's acceptance criteria and study results from this document.
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May 17, 2019
DePuy (Ireland) % Yayoi Fujimaki Regulatory Affairs Project Manager DePuy Orthopaedics, Inc. 700 Orthopaedic Dr. Warsaw, Indiana 46582
Re: K183077
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, HSD Dated: April 17, 2019 Received: April 18, 2019
Dear Yayoi Fujimaki:
This letter corrects our substantially equivalent letter of May 17, 2019.
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.
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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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 CAPT Raquel Peat, PhD, MPH, USPHS Director DHT6A: Division of Joint Arthroplasty Devices OHT 6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
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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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 EstablishmentRegistration Number | 9616671 | |
| 510(k) Contact | Yayoi FujimakiDePuy SynthesRegulatory Project Manager | Phone: 508.828.3541Email: yfujima1@its.jnj.com |
| Date prepared | November 2, 2018 | |
| 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, HSD | |
| Classification panel | Orthopedics panel | |
| Legally marketeddevice(s) to whichequivalence is claimed | DELTA XTEND Reverse Shoulder System (DePuy: K062250,K120174),Aequalis Reversed Prosthesis (Tornier SAS: K030941, K061439,K081059, K140478, K151293) | |
| Reason for 510(k)submission | Addition of lateralized glenosphere components to the Delta XtendReverse Shoulder System | |
| Device description | The Delta Xtend Reverse Shoulder System consists of humeralstem, modular epiphysis, humeral spacer, humeral cup,glenosphere, metaglene and metaglene screws. The glenosphere andmetaglene are used for total reverse shoulder arthroplasty. Thehumeral spacer can be added between the epiphysis and thehumeral cup if necessary. Humeral head can be used in hemi-shoulder arthroplasty in place of the humeral cup and glenoidcomponents. | |
| Intended use of the device | The Delta Xtend Reverse Shoulder prosthesis is intended for use intotal 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 intreatment 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. | ||
| Testing Data | ||
| Summary of non-clinicalstudy | Biocompatibility was confirmed per ISO10993-1. Theoreticalsimulated range of motion analyses showed increase of range ofmotion compared to the predicate non-lateralized glenosphere.Glenoid loosening/disassociation study demonstrated substantialequivalency of glenoid fixation performance to the predicate. | |
| Summary of animal study | Animal study was not necessary. | |
| Summary of clinical study | Clinical study was not necessary. | |
| Conclusion | Substantial equivalency to the predicate devices can bedemonstrated on following grounds:- the subject lateralized glenosphere has the same intended use asthe predicate glenosphere of the Delta Xtend Reverse shouldersystem and the Aequalis Reversed Shoulder Prosthesis.- the subject lateralized glenosphere's technologicalcharacteristics are equivalent to the predicate AequalisReversed Shoulder Prosthesis glenosphere.- different technological characteristic between the subject andthe predicate Delta Xtend Reverse Shoulder System isglenosphere lateralization. Addition of the lateralizedglenosphere does not change the intended use, indications,principle of operation or surgical procedure. No new questionis raised. Performance study demonstrated substantialequivalency to the predicate.Therefore, the subject Delta Xtend lateralized glenosphere issubstantially equivalent to the predicate Delta Xtend Reverseshoulder system. The design, intended use, and materials are alsoequivalent to the Tornier Aequalis Reversed Shoulder Prosthesis |
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(K151293, K140478, K081059, K061439, K030941).
| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE | ||
|---|---|---|
| COMPARED TO THE PREDICATE DEVICES | ||
| Device | Subject Device: | Predicate: Delta Xtend Reverse |
| Delta Xtend Reverse Shoulder System | Shoulder System | |
| Lateralized glenosphere | Glenosphere | |
| 510(k)# | This submission | K062250, K120174 |
| (DePuy) | (DePuy) | |
| Intended Use | Reverse Shoulder Arthroplasty | Reverse Shoulder Arthroplasty |
| Glenosphere Material | ||
| Body | CoCrMo alloy | CoCrMo alloy |
| Fixation component | Titanium alloy | Titanium alloy |
| Glenosphere Design | ||
| Sizes | 38, 42mm | 38, 42mm |
| Sphere | Centered, eccentric (2mm) | Centered, eccentric (2mm) |
| Lateralization | 0, 2, 4, 6, 8mm | 0mm |
| Fixation with base | Taper lock and screw | Taper lock and screw |
| plate | ||
| Others | ||
| Sterilization | Gamma, single use | Gamma, single use |
| Shelf Life | 5 years | 5 years |
§ 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.”