(143 days)
Not Found
No
The document describes a mechanical shoulder prosthesis and does not mention any software, algorithms, or data processing related to AI or ML.
Yes
The device is a prosthesis designed for the treatment of severe shoulder conditions like arthropathy, failed joint replacements, and fractures, indicating its use for restoring function and alleviating symptoms.
No
Explanation: This device is a shoulder prosthesis, an implant used in treatment, not a tool for diagnosing medical conditions. Its intended use describes conditions it treats, not conditions it identifies.
No
The device description clearly states it is a "total shoulder prosthesis that consists of monobloc and modular humeral stems, humeral cup, humeral head, humeral spacer, glenosphere, metaglene and metaglene screws," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description and intended use clearly state that the Delta Xtend Shoulder Prosthesis is a total shoulder prosthesis designed to be implanted into a patient's shoulder joint. It is a surgical implant used to replace damaged joint components.
- Lack of In Vitro Testing: The document does not mention any testing performed on samples outside of the body. The performance studies described are non-clinical testing related to the device's design and compatibility, not diagnostic testing on biological samples.
Therefore, based on the provided information, the Delta Xtend Shoulder Prosthesis is a surgical implant, not an In Vitro Diagnostic device.
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 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.
Product codes
PHX, KWS, HSD
Device Description
The DePuy Delta Xtend™ Reverse Shoulder System is a total shoulder prosthesis that consists of monobloc and modular humeral stems, humeral cup, humeral head, humeral spacer, glenosphere, metaglene and metaglene screws.
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
PERFORMANCE DATA SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
A stack analysis of the subject and predicate metaglene devices concluded the components to be equivalent in design except in peg length. The analysis also concluded the subject metaglene device to be compatible with the existing glenosphere.
No non-clinical testing was required to demonstrate substantial equivalence.
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
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized eagle or bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2016
DePuy Orthopaedics Ms. Megan Burns Associate, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46580
Re: K120174
Trade/Device Name: DePuy 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: May 11, 2012 Received: May 14, 2012
Dear Ms. Burns:
This letter corrects our substantially equivalent letter of June 11, 2012.
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. 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 801); medical device reporting (reporting of medical
1
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Section 4: Indications for Use Statement
510(k) Number (if known): Kollette K120174
Device Name: DePuv Delta Xtend™ Reverse Shoulder System
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.
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K12-01
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter-Use
(Part 2.1 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
JUN 1 ] 2012 - .
Section 5: 510(k) Summary
(as required by 21 CFR 807.92)
| Submitter Information | |||||
|---|---|---|---|---|---|
| Name: | DePuy Orthopaedics | ||||
| Address: | 700 Orthopedic Drive | ||||
| Phone number: | 574-372-7745 | ||||
| Fax number: | 574-371-4987 | ||||
| Establishment Registration: | 1818910 | ||||
| Name of contact person: | Megan Burns | ||||
| Date prepared: | 9 May 2012 | ||||
| Device Information | |||||
| Trade or proprietary name: | DePuy Delta Xtend™ Reverse Shoulder System | ||||
| Common or usual name: | Shoulder Prosthesis | ||||
| Class: | II | ||||
| Classification name: | 21 CFR 888.3660: Prosthesis, shoulder, semi-constrained, metal/polymer | ||||
| cemented | |||||
| Class II Device per 21 CFR 888.3690: Prosthesis, Shoulder, Hemi, | |||||
| Humeral, Metallic, Uncemented | |||||
| Classification panel: | Orthopedics | ||||
| Regulation: | 21 CFR 888.3660: Shoulder joint metal/polymer semi-constrained | ||||
| cemented prosthesis | |||||
| 21 CFR 888.3690: Shoulder joint humeral (hemi-shoulder) metallic | |||||
| uncemented prosthesis | |||||
| Product Code(s): | KWS, HSD | ||||
| Legally marketed device(s) | |||||
| to which equivalence is | |||||
| claimed: | DePuy Delta Xtend™ Reverse Shoulder System. K062250 | ||||
| Comprehensive® Reverse Shoulder, K080642 | |||||
| Aequalis® Reversed Fracture Shoulder Prosthesis, K082120 | |||||
| Reason for 510(k) | |||||
| submission: | Line extension and additional indication | ||||
| Device description: | The DePuy Delta Xtend™ Reverse Shoulder System is a total shoulder | ||||
| prosthesis that consists of monobloc and modular humeral stems, humeral | |||||
| cup, humeral head, humeral spacer, glenosphere, metaglene and metaglene | |||||
| screws. | |||||
| Intended Use: | The DePuy Delta Xtend™ Reverse Shoulder Prosthesis is intended for use | ||||
| in total shoulder or hemi-shoulder replacement procedures in patients with | |||||
| non-functional rotator cuffs, with or without bone cement. HA-coated | |||||
| components are for cementless use only. |
・・・
4
: : : :
のお買い物が、
: ……
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
:
| Device Information, continued: | |||||
|---|---|---|---|---|---|
| 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. | |||||
| Summary of the technological characteristics of the device compared to the predicate device | |||||
| CHARACTERISTIC | Subject Device: | ||||
| Delta XtendTM | |||||
| Reverse Shoulder | |||||
| (Long Peg | |||||
| Metaglene & | |||||
| Fracture Indication) | Metaglene Predicate | ||||
| Device: | |||||
| Delta XtendTM | |||||
| Reverse Shoulder | |||||
| (DEPUY) | |||||
| K062250 | Fracture Predicate | ||||
| Device: | |||||
| Aequalis Reversed | |||||
| Fracture | |||||
| (TORNIER) | |||||
| K082120 | Fracture Predicate | ||||
| Device: | |||||
| Comprehensive | |||||
| Reverse (BIOMET) | |||||
| K080642 | |||||
| Shoulder System | • Reverse articulation, | ||||
| modular humeral | |||||
| implant & monobloc | |||||
| humeral implant | • Reverse articulation, | ||||
| modular humeral | |||||
| implant & monobloc | |||||
| humeral implant | • Reverse articulation, | ||||
| monobloc humeral | |||||
| implant | • Reverse articulation, | ||||
| modular humeral | |||||
| implant | |||||
| Intended Use | • Total or hemi shoulder | ||||
| arthroplasty | • Same | • Same | • Same | ||
| Summary of the technological characteristics, continued: | |||||
| CHARACTERISTIC | Subject Device: | ||||
| Delta XtendTM | |||||
| Reverse Shoulder | |||||
| (Long Peg | |||||
| Metaglene & | |||||
| Fracture Indication) | Metaglene Predicate | ||||
| Device: | |||||
| Delta XtendTM | |||||
| Reverse Shoulder | |||||
| (DEPUY) | |||||
| K062250 | Fracture Predicate | ||||
| Device: | |||||
| Aequalis Reversed | |||||
| Fracture | |||||
| (TORNIER) | |||||
| K082120 | Fracture Predicate | ||||
| Device: | |||||
| Comprehensive | |||||
| Reverse (BIOMET) | |||||
| K080642 |
5
| Components | ||||
|---|---|---|---|---|
| CoCr Monobloc stem and epiphysis Titanium modular epiphysis with HA coating Titanium modular stem with HA coating Titanium metalback standard metaglene with HA coating Titanium metalback long peg metaglene with HA coating (new components) Titanium screws CoCr hemispherical glenosphere component Ultra-high Molecular Weight Polyethylene (UHMWPE) or Premicron™ X-Linked Polyethylene cups Titanium humeral spacer | CoCr Monobloc stem and epiphysis Titanium modular epiphysis with HA coating Titanium modular stem with HA coating Titanium metalback standard metaglene with HA coating Titanium screws CoCr hemispherical glenosphere component Ultra-high Molecular Weight Polyethylene (UHMWPE) or Premicron™ X-Linked Polyethylene cups Titanium humeral spacer | Titanium alloy Monobloc stem and epiphysis Titanium metalback standard metaglene with HA coating Titanium metalback long peg Metaglene with HA coating Titanium alloy screws Cobalt Chromium hemispherical glenosphere component Ultra-high Molecular Weight Polyethylene (UHMWPE) cups CoCr alloy humeral spacer | Titanium alloy Monobloc stem and epiphysis Titanium modular epiphysis plate Titanium modular distal stem Titanium metalback standard metaglene with porous coating Titanium screws Cobalt Chromium hemispherical glenosphere component Ultra-high Molecular Weight Polyethylene (UHMWPE) cups | |
| Fixation | ||||
| Bone cement | Cemented/cementless | Same | Cemented only | Same |
| Suture Holes | Yes | Yes | Yes | Yes |
| PERFORMANCE DATA | ||||
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF | ||||
| SUBSTANTIAL EQUIVALENCE | ||||
| Performance Test Summary-New Device | ||||
| Characteristic | Standard/Test/FDA Guidance | Results Summary | ||
| A stack analysis of the subject and predicate metaglene devices concluded the components to be | ||||
| equivalent in design except in peg length. The analysis also concluded the subject metaglene device to be | ||||
| compatible with the existing glenosphere. | ||||
| Comparative Performance Information Summary | ||||
| Characteristic | Requirement | New Device | Predicate Device | |
| No non-clinical testing was required to demonstrate substantial equivalence. | ||||
| 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 results of the non-clinical testing demonstrate substantial equivalence to the predicate. |
..
. . . . . .
・