(86 days)
No
The document describes a mechanical shoulder implant system and its components, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are mechanical tests, not data-driven analyses.
Yes
The device replaces or reconstructs a diseased or damaged joint, which is a therapeutic intervention.
No
The device is an orthopedic implant for shoulder replacement, indicated for conditions like arthritis and fractures, not for diagnosing diseases or conditions.
No
The device description clearly states it consists of physical components made of Ti-6Al-4V material, which are implanted in the shoulder joint. This is a hardware medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The Promos Modular Shoulder System is a surgical implant designed to replace or reconstruct the shoulder joint. Its intended use is to treat conditions like arthritis, avascular necrosis, and fractures.
- Lack of Diagnostic Function: The device itself does not perform any tests on biological samples to diagnose a condition. It is a physical component implanted into the body.
The provided information clearly describes a prosthetic device for surgical implantation, not a diagnostic tool used outside the body.
N/A
Intended Use / Indications for Use
The Promos Modular Shoulder System is indicated for:
- Advanced degeneration of the shoulder joint as a result of degenerative, post-traumatic or inflammatory arthritis
- Avascular necrosis of the humeral head
- Complex fractures of the proximal humerus
- Functional impairment especially in the case of post-traumatic loss of the joint configuration
The humeral component is intended for cementless use. The glenoid component is for use with bone cement only.
Product codes
HSD, KWS
Device Description
The Promos Modular Shoulder System, as cleared via premarket notification K063578, consists of two primary components: the glenoid component and the modular humeral component. The modular humeral component consists of a distal stem, body, inclination set, and humeral head. Subject of this premarket notification is a review of changes to the Promos inclination set. No changes will be made to the glenoid, humeral head, body, or distal stem as a result of this premarket notification. Modifications to the inclination set components are intended to increase the overall strength and stability of the construct. The design concept remains the same, and the inclination set continues to mate with the humeral head and proximal body in the same way.
The modified devices consist of three components: internal cone, sleeve, and set screw. The subject inclination sets are manufactured from Ti-6Al-4V material conforming to ISO 5832-3 and are available in four sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder joint, humeral head, proximal humerus
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)
A review of the mechanical data indicates that the Promos Modular Shoulder System is capable of withstanding expected in vivo loading without failure. The following mechanical testing of the Promos Modular Shoulder System was performed:
- Static testing of set screw .
- . Pre-fatigue taper strength
- Construct fatigue, including post-fatigue taper evaluations
A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
JAN - 5 2012 - We are smith&nephew
| Submitted by: | Smith & Nephew, Inc.
1450 Brooks Road
Memphis, Tennessee 38116 |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Summary: | January 4, 2012 |
| Contact Person: | Megan Bevill, Regulatory Affairs Project Manager
T (901) 399-5340
F (901) 566-7086 |
| Name of Device: | Promos Modular Shoulder System |
| Common Name: | Hemi or Total Shoulder |
| Device Classification Name and
Reference: | 21 CFR 888.3690 Prosthesis, shoulder, hemi-, humeral,
metallic uncemented - Class II
21 CFR 888.3660 Prosthesis, shoulder, semi-constrained,
metal/polymer cemented - Class II |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | HSD, KWS |
Device Description
The Promos Modular Shoulder System, as cleared via premarket notification K063578, consists of two primary components: the glenoid component and the modular humeral component. The modular humeral component consists of a distal stem, body, inclination set, and humeral head. Subject of this premarket notification is a review of changes to the Promos inclination set. No changes will be made to the glenoid, humeral head, body, or distal stem as a result of this premarket notification. Modifications to the inclination set components are intended to increase the overall strength and stability of the construct. The design concept remains the same, and the inclination set continues to mate with the humeral head and proximal body in the same way.
The modified devices consist of three components: internal cone, sleeve, and set screw. The subject inclination sets are manufactured from Ti-6Al-4V material conforming to ISO 5832-3 and are available in four sizes.
Technological Characteristics
A review of the mechanical data indicates that the Promos Modular Shoulder System is capable of withstanding expected in vivo loading without failure. The following mechanical testing of the Promos Modular Shoulder System was performed:
- Static testing of set screw .
- . Pre-fatigue taper strength
- Construct fatigue, including post-fatigue taper evaluations �
A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject devices.
Page 1 of 2
ર-1
1
Image /page/1/Picture/0 description: The image contains a sequence of alphanumeric characters. The characters are 'K', 'I', 'I', '3', '0', '1', and '2'. The characters are written in a handwritten style.
Intended Use
The Promos Modular Shoulder System is indicated for:
- Advanced degeneration of the shoulder joint as a results of degenerative, post-traumatic or . inflammatory arthritis
- Avascular necrosis of the humeral head .
- . Complex fractures of the proximal humerus
- Functional impairment especially in the case of post-traumatic loss of the joint configuration .
The humeral component is intended for cementless use. The glenoid component is for use with bone cement only.
Substantial Equivalence Information
The subject devices are identical in function, intended use, indications for use, and material m ourition, and very similar in overall design to the Promos Modular Shoulder System Inclination Sets cleared via premarket notification K063578. They are also similar in intended use to the Cofield 2 Shoulder System cleared via premarket notification K955767.
Table 1: Substantially equivalent predicate devices
| Manufacturer | Description | Submission
Number | Clearance
Date |
|----------------------------------------------------------------|-----------------------------------|----------------------|-------------------|
| Smith & Nephew Orthopaedics AG
(former Plus Orthopedics AG) | Promos Modular Shoulder
System | K063578 | 3/2/2007 |
| Smith & Nephew, Inc. | Cofield 2 Shoulder System | K955767 | 4/8/1996 |
Conclusion
As neeviously noted, this Traditional 510(k) Premarket Notification is being submitted to request clearance for the modified Inclination Sets of the Promos Modular Shoulder System. Based on the similarities to the predicate components and a review of the mechanical testing performed, the devices are substantially equivalent to above predicate shoulder system.
Page 2 of 2
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure. The symbol is composed of three curved lines that converge to form the head and body of the bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN - 5 2012
Smith & Nephew, Incorporated % Ms. Megan Bevill Regulatory Affairs Project Manager 1450 Brooks Road Memphis Tennessee 38116
Re: K113012
Trade/Device Name: Promos Modular Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained prosthesis Regulatory Class: Class II Product Code: KWS, HSD Dated: October 7, 2011 Received: October 11, 2011
Dear Ms. Bevill:
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. ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ ーーーーー
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 (reporting of medical
3
Page 2 - Ms. Megan Bevill
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,
Sincerely yours,
for
Mark N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Promos Modular Shoulder System
The Promos Modular Shoulder System is indicated for:
- Advanced degeneration of the shoulder joint as a result of degenerative, post-traumatic or . inflammatory arthritis '
- Avascular necrosis of the humeral head o
- Complex fractures of the proximal humerus �
- Complex freetarse of the precially in the case of post-traumatic loss of the joint configuration .
The humeral component is intended for cemented or cementless use. The glenoid component is for use with bone cement only
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(Please Do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
BBhach
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113012