(29 days)
The DELTA XTEND™ Reverse Shoulder System is intended for use in total or hemi-shoulder arthroplasty procedures in patients with non-functional rotator cuffs, with or without bone cement. HA components are for cementless use only.
The DELTA XTEND™ Reverse Shoulder System 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 and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. DELTA XTEND™ Reverse Shoulder System 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 System. The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation. All other metallic components are intended for cemented use only.
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
The provided text is a 510(k) Summary for the DELTA XTEND™ Reverse Shoulder System. It outlines the device, its intended use, and its substantial equivalence to previously cleared predicate devices.
However, the primary purpose of this submission (as stated in section 510(K) SUMMARY) is "to extend the current approved shelf life of 5 years to 10 years" of the DELTA XTEND™ Reverse Shoulder System.
Therefore, the performance data provided focuses solely on testing related to shelf-life extension, specifically regarding the HA coating on shelf-aged products. There is no information within this document about acceptance criteria or studies related to AI-powered medical devices, human reader improvements with AI assistance, or algorithm-only performance.
The document explicitly states:
"NO CLINICAL TESTS WERE CONDUCTED TO DEMONSTRATE SUBSTANTIAL EQUIVALENCE."
Therefore, I cannot provide the detailed information requested in your prompt regarding acceptance criteria, study details (sample sizes for test/training sets, data provenance), expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for an AI device, as this documentation pertains to a traditional medical device (shoulder replacement system) and not an AI/ML device.
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February 19, 2021
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
DePuy Orthopaedics Inc. Megan Bernier Regulatory Affairs Specialist 700 Orthopaedic Drive Warsaw. Indiana 46582
Re: K210167
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, KWS Dated: January 15, 2021 Received: January 21, 2021
Dear Megan Bernier:
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
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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 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 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
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Indications for Use
510(k) Number (if known) K210167
Device Name
Trade Name: DELTA XTEND™ Reverse Shoulder System
Indications for Use (Describe) DELTA XTEND™ Reverse Shoulder System
The DePuy DELTA XTEND™ Reverse Shoulder System 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 alternate 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™ Reverse Shoulder System 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 System. The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation. 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(K) SUMMARY
(As required by 21 CFR 807.92 and 21 CFR 807.93)
| Submitter Information | |
|---|---|
| Name | DePuy Orthopaedics, Inc. |
| Address | 700 Orthopaedics DriveWarsaw, Indiana 46581-0988 |
| Phone number | 651-325-1178 |
| Fax number | 612-435-2372 |
| EstablishmentRegistration Number | 1219655 |
| Name of contact person | Megan Bernier |
| Email of contact person | Mbernie1@its.jnj.com |
| Date prepared | 15, January 2021 |
| Name of device | |
| Trade or proprietaryname | DELTA XTEND ™ Reverse Shoulder System |
| Common or usualname | Shoulder Prosthesis |
| Classification name | Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis;Shoulder joint metal/polymer semi-constrained cemented prosthesis |
| Class | Class II |
| Classification panel | Orthopedics |
| Regulation | 21 CFR 888.3690, 888.3660 |
| Product Code(s) | PHX, HSD, KWS |
| Legally marketeddevice(s) to whichequivalence is claimed | DELTA XTEND ™ Reverse Shoulder System (DePuy: K062250,K071379, K120174, K192448) |
| Reason for 510(k)submission | The purpose of this submission is to extend the current approved shelf life of 5years to 10 years |
| Device description | The DELTA XTEND™ Reverse Shoulder System is currently clearedand marketed by DePuy Synthes and is comprised of multiple humeraland 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 System is intended for use in total or hemi-shoulder arthroplasty procedures in patients with non-functional rotator cuffs, with or without bone cement. HA components are for cementless use only. |
| Indications for use | The DELTA XTEND™ Reverse Shoulder System 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 and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.DELTA XTEND™ Reverse Shoulder System 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 System.The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation. All other metallic components are intended for cemented use only. |
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| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE | ||||
|---|---|---|---|---|
| COMPARED TO THE PREDICATE DEVICE | ||||
| Characteristics | Subject Device:DELTA XTEND™Reverse ShoulderSystem | PredicateDevice:DELTA XTEND™Reverse ShoulderSystem(K192448) | Predicate Device:DELTA XTEND™Reverse ShoulderSystem (K071379,K120174) | Primary Device:DELTA XTEND™Reverse ShoulderSystem (K062250) |
| IntendedUse | Reverse shoulderarthroplasty | Reverse shoulderarthroplasty | Reverse shoulderarthroplasty | Reverse shoulderarthroplasty |
| MaterialHumeralImplants(ModularHumeralStem,ModularEpiphysis) | Titanium Alloy(Ti6Al4V) withplasma sprayed HAcoating | Titanium Alloy(Ti6Al4V) withplasma sprayed HAcoating | Titanium Alloy(Ti6Al4V) with plasmasprayed HA coating | Titanium Alloy(Ti6Al4V) withplasma sprayed HAcoating |
| MaterialGlenoidImplants(Metaglene) | Titanium alloywith HA coating | Titanium alloywith HA coating | Titanium alloywith HA coating | Titanium alloywith HA coating |
| Modular, withoutcement,composed of anepiphysis and ahumeral stemmade out oftitanium andcoated withhydroxyapatite. | Modular,without cement,composed of anepiphysis and ahumeral stemmade out oftitanium andcoated withhydroxyapatite. | Modular, withoutcement, composedof an epiphysisand a humeralstem made out oftitanium andcoated withhydroxyapatite. | Modular, withoutcement,composed of anepiphysis and ahumeral stemmade out oftitanium andcoated withhydroxyapatite. | |
| FixationHumeralImplants(ModularHumeralStem,ModularEpiphysis) | The epiphysis isavailable instandard or longversion and intwo sizes in orderto be able to adaptas well aspossible to thehuman anatomy.The distal stem isavailable inseveral diametersto maximize theadaptability ofhumeral canal. | The epiphysis isavailable instandard or longversion and intwo sizes inorder to be ableto adapt as wellas possible to thehuman anatomy.The distal stemis available inseveral diametersto maximize theadaptability ofhumeral canal. | The epiphysis isavailable instandard or longversion and in twosizes in order to beable to adapt aswell as possible tothe humananatomy. Thedistal stem isavailable inseveral diametersto maximize theadaptability ofhumeral canal. | The epiphysis isavailable instandard or longversion and in twosizes in order to beable to adapt aswell aspossible to thehuman anatomy.The distal stem isavailable inseveral diametersto maximize theadaptability ofhumeral canal. |
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| FixationGlenoidImplants(Metaglene) | The GlenoidImplant iscomprised of aglenosphere thatis fixed on themetaglene by aconical joint and acentral pin.The metaglene iscoated withhydroxyapatiteand is fixed insidethe bone with 4screws.This submissionpertains to themetaglenecomponent of theGlenoid Implantonly. | The GlenoidImplant iscomprised of aglenosphere thatis fixed on themetaglene by aconical joint anda central pin.The metaglene iscoated withhydroxyapatiteand is fixedinside the bonewith 4 screws.This submissionpertained to themetaglenecomponent ofthe GlenoidImplant only. | The GlenoidImplant iscomprised of aglenosphere that isfixed on themetaglene by aconical joint and acentral pin.The metaglene iscoated withhydroxyapatiteand is fixed insidethe bone with 4screws. | The GlenoidImplant iscomprised of aglenosphere thatis fixed on themetaglene by aconical joint anda central pin.The metaglene iscoated withhydroxyapatiteand is fixedinside the bonewith 4 screws. |
|---|---|---|---|---|
| SterileMethod | Gamma (single useonly) | Gamma (single useonly) | Gamma (single useonly) | Gamma (single useonly) |
| Packaging | ||||
| Both systemsutilized a doublesterile barrier.The HumeralStems are placedinto a foamenvelope or polyprotector, placedinto a nylonpouch that isvacuumed sealedand then placedinto a PETG traysealed with Tyveklid stock. | Both systemsutilized a doublesterile barrier.The device isplaced into a foamenvelope, placedinto a nylon pouchthat is vacuumedsealed and thenplaced into aPETG tray sealedwith Tyvek lidstock. | Both systemsutilized a doublesterile barrier.The device isplaced into afoam envelope,placed into anylon pouch thatis vacuumedsealed and thenplaced into aPETG tray sealedwith Tyvek lidstock. | ||
| Both systemsutilized a doublesterile barrier.The HumeralStems are placedinto a foamenvelope or polyprotector, placedinto a nylonpouch that isvacuumed sealedand then placedinto a PETG traysealed withTyvek lid stock. | ||||
| The ModularEpiphysis andMetaglenecomponents areplaced into aninner PETGblister fitted witha polyurethaneinsert and thensealed with Tyveklid stock. Theinner blister forall components isthen placed intoan outer PETGblister sealed withTyvek lid stock. | ||||
| The ModularEpiphysis andMetaglenecomponents areplaced into aninner PETGblister fitted witha polyurethaneinsert and thensealed withTyvek lid stock.The inner blisterfor allcomponents isthen placed intoan outer PETGblister sealedwith Tyvek lidstock. | ||||
| Shelf Life | 10 years | 5 years | 5 years |
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PERFORMANCE DATA
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:
- . HA coating testing on shelf-aged product per
- o ISO-13779-3: Implants for surgery - Hydroxyapatite Part 3: Chemical analysis and characterization of crystallinity and phase purity.
- ASTM F1854 Standard test method for stereological evaluation of porous coatings on o medical implants.
- ASTM E2109 Standard test methods for determining area percentage porosity in thermal o sprayed coatings.
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 subject device DePuy DELTA XTEND™ Reverse Shoulder System is substantially equivalent to the predicate DePuy Synthes DELTA XTEND™ Reverse Shoulder System (K062250, K071379, K120174, K192448).
§ 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.”