(27 days)
A Delta CTA™ Reverse Shoulder Prosthesis is indicated for use in
• Grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient joint.
• 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.
• The metaglene component is HA coated and is intended for cementless application with the addition of screws for fixation. For US Use Only: All other components are intended for cemented use only.
The Delta CTA™ Reverse Shoulder is DePuy's first generation reverse shoulder system. In a reverse shoulder, the articulation is "inverted" compared to traditional, anatomical total shoulder prosthesis so that the "ball" of the articulation is incorporated into the glenoid prosthesis and the "cup" of the articulation is incorporated into the humeral prosthesis. This inverted design helps stabilize a shoulder in the absence of a functional rotator cuff.
The provided document is a 510(k) premarket notification summary for the DePuy Delta CTA™ Reverse Shoulder System. It focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing acceptance criteria and performance data for a new AI/software medical device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies for an AI/software device cannot be extracted from this document. This document describes a traditional medical device (shoulder prosthesis) and evaluates its substantial equivalence based on non-clinical performance and material characteristics, not AI performance.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
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: K122442
Trade/Device Name: DePuy Delta CTA™ 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: August 9, 2012 Received: August 10, 2012
Dear Ms. Burns:
This letter corrects our substantially equivalent letter of September 6, 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. Iisting 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
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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/ResourcesforYou/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
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Section 4: Indications for Use Statement
510 (k) Number (if known):
Device Name: DePuy Delta CTA™ Reverse Shoulder System
Indications for Use:
A Delta CTA™ Reverse Shoulder Prosthesis is indicated for use in
- Grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint . replacement with a grossly rotator cuff deficient joint.
- 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.
- The metaglene component is HA coated and is intended for cementless application . with the addition of screws for fixation. For US Use Only: All other components are intended for cemented use only.
| Prescription Use | X (Part 21 CFR 801 Subpart D) |
|---|---|
| AND/OR | Over-The-Counter Use (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off:
Division of Surgical, Orthopedic, and Restorative Devices
| 510(k) Number | K122442 |
|---|---|
| 00012 |
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K 122442 (1/2)
SEP 6 2012
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Section 5: 510(k) Summary
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(as required by 21 CFR 807.92 and 21 CFR 807.93)
| 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 | August 9, 2012 |
| Name of device | |
| Trade or proprietary name | Delta CTATM Reverse Shoulder System |
| Common or usual name | Shoulder Prosthesis |
| Class | II |
| Classification panel | 87 - Orthopedics |
| Regulation | 21 CFR 888.3660 - Shoulder joint metal/polymer semi-constrained cemented prosthesis |
| Product Code(s) | KWS |
| Legally marketed device(s) towhich equivalence is claimed | Delta CTATM Reverse Shoulder System - Humeral Cups(K050315, cleared May 16, 2005) |
| Reason for 510(k) submission | Line Extension |
| Device description | The Delta CTATM Reverse Shoulder is DePuy's first generationreverse shoulder system. In a reverse shoulder, the articulation is"inverted" compared to traditional, anatomical total shoulderprosthesis so that the "ball" of the articulation is incorporatedinto the glenoid prosthesis and the "cup" of the articulation isincorporated into the humeral prosthesis. This inverted designhelps stabilize a shoulder in the absence of a functional rotatorcuff. |
| Intended use of the device | Reverse Shoulder Arthroplasty |
| Indications for use | A Delta CTA TM Reverse Shoulder Prosthesis is indicated for usein• Grossly rotator cuff deficient joint with severe arthropathy ora previous failed joint replacement with a grossly rotator cuffdeficient joint.• The patient's joint must be anatomically and structurallysuited to receive the selected implant(s), and a functionaldeltoid muscle is necessary to use the device.• The metaglene component is HA coated and is intended forcementless application with the addition of screws forfixation. For US Use Only: All other components areintended for cemented use only. |
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| CHARACTERISTICS | Subject Device:DePuy DELTA CTA™Hybrid Humeral cups. | Predicate Device:DePuy DELTA CTA™Humeral cups (K0503- | |
|---|---|---|---|
| Intended Use | Reverse Shoulder ArthroplastyA Delta CTA™ Reverse Shoulder | SAME | |
| Indications for Use | Prosthesis is indicated for use in• Grossly rotator cuff deficient jointwith severe arthropathy or aprevious failed joint replacementwith a grossly rotator cuff deficientjoint.• The patient's joint must beanatomically and structurallysuited to receive the selectedimplant(s), and a functional deltoidmuscle is necessary to use thedevice.• The metaglene component is HAcoated and is intended forcementless application with theaddition of screws for fixation. ForUS Use Only: All othercomponents are intended forcemented use only. | SAME | |
| Material | UHWMPE | SAME | |
| Sizes | Diameters: 38 mm and 42mmThickness: +3mm, +6mm, +9mm | Diameters: 36mm and 42mmThickness: +3mm and +9mm | |
| PERFORMANCE DATA | |||
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OFSUBSTANTIAL EQUIVALENCE | |||
| Performance Test Summary-New Device | |||
| Characteristic | Standard/Test/FDA Guidance | Results Summary | |
| Stack analyses demonstrated the subject device to be compatible with the existing matingcomponents (Delta CTA epiphysis and Delta Xtend glenospheres). | |||
| COMPARATIVE PERFORMANCE INFORMATION SUMMARY | |||
| Characteristic | Requirement | New Device Predicate Dev | |
| The results of the non-clinical testing demonstrate substantial equivalence to the predicate | |||
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OFSUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION | |||
| No clinical tests were conducted to demonstrate substantial equivalence. |
. .
§ 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.”