(194 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and design of a shoulder prosthesis, with no mention of AI or ML technologies.
Yes
The device is intended to treat a severely painful and/or disabled shoulder joint resulting from osteoarthritis or traumatic arthritis, which is a therapeutic purpose.
No
Explanation: The device description clearly states it is a "canal-sparing prosthesis intended for use in an anatomic Total Shoulder Arthroplasty (aTSA) application." This indicates it is an implantable medical device for surgical repair, not a device used to diagnose a condition.
No
The device description clearly outlines physical components made of metal (Ti-6Al-4V and CoCr) intended for surgical implantation, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The AltiVate Anatomic CS Shoulder is a surgical implant designed to replace a damaged shoulder joint. It is a physical device implanted into the body.
- Intended Use: The intended use is to treat severely painful and/or disabled shoulder joints resulting from osteoarthritis or traumatic arthritis by replacing the joint. This is a surgical intervention, not a diagnostic test performed on a specimen.
The provided information clearly describes a medical device used for surgical treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The AltiVate® Anatomic CS Shoulder is indicated for severely painful and/or disabled shoulder joint resulting from osteoarthritis or traumatic arthritis.
The humeral components with a porous coated surface are indicated for uncemented (press-fit) applications. Glenoid components are indicated for cemented use only.
Product codes
PKC
Device Description
The AltiVate Anatomic Canal-Sparing (CS) Shoulder is a canal-sparing prothesis intended for use in an anatomic Total Shoulder Arthroplasty (aTSA) application. The canal-sparing prosthesis is a modular humeral component consisting of a metaphyseal humeral stem and humeral neck that are compatible with previously cleared DJO humeral heads and DJO keeled and pegged glenoids.
AltiVate Anatomic CS Humeral Stem - The AltiVate Anatomic CS Humeral Stem component (Ti-6Al-4V per ASTM F1472) is a 3-fin design that extend radially from the central body and are equally spaced at 120°. It has a female Morse taper to accept the humeral neck component. The stem is tapered and has one consistent collar diameter. It has porous coating applied around the outer central body, fins, and bottom of the collar for cementless fixation in the proximal humerus. The stem is offered in three sizes, ranging from 18mm to 24mm in length.
AltiVate Anatomic CS Humeral Neck - The AltiVate Anatomic CS Humeral Neck component (CoCr per ASTM F1537) is a dual Morse taper and is the modular connection between the humeral stem and the humeral head and is offered in one neutral size.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Non-Clinical Testing: Non-clinical testing has demonstrated the device's ability to perform under expected conditions. This testing includes:
- Taper Disassociation Testing
- Humeral Construct Fatigue Testing
- Torque-Out Testing
- Axial Pull-Out Testing
- Humeral Micromotion - Cadaveric Experimental Analysis
- Humeral Micromotion - Finite Element Analysis (FEA)
- Humeral Fit Analysis o
All testing has determined that the device is substantially equivalent to the predicate devices.
Endotoxin Assessment: DJO Surgical conducts device testing to assure that pyrogen limit specifications are met via the Kinetic Chromogenic method for bacterial endotoxin testing.
Clinical Testing: Clinical testing was not required
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s):
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
June 3, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
Encore Medical, L.P Teffany Hutto Manager, Regulatory Affairs 9800 Metric Blvd Austin, Texas 78758
Re: K193226
Trade/Device Name: AltiVate® Anatomic Canal-Sparing (CS) Shoulder Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PKC Dated: April 30, 2020 Received: May 1, 2020
Dear Teffany Hutto:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 (OS) 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 medical devices and radiation-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,
For: Michael Owens Acting 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K193226
Device Name
AltiVate® Anatomic Canal-Sparing (CS) Shoulder
Indications for Use (Describe)
The AltiVate® Anatomic CS Shoulder is indicated for severely painful and/or disabled shoulder joint resulting from osteoarthritis or traumatic arthritis.
The humeral components with a porous coated surface are indicated for uncemented (press-fit) applications. Glenoid components are indicated 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) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| ☑ 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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
510(k) Summary
Date: May 28, 2020
Manufacturer: DJO Surgical (Legal Name: Encore Medical, L.P.) 9800 Metric Blvd Austin, TX 78758
Contact Person: Teffany Hutto Manager, Regulatory Affairs Phone: (512) 834-6255 Fax: (760) 597-3466 Email: teffany.hutto@djoglobal.com
| Product | Common Name | Classification | Product Code |
|---|---|---|---|
| AltiVate® Anatomic | |||
| Canal-Sparing (CS) Shoulder | Total Shoulder Implant | Class II | PKC |
| Product Code | Regulation and Classification Name |
|---|---|
| PKC | Shoulder joint metal/polymer semi-constrained cemented prosthesis per CFR 888.3660 |
Description:
The AltiVate Anatomic Canal-Sparing (CS) Shoulder is a canal-sparing prothesis intended for use in an anatomic Total Shoulder Arthroplasty (aTSA) application. The canal-sparing prosthesis is a modular humeral component consisting of a metaphyseal humeral stem and humeral neck that are compatible with previously cleared DJO humeral heads and DJO keeled and pegged glenoids.
AltiVate Anatomic CS Humeral Stem -
The AltiVate Anatomic CS Humeral Stem component (Ti-6Al-4V per ASTM F1472) is a 3-fin design that extend radially from the central body and are equally spaced at 120°. It has a female Morse taper to accept the humeral neck component. The stem is tapered and has one consistent collar diameter. It has porous coating applied around the outer central body, fins, and bottom of the collar for cementless fixation in the proximal humerus. The stem is offered in three sizes, ranging from 18mm to 24mm in length.
AltiVate Anatomic CS Humeral Neck -
The AltiVate Anatomic CS Humeral Neck component (CoCr per ASTM F1537) is a dual Morse taper and is the modular connection between the humeral stem and the humeral head and is offered in one neutral size.
Indications for Use:
The AltiVate Anatomic CS Shoulder is indicated for severely painful and/or disabled shoulder joint resulting from osteoarthritis or traumatic arthritis.
The humeral components with a porous coated surface are indicated for uncemented (press-fit) applications. Glenoid components are indicated for cemented use only.
Predicate Devices:
| Device | Manufacturer | 510(k) Number |
|---|---|---|
| Simpliciti Shoulder System | Tornier | K143552 |
| AltiVate Anatomic Shoulder System | Encore Medical, L.P. | K162024 |
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Comparable Features to Predicate Device(s):
- Intended Use and Indications for Use ●
- Material (Stem and Neck) ●
- Porous Coating ●
- Bone Fixation
- Quantity of Fins
- Size Offerings ●
- . Length Offerings
Key Differences in Subject Device to Predicate:
- . Fin width of subject device increases incrementally
- Collar diameter is smaller than predicate
Non-Clinical Testing: Non-clinical testing has demonstrated the device's ability to perform under expected conditions. This testing includes:
- Taper Disassociation Testing
- Humeral Construct Fatigue Testing
- Torque-Out Testing
- Axial Pull-Out Testing
- Humeral Micromotion - Cadaveric Experimental Analysis
- Humeral Micromotion - Finite Element Analysis (FEA)
- Humeral Fit Analysis o
All testing has determined that the device is substantially equivalent to the predicate devices.
Endotoxin Assessment: DJO Surgical conducts device testing to assure that pyrogen limit specifications are met via the Kinetic Chromogenic method for bacterial endotoxin testing.
Clinical Testing: Clinical testing was not required
Conclusions: All testing and evaluations demonstrate that the device is substantially equivalent to the predicates identified.