(216 days)
No
The summary describes a mechanical shoulder prosthesis and its components. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The performance studies focus on mechanical testing and material properties.
Yes.
The device is a reverse shoulder replacement for patients with severe arthropathy, failed joint replacements, fractures, bone defects, degenerative diseases, and inflammatory arthritis, all of which are medical conditions that the device is intended to treat or alleviate.
No
This device is a shoulder prosthesis designed for surgical implantation to replace a diseased or damaged shoulder joint. It is a treatment device, not one that identifies or diagnoses a condition.
No
The device description clearly states it is a shoulder prosthesis consisting of physical implants made from materials like Ti-6Al-4V and CoCrMo, and includes accessories/instruments for implantation. This indicates a hardware medical device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "reverse shoulder replacement" for patients with specific shoulder conditions. This is a surgical implant used in the body to replace a joint, not a device used outside the body to test samples (like blood, urine, or tissue) for diagnostic purposes.
- Device Description: The description details the materials and components of a shoulder prosthesis (baseplates, screws, pegs, glenospheres), which are all parts of a surgical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
This device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AltiVate Reverse® Shoulder Prosthesis is indicated as a reverse shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to:
- Severe arthropathy with a grossly deficient rotator cuff;
- Previously failed joint replacement with a grossly deficient rotator cuff;
- Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection;
- Bone defect in proximal humerus;
- Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid;
- Inflammatory arthritis including rheumatoid arthritis;
- Correction of functional deformity.
The glenoid baseplate is intended for cementless application with addition of screws for fixation. This device may also be indicated in the salvage of previously failed surgical attempts for anatomic and hemi procedures.
All RSP® Monoblock and AltiVate Reverse® humeral stems are intended for cemented or cementless use.
Product codes (comma separated list FDA assigned to the subject device)
PHX, KWS
Device Description
The AltiVate Reverse® Glenoid is a line extension to the existing RSP Glenoid System consisting of additional size offerings, modularity, and augment/revision offerings for varying glenoid morphologies for use in reverse Total Shoulder Arthroplasty (TSA) applications. The new implants consist of modular neutral and augmented baseplates, Torx peripheral screws, porous coated pegs, and additional offsets of glenospheres. All of the subject device implants are manufactured from Ti-6Al-4V except the glenospheres, which are manufactured from CoCrMo. New device specific accessories/instruments have been developed and are intended to facilitate proper implantation of the glenoid shoulder system.
For peripheral fixation when using a neutral baseplate, a minimum of two 5.0mm Torx Locking Screws that are 22mm or greater in length are indicated. When using only two peripheral locking screws, the screws should be placed in the superior and inferior holes of the baseplate. For peripheral fixation when using a wedge baseplate, a minimum of two 5.0mm Torx Locking Screws that are 26mm or greater in length are indicated. When using only two peripheral locking screws should be placed in the superior and inferior holes of the baseplate. When using more than two locking screws, the screw through the thickest portion of the wedge should be 18mm or greater.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint / Glenohumeral joint
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing:
- Glenoid loosening testing per ASTM F2028
- Taper disassociation testing per ASTM F2009
- Screw testing per ASTM F543
- Range of motion evaluation per F1378
- Porous coating characterization
- Corrosion evaluation
- MRI compatibility evaluation
Performance testing demonstrated substantial equivalence between the subject and predicate device and did not raise different questions of safety and effectiveness.
Animal Studies: No animal studies were undertaken.
Clinical Studies: Clinical data 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.
K041066, K051075, K092873, K112069, K161742
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
May 29, 2024
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized image of a human figure. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Encore Medical, L.P. Sherri Mellingen Director, Regulatory Affairs 9800 Metric Boulevard Austin, Texas 78758
Re: K233481
Trade/Device Name: AltiVate Reverse® Glenoid 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: April 12, 2024 Received: April 15, 2024
Dear Sherri Mellingen:
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" (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).
1
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.
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 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,
Farzana
Digitally signed by
Farzana Sharmin -S
Sharmin -S Date: 2024.05.29
09:35:26 -04'00'
Farzana Sharmin, Ph.D. 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
2
Indications for Us
Submission Number (if known)
Device Name
AltiVate Reverse® Glenoid
Indications for Use (Describe)
The AltiVate Reverse® Shoulder Prosthesis is indicated as a reverse shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to:
Severe arthropathy with a grossly deficient rotator cuff;
Previously failed joint replacement with a grossly deficient rotator cuff;
Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection;
Bone defect in proximal humerus;
Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid;
Inflammatory arthritis including rheumatoid arthritis;
Correction of functional deformity.
The glenoid baseplate is intended for cementless application with addition of screws for fixation. This device may also be indicated in the salvage of previously failed surgical attempts for anatomic and hemi procedures.
All RSP® Monoblock and AltiVate Reverse® humeral stems are intended for cemented or cementless use.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
Image /page/4/Picture/1 description: The image shows the logo for "enovis". The word "eno" is in red, and the "vis" is in black. There is a black circle around the "o" in "enovis". The letters "TM" are in the bottom right corner of the logo.
510(k) Summary
I. SUBMITTER
Encore Medical, L.P. 9800 Metric Blvd. Austin, TX 78758
Phone: (952) 913-6383 Fax: (512) 834-6313
Contact Person: Sherri Mellingen, Director, Regulatory Affairs Date Prepared: April 11, 2024
II. DEVICE
Name of Device: AltiVate Reverse® Glenoid Common Name: Reverse Shoulder Prosthesis Classification Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis (21 CFR 888.3660) Regulatory Class: II Product Code(s): PHX, KWS
III. PREDICATE DEVICE
Substantial equivalence of the subject AltiVate Reverse® Glenoid is being claimed with the primary predicate device, Encore Reverse Shoulder Prosthesis® (RSP) Glenoid System (K041066, K051075, K092873, and K112069), and the additional predicate Tornier Perform Reversed Augmented Glenoid (K161742).
This predicates have not been subject to a design-related recall.
Reference devices: SMR Reverse Liner (K220792)
IV. DEVICE DESCRIPTION
The AltiVate Reverse® Glenoid is a line extension to the existing RSP Glenoid System consisting of additional size offerings, modularity, and augment/revision offerings for varying glenoid morphologies for use in reverse Total Shoulder Arthroplasty (TSA) applications. The new implants consist of modular neutral and augmented baseplates, Torx peripheral screws, porous coated pegs, and additional offsets of glenospheres. All of the subject device implants are manufactured from Ti-6Al-4V except the glenospheres, which are manufactured from CoCrMo. New device specific accessories/instruments have been developed and are intended to facilitate proper implantation of the glenoid shoulder system.
For peripheral fixation when using a neutral baseplate, a minimum of two 5.0mm Torx Locking Screws that are 22mm or greater in length are indicated. When using only two peripheral locking screws, the screws should be placed in the superior and inferior holes of the baseplate. For peripheral fixation when using a wedge baseplate, a minimum of two 5.0mm Torx Locking Screws that are 26mm or greater in length are indicated. When using only two peripheral locking screws should be placed in the
5
Image /page/5/Picture/1 description: The image shows the logo for Enovis. The word "enovis" is written in a sans-serif font, with the "eno" in red and the "vis" in black. There is a black and gray circular design element between the "o" and the "v". The letters "TM" are in superscript to the right of the "s".
superior and inferior holes of the baseplate. When using more than two locking screws, the screw through the thickest portion of the wedge should be 18mm or greater.
V. INDICATIONS FOR USE
The AltiVate Reverse® Shoulder Prosthesis is indicated as a reverse shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to:
- · Severe arthropathy with a grossly deficient rotator cuff;
- · Previously failed joint replacement with a grossly deficient rotator cuff;
- Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection;
- · Bone defect in proximal humerus;
- Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid;
- Inflammatory arthritis including rheumatoid arthritis;
- Correction of functional deformity.
The glenoid baseplate is intended for cementless application with addition of screws for fixation. This device may also be indicated in the salvage of previously failed surgical attempts for anatomic and hemi procedures.
All RSP® Monoblock and AltiVate Reverse® humeral stems are intended for cementless use.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Substantial equivalence of the subject AltiVate Reverse® Glenoid has been demonstrated with the predicate device, Encore Reverse Shoulder Prosthesis® (RSP) glenoid system with the same materials, indications for use, and intended use.
Non-Clinical Performance Testing
- Glenoid loosening testing per ASTM F2028
- Taper disassociation testing per ASTM F2009
- Screw testing per ASTM F543
- Range of motion evaluation per F1378
- Porous coating characterization
- Corrosion evaluation
- MRI compatibility evaluation
Performance testing demonstrated substantial equivalence between the subject and predicate device and did not raise different questions of safety and effectiveness.
Animal Studies
No animal studies were undertaken.
6
Image /page/6/Picture/1 description: The image shows the logo for "enovis". The word "enovis" is written in a stylized font, with the "eno" in red and the "vis" in black. The "o" in "enovis" is a black circle that is slightly tilted to the right. The letters are connected to each other, and there is a trademark symbol next to the "s".
Clinical Studies
Clinical data was not required.
VIII. CONCLUSIONS
All testing and evaluations demonstrate that the subject device is substantially equivalent to the predicate device identified.