(88 days)
Not Found
No
The document describes a mechanical shoulder prosthesis and its indications for use. There is no mention of software, algorithms, image processing, or any other technology that would typically incorporate AI/ML. The performance studies are focused on mechanical testing.
Yes.
The device is a prosthesis indicated for joint replacement due to various painful and dysfunctional conditions of the shoulder, aiming to restore function and alleviate symptoms.
No
This device, the AltiVate™ Shoulder Prosthesis Stem, is an implantable medical device used for joint replacement, not for diagnosing conditions. Its indications for use describe the conditions it is intended to treat, such as various forms of arthritis and avascular necrosis, rather than to identify or characterize them.
No
The device description clearly states it consists of physical components (humeral stem, socket insert, spacer, hemi-adaptor) and instrumentation, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a shoulder joint replacement for patients suffering from pain and dysfunction due to various conditions affecting the shoulder. This is a surgical implant, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the components of a shoulder prosthesis (humeral stem, socket insert, etc.), which are physical implants used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The device is directly implanted into the patient.
Therefore, the AltiVate™ Stem is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AltiVate™ Shoulder Prosthesis Stem is indicated as an Anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to:
- Noninflammatory degenerative joint disease including osteoarthritis;
- Inflammatory arthritis of the glenohumeral join including rheumatoid arthritis;
- Post-traumatic arthritis of the glenohumeral joint;
- Avascular necrosis of the humeral head with and without involvement of the glenoid;
- Correction of functional deformity ●
The all-poly glenoid is intended for cemented use
The AltiVate™ Shoulder Prosthesis Stem is indicated as a hemi shoulder joint replacement for patients suffering from pain and dysfunction due to:
- Noninflammatory degenerative joint disease including osteoarthritis; ●
- Inflammatory arthritis of the glenohumeral joint including rheumatoid arthritis; ●
- Post-traumatic arthritis of the glenohumeral joint;
- Avascular necrosis of the humeral head with and without involvement of the glenoid;
- Correction of functional deformity;
- Rotator cuff tear arthropathy;
- Humeral fracture.
- Failed previous shoulder surgery
The AltiVate™ Shoulder Prosthesis Stem is 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 humeral stems are intended for cemented or cementless use.
Product codes (comma separated list FDA assigned to the subject device)
KWS, HSD, PHX
Device Description
The AltiVate™ Reverse Small Shell Shoulder is a line extension to the AltiVate Reverse System. It consists of four primary components: humeral stem, socket insert, spacer and hemi-adaptor. Device specific instrumentation will also be used. Components are offered for either primary or revision surgery applications, in a hemi or total shoulder application.
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
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)
Mechanical testing has demonstrated the device's ability to perform under expected conditions. This testing included assessment of lever out, torsional strength, push-out strength, snap geometry, porous coating, fatigue, tensile strength, and screw strength, All testing has determined that the device is substantially equivalent to the predicate devices.
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.
K141990, K100741, K111061, K111735, K141006, K052906
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.
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
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized eagle. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" underneath.
October 30, 2017
Encore Medical, L.P. Teffany Hutto Manager, Regulatory Affairs 9800 Metric Blvd Austin, Texas 78758
Re: K172351
Trade/Device Name: AltiVate Reverse Humeral Stem. AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: KWS. HSD. PHX Dated: September 28, 2017 Received: October 2, 2017
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. 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); 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
1
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 (DICE) 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" (21 CFR 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 (DICE) 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
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KT72351 510(k) Number (if known
Device Name
AltiiVate M Reverse Shoulder System
Indications for AltiVate™ Stern Indications for Use (Describe)
Anatomic Total Shoulder Indications
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4
510(k) Summary
Date: September 29, 2017
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 Reverse® Small Shell Shoulder | Total Shoulder Implant | Class II | KWS, HSD, |
| PHX |
| Product Code | Regulation and Classification Name |
|---|---|
| KWS | Shoulder joint metal/polymer semi-constrained prosthesis per 21 CFR 888.3660 |
| HSD | Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis per CFR 888.3690 |
| PHX | Shoulder joint metal/polymer semi-constrained cemented prosthesis per CFR 888.3660 |
Description:
The AltiVate™ Reverse Small Shell Shoulder is a line extension to the AltiVate Reverse System. It consists of four primary components: humeral stem, socket insert, spacer and hemi-adaptor. Device specific instrumentation will also be used. Components are offered for either primary or revision surgery applications, in a hemi or total shoulder application.
Indications for Use:
Indications for AltiVate™ Stem:
Anatomic Total Shoulder Indications:
The AltiVate™ Shoulder Prosthesis Stem is indicated as an Anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to:
- Noninflammatory degenerative joint disease including osteoarthritis;
- Inflammatory arthritis of the glenohumeral join including rheumatoid arthritis;
- Post-traumatic arthritis of the glenohumeral joint;
- Avascular necrosis of the humeral head with and without involvement of the glenoid;
- Correction of functional deformity ●
The all-poly glenoid is intended for cemented use
Hemi Shoulder Indications:
The AltiVate™ Shoulder Prosthesis Stem is indicated as a hemi shoulder joint replacement for patients suffering from pain and dysfunction due to:
- Noninflammatory degenerative joint disease including osteoarthritis; ●
- Inflammatory arthritis of the glenohumeral joint including rheumatoid arthritis; ●
- Post-traumatic arthritis of the glenohumeral joint;
- Avascular necrosis of the humeral head with and without involvement of the glenoid;
- Correction of functional deformity;
- Rotator cuff tear arthropathy;
- Humeral fracture.
- Failed previous shoulder surgery
5
Reverse Total Shoulder Indications:
The AltiVate™ Shoulder Prosthesis Stem is 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 humeral stems are intended for cemented or cementless use.
Predicate Devices:
- Encore Humeral Shoulder Stem (now called AltiVate Reverse) K141990 ●
- Reverse® Shoulder Prosthesis Monoblock K100741, K111061, K111735, K141006 ●
- . Zimmer Trabecular Metal Reverse - K052906
Comparable Features to Predicate Device(s):
The AltiVate Reverse Small Shell Shoulder line extension includes a diametrically reduced shell geometry with features comparable to predicate devices including the same material substrate, same porous coating material, surface finishes, size offering, mating interface snap mechanism, sterilization and packaging, indications, intended use, and surgical implantation technique.
Key Differences in Subject Device to Predicate:
Differences to the predicates include a diametrically reduced shell geometry, additional size offerings/thickness and P2 porous coating surface area.
Non-Clinical Testing:
Mechanical testing has demonstrated the device's ability to perform under expected conditions. This testing included assessment of lever out, torsional strength, push-out strength, snap geometry, porous coating, fatigue, tensile strength, and screw strength, 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 mentod for bacterial endotoxin testing. Testing has also been performed to establish product non-pyrogenicity.
Clinical Testing: Clinical testing was not required.
Conclusions: All testing and evaluations demonstrate that the device is substantially equivalent to the predicates identified.