(50 days)
No
The description focuses solely on the material and mechanical design of a humeral stem for shoulder arthroplasty. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML.
Yes
The device is a humeral stem intended for use in total shoulder arthroplasty to relieve pain and restore shoulder motion, directly addressing a medical condition (arthritis, fracture).
No
Explanation: The device description clearly states it is a "humeral stem" designed for surgical implantation in total shoulder arthroplasty to treat conditions like arthritis and fractures. Its purpose is to relieve pain and restore motion, which are therapeutic outcomes, not diagnostic.
No
The device description clearly indicates it is a physical humeral stem made of titanium alloy, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a humeral stem used as part of a total shoulder system for surgical implantation to treat various shoulder conditions. This is a surgical implant, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details the physical characteristics and materials of a surgical implant designed to be placed within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an IVD.
N/A
Intended Use / Indications for Use
This humeral stem will be used as part of a total shoulder system intended for treatment of patients who are candidates for total shoulder arthroplasty because the natural head and/or glenoid has been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or proximal humeral fracture, and revision arthroplasty where bone loss is minimal. The humeral stem may be used with or without bone cement. These devices are intended to aid the surgeon in relieving the patient of shoulder pain and restoring shoulder motion.
Product codes
KWT
Device Description
The humeral stem is manufactured from wrought/forged titanium alloy(Ti-6A1-4V) that conforms to ASTM F136. The entire stem has heavy grit blasting to a surface roughness that ranges from 4um to 6Um.
The proximal body is rectangular in cross-sectional geometry and tapers proximal to distal. The distal stem is cylindrical with four flutes. Anterior, posterior and lateral fins are located on the proximal body to help provide rotational stability. The fins have suture holes to allow reattachment of soft tissue and bone fragments in the case of proximal humeral fracture. A suture hole is also placed medially through the proximal body just below the collar.
A collar is present on the anterior, posterior and medial faces of the proximal body to resist stem subsidence. A 135° neck stem angle is incorporated. The stem has a female Morse type taper to receive modular humeral heads.
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
Surgeon
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)
Not Found
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
Not Found
§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral 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 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
0
JUN 2 9 1999
Summary of Safety and Effectiveness
Encore Orthopedics®, Inc. Debbie De Los Santos 9800 Metric Blvd. Austin, TX 78758 (512) 834-6237
Common Name: Shoulder prosthesis
Classification Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis per 21 CFR 888.3660 and Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis per 21 CFR 888.369
Description: The humeral stem is manufactured from wrought/forged titanium alloy(Ti-6A1-4V) that conforms to ASTM F136. The entire stem has heavy grit blasting to a surface roughness that ranges from 4um to 6Um.
The proximal body is rectangular in cross-sectional geometry and tapers proximal to distal. The distal stem is cylindrical with four flutes. Anterior, posterior and lateral fins are located on the proximal body to help provide rotational stability. The fins have suture holes to allow reattachment of soft tissue and bone fragments in the case of proximal humeral fracture. A suture hole is also placed medially through the proximal body just below the collar.
A collar is present on the anterior, posterior and medial faces of the proximal body to resist stem subsidence. A 135° neck stem angle is incorporated. The stem has a female Morse type taper to receive modular humeral heads.
Intended Use: This humeral stem will be used as part of a total shoulder system intended for treatment of patients who are candidates for total shoulder arthroplasty because the natural humeral head and/or glenoid has been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis. rheumatoid arthritis, avascular necrosis or proximal humeral fracture, and revision arthroplasty where bone loss is minimal. The humeral stem may be used with or without bone cement. These devices are intended to aid the surgeon in relieving the patient of shoulder pain and restoring shoulder motion.
Comparable Features to Predicate Device(s):
This device has the same design and indications as the humeral stem included in the Total Shoulder System (Encore).
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three horizontal lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 1999
Ms. Debbie De Los Santos Encore Orthopedics Regulatory/Clinical Specialist 9800 Metric Blvd. Austin, Texas 78758
Re: K991603 Trade Name: Grit Blasted Humeral Stem Regulatory Class: III Product Code: KWT Dated: May 7, 1999 Received: May 10, 1999
Dear Ms. De Los Santos:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Ms. Debbie De Los Santos
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
Device Name: Grit Blasted Humeral Stem
Indications For Use:
Grit Blasted Humeral Stem Indications For Use
This humeral stem will be used as part of a total shoulder system intended for treatment of patients who are candidates for total shoulder arthroplasty because the natural head and/or glenoid has been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or proximal humeral fracture, and revision arthroplasty where bone loss is minimal. The humeral stem may be used with or without bone cement. These devices are intended to aid the surgeon in relieving the patient of shoulder pain and restoring shoulder motion.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use __ OROver-The-Counter Use _______________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) (Optional Format 1-2-96)_
(Division Sign-Off)
Division General Restorative Devices K991623
510(k) Number