(73 days)
Not Found
No
The summary describes a shoulder replacement system and surgical instruments, with no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes
The device is a shoulder replacement system intended for use in anatomic total shoulder replacement procedures to address conditions like osteoarthritis and post-traumatic arthrosis, directly treating a medical condition.
No
Explanation: The device described is a shoulder replacement system (an implantable prosthesis and associated instruments) intended for use in surgical procedures to treat conditions like osteoarthritis and post-traumatic arthrosis. Its purpose is to replace damaged anatomical structures, not to diagnose medical conditions.
No
The device description clearly details physical implant components (humeral stemless anchor, offset taper adapter, humeral head, glenoid implants) and surgical instruments, indicating it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "anatomic total shoulder replacement procedures" to address conditions like osteoarthritis and post-traumatic arthrosis. This is a surgical procedure performed on the patient's body.
- Device Description: The device components are implants (humeral stemless anchor, humeral head, glenoid) and surgical instruments. These are used during surgery, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant and associated instruments used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
The INHANCE™ SHOULDER SYSTEM with the humeral stemless anchor is in anatomic total shoulder replacement procedures to address the following:
- · Osteoarthritis
- · Post-traumatic arthrosis
- · Focal avascular necrosis of the humeral head.
- · Previous surgeries of the shoulder that do not compromise the fixation
Fixation Methods:
The humeral stemless anchor is intended for cementless use. The anatomic hybrid glenoid are intended for cemented use only.
The INHANCE INTACT™ instruments are intended to be used during orthopedic surgery with INHANCE™ Anatomic Stemless Shoulder System. Cases and trays are intended to hold joint reconstruction instruments during the sterilization process an
Product codes (comma separated list FDA assigned to the subject device)
PKC, PAO, MBF, KWT, KWS
Device Description
The current submission adds INHANCE INTACT™ Instruments to the INHANCE Stemless Anatomic Shoulder System. The implant components of the system are unchanged. The INHANCEINTACT™ Instruments are designed to facilitate a subscapularis sparing total shoulder arthroplasty for the INHANCE™ Anatomic Stemless Shoulder System.
The INHANCETM SHOULDER SYSTEM with a humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures.
The Anatomic Total Shoulder Prosthesis of individually packaged implants: a humeral stemless anchor (titanium alloy), an offset taper adapter (titanium alloy), a humeral head (cobalt- chromium) in combination with an anatomic glenoid (stainless steel x-ray marker pin embedded) or an anatomic hybrid glenoid featuring a metal central post (titanium alloy). All glenoid implants have a Cross-Linked, Vitamin E Ultra High Molecular Weight Polyethylene (Cross-Linked, VE UHMWPE) bearing surface.
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
Orthopedic surgery
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)
The INHANCE INTACT Instruments underwent non-clinical testing and analyses to support a determination of substantial equivalence to the predicate device. The following were completed:
- Biocompatibility Assessments: The contact classification for the subject devices is Instrument, Bone/Tissue with limited duration (
§ 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
December 23, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Depuy Ireland UC % Sanjay Shah Regulatory Affairs NPD Depuy Orthopaedics, Inc. 700 Orthopaedic Dr. Warsaw, Indiana 46582
Re: K243248
Trade/Device Name: Inhance Intact™ Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder ioint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PKC, PAO, MBF, KWT, KWS, HSD Dated: October 4, 2024 Received: October 11, 2024
Dear Sanjay Shah:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Joseph P. Russell - Digitally signed by Joseph P. Russell -S S Date: 2024.12.23 14:45:23 -05'00'
for: Farzana Sharmin, PhD 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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
K243248
Device Name
INHANCE INTACT TM
Indications for Use (Describe)
The INHANCE™ SHOULDER SYSTEM with the humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures to address the following:
- · Osteoarthritis
- · Post-traumatic arthrosis
- · Focal avascular necrosis of the humeral head
- · Previous surgeries of the shoulder that do not compromise the fixation
Fixation Methods:
The humeral stemless anchor is intended for cementless use. The anatomic glenoid and anatomic hybrid glenoid are intended for cemented use only.
The INHANCE INTACT™ instruments are intended to be used during orthopedic surgery with INHANCE™ Anatomic Stemless Shoulder System. Cases and trays are intended to hold joint reconstruction instruments during the sterilization process and for storage.
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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4
| e | 1, 2 | |
|---|---|---|
510(k) Summary
Prepared on: 2024-12-23
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | Depuy Ireland UC | ||||
|---|---|---|---|---|---|
| Applicant Address | Loughbeg Ringaskiddy Ringaskiddy Co. Cork Munster Ireland | ||||
| Applicant Contact Telephone | (612) 812-6462 | ||||
| Applicant Contact | Mr. Sanjay Shah | ||||
| Applicant Contact Email | sshah164@its.jnj.com | ||||
| Correspondent Name | Depuy Orthopaedics, Inc. | ||||
| Correspondent Address | 700 Orthopaedic Dr. Warsaw IN 46582 United States | ||||
| Correspondent Contact Telephone | (612) 812-6462 | ||||
| Correspondent Contact | Mr. Sanjay Shah | ||||
| Correspondent Contact Email | sshah164@its.jnj.com | ||||
| Device Name | |||||
| 21 CFR 807.92(a)(2) | |||||
| Device Trade Name | INHANCE INTACT ™ | ||||
| Common Name | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral | ||||
| Stem With No Diaphyseal Incursion, Semi-Constrained | |||||
| Classification Name | Shoulder joint metal/polymer semi-constrained cemented prosthesis | ||||
| Regulation Number | 888.3660 | ||||
| Product Code(s) | PKC, PAO, MBF, KWT, KWS | ||||
| Legally Marketed Predicate Devices | |||||
| 21 CFR 807.92(a)(3) | |||||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |||
| K203108 | Ignite Stemless Anatomic Shoulder System | PKC | |||
| K212933 | INHANCE Hybrid Anatomic Glenoid Implant | MBF | |||
| Device Description Summary | 21 CFR 807.92(a)(4) |
The current submission adds INHANCE INTACT™ Instruments to the INHANCE Stemless Anatomic Shoulder System. The implant components of the system are unchanged. The INHANCEINTACT™ Instruments are designed to facilitate a subscapularis sparing total shoulder arthroplasty for the INHANCE™ Anatomic Stemless Shoulder System.
The INHANCETM SHOULDER SYSTEM with a humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures.
5
The Anatomic Total Shoulder Prosthesis of individually packaged implants: a humeral stemless anchor (titanium alloy), an offset taper adapter (titanium alloy), a humeral head (cobalt- chromium) in combination with an anatomic glenoid (stainless steel x-ray marker pin embedded) or an anatomic hybrid glenoid featuring a metal central post (titanium alloy). All glenoid implants have a Cross-Linked, Vitamin E Ultra High Molecular Weight Polyethylene (Cross-Linked, VE UHMWPE) bearing surface.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The INHANCE™ SHOULDER SYSTEM with the humeral stemless anchor is in anatomic total shoulder replacement procedures to address the following:
- · Osteoarthritis
- · Post-traumatic arthrosis
- · Focal avascular necrosis of the humeral head.
- · Previous surgeries of the shoulder that do not compromise the fixation
Fixation Methods:
The humeral stemless anchor is intended for cementless use. The anatomic hybrid glenoid are intended for cemented use only.
The INHANCE INTACT™ instruments are intended to be used during orthopedic surgery with INHANCE™ Anatomic Stemless Shoulder System. Cases and trays are intended to hold joint reconstruction instruments during the sterilization process an
Indications for Use Comparison
The indications for use are the same as the predicate device.
Technological Comparison
The INHANCE Stemless Anatomic Shoulder System with INHANCE INTACT instruments are substantially equivalent to the predicate device (K203108 and K212933) in regard to their intended use, indications for use, material, manufacturing process and performance. The implant components of the subject device system are identical to those of the predicate device as thev remain unchanged. The INHANCE INTACT instruments have new design and specification compared to predicate devices instruments. Differences between the subject device system and the predicate device systems do not raise different types of safety and effectiveness questions.
Non-Clinical and/or Clinical Tests Summary & Conclusions
The implant components of the INHANCE Shoulder System are identical to the implant components of the predicate device. This submission includes additional instruments.
The INHANCE INTACT Instruments underwent non-clinical testing and analyses to support a determination of substantial equivalence to the predicate device. The following were completed:
Biocompatibility Assessments:
The contact classification for the subject devices is Instrument, Bone/Tissue with limited duration (