(266 days)
No
The summary describes a mechanical implant for shoulder replacement and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
Explanation: The device is a shoulder joint replacement system intended to treat pain and dysfunction caused by various joint diseases and injuries, which are therapeutic indications.
No
The device is a shoulder joint replacement system, intended to treat pain and dysfunction, not to diagnose a condition.
No
The device description clearly states it is a physical implant component (glenoid component) made of ultra-high molecular weight polyethylene with vitamin E, designed for surgical implantation in the shoulder joint. It is part of a larger shoulder replacement system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing a shoulder joint to treat various musculoskeletal conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the materials and design of a physical implant (a glenoid component for a shoulder replacement). It does not describe any components or processes for analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition based on sample analysis.
Therefore, the AltiVate® Anatomic Shoulder System is a medical device, specifically a surgical implant, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AltiVate® Anatomic Shoulder System is indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to:
• Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis of the natural humeral head and/or glenoid, and post traumatic arthritis
• Rheumatoid and other inflammatory arthritis
• Correction of functional deformity, including fracture malunion
• Humeral head fracture
• Revision of other devices if sufficient bone stock remains
The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for a total shoulder arthroplasty.
Humeral components with a porous coated surface are indicated for either cemented applications. Glenoid components are indicated for cemented use only.
Product codes
KWS, PAO
Device Description
This application is to include the AltiVate® Anatomic Shoulder AG e+™ with Markers, as a component of the AltiVate® Anatomic Shoulder System. The AltiVate® Anatomic Shoulder AG e+™ with Markers are manufactured from ultra-high molecular weight polyethylene with vitamin E. The articulating surface has a radius of curvature greater than the compatible humeral heads to allow translation in the superior/inferior and anterior/posterior directions. The back surface(s) of the component is spherical in geometry and has four pegs for fixation in the glenoid. The central peg has three annular barbs and the peripheral pegs have machined fixation features, referred to as Tri-lobes, to provide immediate fixation to the patient's glenoid when inserted. Radiographic markers are found in all three peripheral pegs.
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
Mechanical and acoustic testing: Dynamic evaluation of glenoid loosening or disassociation was performed per ASTM F2028-17.
Animal Study: No animal studies were undertaken.
Clinical Studies: Clinical data was not required.
Key Metrics
Not Found
Predicate Device(s)
Encore Medical, L.P., AltiVate Anatomic Pegged Glenoid with Markers, K203026, Encore Medical, L.P., AltiVate Anatomic Shoulder, K162024
Reference Device(s)
Tornier, Inc., Aequalis PerFORM+ Shoulder System, K150583, Encore Orthopedics, Inc., Total Shoulder Prosthesis, K950651
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
July 7, 2022
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 acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the full name. The full name of the agency is "U.S. Food & Drug Administration".
Encore Medical, L.P. Michael A. Siano Senior Program Manager, Regulatory Affairs 9800 Metric Boulevard Austin, Texas 78758
Re: K213387
Trade/Device Name: AltiVate® Anatomic Shoulder AG e+™ with Markers Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, PAO Dated: June 2, 2022 Received: June 6, 2022
Dear Michael A. Siano:
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 (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.
For Jiping Chen, M.D., Ph.D., M.P.H. Acting Division 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
2
Indications for Use
510(k) Number (if known)
K213387
Device Name
AltiVate® Anatomic Shoulder AG e+TM with Markers
Indications for Use (Describe)
The AltiVate® Anatomic Shoulder System is indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to:
• Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis of the natural humeral head and/or glenoid, and post traumatic arthritis
· Rheumatoid and other inflammatory arthritis
- · Correction of functional deformity, including fracture malunion
- · Humeral head fracture
- · Revision of other devices if sufficient bone stock remains
The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for a total shoulder arthroplasty.
Humeral components with a porous coated surface are indicated for either cemented applications. Glenoid components are indicated for cemented use only.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the DJO Surgical logo. The logo consists of a red circle on the left, followed by the letters "DJO" in black. To the right of "DJO" is the word "SURGICAL" in a smaller, lighter font. The logo is simple and modern, and the use of red and black gives it a bold and professional look.
510(k) Summary
I. SUBMITTER
Encore Medical, L.P. (dba DJO Surgical) 9800 Metric Blvd. Austin, TX 78758
Phone: (864) 322-3801 Fax: (512) 834-6313
Contact Person: Michael A. Siano, Sr. Program Manager, RA Date Prepared: October 13, 2021
II. DEVICE
Name of Device: AltiVate® Anatomic Shoulder AG e+™ with Markers Common or Usual Name: Total Shoulder Implant Classification Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis (888.3660) Regulatory Class: II Product Code(s): KWS, PAO
III. PREDICATE DEVICE
Encore Medical, L.P., AltiVate Anatomic Pegged Glenoid with Markers, K203026 (Primary Predicate) Encore Medical, L.P., AltiVate Anatomic Shoulder, K162024
Reference devices: Tornier, Inc., Aequalis PerFORM+ Shoulder System, K150583 Encore Orthopedics, Inc., Total Shoulder Prosthesis, K950651
IV. DEVICE DESCRIPTION
This application is to include the AltiVate® Anatomic Shoulder AG e+™ with Markers, as a component of the AltiVate® Anatomic Shoulder System. The AltiVate® Anatomic Shoulder AG e+™ with Markers are manufactured from ultra-high molecular weight polyethylene with vitamin E. The articulating surface has a radius of curvature greater than the compatible humeral heads to allow translation in the superior/inferior and anterior/posterior directions. The back surface(s) of the component is spherical in geometry and has four pegs for fixation in the glenoid. The central peg has three annular barbs and the peripheral pegs have machined fixation features, referred to as Tri-lobes, to provide immediate fixation to the patient's glenoid when inserted. Radiographic markers are found in all three peripheral pegs.
V. INDICATIONS FOR USE
The AltiVate® Anatomic Shoulder System is indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to:
- Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis of the natural humeral head and/or glenoid, and post traumatic arthritis
4
Image /page/4/Picture/1 description: The image shows the logo for DJO Surgical. The logo consists of a red circle with a white design inside, followed by the text "DJO" in black, and then the word "SURGICAL" in a smaller, lighter font. The logo is clean and professional, suggesting a company in the medical or surgical field.
- . Rheumatoid and other inflammatory arthritis
- . Correction of functional deformity, including fracture malunion
- . Humeral head fracture
- . Revision of other devices if sufficient bone stock remains
The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for a total shoulder arthroplasty.
Humeral components with a porous coated surface are indicated for either cemented or uncemented applications. Glenoid components are indicated for cemented use only.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Comparable Elements to Predicate Device(s):
Different Elements to Predicate Device(s):
-
Intended Use and Indications for Use ●
- Augmented back surface geometry
-
Material
. -
Articulating surface geometry
-
. Size Offerings
-
Radiographic markers
-
Sterilization
Any noted differences do not raise different questions of safety and effectiveness.
Endotoxin Assessment
DJO Surgical conducts device testing to assure that pyrogen limit specifications are met via the Kinetic Chromogenic method for bacterial endotoxin testing.
Mechanical and acoustic testing
Dynamic evaluation of glenoid loosening or disassociation was performed per ASTM F2028-17.
Animal Study
No animal studies were undertaken.
Clinical Studies
Clinical data was not required.
VII. CONCLUSIONS
All testing and evaluations demonstrate that the device is substantially equivalent to the predicates identified.